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Applied Medical's Inzii Ripstop Redeployable Retrieval System is indicated for use as a receptacle for the collection and extraction of tissue, organs, and calculi during general and laparoscopic surgical procedures.

The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The device consists of a flexible specimen bag and an introducer tube which can be redeployed for multiple uses within a single procedure. The product will be available in two models, a 10 mm model with a 265 ml specimen bag and a 15 mm model with a 1600 ml specimen bag size. The device is provided sterile and is constructed of a Ripstop nylon specimen bag, various polymers and stainless steel. The major differences between the predicate and the subject device include the subject device featuring a stronger Ripstop nylon specimen bag and the ability to be redeployed multiple times within a single surgical procedure.

The Inzii Ripstop Redeployable Retrieval System is a single-use device designed for the containment and extraction of multiple tissue specimens. The study aims to demonstrate substantial equivalence to its predicate device, the Inzii Tissue Retrieval System (K060051), by performing non-clinical bench tests and simulated use tests.

Acceptance Criteria and Reported Device Performance:

Study Information:

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

   • The document does not explicitly state the exact sample sizes for each specific performance test (e.g., number of devices tested for leak, strength, etc.). It refers to "sample size" generally in the context of the performance data summary.
   • The data provenance is from non-clinical bench tests and simulated use tests conducted by Applied Medical Resources Corporation. There is no indication of country of origin for data or whether it's retrospective or prospective, as these are bench tests.

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

   • This information is not applicable as the document describes performance testing of a physical medical device (specimen retrieval system), not an AI/software device that requires expert-established ground truth. The 'ground truth' here is the objective outcome of the physical/mechanical and biological tests.

3. Adjudication method for the test set:

   • This is not applicable for the type of device and testing described. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving reader interpretations, not for bench testing of physical device performance.

4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

   • No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic/interpretive devices where human readers' performance is augmented by AI. The Inzii Ripstop Redeployable Retrieval System is a physical surgical tool.

5. Standalone (algorithm only without human-in-the-loop performance) study:

   • No, a standalone study was not done. This concept is specific to AI algorithms. The device described functions with human interaction during surgery.

6. Type of ground truth used:

   • For the performance testing, the "ground truth" used was based on objective measurements and observations from the non-clinical bench tests and simulated use tests. This includes parameters like liquid tightness, resistance to tearing/puncture, and mechanical functionality, as well as established ISO standards for biocompatibility.

7. Sample size for the training set:

   • This information is not applicable as the document describes performance testing of a physical medical device, not an AI/machine learning model that requires a training set.

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

   • This information is not applicable as there is no training set for a physical medical device.

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The Voyant Maryland Fusion Device with Single-Step Activation is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant Maryland Fusion device with Single Step is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

The medical device in question is the Voyant® Maryland Fusion Device with Single-Step Activation. It is an electrosurgical device intended for use with the Voyant Electrosurgical Generator to seal and divide vessels and tissue bundles up to 7mm in diameter.

Based on the provided text, here's an analysis of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a direct table with specific numerical acceptance criteria and corresponding reported device performance values. Instead, it states that the devices "met all acceptance criteria" or that results were "sufficient to represent the subject device is safe and effective."

Note: The document generally indicates that the device "met all acceptance criteria" without specifying the exact numerical thresholds for many of these criteria. This type of summary is common in 510(k) submissions where the focus is on demonstrating substantial equivalence rather than presenting a detailed performance report.

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

The document does not explicitly state the exact sample sizes for all test sets. However, it provides some information:

• Burst pressure testing: "vessels representative of the devices' indications" were used. (No specific number mentioned).
• Thermal spread testing: (No specific number mentioned).
• Simulated repeated-use testing: (No specific number mentioned for activations or devices).
• Animal testing: "large porcine animal models" were used. The number of animals or vessels tested is not specified.

