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The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The PROXIMATE PPH Hemorrhoidal Circular Stapler (PPH03) is available in a 33mm diameter size only. The instruments allow surgeon to control tissue compression by varying the height of the closed staple. The instrument has been designed for the procedure for prolapse and hemorrhoids (PPH).

The provided document is a 510(k) summary for the PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, number and qualifications of experts, or adjudication methods for a test set.
• Details of a multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Results of a standalone algorithm-only performance study.
• Type of ground truth used.
• Sample size for the training set or how ground truth for the training set was established.

Explanation:

The 510(k) summary explicitly states that the "Technological and Performance Characteristics The technological and performance characteristics of the device remain unchanged." This indicates that the device being submitted is a modification or re-submission of an existing device (or one substantially equivalent to an existing device) and therefore, extensive new clinical performance data to meet specific acceptance criteria is typically not required or presented in this type of submission. The FDA's review in this case focuses on ensuring that the device is as safe and effective as a legally marketed predicate device.

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The PROXIMATE® PPH Hemorrhoidal Circular Stapler and accessories have application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.

The PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories are a set of instruments that facilitate delivery of a circumferential, staggered, double-row of staples while simultaneously resecting a segment of compressed soft tissue. The set is commonly used in the Procedure for Prolapse and Hemorrhoids, from which the name of the modified device is derived.

The provided text describes a 510(k) submission for the PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories (PPH03). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data with acceptance criteria for device performance as would be seen in a de novo or PMA application.

Based on the provided text, 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

The document states "Preclinical testing," which typically refers to bench testing or animal studies, not human clinical trials. No specific sample size for a "test set" (human subjects) is mentioned. No data provenance in terms of country of origin or retrospective/prospective human data is provided since human clinical studies are not detailed.

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

Not applicable. The "ground truth" in this context would likely be based on technical specifications and performance metrics aligned with the predicate device, not expert consensus on diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no mention of an adjudication process for a "test set" of human data.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document does not describe human reader performance or AI assistance.

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

Not applicable. This device is a surgical stapler, not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on the functional equivalence to the predicate device in terms of its ability to cut and staple intraluminal tissue. This would likely be assessed through engineering specifications, material testing, and potentially animal model performance mimicking the predicate's known capabilities.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical surgical instrument, not an AI model requiring a training set.

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

Not applicable. As above, this is a mechanical device, not an AI model.

Summary from the provided text:

The submission for the PROXIMATE® PPH Hemorrhoidal Circular Stapler and Accessories is a 510(k) application, which primarily aims to demonstrate substantial equivalence to an existing predicate device (PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories, K991030). The "study" mentioned is "Preclinical testing," which focused on demonstrating that the new device could perform its intended function (cutting and stapling intraluminal tissue) in a manner similar to the predicate device. The acceptance criteria essentially align with the functional performance of the predicate device. No human clinical trials, expert reviews for ground truth, or AI-related performance metrics are detailed in this 510(k) summary.

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