(259 days)
The Cortical Fixation Systems are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction.
The Cortical Fixation Systems are available in two (2) models. The first one is the Cortical Fixation System (cortical button with fixed length loop). The second model is the Adjustable Cortical Fixation System (cortical button with adjustable length loop). These devices can be used with an Extended Plate which allows a larger surface of contact with the cortical bone. These products are anchor devices with titanium cortical button and are intended to be used as a soft tissue to bone fixation, especially for the ACL repair. The graft is passed through the loop and the titanium button ensures the tensioning and the fixation of the system.
The provided text describes the 510(k) summary for the Cousin Biotech Cortical Fixation Systems, which are used for fixation of tendons and ligaments during orthopedic reconstruction procedures such as anterior cruciate ligament (ACL) reconstruction. However, it does not contain a specific study that proves the device meets particular acceptance criteria in terms of clinical performance or diagnostic accuracy. Instead, it details the design verification and validation activities performed to ensure the device is safe, effective, and performs as intended, and that it is substantially equivalent to predicate devices.
The acceptance criteria described are largely related to manufacturing, sterility, biocompatibility, and mechanical performance, rather than clinical efficacy as might be found in a study for an AI/CAD product.
Here's a breakdown of the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria/Standard | Device Performance/Validation Result |
|---|---|---|
| Sterilization | ISO 11137-1:2006, Am1:2013 | Complies, SAL 10-6 |
| ISO 11137-2:2013 | Complies | |
| ISO 11737-1:2006, Cor1:2007 | Complies | |
| ISO 11737-2:2009 | Complies | |
| ISO 11135:2014 | Complies | |
| ISO 10993-7:2008, Cor1:2009 | Complies | |
| Pyrogenicity | FDA Guidance (21 Jan 16) | Non-pyrogenic |
| Shelf Life | ISO 11607-1:2006 | Complies |
| ISO 11607-2:2006 | Complies | |
| ASTM D4169-16 | Complies | |
| ASTM F1929-12 | Complies | |
| ASTM F1980-16 | Complies | |
| Biocompatibility | ISO 10993-1:2009 | Complies |
| Performance Testing | IEC 62366:2007 | Complies with predetermined specifications and standards |
| ISO 5832-3:2016 | Complies with predetermined specifications and standards | |
| ISO 14630:2012 | Complies with predetermined specifications and standards |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This document describes a 510(k) submission for a medical device (surgical implant), not an AI/CAD system. Therefore, the concept of a "test set" in the context of diagnostic performance or AI algorithm evaluation is not applicable here. The performance testing refers to bench testing of the physical device, sterilization validation, shelf-life studies, and biocompatibility assessments. These types of tests do not typically involve patient "test sets" or data provenance in the way an AI study would.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device and study. The "ground truth" for these tests would be the established scientific and regulatory standards themselves (e.g., a specific sterility assurance level, a validated packaging seal strength, or a measured material property).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable for this type of device and study. Adjudication methods are typically used in clinical trials or diagnostic studies where expert consensus is needed to establish a definitive diagnosis or outcome.
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 a physical surgical device, not a diagnostic imaging or AI assistance system, so MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical surgical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the verification and validation (V&V) activities described are the published national and international standards (e.g., ISO, ASTM, IEC) for sterilization, biocompatibility, packaging, and material properties, as well as the predetermined technical specifications of the device itself. These are objective engineering and scientific benchmarks, not clinical "ground truth" in the diagnostic sense.
8. The sample size for the training set
Not applicable. This is a physical surgical device, not an AI system that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As above, this is a physical medical device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.