Data Provenance:

• Country of Origin: Not explicitly stated, but typically these studies are conducted by the manufacturer or contract research organizations, often in the country where the manufacturer is based (USA, in this case).
• Retrospective or Prospective: The testing described (simulated repeated-use, system testing, animal testing, software verification) are all prospective studies, designed and executed to evaluate the new or modified device. The reference to the predicate device's data suggests that previously collected prospective data from the predicate was leveraged.

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

The document does not provide any information about the number or qualifications of experts used to establish ground truth for any of the described performance tests. For electrosurgical devices, "ground truth" often refers to objective measurements (e.g., burst pressure, thermal spread measurements, histopathological analysis in animal studies) rather than subjective expert interpretations like in imaging studies.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method. Given that most of the described tests are objective measurements (e.g., electrical parameters, burst pressure, thermal spread, software testing), an adjudication method as typically understood in studies involving human interpretation (like imaging reads) would not be applicable. For animal studies, evaluation of hemostasis and hematoma would typically follow pre-defined histological or gross pathology criteria.

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

No, an MRMC comparative effectiveness study was not done. The device is a direct-use surgical instrument, not an AI-based diagnostic tool requiring human interpretation/reading. Therefore, the concept of human readers improving with AI assistance is not applicable here.

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

While the term "standalone" typically refers to AI algorithms, in the context of this electrosurgical device, the device itself is a "standalone" instrument. The performance tests (electrical, mechanical, system, animal) described are evaluating the performance of the device only (or the device in combination with its specified generator), without a human-in-the-loop actively assisting in output. The software verification tests are also standalone evaluations of the algorithm's performance within the device's control systems.

7. The Type of Ground Truth Used

The ground truth used for various tests includes:

• Objective Measurements: For burst pressure (quantifiable pressure values), thermal spread (measurable tissue damage), and electrical safety/EMC (compliance with quantifiable standards).
• Biological/Pathological Outcomes: For animal studies, this would involve macroscopic and potentially microscopic examination of sealed vessels and surrounding tissues to assess hemostasis, presence of hematoma, and tissue damage, serving as the "ground truth" for seal quality and safety.
• Software Design Specifications: For software verification, the "ground truth" is adherence to predefined design requirements and functional specifications.

8. The Sample Size for the Training Set

The document describes performance testing for an electrosurgical device, not an AI/ML product. Therefore, the concept of a "training set" (used for training machine learning models) is not applicable to this submission.

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

As the concept of a "training set" is not applicable, the question of how its ground truth was established is also not applicable.

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The GelPOINT V-Path Vaginal Access System (VAS) is intended to be inserted in the vagina to allow for entry of minimally invasive instruments while maintaining insufflation for vaginal gynecological procedures.

The GelPOINT V-Path Vaginal Access System consists of an Intravaginal Alexis retractor and two access channels that are placed vaginally to create a pathway to gynecological organs. A GelSeal cap attaches to the retractor at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

This document is a 510(k) summary for the GelPOINT® V-Path Vaginal Access System. It describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request:

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

The document describes functional testing but doesn't explicitly state quantitative acceptance criteria or provide specific numerical device performance metrics in a table format. Instead, it describes general successful outcomes.

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

• Sample Size for Test Set: The document mentions "bench testing" and "Functional bench testing" but does not provide specific sample sizes (e.g., number of devices tested, number of trials).
• Data Provenance: The studies were internal company studies ("A protocol was developed by Applied Medical"). There is no mention of country of origin of data, and these are laboratory bench tests, not patient data, so the retrospective/prospective distinction is not applicable in the usual sense for clinical data.

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 studies are described as functional bench tests, suggesting engineering or quality assurance personnel would evaluate the performance rather than clinical experts establishing a ground truth in the context of diagnostic accuracy.

4. Adjudication method for the test set:

This information is not provided. Given the nature of bench testing, it's unlikely an adjudication method like 2+1 or 3+1 (typically used for clinical imaging assessments) would be applied.

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:

• MRMC Study: No.
• AI Assistance: The document describes a medical device for surgical access, not an AI-powered diagnostic or assistive tool. Therefore, a study on human readers improving with AI assistance is not applicable and was not conducted.

