(26 days)
The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissuc grafts.
Inion Hexalon™ Biodegradable ACL/PCL screws are intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts. The new screws are identical with the other implants in the previously 510(k) cleared Inion Hexalon™ Biodegradable ACL/PCL Screw (K021280) in terms of copolymer composition, colour additive, intended use and indications for use as described in the device labelling. manufacturing method and sterilization method.
This document is a marketing approval for a medical device (510(k) clearance) rather than a study report with detailed performance data or acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving performance cannot be extracted directly from the provided text.
Specifically, the document states: "No applicable mandatory performance standards exist for this device. Compliance to voluntary consensus standards is listed in the application." This indicates that there are no specific, quantitative acceptance criteria for device performance laid out in this clearance document. Instead, the clearance relies on demonstrating substantial equivalence to a predicate device.
Here's what can be extracted from the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify quantitative acceptance criteria or detailed reported device performance in terms of metrics like accuracy, sensitivity, or specificity. It focuses on demonstrating substantial equivalence.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. The document describes a "510(k) summary for the line extension" and states "Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and substantially equivalent with the predicate device". This implies performance data was presented elsewhere in the full 510(k) application, but it is not detailed in this summary. There is no mention of a "test set" in the context of a study demonstrating performance.
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)
- Cannot be provided. Not applicable as no specific test set and ground truth establishment process is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. Not applicable as no specific test set and ground truth establishment process 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
- Cannot be provided. This device is a biodegradable orthopedic screw, not an AI-powered diagnostic device. Therefore, an MRMC study or AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This device is a physical medical implant, not an algorithm. Standalone performance as typically described for software or AI devices is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. The concept of "ground truth" as used in algorithm performance evaluation does not directly apply to the approval of an orthopedic implant based on substantial equivalence. The "truth" in this context relates to the safety and effectiveness of the device compared to a legally marketed predicate.
8. The sample size for the training set
- Cannot be provided. This device is a physical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established
- Cannot be provided. Not applicable to this type of device.
Summary of what the document implies about "meeting criteria":
The device meets the acceptance criteria by demonstrating substantial equivalence to an already approved predicate device (Inion Hexalon™ Biodegradable ACL/PCL Screw, K021280).
The study that proves the device meets the criteria (i.e., is substantially equivalent) is inferred from the statement: "Based on the performance data and specifications presented, it can be concluded that the intended use, material composition and scientific technology, degradation profile and substantially equivalent with the predicate device Inion Hexalon™ Biodegradable ACL/PCT. screw (K021280)."
The "performance data and specifications presented" would have been part of the full 510(k) submission, but are not detailed in this summary. They would typically involve:
- Material composition analysis: Ensuring the new screws use the same copolymer and color additive.
- Mechanical testing: Demonstrating that the new screws have comparable mechanical strength, fatigue resistance, and interference fixation properties to the predicate.
- Degradation profile studies: Showing that the degradation rate and byproducts are similar to the predicate device.
- Biocompatibility testing: As required for implants, although often covered by the predicate if materials are identical.
- Manufacturing and sterilization method consistency: Confirmation that these are identical to the predicate.
The acceptance criterion for approval in this context is the FDA's determination that the new devices do "not raise new questions of safety and effectiveness" compared to the predicate device, thereby confirming substantial equivalence under 21 CFR 807.92(a)(3). The "study" is the entirety of the data and analysis provided in the 510(k) submission to support this claim of substantial equivalence.
§ 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.