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The BioBrace® RC Delivery System is intended for use in rotator cuff surgical procedures for reinforcement of soft tissue where weakness exists. The BioBrace® Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during rotator cuff tendon repair surgery. The BioBrace® Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The Disposable Inserter is intended to facilitate the delivery and positioning of the implant during soft tissue repairs.

The BioBrace® RC Delivery System is comprised of a BioBrace® Implant pre-stitched with HI-FI® suture, a threader assembly that facilitates passing sutures through the BioBrace® Implant, and an inserter to facilitate placement of the BioBrace® Implant into the subacromial space.

The previously cleared BioBrace® Implant is a bioresorbable, reinforced Implant composed of a highly porous collagen sponge made from insoluble bovine tendon type-1 collagen and reinforced with poly-L-lactic-acid (PLLA) multifilament yarn. The BioBrace® Implant is 80% porous with a median pore diameter of 19 µm. BioBrace® implants are approximately 3 mm thick and provided in two rectangular sizes of 23 x 25 mm and 35 x 25 mm.

The BioBrace® RC Delivery System is single-use and supplied sterile (ETO).

The provided text is a 510(k) clearance letter for a medical device called the BioBrace® RC Delivery System. This type of document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed clinical study for novel acceptance criteria.

Therefore, the document does not contain the information requested regarding detailed acceptance criteria for diagnostic performance, a specific study proving the device meets those criteria, sample sizes for test/training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established in the context of diagnostic accuracy.

The document describes performance testing that focused on demonstrating the functional equivalence and safety of the new delivery system and integrated implant compared to the previously cleared implant. This testing includes:

1. Table of Acceptance Criteria and Reported Device Performance (based on provided text):

Since the document does not present quantitative diagnostic performance metrics or acceptance criteria for such, the table below reflects the types of performance aspects mentioned for this delivery system and implant combination. All "reported device performance" are stated as having been successfully completed and demonstrating equivalence/effectiveness/safety.

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

The document does not specify sample sizes for any test sets in the context of diagnostic performance. The studies mentioned appear to be engineering and biological performance tests rather than clinical diagnostic studies. Data provenance (country of origin, retrospective/prospective) is also not provided.

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

This information is not applicable as the document describes performance testing for a surgical mesh delivery system and implant, not a diagnostic device requiring expert-established ground truth for classification.

4. Adjudication Method for the Test Set:

This information is not applicable for the reasons stated above.

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

An MRMC study was not conducted (or at least not reported in this document), as this is not a diagnostic imaging device intended for interpretation by human readers.

6. Standalone (Algorithm Only) Performance:

This information is not applicable as the device is a physical surgical mesh delivery system, not an algorithm or AI software within a diagnostic context.

7. Type of Ground Truth Used:

This information is not applicable as the described tests relate to material properties, sterility, packaging, and functional delivery of a surgical implant, not diagnostic accuracy. For the biocompatibility claims, "ground truth" would be established by the ISO 10993-1 standards themselves.

8. Sample Size for the Training Set:

This information is not applicable as the device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the reasons stated above.

In summary: The provided 510(k) clearance letter details the regulatory submission for a surgical implant delivery system. The "performance data" section refers to a range of engineering, biological, and functional tests demonstrating that the physical device meets safety and effectiveness requirements and is substantially equivalent to a predicate. It does not contain the kind of diagnostic performance study information that would typically involve acceptance criteria for accuracy, ground truth establishment, or human reader performance for AI software.

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The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

The AccuMesh laparoscopic surgical instrument intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. It is comprised of two main sections: operation handle and deployment section which are connected via a tube. Included in the packaging configuration is a furling sleeve intended to assist the surgeons to furl the mesh tightly and rapidly over the AccuMesh positioning system.

The provided document for K130782, the AccuMesh Positioning System, does not contain information related to acceptance criteria or a study proving device performance. This 510(k) submission is solely for adding an orange ink component to an already cleared device.

Therefore, I cannot extract the requested information using the provided text.