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

No. This is a physical medical device, not an algorithm, so "standalone algorithm performance" is not applicable.

7. The type of ground truth used:

For the functional tests, the "ground truth" would be the successful demonstration of the device's intended functions (e.g., maintaining an open pathway, retaining its position, maintaining insufflation). For biocompatibility, the ground truth is established by meeting the pass/fail criteria outlined in the referenced ISO standards and USP . For shelf-life, the ground truth is the device maintaining specifications after accelerated aging.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. As above, this is not an AI/machine learning device.

In summary:

This 510(k) summary focuses on demonstrating the substantial equivalence of a physical surgical access device through functional bench testing, biocompatibility testing, and shelf-life studies. It does not involve clinical studies with patient data, expert review of images, or artificial intelligence algorithms. Therefore, many of your requested points related to AI performance, reader studies, and large-scale data sets are not relevant to this type of device submission.

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The Alexis® Contained Extraction System is indicated to contain and isolate tissue during, or prior to, surgical removal and/or extracorporeal manual morcellation via an abdominal or vaginal approach.

The Alexis® Contained Extraction System is a sterile, single use tissue bag with a guard system component. The polyurethane tissue bag consists of a flexible ring, tabs, strap with a snap fastener, and an attached tether It is available in two models GTB14 and GTB17 with the following dimensions and volumes:

The tissue bag is used to contain and isolate specimens for surgical removal and/or manual morcellation. The strap with snap fastener maintains the folded bag and flexible ring in a collapsed state during insertion. After the device is fully inserted and deployed into the abdominal or pelvic cavity, the opening of the bag returns to its original, circular shape, facilitating placement of the specimen in the bag. When the specimen is ready for removal and/or manual morcellation, the tether, tabs, and strap are used to maneuver the ring to the surface of the extraction site.

If the specimen requires manual morcellation. the ring may be repeatedly flipped to shorten the bag and consequently bring the specimen closer to the extraction site.

The guard system consists of a guard and a self-retaining retractor. The guard is composed of a coiled polyethylene material that conforms to the extraction site. The self-retaining retractor consists of two polyurethane rings connected by a polyurethane sheath and a tether attached to the inner ring. It helps anchor the guard at the extraction site. The guard system provides a robust barrier between the bag and sharp instruments.

The Alexis® Contained Extraction System can be inserted and retrieved either through an abdominal incision or through the vaginal canal and colpotomy. In both cases, manual morcellation is performed extracorporeally at the extraction site.

The provided text describes a 510(k) summary for the Alexis® Contained Extraction System. This notification focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific performance metrics and acceptance criteria for a new AI/software device.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample size for test sets (including provenance, expert qualifications, and adjudication methods), MRMC studies, standalone performance, ground truth establishment, and training set details cannot be extracted from the provided text.

The document details engineering tests related to the physical device's characteristics (biocompatibility, sterilization, shelf life, and functional performance) to support its substantial equivalence to an existing device, as opposed to clinical performance data against defined metrics for a diagnostic or AI-driven system.

The "Discussion of Performance Data" section refers to:

• Biocompatibility: Evaluation in accordance with ISO 10993-1 and FDA guidance.
• Sterilization/Shelf Life: Validation performed in accordance with ISO 11135-2.
• Functional Performance: Design Verification testing for various physical attributes (e.g., integrity of tissue bag, tether, guard system, resistance to penetration, ability to maintain a closed system, specimen capture). This also included "simulated use testing with the subject device in both an abdominal bench model and a vaginal bench model."

However, these are engineering and safety tests typical for a physical medical device, not performance studies as would be conducted for a diagnostic algorithm or AI system.

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Python catheters are indicated for removal of thromboemboli from the peripheral arterial system, and for occlusion and infusion of fluids into a vessel.
The Over-the-Wire Latis Graft Cleaning Catheter is indicated for the removal of thromboemboli from vascular grafts, and for occlusion and infusion of fluids into a graft.

