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The Uni-port is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

Uni-port is a single use manual operated surgical retractor comprised of three components; main body, wound retractor and filter. The main body consist of combinations of several ports of various size (5mm, 12mm, 15mm and 28mm). The wound retractor is a flexible polyurethane film that has two rings attached at each end and a Thandle connected with thread for easily removal after procedure. The single (lower) ring is inserted into the abdomen for fixation and double (upper) ring is connected with main body. The filter is provided separately to filter out harmful gas generated in the abdominal cavity, it is easy to ensure a clear view.

The provided text is a 510(k) summary for the Uni-port device, which is described as a medical device for laparoscopic surgery. It details the device's characteristics, intended use, and comparison to predicate devices to demonstrate substantial equivalence.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to AI or algorithm performance, nor does it discuss acceptance criteria in the context of an AI/ML device. The text exclusively describes a physical medical device (a surgical retractor) and its technical equivalence to existing devices through bench testing and material comparisons.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (for an AI/ML context)
• Sample sizes for test sets or data provenance (related to AI/ML)
• Number of experts or their qualifications for ground truth establishment (related to AI/ML)
• Adjudication method (related to AI/ML)
• MRMC comparative effectiveness study or human reader improvement with AI
• Standalone (algorithm-only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data - related to AI/ML)
• Sample size for the training set (related to AI/ML)
• How ground truth for the training set was established (related to AI/ML)

The acceptance criteria and studies mentioned in the document are for a traditional physical medical device, focusing on:

• Shelf-Life Test
• ISO 10993-5 - Cytotoxicity
• ISO 10993-10 - Sensitization & Intracutaneous Reactivity
• ISO 10993-11 - Acute systemic toxicity & Pyrogens
• Other bench testing: Surface, Measurement, Tensile strength, Airtightness, Fatigue resistance, Extractable substances, Comparative performance.

The conclusion is that "All the test results support substantial equivalence to the predicate devices" and "Bench test results allowed to conclude that Uni-port is substantially equivalent to the predicate devices for its intended use."

To summarize, while the document confirms the device meets acceptance criteria for a physical medical device, it does not provide the specific AI/ML-related details requested in your prompt.

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The CORE-SPORT is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

The CORE-SPORT, an surgical instrument that provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery, and consists of a Port-Assay and a Retractor.

Port-Assay consists of several ports of various sizes. Port-Assay consists of 3 or 4 ports and 5 and/or 12 mm sized ports.

The proposed product is packed in Tray & Tyvek following EO Sterilization (SAL 10°). The device is supplied sterile for single-use and shall be not reused or re-sterilized.

Based on the provided text, the device in question is CORE-SPORT, a surgical instrument for minimally invasive laparoscopic surgery. The document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. As such, the performance data presented is primarily bench testing and comparative testing against self-defined criteria, rather than clinical studies involving human patients or complex AI algorithms requiring ground truth establishment by experts.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify specific sample sizes for each test. It generally states that tests were "conducted" or "performed." For device performance, the data provenance is from bench testing and comparative testing within a laboratory setting. The company is INCORE CO., LTD. from Republic of Korea. The studies described are pre-market testing for regulatory submission, and therefore are inherently prospective in their design (intended to evaluate the device against pre-defined criteria).

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

This document describes a medical device (surgical port), not an AI-assisted diagnostic device. Therefore, the concept of "ground truth established by experts" (e.g., radiologists interpreting images) is not applicable in the context of these described performance tests. The "ground truth" for these tests is based on objective physical measurements, adherence to industry standards (e.g., ISO, USP, ASTM), and the predefined acceptance criteria for mechanical and material properties. There is no mention of human expert readers for "test sets" in the diagnostic sense.

4. Adjudication Method for the Test Set (e.g., 2+1, 3+1, none)

Since this is not an AI diagnostic study relying on human interpretation for "ground truth," there is no adjudication method described or necessary. The "adjudication" is essentially the device passing or failing against the established objective metrics and standards.

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 type of study is relevant for diagnostic AI devices where human performance with and without AI assistance is being evaluated. The CORE-SPORT is a physical surgical instrument, not an AI or diagnostic tool.

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

Again, this question is primarily relevant for AI algorithms. The "standalone performance" described here refers to the device's physical and material properties and its function (e.g., air leak, tensile strength). The tests are designed to show the device's inherent capabilities and safety without human intervention in its functionality, but the evaluation is performed by human testers against these criteria.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests performed on COR-SPORT is based on:

• Industry Standards: ISO 11135 (sterility), ISO 10993 (biocompatibility), USP 38 <661> (extraction), ASTM F1980 (accelerated aging).
• Engineering Specifications and Bench Test Parameters: Pre-defined force limits (10N for tensile strength), pressure maintenance values (15mmHg for 30 seconds for air leak), and size parameters (30mm for cavity access).
• Absence of Adverse Events: "No defects," "no evidence of microbial growth," "no friction, crash, damage."

