Search Results

The Guardenia contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.

The Advanced Surgical Concepts Ltd, Guardenia, is a contained extraction system; proposed under classification regulation 21 CFR 876.1500, device class II and product code GCJ.

The device is provided sterile for single use.

Guardenia consists of a flexible specimen containment/extraction Bag, with an integrated Opening Ring and Bag Tether with a separate Guard component to protect the Bag and incision during morcellation with a scalpel.

The Bag is made from polyurethane (PU) film and comes preloaded in an Introducer. There is a Plunger to deploy the Bag into the abdominal cavity. Any standard sized 12mm trocar cleared to market by the FDA may be used as an accessory for device deployment. A blue arrow on the Introducer provides the user with an indicator of the correct orientation during deployment in the abdominal cavity to ensure the Bag is correctly deployed.

After the Bag is ejected from the Introducer into the abdominal cavity, the nitinol wire Opening Ring recovers its shape, opening the mouth of the Bag. This facilitates the encapsulation of the specimen. When the specimen is encapsulated, the Bag Tether, which extends externally through the trocar after deployment, is pulled, pulling the Opening Ring out through the trocar. This action also closes the mouth of the Bag inside the abdomen.

The incision is then increased to the required size (2.5-6 cm) prior to removal of the trocar is removed, the mouth of the Bag is exteriorized, and then opened outside the abdomen. If the specimen is small enough, the Bag and specimen can be removed at this stage without the need for morcellation or the use of the Guard.

If the specimen requires reduction, the Guard must be deployed first.

To deploy the Guard, the free end of the end opposite to the blue Guard Ring) is inserted through the mouth of the Bag. The yellow Anchor Ring is then inserted through the center of the Guard is actuated by flipping the Rolling Ring inward, until the incision is maximized. The Guard Petals, which are made from a tough polyethylene (PE) film, overlap, and conform to the incision, protecting the incision & Bag from damage due to inadvertent scalpel strikes or the traumatic graspers that are used to grasp and hold the tissue specimen at the incision.

The physician then performs extracorporeal manual morcellation using a grasper and a scalpel. When the tissue specimen has been removed or sufficiently reduced, the surgeon flips the opposite direction two or three times and pulls on the Removal Ribbon to remove the Guard. The Bag is removed by grasping the Opening Ring and carefully removing the Bag from the incision.

This document is a 510(k) premarket notification from the FDA, specifically concerning a labeling change for the "Guardenia (GAR-1)" contained extraction system. The content explicitly states that the submission is for a label change only and that no non-clinical tests were required to support the change. This means there is no study described within this document that proves the device meets acceptance criteria through performance evaluation.

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance based on the provided text. The document does not describe any specific testing, acceptance criteria, sample sizes, expert involvement, or ground truth establishment relevant to device performance outside of the label change.

However, I can extract the relevant information regarding the nature of this submission:

• Device Name: Guardenia (GAR-1)
• Device Type: Contained extraction system (Tissue Bag)
• Regulation Number: 21 CFR 876.1500 (Endoscope And Accessories)
• Regulatory Class: Class II
• Product Code: GCJ
• Indications for Use: To contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation.
• Contraindications:
  • Contraindicated for use with laparoscopic power morcellators.
  • Contraindicated for use with powered cutting devices (e.g., power morcellators, electrosurgical and laser instruments), and when, in the judgment of the physician, use of such a device would be contrary to the best interest of the patient.
• Nature of Submission: Special 510(k) for a label change only.
• Specific Label Change: Removal of the contraindication "Do not use on tissue that is known or suspected to contain malignancy" and addition of a precaution: "Use caution when using the Guardenia contained extraction system for removal/manual morcellation of uterine tissue may contain unsuspected cancer."

Conclusion:

The provided text does not contain any information about performance studies, acceptance criteria, or data proving the device meets performance criteria, as it is a submission solely for a labeling change. The document explicitly states: "This Special 510(k) is for a label change only. There is no non-clinical tests required to support the change."

Ask a specific question about this device

The RedEx contained extraction system is indicated to contain and isolate tissue during, or prior to, surgical removal and /or extracorporeal manual morcellation.

The Advanced Surgical Concepts Ltd, RedEx, is a contained extraction system; proposed under classification regulation 21 CFR 876.1500, device class II and product code GCJ.

The device is provided sterile for single use.

The RedEx consists of a flexible specimen containment Baq, with an integrated Opening Ring and Bag Tether and a separate Guard component to protect the Bag and incision.

The Bag is made from polyurethane (PU) film and comes preloaded in an Introducer. There is a Plunger to deploy the Bag into the abdominal cavity. Any FDA cleared 12mm trocar may be used as an accessory for device deployment. This is a standard sized trocar for use in laparoscopic surgery. A blue arrow on the Introducer provides the user with the correct orientation for insertion of the Introducer to ensure the Bag is correctly deployed.

After the Baq is ejected from the Introducer into the abdominal cavity, the mouth of the Bag returns to its original circular shape. The nitinol wire Opening Ring facilitates placement of the specimen in the Bag. When the specimen is encapsulated and ready for removal or extracorporeal manual morcellation the Bag Tether is pulled, closing the Bag. The Bag Tether and Opening Ring exit through the 12mm trocar, indicating the Bag is fully closed. The incision is then increased to the required size, 2.5-6cm, prior to removal of the trocar is removed, and the mouth of the Bag is opened outside the abdomen. The free end of the Guard. which includes the Guard Petals and is opposite the end with the Guard Ring, is then inserted through the mouth of the Bag followed by the Anchor Ring. The Guard is actuated by flipping the Rolling Ring inward until the incision is maximized. The Guard Petals, which are made from a tough polyethylene (PE) film, overlap and conform to the incision; protecting the incision and Bag material from inadvertent scalpel strikes and from the traumatic graspers that are used to grasp and hold the tissue specimen at the incision.