The Python Embolectomy Catheter & Over-the-Wire Latis Graft Cleaning Catheters are sterile, single use vascular balloon catheters intended for use in the removal of thromboemboli, occlusion of vessels, and the infusion of fluids. The devices are intended for use in arterial vessels and artificial vascular grafts respectively. The body of the catheters utilize a dual lumen design with one inflation lumen used to inflate the balloon, and one through lumen allowing for insertion over a guide wire or infusion of fluids. The outer diameter of the body is designed to accommodate use with a standard percutaneous access sheath. The Over-the-wire Latis Graft Cleaning Catheter includes a braided mesh which surrounds the balloon and is designed to increase engagement with wall of artificial vascular graft.

The provided text describes a medical device's 510(k) submission to the FDA, demonstrating substantial equivalence to predicate devices. It focuses on the physical and material characteristics of the catheters and the bench testing performed. However, it does not contain information pertinent to the typical acceptance criteria or study design for AI/ML-based medical devices, such as a test set size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details.

Therefore, I am unable to provide the requested information based on the input text.

The document discusses the following:

• Device Name: Python Catheter and Over-the-Wire Latis Graft Cleaning Catheter
• Intended Use: Removal of thromboemboli from the peripheral arterial system/vascular grafts, and for occlusion and infusion of fluids into a vessel/graft.
• Testing Performed:
  • Engineering/Bench Testing: Balloon Pull Force, Inflation & Guidewire Hub Pull Force, Catheter Body Tensile Strength, Catheter Balloon Cycling Test, Balloon Burst Pressure Test, Inflated Balloon Diameter Inspection, Guidewire & Inflation Hub Leak Test, Simulated Use Bend Test, Torsion Test, Kink Test.
  • Biocompatibility Testing: Cytotoxicity, Intracutaneous Irritation, Sensitization, Acute Systemic Toxicity, Hemolysis, Materials Mediated Pyrogenicity, Platelet and Leukocyte Counts, Partial Thromboplastin Time, Complement Activation, Thrombogenicity.
• Standards Referenced: ISO 10555-1:ed2:2017 and EN 13868.

This information relates to the physical and biological safety and performance of the catheter itself, not to the performance of an AI/ML component.

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The Voyant Open Fusion Device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures, and should not be used for these procedures.

The Voyant 5mm Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation and division of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device. The device has not been shown to be effective for tubal coagulation for sterilization for sterilization procedures, and should not be used for these procedures.

The Voyant Open Fusion and Voyant 5mm Fusion devices are advanced bipolar instruments that use RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the devices' jaws. Each device features a mechanical, user-actuated blade for the division of sealed tissue.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Voyant Open Fusion Device and Voyant 5mm Fusion Device.

It's important to note that the provided documents (FDA 510(k) summaries) typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed, comprehensive reports on a device's standalone performance or comparative effectiveness studies with human readers. Therefore, some of the requested information may not be explicitly present or might be inferred from the context of a 510(k) submission.

Acceptance Criteria and Reported Device Performance

The documents state that both devices "met all acceptance criteria" and "met the predetermined acceptance criteria" for various tests. However, the specific quantitative acceptance criteria and the precise performance metrics achieved are not explicitly detailed in the provided text. The submission focuses on stating that the criteria were met, implying satisfactory performance relative to either internal company standards, recognized industry standards, or performance established by the predicate devices.

Table 1: Acceptance Criteria and Reported Device Performance (Inferred)

Study Details

1. Sample Sizes and Data Provenance

• Test Set (Clinical/Animal):

  • Animal Testing: "large porcine animal models" were used. The exact number of animals or vessels tested is not specified.
  • Burst Pressure Testing: Used "vessels representative of the devices' indications." The number of vessels is not specified.
  • Data Provenance: The studies were conducted by Applied Medical Resources Corp. (presumably within the US, as they are a US-based company submitting to the FDA). The studies appear to be prospective in nature, designed specifically to test the devices.

