(66 days)
The Inion Hexalon™ Biodegradable ACL/PCL Screw is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.
Inion Hexalon™ Biodegradable ACL/PCL Screw is made of resorbable polylactic acid / trimethylenecarbonate copolymer. The Inion Hexalon™ Biodegradable Screws are coloured green for better visualization during surgical operation.
Inion Hexalon™ Biodegradable ACL/PCL Screws gradually lose their strength during 18-36 weeks. Bioresorption takes place within two to four years. Inion Hexalon™ Biodegradable ACL/PCL Screw is sterile and non-collagenous. The shelf life of the product is three years.
This document is a 510(k) summary for the Inion Hexalon™ Biodegradable ACL/PCL Screw, a medical device for orthopedic fixation. It does not contain information about acceptance criteria or a study proving the device meets them in the way a diagnostic AI would.
This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving the performance of a novel diagnostic algorithm against specific acceptance criteria. This process is common for medical devices.
Therefore, many of the requested categories for a diagnostic AI study on acceptance criteria and performance cannot be directly extracted from this document, as they are not applicable to the type of regulatory submission presented.
Here's a breakdown of what can be derived from the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Not applicable / Not provided in this format. This document does not present acceptance criteria or reported performance as it would for a diagnostic AI. The goal of a 510(k) is to show substantial equivalence to existing devices. The "performance" is implicitly deemed equivalent to the predicate devices.
- The closest "performance" related information is that the device "gradually lose their strength during 18-36 weeks" and "Bioresorption takes place within two to four years." These are characteristics, not performance metrics against acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. This is a medical implant, not a diagnostic AI that uses a test set of data. The "study" mentioned here is the comparison to predicate devices and the characterization of the material properties described above.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Again, this is not a diagnostic AI performance study.
4. Adjudication Method for the Test Set:
- Not applicable.
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 not a diagnostic AI and therefore no MRMC study would be conducted in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of an AI ground truth. For this device, the "ground truth" for substantial equivalence relies on:
- Material composition: Polylactic acid / trimethylenecarbonate copolymer.
- Scientific technology: Biodegradable screw for fixation.
- Degradation profile: 18-36 weeks for strength loss, 2-4 years for bioresorption.
- Mechanical properties: Implied to be similar to predicate devices.
- Predicate devices: Arthrex Interference Screw, Arthrex Tenodesis Screw Family, Biomet Bio-Core Interference Screw, Biomet Resorbable Interference Screw. The "ground truth" for their safety and effectiveness is their prior FDA clearance and market history.
8. The Sample Size for the Training Set:
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
Summary of what can be extracted concerning "acceptance criteria" and "study" for this type of device:
The "study" presented in this 510(k) is primarily a comparative study for substantial equivalence to previously cleared predicate devices.
Acceptance Criteria for Substantial Equivalence (Implicit from the document):
The device is considered to have met "acceptance criteria" for marketing if it is demonstrated to be substantially equivalent to predicate devices, meaning:
- Same intended use: Soft tissue (ligament, tendon, bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand, and wrist.
- Similar technological characteristics: Material composition (resorbable polylactic acid/trimethylenecarbonate copolymer), degradation profile, and mechanical properties are comparable to predicate devices.
- No new questions of safety and effectiveness: The differences between the Inion Hexalon™ screw and the predicate devices do not raise new concerns.
The "Study" that Proves the Device Meets these Criteria:
- The "study" is a technical and scientific comparison to predicate devices, backed by information on the device's material properties and degradation profile.
- The document states: "The evidence demonstrates that the intended use, material composition and scientific technology, degradation profile and mechanical properties of Inion Hexalon™ Biodegradable ACL/PCL Screw are substantially equivalent with the predicate devices."
- Data Provenance: This would typically involve laboratory testing of the Inion Hexalon™ screw's material and mechanical properties (e.g., strength testing, degradation studies) and a review of the predicate devices' characteristics. The document does not specify where these tests were conducted or the specific experimental design, but it implies such data was submitted to the FDA to support the substantial equivalence claim.
- No specific sample sizes for "test sets" or "training sets" are provided because this is not a diagnostic AI or a clinical trial in the conventional sense of proving efficacy or safety from scratch. Instead, it relies on the established safety and efficacy of the predicate devices.
§ 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.