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The Biosteon™ Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon:

• places the graft in tibial and/or femoral tunnels; and
• inserts screws between the tunnel wall and graft to hold the graft in place.

The Biosteon™ Screw is used to provide interference fixation of patellar bone-tendonbone grafts in ACL reconstruction.

The Biosteon™ Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

The Biosteon™ Screw is a cannulated, sterile, single-use bone screw made of an absorbable polymer similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The Biosteon™ Screw is manufactured from a mixture of Hydroxyapatite (HA) and poly (L-lactide) (PLLA).

The provided 510(k) summary for the Biosteon™ Screw (K003641) does not contain detailed acceptance criteria or a study that explicitly proves the device meets specific quantitative acceptance criteria in the way described in your request (e.g., sensitivity, specificity, or other performance metrics typically associated with AI/software-as-a-medical-device studies).

This document pertains to a physical medical device (an absorbable bone screw), not an AI/software device. Therefore, many of the requested fields, such as those related to AI model performance, expert ground truth, sample sizes for test/training sets, and MRMC studies, are not applicable in this context.

Here's an attempt to extract and interpret the available information according to your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document states "Test results" but does not quantify the number of units tested.
• Data Provenance: Not applicable in the context of human data. The tests are laboratory-based mechanical performance tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This is a physical device; ground truth for its mechanical properties is established through standardized engineering tests, not expert human assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. No human adjudication method is described or implied for the mechanical testing of the screw.

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. No MRMC study was conducted as this is not an AI/software device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an algorithm or software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Mechanical Testing Results / Engineering Standards: The ground truth for the device's performance (strength, pull-out force) would be derived from laboratory measurements against established engineering specifications or benchmarks set by predicate devices.

8. The sample size for the training set

• Not Applicable. This is not a machine learning/AI device, so there is no training set in the AI sense. The "training" for the device's design would come from materials science research and iterative design processes.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

Summary of Device Performance Study (as described in the 510(k) summary):

The 510(k) summary indicates that the substantial equivalence of the Biosteon™ Screw to predicate devices (Bio Interference Screw, BioScrew, BioLok® Screw) was supported by performance data, specifically mechanical testing.

• Study Design (Implied): Comparative mechanical testing.
• Primary Outcome: Confirmation of "requisite strength to provide early and sustained fixation of the graft" and "favourable pull out test results" when compared to predicate devices.
• Test Method (Implied): Mechanical assays such as tensile strength, compression, and pull-out force tests, likely conducted in a laboratory setting using surrogate materials or cadaveric models that mimic the surgical environment.
• Results: The device demonstrated "requisite strength" and "favourable pull out test results" compared to its predicates. This satisfied the FDA's requirement for demonstrating substantial equivalence based on technological characteristics and performance.

Conclusion:

The provided document describes the safety and effectiveness of a physical bone fixation screw. The "study" mentioned refers to mechanical performance testing, which is common for such devices. It does not involve any AI components, human readers, or the complex validation methodologies associated with AI-driven medical devices. The acceptance criteria are implicitly met by demonstrating comparable mechanical performance to legally marketed predicate devices.

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The BioLok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon:

• · places the graft in tibial and/or femoral tunnels; and
• · inserts screws between the tunnel wall and graft to hold the graft in place.

The BioLok® Screw is used to provide interference fixation of patellar bone-tendonbone grafts in ACL reconstruction.

The BioLok® Screw is used to provide interference fixation during femoral and/or The Block Screw is assoc to provise using a soft tissue graft (semi-tendonosis gracilis).

The BioLok® Screw is a cannulated, sterile, single-use bone screw made of an absorbable polymer similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The BioLok® Screw is manufactured from a mixture of Tri-Calcium Phosphate (TCP) and poly (L-lactide) (PLLA).

The provided text describes a medical device, the BioLok® Screw, and its 510(k) summary for FDA clearance. However, it does not include the detailed information required to fill out all aspects of your request, particularly regarding specific acceptance criteria, detailed study designs, and performance metrics for AI/algorithm-based devices.

The BioLok® Screw is a physical medical device, not an AI or algorithm-driven system, so many of your requested categories (like MRMC studies, standalone algorithm performance, training set details, ground truth for AI, etc.) are not applicable here.