• Training Set (for Software/AI, if applicable): Not applicable. This device is an electrosurgical tool, not an AI/software-based diagnostic or imaging device in the sense that would require a large training dataset for pattern recognition. The software verification mentioned refers to the control software embedded within the device, not a machine learning algorithm trained on data. Therefore, questions 8 and 9 are not directly relevant in this context.

2. Number of Experts and Qualifications for Ground Truth

• Animal Testing: The evaluation of "hemostasis and signs of hematoma" would likely involve veterinary professionals or researchers with expertise in animal pathology and surgical outcomes. However, the number and specific qualifications of experts establishing ground truth are not provided in this summary.

• Other Testing: For burst pressure, thermal spread, electrical safety, and mechanical testing, the ground truth is established by objective physical measurements and engineering standards, not typically by expert consensus in the same way as a diagnostic medical image.

3. Adjudication Method for the Test Set

Given the nature of the studies (engineering performance, animal model outcomes), formal adjudication methods like "2+1" or "3+1" (common in clinical trial assessments for subjective endpoints or equivocal findings) are not mentioned and generally not applicable to these types of objective performance tests. The results would be based on direct measurements and observations, typically verified by technical experts.

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

• No: An MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., imaging AI) to assess how AI assistance impacts human reader performance in interpreting images or data. The Voyant devices are surgical tools, and their effectiveness is measured by their physical performance (sealing vessels, minimizing thermal spread), not by human interpretation of their output.

5. Standalone Performance Study (Algorithm Only)

• Yes (Implied for the device system): The performance testing described (burst pressure, thermal spread, animal studies, EMC, electrical safety, mechanical testing) assesses the device's inherent functionality and capabilities. While the software is a component, the "standalone" performance here refers to the device system itself without direct human "in-the-loop" decision-making augmentation, but rather as an operated tool. The software verification specifically assesses the algorithm/software components in a standalone context.

6. Type of Ground Truth Used

• Objective Measurements and Observation/Pathology in Animal Models:
  • Burst pressure: Objective physical measurements.
  • Thermal spread: Objective physical measurements/histology (implied).
  • EMC/Electrical Safety: Compliance with objective engineering standards.
  • Mechanical Testing: Objective performance metrics.
  • Animal testing: Direct observation of hemostasis and absence of hematoma, potentially supported by pathology or histological evaluation of tissue.

7. Sample Size for the Training Set

• Not applicable: As discussed above, this device does not utilize machine learning in a way that requires a "training set" of data for algorithm development. The "software" refers to control logic, not AI models.

8. How Ground Truth for Training Set was Established

• Not applicable: (See point 7).

Summary of Gaps in Information (from the perspective of the original prompt):

The provided 510(k) summary is designed to demonstrate substantial equivalence, not to provide a full scientific publication with detailed methodologies and results for each test. Key quantitative details like exact sample sizes for animal/vessel testing, specific numerical acceptance thresholds (e.g., minimum burst pressure in mmHg, maximum thermal spread in mm), and the precise qualifications of evaluators are not included in this high-level summary. This is typical for a 510(k) submission, where the focus is on the conclusion that acceptance criteria were met and substantial equivalence was achieved.

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The Voyant Maryland Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired. The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant Maryland Fusion device is an advanced bipolar instrument that uses RF energy, provided by the Voyant Electrosurgical Generator (K182244), to seal vessels up to and including 7mm in diameter. The device may also be used to seal tissue bundles that can be captured in the device jaws. The device features a mechanical, user-actuated blade for the division of sealed tissue.

Acceptance Criteria and Study for the Voyant Maryland Fusion Device

This document describes the acceptance criteria and the studies that demonstrate the Voyant Maryland Fusion Device meets these criteria. It focuses on the information provided in the given text.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details various tests conducted for the Voyant Maryland Fusion device and states that the device "met the predetermined acceptance criteria" for each. However, the specific quantitative acceptance criteria for each test are not explicitly defined in the provided document. The performance is generally reported as meeting pre-determined criteria and being "substantially equivalent" to the predicate device.