Here's why:

• Nature of the Submission: This is a 510(k) summary for a minor change (component color addition) to an existing, cleared device. Such submissions typically focus on demonstrating that the change does not alter the fundamental safety or effectiveness of the device, rather than presenting new performance studies or acceptance criteria.
• Missing Sections: The document lacks sections typically found in an initial 510(k) submission that would detail performance data, clinical studies, or engineering tests against specific acceptance criteria.
• Focus on Equivalence: The primary goal of this particular 510(k) is to establish substantial equivalence to previously cleared AccuMesh devices, emphasizing that "There are no changes to the technological characteristics as a result of the proposed colorant addition."

If you have a document for an initial clearance of the AccuMesh Positioning System (e.g., K101218, K103269, or K123066), that document might contain the information you're looking for.

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The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during laparoscopic repair of soft tissue defects (e.g. hernia repair).

The AccuMesh Positioning System is laparoscopic surgical instrument intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. It is comprised of two main sections: operation handle and deployment section which are connected via a tube. Included in the packaging configuration is a furling sleeve intended to assist the surgeons to furl the mesh tightly and rapidly over the AccuMesh positioning system.

The provided text describes a 510(k) submission for the AccuMesh Positioning System. The submission is for a component color change and asserts substantial equivalence to previously cleared devices. Therefore, the study details are minimal and do not contain information typically found in a comparative effectiveness study for a new AI/medical device.

Here's the breakdown of the information requested based only on the provided text:

1. Table of acceptance criteria and the reported device performance

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

• Sample Size: Not specified. The document states "Performance testing was performed on the colorant and consisted of opening, closing and articulating with visual inspection following aging at all hinge joints". It does not detail how many units were tested.
• Data Provenance: Not specified. The testing was performed on the device itself.

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

Not applicable. The approval is for a color change, and the performance testing involved mechanical actions (opening, closing, articulating) with visual inspection, not clinical outcomes requiring expert assessment.

4. Adjudication method for the test set

Not applicable. The approval is for a color change, and the performance testing involved mechanical actions (opening, closing, articulating) with visual inspection, not clinical outcomes requiring adjudication.

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. This document does notdescribe an MRMC study or any study involving human readers or AI assistance. The submission is for a minor change (component color) to an existing device.

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

No. This document does not describe an algorithm or AI.

7. The type of ground truth used

"Ground truth" in the typical sense of clinical validation is not applicable here. The "ground truth" for this submission's performance testing was the ability of the device components (after a color change) to perform their intended mechanical functions (opening, closing, articulating) without issues, verified by visual inspection after aging.

8. The sample size for the training set

Not applicable. This document does not describe an AI or an algorithm that requires a training set.

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

Not applicable. This document does not describe an AI or an algorithm that requires a training set.

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The AccuMesh Positioning System is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

The AccuMesh Positioning System is a manual laparoscopic device intended to facilitate hernia mesh delivery and placement in laparoscopic ventral hernia repair. The AccuMesh Positioning System comprises two main sections: operation handle and deployment section which are connected via a tube. Included in the packaging configuration is a furling sleeve intended to assist the surgeons to fur! the mesh tightly and rapidly over the AccuMesh positioning system.

The provided text describes a 510(k) submission for the Covidien AccuMesh Positioning System, specifically regarding the addition of a furling sleeve. It claims substantial equivalence to previously cleared devices (K101218 and K103269). However, the document does not contain the detailed performance data, acceptance criteria, or study specifics required to answer many of your questions.

Here's an analysis of what can and cannot be answered based on the provided text:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not detailed in the document. The text only says: "Performance testing was conducted using sterilized samples of the proposed design of the AccuMesh Positioning System with the furling sleeve. The furling sleeve interface and compatibility with laparoscopic ports and components of the AccuMesh Positioning System were evaluated with various commercially available mesh products." This is a high-level statement about the type of testing, not the results or specific metrics.

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

• Sample Size: Not specified. The document only mentions "sterilized samples" without a number.
• Data Provenance: Not specified. It does not mention country of origin or whether it was retrospective or prospective. Given the nature of a 510(k) for a device like this, it would typically involve prospective lab/bench testing or potentially animal studies, but the document doesn't specify.

