(41 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to cut and staple intraluminal tissue in a manner similar to the predicate device. | Preclinical testing demonstrated the ability of the PPH device to cut and staple intraluminal tissue in a manner similar to the predicate, thus meeting all the requirements of substantial equivalence. |
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.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.