(52 days)
The PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.
The PROXIMATE HCS 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 (PPH). The set is also used for other applications where circular or semicircular stapling of anorectal tissue is desired.
The provided text describes a 510(k) submission for the PROXIMATE® HCS Hemorrhoidal Circular Stapler and Accessories. However, it does not contain information about acceptance criteria, device performance, sample size for testing or training, expert qualifications for ground truth, or adjudication methods.
The submission is primarily focused on demonstrating "substantial equivalence" to a predicate device based on technological characteristics and clinical evidence in the form of published clinical data and other information, rather than a new clinical study with specific performance metrics and acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified for this submission. The device is stated to be "identical to the predicate device" with only changes in "Indications for Use statement and Instructions for Use." Clinical evidence is cited as "Published clinical data and other information demonstrat[ing] the general utility of the HCS device to staple and resect anorectal tissue..." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The submission refers to "Published clinical data and other information" without detailing specific studies or sample sizes.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not specified. The submission relies on existing clinical data and the substantial equivalence principle, not a new test set with expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
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 is not an AI-based device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical stapler, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not explicitly stated for this 510(k) submission itself. For the "Published clinical data" referenced, it would typically involve clinical outcomes data from surgical procedures where the device was used.
8. The sample size for the training set
- Not applicable/Not specified. This is a hardware device, not a machine learning model requiring 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.