The physician then performs extracorporeal manual morcellation using manual surgical instruments (e.g., a grasper and a scalpel). When the tissue specimen has been removed, the surgeon flips the Rolling Ring in the opposite direction two or three times and pulls on the Removal Ribbon to remove the Guard. The Bag is removed by grasping the Opening Ring and carefully removing the Bag from the incision.

The provided text describes the RedEx device, a contained extraction system for tissue removal during surgery, and its comparison to a predicate device to establish substantial equivalence for FDA clearance. However, it does not contain a study that establishes clear acceptance criteria or reports device performance against such criteria in the quantifiable way requested. Instead, it details various performance tests conducted to demonstrate substantial equivalence to a predicate device.

Therefore, I cannot populate the table or answer all sub-questions as requested because the specific acceptance criteria and detailed device performance outcomes are not explicitly stated in the provided text in a quantifiable manner (e.g., sensitivity, specificity, accuracy, or specific thresholds for durability, puncture resistance etc.). The document focuses on demonstrating that the RedEx device performs "as intended" and "as expected" and is "as safe and effective" as the predicate device through various testing, rather than presenting a study with pre-defined, quantifiable acceptance criteria and the RedEx's performance against them.

Here's what can be extracted and what is missing based on the provided text:

1. A table of acceptance criteria and the reported device performance:

This information is not explicitly provided in the document in a quantifiable format. The document states that "In all instances, the RedEx functioned as intended and the results observed were as expected" for the various tests. It also mentions testing areas like "Bag material and seal strength," "Bag material puncture-resistance," "Guard puncture-resistance," "Guard coverage and security," and "Simulated use," but does not provide specific numerical acceptance criteria (e.g., minimum tensile strength, maximum puncture force, minimum coverage percentage) or the corresponding measured performance values for the RedEx device for these tests. The comparison is framed in terms of "Substantial Equivalence," implying that its performance was comparable to the predicate for these aspects.

2. Sample size used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated. The document mentions "Side-by-side testing" and "Additional testing" but does not provide the number of units or cases used in these tests.
• Data Provenance: The document implies the tests were conducted by the manufacturer, Advanced Surgical Concepts Ltd, potentially with independent laboratory assistance for biocompatibility (Toxikon). The data is associated with the device's premarket notification (K211234). There is no mention of country of origin for data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts and qualifications: Not mentioned. The testing described is primarily bench-top and simulated use. There is no mention of human experts establishing ground truth for the performance of the device in a clinical context within this document.

4. Adjudication method for the test set:

• Adjudication method: Not mentioned. Given the nature of the bench and simulated use testing, a formal adjudication method by experts is unlikely to have been part of the evaluation for these specific performance tests.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

• MRMC study: Not applicable/Not mentioned. The device is a contained extraction system (medical device), not an AI-based diagnostic tool for interpretation by human readers. Therefore, an MRMC study or AI-related improvement metrics are not relevant or discussed in this document.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Standalone algorithm performance: Not applicable/Not mentioned. This is not an AI-driven device.

7. The type of ground truth used:

• Type of ground truth: For the performance tests listed (e.g., material strength, puncture resistance, simulated use), the "ground truth" would be established by physical measurements, engineering standards, and functional assessments against design specifications or a predicate device's performance. There is no biological or diagnostic "ground truth" (like pathology or clinical outcomes) being assessed in the context of these specific performance tests described.

8. The sample size for the training set:

• Training set sample size: Not applicable/Not mentioned. This is a physical medical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established:

• How ground truth was established for training set: Not applicable/Not mentioned for the same reason as above.

Ask a specific question about this device

The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, considered benign, resected during single-port or multi- site laparoscopic surgery during power morcellation and removal. When used in women with fibroids, the PneumoLiner is for women who are pre-menopausal and under age 50. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

The ASC PneumoLiner is an inflated morcellation containment system that allows for containment of gynecological tissue, cells and fluids during power morcellation and removal. It is a sterile single use device and requires the surgeon to successfully complete a validated training program before use. The ASC PneumoLiner is for clinical use in a hospital or surgical center operating room. The device consists of the following components: the Retractor Introducer, Boot Assembly, the PneumoLiner Introducer and the PneumoLiner. The first three components (Retractor, Retractor Introducer and Boot Assembly) are used to retract an incision in the abdominal wall and to allow for the introduction of laparoscopic instruments and the PneumoLiner Bag while under pneumoperitoneum and with vision from a laparoscope. The PneumoLiner Bag is introduced via the PneumoLiner introducer and the large valve on the Boot Assembly. The PneumoLiner is intended for use in gynecological power morcellation. It is intended to form a complete containment barrier from the spillage of liquids, cells and tissue from the time the tissue or organ is excised and encapsulated in the PneumoLiner bag, throughout the morcellation procedure and withdrawal of the containment bag with accompanying liquids and debris.

Based on the provided text, the device in question (PneumoLiner) is a medical device for contained morcellation, not an AI/ML powered device. Therefore, the information requested about acceptance criteria and studies proving the device meets them, especially those pertaining to AI/ML device performance (like MRMC studies, standalone algorithm performance, number of experts for ground truth, training set size and ground truth establishment), is largely not applicable to this document.

The document describes a 510(k) submission for a revision to the labeling (indications for use and contraindications) of an existing device, and some non-clinical performance testing related to packaging and shelf-life. There are no mentions of AI/ML or a "study that proves the device meets the acceptance criteria" in terms of an AI/ML algorithm's clinical performance.

However, I can extract the relevant information regarding the changes made and the supporting information for those specific changes, which are primarily based on clinical literature reviews rather than a new clinical study of the device itself.

Since the request is about acceptance criteria and a study proving the device meets them, and this document describes a labeling change for a physical medical device, I will reframe the answer based on the information available:

Acceptance Criteria and Study for PneumoLiner (K192898 Labeling Revision)

The provided document (K192898 510(k) clearance letter) describes a submission primarily for a revision to the Indications for Use and contraindications of an existing medical device, the PneumoLiner. It also includes updated non-clinical performance data for shelf-life and packaging. It does not describe a clinical study of the device's efficacy or safety as an AI/ML system.