8. The Sample Size for the Training Set

The concept of a "training set" applies to machine learning or AI models. Since CORE-SPORT is a physical medical device, there is no training set in this context. The manufacturing process and quality control would be based on established engineering principles and production runs, not data training.

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

As there is no training set for a physical medical device, this question is not applicable.

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The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery minimally invasive surgery. Examples of procedures where the device may be used include colorectal, urological, and general surgery to access the surgical site

The AFS MEDICAL's Sterile Single-Use Access Port System for surgery is a manual device designed to access the peritoneal cavity during laparoscopic surgery. The modular system can be used in a number of configurations as desired by the user. The system is named, JACK . System options include integrated LED lighting to provide additional intrabdominal illumination if desired, insufflation ports, and multiple cap/port options. Other device variants include retractor diameter, height, number of ports and port size configurations, number of LEDs, power line length, with disposable or external/rechargeable battery (to power light source). The device includes a receiving ring that allows for 360° rotation of the port during use.. The device includes blue light indicators on the port head to inform the user that the port head is correctly attached and sealed. The system includes Smart Tubing that contains LED lighting for additional illumination and holes connected to tubing for introduction of CO2 and removal of surgical smoke

The provided text describes a 510(k) premarket notification for the AFS Medical Sterile Single-Use Access Port System. The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and biocompatibility testing, rather than a clinical study evaluating diagnostic performance of an AI-powered device. Therefore, many of the requested categories in your prompt are not applicable to this submission.

However, I can extract the relevant information regarding acceptance criteria and testing results:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Non-Clinical Performance Tests: Sample sizes are not explicitly stated for individual tests. The data provenance is internal testing performed by the manufacturer, likely in a laboratory setting.
• Clinical Testing: "Real-world data was collected from two independent clinical sites in Austria." The number of procedures or patients is not specified. This is prospective data collection.

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

• Non-Clinical Performance Tests: Not applicable, as these are objective engineering and material tests, not reliant on expert interpretation for "ground truth."
• Clinical Testing: The text mentions "multiple clinicians reported no adverse events related to the device and assessed performance of all key attributes as acceptable." The exact number or qualifications of these clinicians are not specified beyond their role in performing procedures at clinical sites.

4. Adjudication method for the test set

• Non-Clinical Performance Tests: Not applicable as these are objective tests.
• Clinical Testing: Not specified, beyond the general statement that "multiple clinicians" assessed performance. There is no mention of a formal adjudication process (e.g., 2+1, 3+1).

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. This submission is for a surgical access port system, not a diagnostic AI device that would utilize such a study design.

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

Not applicable. This device is a manual surgical tool, not an algorithm or an AI-powered system designed for standalone performance.

7. The type of ground truth used

• Non-Clinical Performance Tests: Objective measurements against engineering and materials standards (e.g., force measurements, light intensity, leakage rates, compliance with IEC standards).
• Biocompatibility Testing: Laboratory results from standardized biological tests (ISO 10993 series).
• Clinical Testing: Clinician assessment of device performance and adverse event reporting based on real-world use during surgical procedures.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no "training set."

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

Not applicable. There is no training set for this device.

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The FMX314 Surgical Platform is composed of FMX314 Instruments that are used in minimally invasive abdominal laparoscopic surgery:

• The FMX314 Introducer is intended to establish a path of entry for laparoscopic instruments for use during minimally invasive abdominal laparoscopic surgery in combination with the FMX314 Instruments.

• The FMX314 Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, and suction irrigation of tissues and vessels during laparoscopic procedures.

The FMX314 Surgical Platform is a single-port laparoscopic surgery platform, featuring single-use, disposable articulating surgical instruments for the purpose of doing minimally invasive abdominal laparoscopic surgery by closely mimicking multi-port laparoscopic surgery. The FMX314 Surgical Platform is composed of the reusable FMX314 Introducer, the single-use FMX314 Hub Cap & Sealing Unit, and the single-use FMX314 Instruments that are used as part of laparoscopic surgery according to the intended use. The FMX314 Surgical Platform does not require a larger diameter incision than standard laparoscopic surgery (compatible with a single, standard 15mm trocar) and will utilize currently marketed conventional 15mm laparoscopic access devices (trocars), rigid 5mm laparoscopes, and instrument compatible handles for instrument manipulation and monopolar cutting and cauterizing.

