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The HEMORPEX SYSTEM (HPS) is intended for physician use to examine the anal sphincter and anus and to perform several diagnostic and therapeutic procedures, such as surgical treatment for hemorrhoidal disease.

HEMORPEX SYSTEM (HPS) is a diagnostic and operating anoscope, which is mainly intended for the surgical treatment of the hemorrhodal disease through dearterializing hemorrhoidopexy. HemorPex System (HPS) is a device made by a fixed part which remains in contact with the anoderma and the sensible mucosa of the anal canal, and by a rotating operative part which includes the window through which the suture stitches are posed. The instrument has 6 preset positions of the operative window. In these positions there are the 6 terminal branches of the superior hemorrhoidal artery.

The provided text is a 510(k) Summary for the HEMORPEX SYSTEM (HPS), a disposable anoscope. This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed performance studies with acceptance criteria for a novel AI or diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design, and performance metrics is not available in this document.

Here's a breakdown of what can be inferred and what is explicitly not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for a diagnostic or AI device. The acceptance criteria for a 510(k) submission generally revolve around demonstrating substantial equivalence in terms of intended use, technological characteristics, safety, and effectiveness to a legally marketed predicate device.
• Reported Device Performance: No quantitative performance data (e.g., sensitivity, specificity, accuracy, precision) is reported for the HEMORPEX SYSTEM (HPS) in the context of an AI or diagnostic study. The document focuses on comparing its characteristics to a predicate device.

The comparison table in the document (under "Comparison to predicate devices") highlights characteristics such as intended use, material, single use, and packaging, showing alignment with the predicate device, which serves as the "performance" in a substantial equivalence context for this type of device.

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

• Not applicable. This is a medical device clearance document, not a study evaluating an AI/diagnostic algorithm on a test set. There is no mention of a test set, data provenance, or patient data.

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

• Not applicable. There is no mention of a test set, ground truth, or experts establishing it.

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

• Not applicable.

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 document does not describe a study involving human readers or AI assistance.

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

• Not applicable. This is a physical medical device (anoscope), not an algorithm.

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

• Not applicable. There is no AI or diagnostic algorithm being evaluated that would require ground truth.

8. The sample size for the training set:

• Not applicable. This is a physical medical device.

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

• Not applicable.

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Repol Plug Basic: "Repair of inguinal hernia defects."

Repol Plug Cap: "Repair of inguinal hernia defects."

Repol Plug Flower: "Repair of inguinal hernia defects."

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Wings Mesh: "Use in all kind of hernia repair requiring reinforcement with nonabsorbable support material."

Monofilament polypropylene mesh, available in various weights, rigidity, shapes and sizes, to allow an easy use in surgical techniques.

The document provided describes a 510(k) premarket notification for a surgical mesh, focusing on its substantial equivalence to a predicate device, rather than providing detailed performance studies against specific acceptance criteria. Therefore, most of the requested information cannot be extracted from the given text.

Here is what can be inferred or directly stated from the document:

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

• Acceptance Criteria: Not explicitly stated. The core of a 510(k) submission, as implied by this document, is to demonstrate substantial equivalence to a legally marketed predicate device, rather than meeting pre-defined performance acceptance criteria a new device would need to meet.
• Reported Device Performance: Not reported in terms of specific performance metrics. The document states: "The determination of substantial equivalence is not based on an assessment of performance data."

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

• Not applicable/Not provided. The 510(k) states that substantial equivalence is not based on an assessment of performance data. This implies there was no specific "test set" in the context of device performance testing.

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

• Not applicable/Not provided. No performance studies or test sets are described.

4. Adjudication method for the test set

• Not applicable/Not provided. No test sets requiring adjudication are described.

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/Not provided. This document describes a surgical mesh, not an AI-assisted diagnostic or therapeutic device. No MRMC studies are mentioned.

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

• Not applicable/Not provided. This is not an algorithm or AI device.

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

• Not applicable/Not provided. New performance data or ground truth establishment relevant to specific performance metrics is not mentioned as part of the substantial equivalence determination for this device. The basis for ground truth in this submission is likely the established safety and effectiveness of the predicate device.

8. The sample size for the training set

• Not applicable/Not provided. No training sets for algorithms are relevant to this medical device submission.

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

• Not applicable/Not provided. No training sets for algorithms are relevant to this medical device submission.

Summary based on the provided document:

The provided 510(k) notification focuses on establishing substantial equivalence for a surgical mesh by comparing its intended use, target population, contact type, and technological characteristics (materials, sterility, general shape) to a predicate device (SURGICAL MESH "BARD MESH" produced by DAVOL INC.). The crucial statement, "The determination of substantial equivalence is not based on an assessment of performance data," makes it clear that the submission did not include new performance studies or data against specific acceptance criteria for the device itself. Therefore, the detailed information requested regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for studies demonstrating device performance, is explicitly stated as not being the basis for this particular 510(k) clearance.

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