Therefore, many of the requested points related to AI/ML device performance are not applicable. I will address the relevant points based on the information provided in the document.

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k), the "acceptance criteria" appear to be related to the justification of the labeling changes and the non-clinical performance of packaging and shelf-life. The "performance" is demonstrated through literature review for the labeling changes and specific testing for packaging/shelf-life.

• JMIG Special Article, "Morcellation during Uterine Tissue Extraction: An Update by the Tissue Extraction Task Force Members" (2018).
• FDA Updated Assessment of the Use of Laparoscopic Power Morcellators to Treat Uterine Fibroids (December 2017).
• Seidhoff et al. (2017) meta-analysis.
  These sources stratify the risk of occult leiomyosarcoma (LMS) by age. |
  | Non-Clinical Performance (Shelf-Life & Packaging) | Sterilization validity. | Sterilization validated to ISO 11137-1:2006 and ISO 11137-2:2013. |
  | | Shelf-life validity (updated from 1 year to 3 years). | Tested on samples accelerated aged which underwent simulated shipping, including:
• Sterile Barrier Integrity testing
• Visual inspection per ASTM F1996:2009 (2013)
• Bubble leak testing per ASTM F2096:2011
• Seal strength per ASTM F88:2009.
• Device functionality (leak testing, bond/material strength testing). |

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable for a clinical performance test of an AI/ML algorithm. The "test set" for the labeling changes was the existing body of clinical literature. The provenance is explicitly cited as published academic journals and FDA assessments.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This is not applicable as an AI/ML algorithm was not being evaluated. The "ground truth" for the labeling changes was derived from peer-reviewed clinical literature and FDA assessments, which represent the consensus or findings of multiple medical experts and researchers in the field. The specific number of individual experts directly involved in "establishing ground truth" for this submission is not quantified in the document, as it relied on previously established and published data.

4. Adjudication Method for the Test Set

This is not applicable as an AI/ML algorithm was not being evaluated. The "adjudication" for the literature review was implicitly handled through the peer-review process of the cited publications and the FDA's own assessment methodologies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human performance, which is not the subject of this 510(k) submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This submission is not for an AI-powered device.

7. The Type of Ground Truth Used

For the labeling changes, the "ground truth" was derived from published clinical literature, meta-analyses, and FDA assessments regarding the risk stratification of occult leiomyosarcoma (LMS) by age in women with presumed fibroids. This effectively represents:

• Expert Consensus (via peer-reviewed publications): The conclusions drawn in the cited articles reflect the collaborative findings and consensus (or significant findings) of experts in gynecology and oncology.
• Outcomes Data (clinical studies summarized in literature): The literature reviewed is based on real-world clinical outcomes and patient data that informed the risk stratification.

8. The Sample Size for the Training Set

This is not applicable as there was no AI/ML algorithm to train.

9. How the Ground Truth for the Training Set Was Established

This is not applicable as there was no AI/ML algorithm to train.

In summary, the provided document describes a regulatory submission for a physical medical device (PneumoLiner) that involves labeling revisions and non-clinical performance testing for shelf-life and packaging. It is crucial to note that this is not an AI/ML-powered device and therefore, most of the questions related to AI/ML study methodologies are not relevant to this specific 510(k) clearance letter. The justification for labeling changes was based on existing clinical literature and expert-driven assessments.

Ask a specific question about this device

The ContainOR is a bag containment system intended for use by qualified surgeons for tissue extraction and/or power morcellation during general laparoscopic procedures. The ContainOR is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15mm and 18mm in shaft outer diameter and 135mm and 180mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

The ContainOR device consists of two main components:

• A laparoscopic multi-instrument port .
• Tissue pouch (Bag) intended to provide a contained space in the abdomen for the safe morcellation of tissue.

Here's a breakdown of the acceptance criteria and the studies conducted for the ContainOR device, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the "Special Controls" section and the results reported in the "Design Verification" table and "Immersion Testing" section. Due to the nature of the device (a containment system), many acceptance criteria are "Pass" for integrity or functionality. Quantitative criteria are present for immersion testing, shelf life, and some simulated use cases.

2. Sample Sizes Used for the Test Set and Data Provenance

Due to the nature of the device and the studies, "test sets" often refer to multiple samples of the physical device or simulated procedures.

• Filter Testing (Impermeability to bacteria):
  • Initial: 25 samples of pouch material.
  • After accelerated aging: 32 test samples (and 1 control).
• Immersion Testing (Pouch Integrity Post-Morcellation):
  • Initial: 25 samples.
  • First Morcellation Test Group: 22 test samples (35 initially, 6 excluded for initial leak, 4 excluded for aberrant bacteria).
  • Second Morcellation Test Group (Revised Protocol): 10 test samples (24 initially, 3 excluded for initial leak, 6 excluded for contamination, 2 excluded for leak post-incubation).
  • Total for analysis: 32 test samples.
• Shelf Life Testing:
  • Visual Inspection & Bubble Leak: 15 samples.
  • Seal Strength: 60 samples.
  • Device Functionality (simulated use): 35 samples.
• Preliminary Bench Testing:
  • Laparoscope puncture: 30 test samples.
  • Tenaculum damage: 5 different tenacula, each with 30 material samples (150 total).
  • Powered Morcellation (contact with liner): 5 morcellators, used once each.
  • Pressure/Burst Testing: 30 ContainOR system samples.
  • Obstruction Testing: 30 samples.
• Design Verification (Table 1): Each of the 9 separate tests included 30 or more device samples.
• Clinical Simulation of Morcellation (Animal tissue in SSTR): 34 ContainOR pouches, 5 ContainOR system valve assembly and retractors.
• Additional Testing to Support Use with Stones:
  • Stone validation: Not specified, but involved urologists.
  • ContainOR performance with stones: Not specified, but involved porcine kidneys in a simulator.
  • Surgeon training with stones: 5 general surgeons.
• Animal Model (Training Validation): 34 participants, total of 102 ContainOR systems used.
• Animal Model (Design Validation): 31 participants, 31 ContainOR systems used.

