(86 days)
The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended to be used for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts.
The Inion Hexalon™ Biodegradable ACL/PCL Screw is made of resorbable polylactic acid / trimethylenecarbonate copolymers and it is provided in the various lengths and diameters typical of the other marketed devices. The Inion Hexalon™ Biodegradable ACL/PCL Screw is offered both undyed and coloured for better visualization during surgical operation. Colour additive used for dying the device is FDA approved colourant: D&C Green No.6, in accordance with the Title 21 CFR 74.3206. The Inion Hexalon™ Biodegradable ACL/PCL Screws gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years.
The provided text describes a 510(k) summary for a medical device, the Inion Hexalon™ Biodegradable ACL/PCL Screw. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a dedicated study.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not present in this document because they are typically required for performance studies, not for 510(k) substantial equivalence submissions.
Here's a breakdown of the available information:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of quantitative performance metrics for the device itself. | Mechanical testing demonstrated substantial equivalence to predicate devices. The device gradually loses strength over 18-36 weeks and bioresorbs within two to four years. |
| Substantial equivalence to predicate devices (Linvatec BioScrew®, Arthrex Bio-Interference Screw, Arthrotek Interference Screw, Sysorb Interference Screw) in terms of intended use, principles of operation, and similar design characteristics. (Implied Acceptance Criteria) | The Inion Hexalon™ Biodegradable ACL/PCL Screw was found substantially equivalent to the listed predicate devices. |
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 for test set: Not specified. The document states "Mechanical testing demonstrates that the device is substantially equivalent to the predicate," but does not provide details on the number of samples tested.
- Data provenance: Not specified. The manufacturer is Inion Ltd., based in Tampere, Finland.
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. Ground truth establishment with experts is usually relevant for diagnostic devices or those requiring subjective assessment. For a mechanical device demonstrating equivalence, expert consensus on performance metrics is not typically the primary method.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in studies involving subjective interpretation of data (e.g., medical images). Mechanical testing typically relies on objective measurements.
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 type of study (MRMC, AI assistance) is not applicable to an orthopedic fixation screw primarily evaluated for mechanical equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The implicit "ground truth" used for demonstrating substantial equivalence was the established performance and safety profile of the predicate devices, as assessed through mechanical testing. The document states, "Mechanical testing demonstrates that the device is substantially equivalent to the predicate," implying direct comparison of measured mechanical properties against those of the predicate devices or accepted standards for such devices.
8. The sample size for the training set
- Not applicable/Not specified. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning or AI 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.