2. Sample Size and Data Provenance

• Test Set Sample Size: The exact sample sizes for each test are not explicitly mentioned in the provided text.
  • Burst pressure testing: "vessels representative of the devices' indications" were used.
  • Thermal spread testing: No specific sample size given for tissues.
  • Animal testing: "large porcine animal models" were used, but the number is not specified.
• Data Provenance: The text does not specify the country of origin for the data. The studies appear to be prospective as they were conducted as part of the device evaluation for 510(k) submission.

3. Number of Experts and Qualifications for Ground Truth

The provided text does not mention the number of experts used to establish ground truth or their qualifications for any of the performance tests.

4. Adjudication Method for the Test Set

The provided text does not mention any adjudication method (e.g., 2+1, 3+1, none) for the test set.

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

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done. The document focuses on the performance of the device itself, not human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone study (algorithm/device only without human-in-the-loop performance) was completed for the Voyant Maryland Fusion device. The entire "Discussion of Performance Testing" section details laboratory and animal studies of the device's technical capabilities and clinical performance without human interaction being assessed as part of the primary endpoint.

7. Type of Ground Truth Used

• EMC, Electrical Safety, Mechanical Testing, Simulated Repeated-Use Testing, Software Verification: Ground truth for these tests would be based on engineering specifications, regulatory standards (e.g., IEC 60601 series), and predefined functional requirements.
• Burst Pressure Testing: Ground truth would be based on quantitative measurement of burst pressure of the sealed vessels, likely compared to a control or predicate device, and potentially established physiological limits for vessel integrity.
• Thermal Spread Testing: Ground truth would be based on quantitative measurement of tissue damage (e.g., area of necrosis), likely determined histologically or via thermal imaging, and compared to the predicate device.
• Animal Testing: Ground truth would be based on direct observation of physiological outcomes (e.g., hemostasis, presence/absence of hematoma, long-term seal quality, adverse effects on adjacent structures) by veterinary professionals or researchers, potentially supported by pathology (e.g., histological examination of sealed tissues post-mortem).

8. Sample Size for the Training Set

The provided text does not mention any "training set." This type of terminology is typically associated with machine learning or AI algorithm development. The Voyant Maryland Fusion device is described as an electrosurgical device with an "updated software script," but not as an AI-powered diagnostic or assistive tool that would require a distinct training set for algorithm development. The software verification focuses on its design, implementation, and performance, not on learning from data.

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

As there is no mention of a "training set" in the context of an AI/ML algorithm, this question is not applicable based on the provided document. The software verification was likely based on standard software engineering principles and testing against established functional requirements and specifications.

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The Voyant [5mm/Maryland] Fusion device is a bipolar, electrosurgical device indicated for use with the Voyant electrosurgical generator in open and laparoscopic procedures where the ligation of vessels and tissue bundles is desired.

The device can seal and divide vessels up to and including 7mm in diameter and tissue bundles that can be captured in the jaws of the device.

The device has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Voyant 5mm and Maryland Fusion devices are advanced bipolar instruments that uses RF energy, provided by the Voyant Electrosurgical Generator (K141288 & K182244), to seal vessels up to and including 7mm in diameter. The devices may also be used to seal tissue bundles that can be captured in the device jaws. The devices feature a mechanical, user-actuated blade for the division of sealed tissue.

This FDA 510(k) summary for the Voyant 5mm Fusion Device and Voyant Maryland Fusion Device (K193292) does not contain information about a study with acceptance criteria and observed device performance in the way a clinical trial or algorithm performance study would.

Instead, this document focuses on demonstrating substantial equivalence to previously cleared predicate devices (K141288, K172624, K182653). The core argument for safety and efficacy relies on the fact that the subject devices are identical in material and technological characteristics to the predicates, and thus, the existing performance, sterility, shelf life, and electrical testing of the predicate devices are leveraged.