Data Provenance: All data appears to be from in-house studies conducted by the manufacturer, within a controlled laboratory or simulated environment, and an animal model. The country of origin for the device contact is Ireland, implying studies were likely conducted either there or at a contract research organization. The studies are prospective in nature, as they are designed to test the device's performance against pre-defined criteria.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Experts for Stone Simulant Validation: Two urologists. Their specific qualifications (e.g., years of experience) are not detailed beyond "urologists." They confirmed that simulant stones accurately mimicked actual kidney stones.
• Experts for Animal Model Training and Design Validation:
  • Training Validation: 34 participants with a range of experience in laparoscopic procedures. "Experienced" was defined as having previously performed at least 5 power morcellation procedures. "Inexperienced" was the remainder.
  • Design Validation: 31 participants (from the training validation study, minus 3 inexperienced subjects), same qualification breakdown.
  • Additional Training with Stones: 5 general surgeons. Their specific experience level is not detailed, but they successfully completed validated training for the PneumoLiner and proposed ContainOR IFU.

For most bench and simulated use tests (like impermeability, leakage, strength, setup times), the "ground truth" is established by direct measurement or observation of the physical properties and performance of the device against engineering specifications, rather than expert consensus on an interpretation of data.

4. Adjudication Method for the Test Set

Adjudication methods like 2+1 or 3+1 are typically used for clinical endpoints, especially when interpreting subjective data (e.g., image reads). For the ContainOR device, which is evaluated primarily through objective performance metrics (leakage, strength, setup times, successful operation), such formal adjudication methods are not explicitly mentioned or typically necessary.

• Leakage Tests (Immersion, Animal Model): The presence or absence of a leak was determined by inspection (e.g., visual check for water/bacterial growth). This is a binary, objective outcome.
• Design Verification Tests: "Pass" results are based on meeting pre-defined quantitative or qualitative engineering criteria.
• User Performance (Animal Model): Success was judged by the participant's ability to "successfully set up and use the ContainOR system" and the subsequent "no leaks" observation, confirmed by a test coordinator.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done for this device. This type of study is more common for diagnostic imaging AI algorithms where the question is how AI assistance changes human reader performance in making diagnoses. The ContainOR is a surgical containment device, and its evaluation focuses on its physical and functional integrity, and the ability of surgeons to effectively use it, rather than interpret data.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The ContainOR is a physical medical device, not an AI algorithm. Its performance is always evaluated "standalone" in the sense that its intrinsic properties are being tested (e.g., material strength, impermeability), or its use standalone by a human surgeon (without other AI assisting the surgeon during the procedure being evaluated).

7. Type of Ground Truth Used

The ground truth for most of the studies is based on:

• Direct Physical Measurement/Observation: For strength, leakage, impermeability to bacteria, setup times, flow rates, and visual inspection criteria.
• Engineering Specifications/Acceptance Criteria: For quantitative and qualitative "Pass/Fail" determinations in design verification.
• Expert Consensus (Limited): Two urologists provided consensus on the accuracy of stone simulants.
• Performance Outcome: Successful completion of a surgical procedure in a simulated or animal model, determined by the absence of leaks in the device and the ability of users to follow instructions.

8. Sample Size for the Training Set

The concept of a "training set" as understood in AI (data used to train a machine learning model) does not apply to this physical device.

However, if "training set" refers to the data or procedures used to train human users of the device:

• Training Validation Study: 34 participants were explicitly "trained" in the use of the ContainOR system through a structured program. This involved both assisted and unassisted use in a training rig and a porcine model.

9. How the Ground Truth for the Training Set Was Established

Again, this question directly applies to AI/ML context. For the training of human users:

• The "ground truth" for the training program was established by the manufacturer through their validated instructional methods and procedures for the ContainOR system, referencing the Instructions for Use (IFU).
• The effectiveness of this human training was then "validated" by observing whether participants (both experienced and inexperienced) could successfully set up and use the device without compromising its integrity (i.e., without leaks), as determined by objective leak tests conducted by a test coordinator. User feedback also contributed to refining the IFU and training.

Ask a specific question about this device

The PneumoLiner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue considered benign, resected during single-port or multi-site laparoscopic surgery during power morcellation and removal. The PneumoLiner is compatible with bipolar or electromechanical laparoscopic power morcellators that are between 15 mm and 18 mm in shaft outer diameter and 135 mm and 180 mm in shaft working length and which have an external component that allows for the proper orientation of the laparoscope to perform a contained morcellation.

The PneumoLiner System consists of two main components:

• A laparoscopic multi-instrument port
• Tissue pouch (PneumoLiner) intended to provide a separately contained space within the abdomen for the safe morcellation of tissue

As depicted in Figure 1 below, the laparoscopic multi-instrument port consists of the Retractor, Retractor Introducer and the Boot Assembly.

The provided text describes the acceptance criteria and performance of the PNEUMOLINER system, but it does not include a study that directly compares human readers with and without AI assistance (a multi-reader multi-case comparative effectiveness study). The device itself is a medical containment system, not an AI-powered diagnostic or assistive tool. Therefore, some of the requested information regarding AI-specific studies will not be present.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document details extensive performance testing. Here, we compile a table based on the "Design Verification" section, which includes quantitative acceptance criteria, and other key performance tests.

Note: (b) (4) indicates redacted information, typically quantitative values or specific methods.

