(56 days)
The Femoral Intrafix Screw and Sheath is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.
The Femoral Intrafix Screw and Sheath are non-absorbable implants used to secure soft tissue grafts to the bone during cruciate ligament reconstruction. The two-part system consists of an expandable sheath that is inserted into the center of the tunnel. The sheath separates the graft strands and places them against the tunnel wall. The screw is inserted into the center of the expansion sheath. sheath and compresses the tissue against the bone. This device system consists of the following components: Femoral Intrafix Screws and Sheaths in various sizes *Various manual surgical instruments * The various manual surgical instruments are Class I exempt (per 21 CFS 888.4540 "Orthopaedic Manual Surgical Instruments) stand-alone instruments used as an aide during the surgical application.
The provided text describes a 510(k) summary for a medical device called "Femoral Intrafix Screw and Sheath." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a standalone study structured to meet specific efficacy endpoints.
Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not directly applicable or available in the provided 510(k) summary.
Here's a breakdown of why these questions cannot be answered based on the provided text, and what information is available:
1. A table of acceptance criteria and the reported device performance
- Not applicable/Available: The 510(k) pathway for medical devices focuses on demonstrating substantial equivalence to a predicate device, not on meeting specific, de novo acceptance criteria for performance. The summary states, "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." It does not provide a table of acceptance criteria or detailed performance metrics.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available: The summary does not describe a clinical study or a test set with a specific sample size for evaluating performance in the way implied by the question. The "performance and safety testing" mentioned would typically involve mechanical testing, biocompatibility, and sterilization validation, not patient-level data.
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/Available: No clinical test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Available: No clinical test set is described.
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/Available: This device is a surgical implant (screw and sheath), not an AI-powered diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Available: This device is not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable/Available: No clinical study requiring ground truth is described.
8. The sample size for the training set
- Not applicable/Available: This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Available: This device is not an AI algorithm.
Summary of available information from the text:
- Device Name: Femoral Intrafix Screw and Sheath
- Indications for Use: Fixation of soft tissue grafts during cruciate ligament reconstruction.
- Predicate Devices: Intrafix Screw and Sheath (K983560); Milagro Interference Screw (K032717); Bio-Intrafix Screw and Sheath (K032167).
- Safety and Performance Statement: "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices." This is the core "study" and "acceptance criteria" in the context of a 510(k) – showing equivalence, not de novo performance against specific metrics.
- Device Description: A two-part non-absorbable implant system (expandable sheath and screw) used to secure soft tissue grafts against the tunnel wall during cruciate ligament reconstruction.
- Classification: Class II, Product Codes MBI and HWC, under 21 CFR 888.3040 (Smooth or threaded metallic bone fixation fastener).
§ 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.