The FMX314 Introducer is a reusable, single port access device for abdominal laparoscopic surgical procedures to be used in combination with a standard 15 mm trocar, FMX314 Hub Cap & Sealing Unit assembly (accessory), and the FMX314 Introducer is designed for introducer is designed for introducing, holding, supporting and guiding the FMX314 Instruments and a standard, rigid 5 mm laparoscope. The cavity at the top of the FMX314 Introducer (hub) is designed to place the single-use FMX314 Hub Cap & Sealing Unit. The FMX314 Hub Cap & Sealing Unit is designed to maintain pneumoperitoneum in the abdomen during the surgical procedure, whether or not one or more FMX314 Instruments are inserted in the instrument lumen(s) of the Introducer. Locking recesses in the hub guide the correct placement of the FMX314 Sealing Unit. The bayonet fitting at the hub is designed to properly position the single-use FMX314 Hub Cap & Sealing Unit on the FMX314 Introducer and to lock the FMX314 Sealing Unit in the hub. By turning the FMX314 Hub Cap clockwise a "click" is heard indicating that the FMX314 Hub Cap & Sealing Unit is locked into position. Prior to its reuse after completion of a procedure the FMX314 Introducer has to be disassembled and sterilized per Instructions For Use.

The FMX314 Surgical Platform comprises six (6) disposable articulating laparoscopic surgical instruments (i.e. FMX314 Grasper, Maryland, Clip Applier, Scissors, Hook-knife, and Suction/Irrigation Instrument). The FMX314 Instruments are locked into position in the instrument clamps of the FMX314 Introducer to activate a triangulated approach within the surgical field and facilitate independent anterior/posterior mobility. Each instrument is capable of 360 degree axial rotation of the end-effector as well as multidirectional lateral and superior/inferior mobility.

The FMX314 Instruments and FMX314 Hub Cap & Sealing Unit are provided sterile and are single-use, disposable. When the surgical procedure is completed, the single-use FMX314 Instruments as well as the FMX314 Hub Cap & Sealing Unit are removed from the Introducer and discarded according to standard hospital protocol.

The provided text describes the 510(k) premarket notification for the FMX314 Surgical Platform. It outlines the device's indications for use, its comparison to predicate devices, and the non-clinical performance data used to demonstrate substantial equivalence.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document lists various performance tests and states that the device "PASSED all testing" or "PASSED required testing." Specific quantitative acceptance criteria are generally not provided in this summary, only the qualitative outcome.

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

• Non-Clinical Performance Tests: Sample sizes are not explicitly mentioned for the various bench tests. They are generally reported as "PASSED required testing" or "PASSED all testing."
• Animal Model Studies (in vivo): The document states "The animals were each processed through a surgical procedure..." but does not specify the number of animals used for either the acute or chronic studies. The data provenance is stated as "animal model in vivo study."
• Human Cadaver Study (ex vivo): The document mentions "A human cadaver study was performed..." but does not specify the number of cadavers used. The data provenance is "ex vivo cadaver studies."
• Usability Study: This was conducted during the animal and cadaver studies, implying the sample size would correlate to the users performing those studies, but no specific number is provided for users or cases.

The document does not explicitly state the country of origin for the data from these studies.

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

The document does not specify the number of experts or their qualifications for establishing ground truth in any of the studies (bench, animal, cadaver, or usability). It mentions "negative feedback was given by the user" for the cadaver study and "feedback that was obtained from each of the users" for the usability study, implying at least one user/expert per study.

4. Adjudication Method for the Test Set

The document does not describe any formal adjudication method (e.g., 2+1, 3+1, none) for any of the studies. The results are reported as "PASSED" or "no negative feedback," suggesting a direct verification against predefined criteria rather than a multi-expert consensus adjudication process for discrepancies.

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

No MRMC comparative effectiveness study was done comparing human readers with AI assistance versus without AI assistance. The device is a surgical platform, not an AI-powered diagnostic tool, so this type of study would not be applicable.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Not applicable. The FMX314 Surgical Platform is a physical surgical device designed for human use, not a standalone algorithm.

7. Type of Ground Truth Used

• Non-Clinical Performance Tests: The "ground truth" for these tests would be the established engineering specifications, national/international standards (e.g., ISO 10993-1, AAMI/ANSI ES60601-1, IEC 60601-2-2, IEC 60601-2-18, ISO 11137), and internal requirements for factors like friction, mobility, stiffness, sterilization, and shelf life.
• Animal Model Studies: The ground truth involved "defined criteria" for tissue testing (cut accuracy, coagulation depth, thermal spread and damage, tissue adherence, compatibility) evaluated both grossly and histopathologically. This suggests a combination of quantitative measurements and expert pathological assessment.
• Human Cadaver Study: "Relevant human landmarks" and "dimensional and functional adequacy" were assessed, implying a physical verification against anatomical expectations and user experience.
• Usability Study: The ground truth was based on "feedback" from intended users regarding the unpacking, installation, surgical procedure, and reprocessing steps.