2. Sample Size Used for the Test Set and Data Provenance

• Barrier Testing (Filter Test):
  • Accelerated Aged: 32 test samples (plus 1 control).
  • Provenance: Bench testing, in-vitro.
• Barrier Testing (Immersion Test):
  • Initial Group: 22 test samples (from an initial 35, with 6 excluded for initial leaks and 4 for aberrant bacteria).
  • Additional Group: 10 test samples (from an initial 24, with 3 excluded for initial leaks and 6 for contamination).
  • Total for Analysis: 32 samples (plus controls).
  • Provenance: Bench testing, using TSB (Tryptone Soya Broth) and B. diminuta.
• Bench Testing (Preliminary):
  • Laparoscope Puncture: 30 test samples.
  • Tenaculum Damage: 30 material samples per each of 5 different tenacula.
  • Pressure/Burst Testing: 30 PneumoLiner System samples.
  • Obstruction Testing: 30 samples.
  • Provenance: Bench testing, in-vitro.
• Design Verification (Table 1): Over 30 device samples per test. (Specific counts not always provided but stated as "30 or more").
  • Provenance: Bench testing, in-vitro.
• Clinical Simulation of Morcellation: 34 PneumoLiner pouches and 5 PneumoLiner System boot assembly and retractors.
  • Provenance: Simulated use in a surgical simulation test rig (SSTR) using animal tissue (lamb heart, beef tongue).
• Training Validation: 34 participants, each using at least 3 PneumoLiner Systems. A total of 102 PneumoLiner Systems were used.
  • Provenance: Porcine model (animal study, in-vivo simulation).
• Design Validation: 31 participants, each using one PneumoLiner System.
  • Provenance: Porcine model (animal study, in-vivo simulation).

No Human Data: All listed studies are non-clinical (bench or animal models). Therefore, there is no country of origin for human data, as no human data was used directly to support device performance. The studies are prospective in design.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This device is not an AI diagnostic device. Therefore, the concept of "experts establishing ground truth" in the traditional sense of medical image interpretation (e.g., radiologists reviewing images) does not directly apply here.

However, for the Training Validation and Design Validation studies, participants included "surgeons with advanced training in laparoscopic techniques," with varying levels of experience (categorized as "Experienced" and "Inexperienced"). These are the "users" of the device, whose ability to correctly use the device and avoid damage established a form of "ground truth" for usability and safety in a simulated clinical scenario.

• Training Validation: 34 participants (experts/users).
• Design Validation: 31 participants (experts/users).

Their qualifications are described as participants with a "range of experience in laparoscopic procedures," with the device being intended for "surgeons with advanced training in laparoscopic techniques."

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used for establishing consensus on ground truth in studies involving expert review of data (e.g., radiology reads). As this is a study about the physical performance and usability of a medical device, such an adjudication method is not applicable.

Instead, the "ground truth" for the performance tests was based on:

• Pre-defined objective criteria (e.g., absence of bacterial growth, lack of leaks, force thresholds, time limits, visual inspection for defects).
• For the simulated use studies (Training and Design Validation), the "ground truth" on successful device use and absence of leaks was assessed by a "test coordinator" or the test team against clearly defined pass/fail criteria (e.g., visual inspection for leaks after a water test).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.

MRMC studies typically compare multiple human readers' diagnostic performance on multiple cases, often to evaluate the impact of an AI algorithm on reader accuracy or efficiency. The PNEUMOLINER is a physical medical device, not an AI diagnostic tool, so this type of study is not relevant to its assessment.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study in the context of an AI algorithm was not done.

This terminology applies to AI algorithms. The PNEUMOLINER is a physical device that requires human operation. Its "standalone" performance is measured through bench testing and simulated use, where the device itself is tested against physical parameters (e.g., impermeability, strength, ability to contain tissue). These tests were conducted without human interaction beyond operating the test equipment or, in simulations, the device itself.

7. The Type of Ground Truth Used

The ground truth used for the various performance tests includes:

• Objective Physical Measurements: Force thresholds, pressure levels, time metrics, visual inspection for damage, dimensional accuracy.
• Biological Impermeability: Absence of bacterial growth (B. diminuta) after challenge.
• Integrity Assessment: Absence of leaks after water filling and visual inspection.
• Usability/Safety: Successful setup and operation of the device by trained users, and absence of device compromise (damage/leakage) in simulated clinical scenarios (porcine models). This is based on observation by test coordinators against predefined success/failure criteria.

8. The Sample Size for the Training Set

The concept of a "training set" typically refers to data used to train machine learning models. As the PNEUMOLINER is a physical medical device and not an AI algorithm, there is no "training set" in this sense.

However, if we interpret "training set" as the data used to inform the design and development of the device (before formal verification/validation), or the data used for the training program for users, then:

• Device Development Data: The document mentions "preliminary tests intended to generate acceptance criteria for their design verification tests as well as to validate the surgical simulator and training rig." These tests (e.g., Laparoscope puncture (30 samples), Tenaculum damage (150 samples), Powered Morcellation (5 samples), Pressure/Burst (30 samples), Obstruction Testing (30 samples)) could be considered analogous to data used in the formative stages.
• User Training Program Data: The "Training Validation" study itself involved 34 participants using a total of 102 PneumoLiner Systems in a porcine model. This study validated the effectiveness of the user training program, which is crucial for the device's safe and effective use.

9. How the Ground Truth for the Training Set Was Established

Again, applying the AI model analogy, there is no "ground truth" for an AI training set here.

If referring to the "Training Validation" study for users:

• The ground truth was established by objective observation of user performance by a study coordinator against predefined criteria for successful setup, use, and removal of the device, as well as post-procedure leak testing of the PneumoLiner pouch. The Instructions for Use (IFU) served as the standard against which user performance was evaluated. The outcome was binary: successful execution of steps and no leaks.

Ask a specific question about this device

The QuadPort+ is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC QuadPort+ Laparoscopic Access Devices are, like the parent TriPort+ device cleared by the FDA under K110004, laparoscopic multi-instrument ports which perform the following two functions.

• Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery.
• Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the device.
  The QuadPort+ laparoscopic multi-instrument port is sterile and disposable. The QuadPort+ laparoscopic multi-instrument ports perform the same function as the TriPort+ parent device.
  Like the parent ASC TriPort+ Laparoscopic Access Device, the QuadPort+ laparoscopic multiinstrument port is comprised of the following three components:
• An introducer component, which delivers the Distal Ring of the device through a pre-made . incision, into the abdominal cavity.
• A retroctor component, which retracts an abdominal incision to allow the passage of ● laparoscopic instruments.
• A valve component which maintains the pneumoperitoneum established for the surgical ● procedure.
  The QuadPort+ laparoscopic multi-instrument port is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The QuadPort+ laparoscopic multi-instrument port functions in the same way as the ASC parent TriPort+ device cleared by the FDA under K110004.

