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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.

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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.

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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

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.

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