8. Sample Size for the Training Set

Not applicable. The FMX314 Surgical Platform is a physical medical device. It does not utilize machine learning or AI algorithms that require a "training set."

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

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

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The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery.

This device is single use and sterilized.

The Endo Keeper is intended to provide access for multiple instruments and/or endoscope to the abdominal cavity through a single incision during minimally invasive laparoscopic surgery. This device is single use and sterilized.

The Endo Keeper is laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.

The Urethane Forming Sheet (components of the Endo Keeper) function is to cover the incision site of abdominal.

The provided text describes a 510(k) premarket notification for a medical device called "Endo Keeper." This document focuses on demonstrating that the Endo Keeper is substantially equivalent to a legally marketed predicate device, the "Glove Port" (K141715). The information primarily outlines the device's intended use, technological characteristics, and performance testing conducted to support this claim.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for performance metrics in a table. It states that "Bench testing is performed to demonstrate the functionality and mechanical safety as following items." The reported performance is summarized as demonstrating "functionality and mechanical safety" and being "same as functional and effective as the legally marketed predicate device."

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

The document mentions "Bench testing" and "Animal test" as performance data.

• Bench Testing: The sample sizes for each specific bench test (leak rate, tensile strength, etc.) are not specified in the provided text.
• Animal Test: The sample size (number of animals) for the in-vivo test is not specified.
• Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given that this is a 510(k) submission for a Korean company (NELIS), it's highly probable the testing was conducted in Korea or at an accredited facility. It is prospective testing, as it was performed to support device approval.

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

This information is not provided in the document. The performance data is based on bench tests and an animal study, not human interpretation requiring experts for ground truth establishment in the traditional sense of diagnostic AI.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are bench and animal tests, not studies involving human interpretation that would require an adjudication method.

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

A MRMC comparative effectiveness study was not performed. The studies described are engineering bench tests and an animal biocompatibility/functionality study. The document explicitly states the comparison is between the "Endo Keeper" and the "Glove Port (K141715)" based on "materials, structure and component" and "function and effectiveness" through bench and animal testing, not human reader performance.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

This concept is not applicable to the "Endo Keeper" device, which is a physical surgical access port, not an algorithm or AI system. The performance studies are for the physical device itself.

7. Type of Ground Truth Used

• Bench Testing: The "ground truth" for the bench tests would be the established engineering and ISO standards for properties like leak rate, tensile strength, insertion/withdrawal forces, etc. The comparison is against the predicate device's performance.
• Animal Test: The "ground truth" for the in-vivo test regarding feasibility, functionality, irritations, and necrosis would be direct observation and pathological examination of the animal tissues, assessed against established biological response criteria (e.g., ISO 10993).

8. Sample Size for the Training Set

This information is not applicable as the "Endo Keeper" is a medical device, not an AI model that requires a training set.

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

This information is not applicable as the "Endo Keeper" is a medical device, not an AI model that requires a training set.

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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.

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The KeyPort AR System access device is an endoscopic accessory intended for use as a multiple instrument and/or camera port during minimally invasive anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision).

The KeyPort AR System is a reusable device used for creating and maintaining an artificial access port to body cavities including the necessary pneumoperitoneum. The KeyPort AR System allows multiple instruments and /or camera access during minimally invasive procedures, which include anal-rectal procedures such as Transanal Endoscopic Microsurgery (no incision). This product is exclusively intended for use by specialized medical personnel and must only be used by medically qualified and adequately trained persons. The KeyPort AR System is comprised of KeyPort silicone sealing insert (1), KeyPort AR trocar sleeve (2), and KeyPort trocar (3). The KeyPort AR System is used in conjunction with CO2 insufflator, Pump for smoke gas evacuation, and required instruments which are selected in accordance with the indications as well as the surgeon's requirements. Unless otherwise specified, all components of the KeyPort AR System are reusable and require sterilization before use. Methods of cleaning, disinfection, and sterilization are detailed in Instruction Manual GA-B 253-2 USA.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the KeyPort AR System:

1. Table of acceptance criteria and the reported device performance:

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

• Sterilization validation: The sample size is not explicitly stated, but the results indicate that "All acceptance criteria were met."
• Gas-tight seal testing: The sample size is not explicitly stated.
• Preclinical test (incision size): The sample size is not explicitly stated, but it was conducted using "pigs."
• Data Provenance: The document does not specify the country of origin for the sterilization and gas-tight seal tests. The preclinical test used "pigs," implying an animal model study, which is typically prospective.