The provided document describes the acceptance criteria and study for the ASC QuadPort+ Laparoscopic Access Device.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a number of subjects. The study involved a "porcine model," implying animal subjects.
• Data Provenance: The study was conducted on a "porcine model," which suggests an experimental, prospective study in a controlled animal setting. The country of origin is not specified but is likely the location of Advanced Surgical Concepts (Ireland) or a contracted research facility.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not explicitly stated as a specific number. The document mentions "clinicians who were experienced with single port devices."
• Qualifications of Experts: They were "experienced with single port devices." Specific qualifications like "radiologist with 10 years of experience" are not provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The criteria are reported as direct observations (e.g., "The device was easy to insert"), implying a consensus or direct observation by the participating clinicians rather than a secondary adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This device is a laparoscopic access device, not an AI-powered diagnostic tool. The performance study evaluated its functional aspects in a surgical setting.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• No, a standalone (algorithm only) performance study was not done. This device is a physical surgical instrument, not an algorithm. The performance was evaluated with clinicians using the device.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

• Type of Ground Truth: The ground truth was established through expert observation and assessment during a simulated surgical procedure in a porcine model. The clinicians directly observed and evaluated the device's functional performance against predefined criteria.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable/not provided. This device is a physical medical instrument, not a machine learning algorithm that requires a training set. The "design inputs" and "design verification testing" serve a similar purpose to initial development and validation, but not in the context of a "training set" for AI.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth for Training Set Was Established: Not applicable/not provided for the reasons stated above. The "ground truth" for the device's design and manufacturing (analogous to training for an algorithm) would be established through engineering specifications, material testing, and internal design verification processes against known quality and safety standards, but not in the sense of labeled data for AI.

Ask a specific question about this device

The ASC TriPort 15 Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort 15 Laparoscopic Access Device is a faparoscopic multi-instrument port which performs the following two functions:

• Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass . through to the abdomen at the same time during laparoscopic surgery.
• Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical . procedure, whether or not one or more laparoscopic instruments are passing through the device.

The ASC TriPort 15 Laparoscopic Access Device is comprised of the following three components:

• An introducer component, which delivers the Distal Ring through a pre-made incision, . into the abdominal cavity.
• A refractor component, which retracts an abdominal incision to allow the passage of . laparoscopic instruments.
• A valve component which maintains the pneumoperitoneum established for the surgical . procedure.

The minor design changes to the cleared TriPort+ (K110004) device to create the TriPort 15 are as follows:

• 1. Changing the valve configuration from a four valve (3 x 5mm & 1 x 10mm) to a three valve (2 x 5mm & 1 x 15mm) configuration.
• 2. The introduction of a new colorant for the 15mm Valve Cap. Note that this portion of the device does not contact the patient.

The changes made to the parent TriPort+ Laparoscopic Access Devices to produce the TriPort 15 are minor and do not represent changes to its intended use, or the operating principles or mechanism of action of the device.

The ASC TriPort 15 Laparoscopic Access Device is sterile and disposable.

The provided text is a 510(k) summary for the ASC TriPort 15 Laparoscopic Access Device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and expert reviews in terms of clinical performance metrics like sensitivity, specificity, or reader improvement.

Therefore, the requested information, which is typical for a study validating the diagnostic accuracy or clinical effectiveness of a device, is not present in the provided text.

Specifically, the document states:
"Sterilization and shelf life testing, biocompatibility testing, design validation testing, and animal testing of the TriPort 15 was conducted to verify that the changes to the technological characteristics do not affect safety or effectiveness. In all instances, the TriPort 15 functioned as intended."
And:
"Performance data demonstrate that the TriPort 15 is as safe and effective as the predicate device."

This indicates that the "acceptance criteria" were related to verifying safety and effectiveness through non-clinical performance testing (sterilization, shelf life, biocompatibility, design validation, animal testing) to ensure the minor changes from the predicate device did not introduce new safety concerns or alter its intended function.

Since this is a submission for a laparoscopic access device (a surgical tool, not a diagnostic or AI-driven device), the nature of the "acceptance criteria" is fundamentally different from a diagnostic device that would involve human reader performance, ground truth establishment by experts, and statistical metrics like sensitivity and specificity.

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the format requested (which implies clinical performance metrics), nor details about sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment relevant to an AI/diagnostic device.

The study described is an engineering validation and non-clinical performance study to demonstrate that the modified device (TriPort 15) is as safe and effective as its predicate (TriPort+), primarily through bench testing and animal studies, not through clinical trials involving human subjects or expert interpretations of images.

Ask a specific question about this device

The ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort+ Laparoscopic Access Device is, like the parent TriPort and QuadPort devices cleared by the FDA under K101794, a laparoscopic multi-instrument port which performs the following two functions.

• Retracting a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen at the same time during laparoscopic surgery.
• Ensuring that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the device.
  The ASC TriPort+ Laparoscopic Access Device is sterile and disposable. The proposed ASC TriPort+ Laparoscopic Access Device performs the same function as the TriPort and QuadPort parent devices.
  Like the parent ASC TriPort Laparoscopic Access Device, the proposed ASC TriPort+Laparoscopic Access Device is comprised of the following three components:
• An introducer component, which delivers the Distal Ring of the ASC TriPort+ through a premade incision, into the abdominal cavity.
• A retractor component, which retracts an abdominal incision to allow the passage of laparoscopic instruments.
• A valve component which maintains the pneumoperitoneum established for the surgical procedure.
  The ASC TriPort+ Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC TriPort+ Laparoscopic Access Device is identical in function to the ASC TriPort & QuadPort Laparoscopic Access Devices, which have been cleared for marketing under K101794.