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

• Not Applicable. This device is a manual surgical instrument, not an AI or imaging diagnostic tool that typically relies on expert ground truth for performance evaluation in the way you're asking. Its performance evaluation likely focuses on mechanical and functional aspects, compatibility, and usability by surgeons.

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

• Not Applicable. See point 3.

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 is not an AI-assisted diagnostic or imaging device. It's a manual surgical instrument.

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

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

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

• Not Applicable/Not Specified. For a manual surgical tool, "ground truth" would relate to its ability to perform its stated function (e.g., correctly deliver and position mesh without failure, demonstrating compatibility). The document does not detail how this "truth" was established beyond the general statement about performance testing.

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an AI model requiring a training set.

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

• Not Applicable. See point 8.

Summary of what is missing from the provided text to answer your questions:

The provided text is a 510(k) summary focused on the administrative aspects and the claim of substantial equivalence for a manual surgical instrument. It explicitly states that "Performance testing was conducted using sterilized samples..." but does not provide any specific data, metrics, acceptance criteria, or detailed methodology from those tests. Therefore, most of your questions, which are geared towards performance evaluation of AI/diagnostic tools, cannot be answered from this document.

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The PatchAssist™ device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

The PatchAssist™ device is used to facilitate the delivery of mesh during the laparoscopic hernia repair. It is a tray like device that holds the mesh under tension and enables the surgeon to connect the mesh to its proper place. The PatchAssist™ device are manual laparoscopic surgical instrument. The surgeon connects a standard hernia mesh (not part of the device) to the device using a dedicated stapling apparatus, furls the mesh on the device deployment section (as it is a dedicated stapling apparatus), and inserts the device into the abdominal cavity through a standard laparoscopic port (trocar). Once inside the abdominal cavity, the device enables the surgeon to rapidly maneuver the mesh into position over the hernia, over the desired surgical location. The mesh is attached and placing the mesh is connected to the tissue using the same technique as currently performed by the surgeon (e.g., suturing or using fixated tacks). Upon the mesh fixation to the tissue, the surgeon releases the mesh from the device and removes the device from the abdominal cavity leaving the fixated mesh in its desired location. The PatchAssist™ Large is another model of the PatchAssist™ that has a slightly larger deployment frame to facilitate the insertion of large size meshes.

Acceptance Criteria and Device Performance Study for PolyTouch Medical Ltd. PatchAssist™ Large

This document summarizes the acceptance criteria and the study conducted to demonstrate that the PolyTouch Medical Ltd. PatchAssist™ Large device meets these criteria, as described in K103269.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this 510(k) summary is for a device asserting substantial equivalence to an already cleared predicate device (K101218) and the primary change is a larger deployment frame, the acceptance criteria are implicitly tied to demonstrating that the change does not introduce new safety or efficacy issues. The performance tests conducted are designed to confirm this.

2. Sample Size and Data Provenance

The 510(k) summary does not explicitly state specific sample sizes for the performance tests conducted for the PatchAssist™ Large. It mentions "A series of performance testing," implying multiple tests.

• Test Set Sample Size: Not explicitly stated. The tests appear to be conducted on the device itself (engineering tests) rather than on patient data.
• Data Provenance: The tests were performed by PolyTouch Medical Ltd. (the manufacturer). The report does not specify the country of origin for the data beyond the manufacturer's location in Israel. The studies are prospective in the sense that they were conducted specifically for this 510(k) submission to demonstrate the performance of the new, larger device.

3. Number of Experts and Their Qualifications for Ground Truth

This 510(k) is for a surgical mesh deployer, and the performance evaluation largely pertains to the mechanical and functional aspects of the device in facilitating mesh delivery during laparoscopic surgery. Ground truth in this context is likely established through engineering and simulated use testing, potentially involving surgical experts for ergonomic and usability assessments.

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated. However, for a "Performance Evaluation," it is highly probable that qualified engineers and potentially surgeons (or individuals with surgical expertise) were involved in assessing the device's functionality, ease of use, and overall performance in a simulated surgical environment.