3. 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 document. The tests performed (sterilization, gas-tight seal, preclinical incision size) do not typically involve human expert ground truth for their evaluation.

4. Adjudication method for the test set:

This information is not provided as the types of tests described do not involve adjudication by multiple experts in the same way clinical studies or image-based AI studies would.

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:

No MRMC comparative effectiveness study was done. The device is a surgical access system, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. The device is a physical medical instrument, not a software algorithm.

7. The type of ground truth used:

• Sterilization validation: The ground truth would be established by specific performance standards for sterilization effectiveness (e.g., sterility assurance level), likely measured through microbiological assays.
• Gas-tight seal testing: The ground truth would be established by quantifiable pressure measurements and leakage rates against predefined thresholds.
• Preclinical test (incision size): The ground truth would be a direct observation of the surgical outcome (sufficiency of the incision) in the animal model.

8. The sample size for the training set:

Not applicable. This device is a physical medical instrument, not a machine learning algorithm that requires a training set.

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

Not applicable. As above, there is no training set for a physical medical device.

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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.

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The OCTO™ Port is intended to use as a multiple instrument and/or camera port during minimally invasive abdominal laparoscopic surgery.

The OCTO™ Port is a sterile, disposable laparoscopic instrument port which retracts a small abdominal incision to allow multiple laparoscopic instruments to pass through to the abdomen.

The provided text describes modifications to an existing device (OCTO™ Port) and asserts its substantial equivalence to a predicate device (OCTO™ K100045) rather than presenting detailed acceptance criteria and a study to prove they are met. The document focuses on demonstrating that the new modifications do not alter the fundamental safety or effectiveness of the device.

Here's an analysis based on the information provided and how it relates to your requested points:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria with corresponding performance results in a tabular format. Instead, it lists general types of bench tests conducted to ensure the device performs as expected after modifications.

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

The document does not specify the sample size used for any of the bench tests listed. It states "The testing scope for Bench Test was selected to include..." which indicates tests were performed, but no details on the number of samples or data provenance are given.

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

This information is not applicable or provided in the context of this 510(k) submission. No clinical study involving experts establishing ground truth is described. The assessment is based on physical and functional changes to the device compared to a predicate.

4. Adjudication Method for the Test Set

This information is not applicable or provided. There's no mention of expert adjudication for the bench tests.

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

No MRMC comparative effectiveness study was conducted or mentioned. The device is a surgical access port, not an imaging or diagnostic device that would typically involve MRMC studies for AI assistance.

6. Standalone (Algorithm Only) Performance

This is not applicable as the device is a physical surgical instrument, not an algorithm or AI.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For the bench tests, the "ground truth" would be established engineering specifications, performance standards, and comparisons to the known performance of the predicate device. For example, "pressure leak test" would likely have a pre-defined maximum allowable leak rate, and the test results would be compared against that.

8. Sample Size for the Training Set

This is not applicable as the device is not an AI or machine learning model that requires a training set.

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

This is not applicable as the device is not an AI or machine learning model.

Summary Explanation:

This 510(k) submission (K112196) is for modifications to an already cleared medical device (OCTO™ Port, predicate K100045). The purpose of the submission is to demonstrate "substantial equivalence" of the modified device to the predicate. This means showing that the changes (e.g., color, thickness, gas valve addition/relocation) do not fundamentally alter the device's safety, effectiveness, indications for use, or technological characteristics.

Instead of presenting detailed acceptance criteria and performance data for a novel device, the submission asserts that:

• The modified system has the "same intended use and fundamental scientific technology" as the previously-cleared system.
• "Performance testing (Bench)" was conducted to include a list of various physical and mechanical tests (e.g., pressure leak, tensile strength, instrument insertion/removal). However, no specific acceptance criteria or quantitative performance results for these tests are provided in this summary. The implication is that the device passed these tests and met internal specifications consistent with its intended use and comparison to the predicate.
• "No additional animal testing was performed" because the mechanism and materials are "identical and consistent with the previously submitted models."
• "No additional biocompatibility testing was performed" for the same reason.

In essence, the "study" proving the device meets criteria is a battery of specified bench tests, but the specific quantifiable passing criteria and detailed results are not included in this high-level summary. The FDA's clearance (SEP 14 2011) indicates that they were satisfied with the provided information, which presumably included detailed test reports that are not part of this public summary.

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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.

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