The provided text describes a 510(k) submission for the ASC TriPort+ Laparoscopic Access Device. The submission focuses on demonstrating substantial equivalence to a predicate device (TriPort & QuadPort Laparoscopic Access Devices, K101794) rather than presenting a study to prove the device meets specific acceptance criteria in a quantitative sense as might be expected for an AI/CADe device.

Therefore, the information required for a detailed acceptance criteria table and a study analysis is largely not present in the provided document, as the submission emphasizes functional equivalence and design verification rather than performance metrics from a comparative clinical trial.

However, I can extract the relevant information where available and note where specific details are missing based on the prompt's requirements.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a number of cases or subjects in a traditional clinical study sense. The document refers to "Performance Testing" which included "Validation testing of the TriPort+ in a porcine model" and "on a simulator." The number of porcine models or simulation runs is not specified.
• Data Provenance: Porcine model (animal study) and simulator. The country of origin for this testing is not specified, but the submitter is based in Ireland. The testing is prospective in nature, as it was conducted specifically for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

• Number of Experts: "Clinicians with various levels of experience and expertise" were enrolled in the porcine model testing. The specific number is not provided.
• Qualifications of Experts: General description of "various levels of experience and expertise." No specific qualifications (e.g., "radiologist with 10 years of experience") are given. Their role appears to be operational and observational of the device's function rather than establishing ground truth in the sense of diagnostic interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not described. The testing involved direct observation of device function by clinicians. There's no mention of conflicting interpretations or a need for adjudication among multiple experts to establish a "ground truth" for diagnostic purposes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, an MRMC comparative effectiveness study was not performed as described in the document. This type of study is typical for assessing the impact of AI on human reader performance, which is not the focus of this device (a surgical access port).
• Effect Size: Not applicable, as no MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. The ASC TriPort+ is a physical medical device (laparoscopic access port), not an algorithm or AI software. Therefore, the concept of "standalone (algorithm only)" performance does not apply.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context is the successful and safe operation of the physical device as assessed by observed performance and clinician feedback during the porcine model and simulator testing. This is analogous to "expert observation/assessment" of device functionality, rather than a diagnostic ground truth like pathology or outcomes data.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI algorithms. The device design was iteratively improved, but these are design and engineering processes, not algorithmic training.

9. How the Ground Truth for the Training Set Was Established

• Training Set Ground Truth: Not applicable, as there is no training set. The "ground truth" for the device's design and modifications would be based on engineering principles, user feedback, predicate device performance, and internal design verification/validation testing.

Ask a specific question about this device

The ASC TriPort and QuadPort Laparoscopic Access Devices are intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The modified ASC TriPort Laparoscopic Access Device, like the parent TriPort cleared by the FDA under K073719, is still comprised of the following three components:

• an introducer component which creates an abdominal incision (except in the case where the surgeon creates a Hasson cut-down incision) and delivers the Distal Ring of the ASC TriPort into the abdominal cavity
• a retractor component which retracts an abdominal incision to allow the passage of laparoscopic instruments
• a valve component which maintains the pneumoperitoneum established for the surgical procedure

The modified ASC TriPort Laparoscopic Access Device is still intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The modified ASC TriPort Laparoscopic Access Device is identical in function to the parent device, which has been cleared for marketing under K073719.

The modifications made to the parent device labeling to produce the proposed TriPort Laparoscopic Access device informs users and patients that the device does not contain Natural Rubber Latex. Additionally the labelling has been revised to extend the shelf life from three months to three years as notified in the original 510(k) and to make the device safer and easier to use. The changes made to the parent TriPort Laparoscopic Access Device to produce the proposed TriPort are minor and do not represent modifications to the indications for use, operating principles, or mechanism of action for the device.

The TriPort has additionally been modified resulting in the QuadPort device. The modifications to the TriPort comprise the following:

• A fourth valve was added to accommodate an additional laparoscopic instrument.
• The Boot is larger in diameter to accommodate the fourth instrument valve.
• An Introducer and Retaining Clips are not required.
• The Removal Ring is made from a different material (the same material as is used for the TriPort distal ring).

The ASC TriPort and QuadPort Laparoscopic Access Devices are laparoscopic multiinstrument ports which perform the following two functions:

• They retract a small abdominal incision to allow multiple laparoscopic instruments to pass through a small incision to the abdomen at the same time during laparoscopic surgery.
• They ensure that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through them.

The ASC TriPort and QuadPort Laparoscopic Access Devices apply radial force upon the incision creating an aperture though which the laparoscopic instruments pass. The ability to remove the boot, allows the clinician to deliver specimens without removing the entire port, and with the QuadPort, generally without the need to extend the incision.

The physical design and performance of the modified TriPort is unchanged. Materials changes relate to substitution with materials already used for the TriPort. The physical properties of the QuadPort differ from the TriPort in that the diameter of the boot is increased, allowing space for the addition of a fourth port.

The document provided describes the ASC TriPort and QuadPort Laparoscopic Access Devices, which are intended for use as multiple instrument and/or camera ports during minimally invasive abdominal laparoscopic surgery. This submission is a Special 510(k), indicating modifications to an already cleared device (the parent TriPort cleared under K073719).

Here's an analysis of the acceptance criteria and study information:

1. A table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative "acceptance criteria" in terms of performance metrics (e.g., success rates, leak rates, specific force thresholds) against which the device was evaluated. Instead, the "acceptance criteria" can be inferred from the regulatory context of a 510(k) submission, which relies on demonstrating substantial equivalence to predicate devices and ensuring that modifications do not raise new issues of safety or effectiveness.

The reported device performance is described qualitatively in relation to these overarching goals.

