(56 days)
The easyPPHTM Hemorrhoidal Stapler for Single Use has application throughout the anal to perform surgical treatment of hemorhoidal disease.
The easyPPH™ Hemorrhoidal Stapler for Single Use place two double staggered rows of titanium staples and simultaneously cut and divides tissue between the two double rows. The device is available in 33mm length with 3.5mm staple size.
This document describes the FDA's 510(k) clearance for the easyPPH™ Hemorrhoidal Stapler for Single Use (K183477). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving independent acceptance criteria for a novel AI/imaging device. Therefore, many of the requested elements for describing a study proving an AI device meets acceptance criteria are not applicable in this context.
However, I can extract the relevant information regarding the non-clinical tests used to support the substantial equivalence claim.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Tests)
The document primarily relies on non-clinical performance and biocompatibility tests to demonstrate substantial equivalence to a predicate device. It doesn't explicitly state distinct "acceptance criteria" with numerical thresholds alongside "reported device performance" in a table format for each test. Instead, it states that the tests verified that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The implication is that the proposed device's performance in these non-clinical tests was comparable to or within acceptable limits relative to the predicate.
| Test Item | Acceptance Criteria (Implied: Comparable to Predicate Device and Design Specifications) | Reported Device Performance (Implied: Met Criteria) |
|---|---|---|
| Firing Force Test | Performance comparable to predicate device | Performed and found to be SE |
| Staple Formation Test | Staple formation comparable to predicate device | Performed and found to be SE |
| Staple Line Pressure Test | Staple line pressure comparable to predicate device | Performed and found to be SE |
| Staple Line Tensile Test | Staple line tensile strength comparable to predicate device | Performed and found to be SE |
| Closed Staple Height Test | 1.0-1.6mm (explicitly stated in comparison table) | Met (implied by SE conclusion) |
| Package Integrity Test | Maintain sterility and integrity | Performed and found to be SE |
| Bacterial Endotoxin Test | Met (implied by SE conclusion) | |
| Shelf Life Test | Maintain performance over specified shelf life | Performed and found to be SE |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for each non-clinical test. The document states "performance tests were performed on both proposed device and predicate device" but does not quantify the number of units tested.
- Data Provenance: Not explicitly stated (e.g., country of origin, specific labs). These were non-clinical, in-vitro/bench tests. The applicant is Ezisurg Medical Co., Ltd. located in Shanghai, China, suggesting the testing was likely conducted in China. The data would be considered prospective for the purpose of this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as this is a medical stapler device, not an AI or imaging device requiring expert consensus for ground truth on a test set. The "ground truth" for the non-clinical tests would be the objective measurements obtained through standard test methods.
4. Adjudication Method for the Test Set
- Not applicable for non-clinical bench testing.
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 device. The study was non-clinical.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is not an AI algorithm. Its performance is inherent to the physical device.
7. The Type of Ground Truth Used
- For the non-clinical tests, the "ground truth" was established by objective laboratory measurements based on recognized standards (e.g., ISO, ASTM, USP) for properties like staple dimensions, firing force, tensile strength, and biocompatibility. The comparison was primarily against the predicate device's characteristics and the device's own design specifications.
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.
§ 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.