4. Adjudication Method for the Test Set

Given the nature of the performance tests (Mesh Rolling and Insertion, Articulation and Maneuverability, Performance Evaluation), an formal adjudication method like "2+1" or "3+1" is not applicable. These tests likely involved:

• Direct observation and measurement: For mechanical properties and functional execution.
• Expert assessment/feedback: For subjective aspects like maneuverability and overall performance in a simulated surgical setting.
  The results would likely be documented and reviewed by the development team and internal quality control, rather than through a multi-reader adjudication process typically seen in diagnostic imaging studies.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the AI's impact on their performance (e.g., accuracy, efficiency) is evaluated. The PatchAssist™ Large is a surgical instrument, not a diagnostic AI device. Therefore, the concept of improving human reader performance with AI assistance is not applicable.

6. Standalone Performance Study

Yes, standalone performance studies were done. The "Mesh Rolling and Insertion using the PatchAssist™ Large Device," "Articulation and Maneuverability Test," and "PatchAssist™ Large Performance Evaluation" are all examples of standalone performance studies. These tests evaluate the device's own functional capabilities and performance characteristics directly, without involving human-in-the-loop performance measurement on diagnostic tasks. The device itself (algorithm) is not performing any independent diagnostic or therapeutic decision-making tasks here; it is a tool.

7. Type of Ground Truth Used

The ground truth for the performance tests would be based on:

• Engineering specifications and objective measurements: For parameters like rolling capability, articulation range, and physical dimensions.
• Simulated use performance: Successful completion of simulated surgical tasks (e.g., deploying large meshes) as assessed by engineers and potentially surgical experts.
• Comparison to predicate device: Implicitly, the ground truth for "no new safety or efficacy issues" is that the PatchAssist™ Large performs comparably to the predicate device K101218, especially concerning the larger mesh capabilities, without introducing adverse effects.

It is not based on pathology, outcomes data, or expert consensus on patient diagnoses, as these are not relevant to the evaluation of a surgical instrument's mechanical and functional performance in this context.

8. Sample Size for the Training Set

This question is not applicable. The PatchAssist™ Large is a mechanical surgical instrument, not an AI or machine learning algorithm that requires a "training set" of data in the computational sense. The device's design is based on engineering principles and iterative development, not on learning from a dataset.

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

This question is not applicable, as there is no "training set" for a mechanical device like the PatchAssist™ Large.

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The PatchAssist device is intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.g. hernia repair).

The PatchAssist device is a single use device that will be provided sterile.

This document is a 510(k) summary for the PatchAssist device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone performance study with specific acceptance criteria and detailed quantitative results. Therefore, many of the requested items are not explicitly available in the provided text.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria or provide specific numerical performance metrics in a table format. Instead, it describes general performance demonstrations.

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

• Test Set Sample Size: Not specified. The document mentions "a full battery of bench tests and animal studies" and "usability testing" but does not detail the number of units tested, animals used, or participants in usability testing.
• Data Provenance: The document implies the tests were conducted by PolyTouch Medical Ltd. or its partners. The country of origin of the data is not explicitly stated. The nature of the studies (bench and animal) suggests they are prospective, designed specifically for this submission.

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

• This information is not provided. The testing described (bench, animal, usability) would typically involve engineers, veterinarians, and possibly surgeons/medical professionals for usability, but their specific number or qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided. Since the studies described are primarily technical performance and usability, a formal adjudication process as seen in clinical trials with expert consensus is less likely to be detailed in this type of submission.

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. This is a medical device for facilitating surgical procedures, not an AI diagnostic or interpretive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not applicable and was not performed.

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

• No. The PatchAssist device is a physical surgical tool that is used by a human surgeon. It's not an algorithm, and therefore standalone performance (without human interaction) is not relevant or applicable.

7. The Type of Ground Truth Used

• For the bench tests: Engineering specifications, physical measurements, and possibly simulated anatomical models.

• For the animal studies: Surgical outcomes, tissue integrity, absence of adverse events, proper mesh deployment.

• For usability testing: User feedback, successful task completion, absence of reported difficulties.

  The document broadly states that testing demonstrated "safe and effective performance," implying that the outcomes of these tests served as the "ground truth" for the device's function.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device is a physical surgical tool, not a machine learning model that requires a training set.

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

• Not applicable. As this is not a machine learning device, there is no training set or associated ground truth establishment process in that context.

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