2. Sample size used for the test set and the data provenance:

• Test Set Description:
  • Modified TriPort: "Biocompatibility and performance verification testing." The document does not specify the sample size for this testing.
  • QuadPort: "Validation testing of the ASC QuadPort in a porcine model." The document does not specify the sample size (number of animals) used in this porcine model study.
• Data Provenance: The document does not explicitly state the country of origin for the testing data. The manufacturer is based in Ireland. The testing was "non-clinical performance testing," indicating it was conducted in a laboratory or animal setting, not on human patients. The study was likely prospective in design, as it describes a planned validation test of a new device modification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• For the QuadPort porcine model study, it "enrolled clinicians with various levels of experience."
• The document does not specify the exact number of clinicians/experts used.
• It does not specify the exact qualifications beyond "various levels of experience" (e.g., number of years, surgical specialty).
• For the TriPort biocompatibility and performance verification testing, no explicit mention of human experts evaluating the "ground truth" is made, as this typically involves standardized technical testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• The document states that the QuadPort study "enrolled clinicians with various levels of experience" who demonstrated that it "functioned as intended."
• It does not describe an adjudication method (like 2+1 or 3+1 consensus) for establishing a "ground truth" based on expert opinion. The assessment appears to be a direct observation of the device's function by the clinicians during the porcine model procedure, rather than an interpretation of complex data requiring consensus.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was done.
• This device is a physical surgical access port, not an AI-assisted diagnostic or interpretative tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This question is not applicable. The device is a physical surgical tool and does not involve an algorithm. Performance assessment inherently involves human interaction (clinicians using the device).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• For the TriPort modifications, the "ground truth" for demonstrating safety and effectiveness relies on standard performance verification testing (e.g., mechanical strength, seal integrity, material biocompatibility) and comparison to the known performance of the predicate device.
• For the QuadPort porcine model study, the "ground truth" was based on the direct observation and assessment by clinicians during a simulated surgical procedure that the device "functioned as intended" and "did not raise new issues of safety and effectiveness."

8. The sample size for the training set:

• This concept is not directly applicable to a physical medical device submission for regulatory clearance. There is no "training set" in the context of machine learning or AI algorithms. The device design and manufacturing processes are refined through engineering and iterative testing, not by training an algorithm on a dataset.

9. How the ground truth for the training set was established:

• Not applicable, as no "training set" in the AI/ML context exists for this device.

Ask a specific question about this device

The ASC TriPort Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The ASC TriPort Laparoscopic Access Device is a laparoscopic multi-instrument port which performs the following two functions:

• t It retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen at the same time during laparoscopic surgery
• . It ensures that pneumoperitoneum is maintained in the abdomen during the surgical procedure, whether or not one or more laparoscopic instruments are passing through the TriPort
  The ASC TriPort Laparoscopic Access Device is sterile and disposable. The proposed ASC TriPort Laparoscopic Access Device performs the same function as other legally marketed port systems and standard trocars.
  Like the parent ASC R-Port II Laparoscopic Access Device, the proposed ASC TriPort Laparoscopic Access Device is comprised of the following three components:
• an introducer component which creates an abdominal incision (except in the . case where the surgeon creates a Hasson cut-down incision) and delivers the Distal Ring of the ASC TriPort into the abdominal cavity
• a retractor component which retracts an abdominal incision to allow the . passage of laparoscopic instruments
• . a valve component which maintains the pneumoperitoneum established for the surgical procedure
  The ASC TriPort Laparoscopic Access Device is intended for use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery. The ASC TriPort Laparoscopic Access Device is identical in function to the ASC R-Port II Laparoscopic Access Device, which has been cleared for marketing under K073170.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ASC TriPort Laparoscopic Access Device:

Acceptance Criteria and Reported Device Performance

The provided text does not list explicit, quantifiable acceptance criteria (e.g., "device must maintain pneumoperitoneum with less than X ml/min gas leakage"). Instead, it describes the device's functions and states that it performs them "as intended." The performance is largely framed by its similarity and improvements over predicate devices.

Study Details:

The document is a Special 510(k) Summary. For such submissions, the primary "study" is demonstrating substantial equivalence to a previously cleared predicate device. This is typically achieved through comparative analysis of technological characteristics and performance testing.

1. Sample Size used for the test set and the data provenance:

   • The document states, "Biocompatibility, verification and validation testing have been performed which demonstrate that the ASC TriPort Laparoscopic Access Device functions as intended and is safe and effective for its intended use." (page 5)
   • However, specific details on the sample size for these tests, the type of data (e.g., in-vitro, ex-vivo, animal, human), or the country of origin are not provided in the given text. The testing appears to be internal validation by the manufacturer, rather than external clinical trials.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This information is not provided in the text. Given the nature of mechanical/performance testing for a device modification, "ground truth" would likely be established through engineering specifications, validated test methods, and direct measurement, rather than expert consensus on a dataset.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not provided. The concept of adjudication methods is typically relevant for studies involving subjective human interpretation (e.g., image reading), which doesn't seem to be the primary focus here.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices, which this laparoscopic access device is not. The document focuses on the mechanical and functional equivalence/improvements of a surgical instrument.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This device is a manual surgical instrument, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for this device would be its ability to meet engineering specifications for mechanical properties, seal integrity (for pneumoperitoneum), material biocompatibility, and functional performance (e.g., allowing instrument passage, specimen removal). This would be based on direct physical measurement and testing against predefined criteria. No mention of expert consensus, pathology, or outcomes data for establishing ground truth is made, nor would it typically be expected for this type of device in a 510(k) summary.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

Summary of Study Approach for the 510(k) Special Submission:

Given that this is a "Special 510(k)," the core "study" is a demonstration that the modifications to the device (TriPort from R-Port II) "are minor and do not represent modifications to the indications for use, operating principles, or mechanism of action for the device." This is achieved by:

• Detailed comparison to predicate devices: Highlighting how the TriPort is similar to the R-Port II (K073170) and other predicates (K070158, K010007, K032676, K010711) in function and intended use.
• Description of modifications: Explaining the changes (outer diameter increase, removable valve section, separate instrument valves, material change) and arguing that these are improvements rather than fundamental changes.
• Performance Testing Statement: A general statement on "Biocompatibility, verification and validation testing" having been performed to confirm it "functions as intended and is safe and effective." This suggests in-house testing to validate the engineering design and functionality. Specific results or detailed methodologies are not included in this summary document, as is common for 510(k) summaries which focus on demonstrating substantial equivalence rather than presenting full clinical trial results.

Ask a specific question about this device