(643 days)
The Ace Connex™ Pre-Sutured Fascia is intended for use as a component in soft tissue surgical procedures where constructs including those with allograft tissues are used for reconstruction, replacement, or augmentation of the hip labrum.
The Labrum Replacement and Augmentation Device, marketed as AceConnex™ Pre-Sutured Fascia subject device is a pre-assembled surgical construct comprised of allograft tissue and non-absorbable, synthetic suture. The allograft fascia lata tissue is terminally cleaned and disinfected using a proprietary process. The fascia lata tissue is pre-sutured with Force Fiber® ultra-high molecular weight polyethylene (UHMWPE) non-absorbable surgical suture cleared under K063778, and the device is terminally sterilized by low dose electron beam irradiation.
The device has a smooth side for articulating against the rotating cartilage surface and a sutured side which is secured against the bone and comes in three sizes to accommodate the needs of surgeons performing segmental (40-60mm and 60-100mm) and full circumferential (100-140mm) augmentations or reconstructions. Each device contains two adjustable sections where the device may be cut to provide adjustment options so that the device may be trimmed to fit the needs of patient and surgeon.
This document does not contain information about the acceptance criteria and study proving the device meets the acceptance criteria in the manner requested. The provided text is a 510(k) summary for the AceConnex™ Pre-Sutured Fascia, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report with specific acceptance criteria and performance data in a tabular format.
Here's why the requested information cannot be extracted from this document:
- Table of Acceptance Criteria and Reported Device Performance: While the document states that "the subject device passed all product performance tests" and lists some characteristics (e.g., "suture pullout strength greater than the estimated force on the labrum in a healthy hip during jogging"), it does not provide a formal table with quantitative acceptance criteria and corresponding quantitative device performance results.
- Sample Size, Data Provenance, Expert Information, Adjudication Method, MRMC Study, Standalone Study, Ground Truth Type, Training Set Size, Training Set Ground Truth: None of these details, which are typical for clinical performance studies, are present in this 510(k) summary. This type of submission relies on demonstrating substantial equivalence through comparison to an already cleared predicate device, often supported by bench testing (product performance testing) rather than extensive clinical studies with human subjects and expert evaluations.
Based on the provided text, the following information can be extracted:
- Device Name: AceConnex™ Pre-Sutured Fascia
- Device Type: Pre-assembled surgical construct comprised of allograft tissue and non-absorbable, synthetic suture.
- Intended Use: As a component in soft tissue surgical procedures where constructs including those with allograft tissues are used for reconstruction, replacement, or augmentation of the hip labrum.
Regarding the "study that proves the device meets the acceptance criteria," the document mentions "Product Performance Testing," which included:
- Visual, physical, mechanical, and clinical properties assessment.
- Outcomes reported (without specific quantitative acceptance criteria or detailed study methodology):
- Device integrity maintained during surgical preparation and application.
- Device length was adjustable.
- Device conformed to the acetabular rim.
- Device was securable with knotted and knotless suture anchors.
- Suture pullout strength greater than the estimated force on the labrum in a healthy hip during jogging.
- Retains necessary tensile strength after two years frozen storage.
- Similar physical properties of surgeon fascia allografts.
- Bacterial Endotoxin Testing: Resulted in less than 20 EU/Device, meeting bacterial endotoxin testing requirements (standards listed: USP chapter , ANSI/AAMI ST72:2011, FDA Guidance for Industry: Pyrogen and Endotoxins Testing).
In summary, the provided document does not contain the detailed clinical study information requested. It focuses on engineering and bench testing results to support substantial equivalence.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.