Therefore, the requested tables and details regarding sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable to this specific submission as it's not a de novo study for a novel device or AI algorithm.

However, I can extract the acceptance criteria and "results" as presented in the document based on the performance testing of the predicate devices, which are deemed sufficient for the subject devices due to identical design.

Here's a breakdown of the information that is available (or not available) based on your request, framed within the context of substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a substantial equivalence submission based on identical design, the "acceptance criteria" are implied by the standards and successful results achieved by the predicate devices. The document states that the predicate devices "met all acceptance criteria" for the listed tests.

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

• Sample Size: Not specified in the document for any of the tests. The document refers to "representative vessels" and "surgical sites" for the bench and animal testing, respectively, but does not provide numbers.
• Data Provenance: The data comes from prior testing associated with the predicate devices (K141288, K172624, K182653). The document does not specify the country of origin or if the studies were retrospective or prospective, though animal and bench testing are typically prospective experiments.

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

• Not Applicable. This submission is not evaluating an AI algorithm or diagnostic device requiring expert interpretation of results to establish ground truth. The tests are laboratory-based (biocompatibility, electrical, mechanical, bench) and animal studies, which have objective endpoints.

4. Adjudication Method for the Test Set:

• Not Applicable. As above, no expert consensus or adjudication process is described for these types of engineering and biological tests.

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

• No. This document does not describe any MRMC study. The device is an electrosurgical tool, not a diagnostic imaging device that would typically involve human readers.

6. Standalone (Algorithm Only) Performance Study:

• No. The device is a surgical instrument. This concept is not applicable.

7. Type of Ground Truth Used:

• For biocompatibility tests: Standardized laboratory assays based on cell viability, immune response, etc.
• For electrical tests: Measurement against established IEC standards.
• For mechanical tests: Objective measurements of force, integrity, and electrical continuity.
• For bench testing: Measurements of burst pressure and thermal spread, which are objective physical parameters.
• For animal testing: Histological examination, observation of hemostasis, and absence of hematoma, likely evaluated by veterinary pathologists or study investigators based on established criteria.

8. Sample Size for the Training Set:

• Not Applicable. This is not an AI or machine learning device that requires a training set.

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

• Not Applicable.

In summary: This 510(k) submission explicitly states that the subject devices are identical to predicate devices and therefore leverages the prior testing data of those predicates. It does not present new studies with a detailed breakdown of acceptance criteria and performance for a novel device or AI algorithm, but rather relies on the successful historical performance of prior substantially equivalent devices.

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Applied Medical Laparoscopic Linear Cutter has applications in open and/or minimally invasive general, urologic, gynecologic, pediatic and thoracic surgery for resection and or creation of anastomosis. The instruments may also be used for transection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney and spleen. It can be used with staple line or tissue buttressing materials.

The Applied Medical Laparoscopic Linear Cutter (LLC) is a sterile, single-use stapling system that is intended to be used for mechanically transecting, resecting, and sealing tissue during laparoscopic and open surgical procedures. The stapler places six staggered rows of titanium staples, three on either side of the transection line. The shaft can rotate freely in both directions and the jaws articulate to facilitate access to the operative site. The Applied LLC is available in 3 different shaft lengths (20cm, 37cm, 50cm) that can each accommodate 3 different industrystandard reload lengths (60mm, 45mm, 30mm). Each of the reload lengths is available in three industry-standard reload colors and formed staple heights to accommodate various tissue thicknesses: 1.0mm (white reload), 1.5mm (blue reload), and 2.0mm (green reload).

This document describes the FDA's 510(k) clearance for the Applied Medical Laparoscopic Linear Cutter (LLC), asserting its substantial equivalence to a predicate device. As such, the information provided focuses on the performance testing conducted to demonstrate this equivalence rather than a study proving a device meets specific clinical acceptance criteria for an AI/CADe device.

Therefore, many of the requested categories for AI/CADe systems (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable to this type of medical device submission. The device in question is a surgical stapler, not an AI or imaging diagnostic tool.