Here's the information that can be extracted or inferred from the provided text, along with explanations for the unfillable sections:

1. A table of acceptance criteria and the reported device performance

Explanation: The document does not explicitly list numerical acceptance criteria (e.g., "pull-out strength must be X Newtons"). Instead, it states that the device "has the requisite strength" and "compares favourably" to predicate devices, which implies that the acceptance criteria were met by demonstrating equivalence or non-inferiority to already cleared devices.

2. Sample sized used for the test set and the data provenance

• Sample Size: Not specified. The document mentions "test results" but does not quantify the number of screws or conditions tested.
• Data Provenance: Not specified. The country of origin for the device manufacturer is the United Kingdom (Biocomposites Ltd, Etruscan Street, Etruria, Stoke-on-Trent, ST1 5PQ, England). Whether the testing was conducted there or elsewhere is not stated. The data type is prospective, as it refers to performance testing of the device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This device is a physical implant. The "ground truth" for its performance is established through biomechanical testing and material science, not through expert clinical interpretation of data.

4. Adjudication method for the test set

• Not Applicable. See point 3.

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 a physical medical device, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a physical medical device.

7. The type of ground truth used

• Biomechanical Testing and Material Science Data: The "ground truth" for the BioLok® Screw's acceptance criteria would be derived from:
  • Mechanical Property Measurements: Strength (tensile, compression, shear, torsional, etc.), degradation rates.
  • Material Characterization: Composition, purity, molecular weight distribution, etc.
  • In Vitro Performance: Pull-out tests, degradation studies in simulated physiological environments.
  • Comparison to Predicate Devices: Performance data from legally marketed predicate devices served as a benchmark for substantial equivalence.

8. The sample size for the training set

• Not Applicable. This is a physical medical device. There is no "training set" in the context of an algorithm. Material formulation and manufacturing processes are optimized through development, but this is not typically referred to as a "training set" for a device like this.

9. How the ground truth for the training set was established

• Not Applicable. See point 8.

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The BioLok® Screw is indicated for use in anterior cruciate ligament (ACL) reconstruction procedures where the surgeon:

• places the graft in tibial and/or femoral tunnels; and .
• inserts screws between the tunnel wall and graft to hold the graft in place. .

The BioLok® Screw is used to provide interference fixation of patellar bone-tendon-bone grafts in ACL reconstruction.

The BioLok® Screw is used to provide interference fixation during femoral and/or tibial fixation in ACL reconstruction using a soft tissue graft (semi-tendonosis gracilis).

The BioLok® Screw is a cannulated, sterile, single-use bone screw made of an absorbable polymer similar to that used in bioabsorbable suture and will gradually be absorbed into the body. The BioLok® Screw is manufactured from a mixture of Tri-Calcium Phosphate (TCP and poly (L-lactide) (PLLA).

The provided document is a 510(k) summary for the BioLok® Screw, a medical device. This type of document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. It does not typically include information about clinical trials, extensive performance studies, or AI-related aspects like multi-reader multi-case studies, ground truth establishment for training data, or sample sizes related to AI model development.

Based on the provided information, I can answer the following:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria in the format typically seen for rigorous performance metrics (e.g., specific thresholds for strength, pull-out force, etc.). Instead, the performance data provided is comparative.

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for any mechanical or performance tests. It also does not mention data provenance (e.g., country of origin, retrospective/prospective) for any test data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The device is a bone fixation screw; its performance is evaluated through mechanical testing, not by expert interpretation of images or data requiring ground truth establishment in the way an AI diagnostic device would.

4. Adjudication method for the test set

This information is not applicable and not provided. The evaluation of mechanical test results does not typically involve adjudication methods like those used for expert consensus in clinical trials or diagnostic studies.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images. The BioLok® Screw is a physical surgical implant, not an AI diagnostic tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. The BioLok® Screw is a physical device, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, outcomes data, expert consensus on images) is not directly applicable here. The "ground truth" for a mechanical device like the BioLok® Screw would be the objective measurements of its physical and mechanical properties and its performance in specific tests (e.g., force required for pull-out, material degradation rates). The document states "Test results confirm that this composite has the requisite strength over time" and "Pull out test results compare favorably with the predicate devices," implying these mechanical test outcomes are the basis for evaluation.

8. The sample size for the training set

This information is not applicable and not provided. There is no mention of a "training set" as the device is not an AI model.

9. How the ground truth for the training set was established

This information is not applicable and not provided, as there is no training set for an AI model.

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