However, I can extract the information relevant to establishing the substantial equivalence of this device based on the provided text.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All performance testing acceptance criteria were met." It does not provide the specific numerical acceptance criteria for each test or detailed quantitative results, but rather lists the tests performed and their objectives.

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

• Test Set (Preclinical Studies): Two porcine studies were conducted. The specific number of animals or cases in these studies is not detailed in the provided text.
• Data Provenance: The studies are described as "preclinical testing" which typically implies laboratory animal studies. The country of origin is not specified but implicitly within the context of an FDA submission, the testing would be expected to meet U.S. regulatory standards. These are prospective studies given they are conducted specifically for the regulatory submission.

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

• Not applicable / Not specified. This device is a surgical instrument, and its performance evaluation involves physical and biological testing, not expert interpretation of diagnostic images.

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

• Not applicable. This concept pertains to establishing ground truth for diagnostic image interpretation, which is not relevant to the testing of a surgical stapler.

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

• Not applicable. This study design is for evaluating AI/CADe systems in diagnostic imaging. The Applied Medical Laparoscopic Linear Cutter is a surgical device.

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

• Not applicable. This device is a manual surgical instrument. No algorithm is involved.

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

• For Bench Tests: Ground truth is established through physical measurements, engineering standards, and biological models (e.g., media, tissue analogues).
• For Preclinical Tests: Ground truth is established through direct observation of in-vivo performance (e.g., hemostasis) and histopathological evaluations of animal tissues post-procedure.
• For Biocompatibility Tests: Ground truth is established by standardized biological assays (e.g., cytotoxicity, sensitization, systemic toxicity) and chemical characterization following specific ISO standards.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning system. There is no concept of a "training set."

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

• Not applicable. As above, no training set for an AI/ML model exists for this device.

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The Transvaginal Access Platform is intended to be inserted transvaginally to establish a path of entry for minimally invasive instruments while maintaining insufflation during laparoscopic-assisted and vaginal gynecological procedures. The device is also a conduit for the extraction of specimens.

The Transvaginal Access Platform consists of an access channel component that is placed transvaginally to create a pathway to gynecological organs in the pelvic cavity. A GelSeal cap attaches to the access channel at the opening of the vagina. The cap allows for insufflation and smoke evacuation. Sleeves inserted through the cap allow for passage of 5mm to 12mm laparoscopic instrumentation. Visualization is achieved via introduction of an endoscope through a sleeve. The device is provided sterile.

The Acceptance Criteria and supporting study information are derived from the "Discussion of Performance Data" and "Comparison with the Predicate Device" sections of the provided text.

Here's a breakdown of the requested information:

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size:
  • Baekelandt et al. (2018) study: n=70
  • iNOTESs Society Registry data: n=906
• Data Provenance: The document does not specify the country of origin for either dataset.
  • Baekelandt et al. (2018): Randomized, single-center, single-blinded trial (Prospective).
  • iNOTESs Society Registry data: Registry data (Likely prospective, though details aren't fully specified).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies report "acceptable rates of peri- and post-operative complications," implying clinical assessment, but the number or qualifications of experts involved in determining these outcomes are not detailed.

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

This information is not provided in the document.

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 study was done that involved AI vs. human readers. The studies described (Baekelandt et al. and iNOTESs Registry) are clinical performance studies of a medical device (Transvaginal Access Platform), not an AI diagnostic tool. They compare different surgical approaches or document outcomes with the device.

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

• Not applicable. The device is a physical surgical access platform, not an algorithm. Therefore, no standalone algorithm performance study was performed.

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

• The ground truth for the clinical performance criteria ("acceptable rates of peri- and post-operative complications") appears to be clinical outcomes data, likely assessed by healthcare professionals involved in the care of the patients. This would include direct observation, patient follow-up, and review of medical records for complications.

8. The sample size for the training set

• Not applicable. This device is a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set."

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

• Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

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