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The Integrity™ Bone Staple Fixation System is indicated for the fixation of soft tissue grafts or reinforcement meshes to bone during rotator cuff repairs.

The Integrity™ Bone Staple Fixation System consists of bone staples and a delivery instrument. The bone staple is a staple-shaped tack with barbed ends and is comprised of non-absorbable poly(ether ether ketone) [PEEK]. The bone staples are designed to provide fixation of soft tissue grafts or reinforcement meshes to bone at surgery and are used in conjunction with a Delivery instrument from Anika. The device is sterilized by radiation with a SAL of 10-9. The bone staples and delivery instruments are provided sterile for single use only. The staples are packaged in a caddy within a dual sterile packaging configuration.

The provided text describes a 510(k) premarket notification for the "Integrity™ Bone Staple Fixation System," which is a Class II medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy through multi-reader, multi-case studies or extensive standalone AI performance evaluations.

Therefore, the document does not contain the kind of information typically found in studies for AI/ML-driven diagnostic devices, such as:

• Acceptance criteria tables for AI performance metrics (e.g., sensitivity, specificity, AUC)
• Sample sizes for test sets used to evaluate AI performance
• Details on data provenance for AI model development/testing (e.g., country of origin, retrospective/prospective)
• Number and qualifications of experts for ground truth establishment
• Adjudication methods for ground truth
• Multi-reader multi-case (MRMC) comparative effectiveness studies
• Standalone algorithm performance
• Training set sample sizes
• Methods for establishing training set ground truth

Instead, the submission focuses on mechanical performance testing, biocompatibility, and comparison of physical characteristics to the predicate device to demonstrate substantial equivalence.

Here's a breakdown of the relevant information provided:

1. Acceptance Criteria and Device Performance (Mechanical/Biocompatibility):

The document does not present a formal table of "acceptance criteria" for AI performance metrics. Instead, it describes performance testing related to the physical and biological characteristics of the bone staple. The "reported device performance" is summarized qualitatively as having "higher tensile and shear retention strength" demonstrated in mechanical performance testing, and passing biocompatibility tests.

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

• Test Set Sample Size: Not specified in terms of number of cases/patients. "Performance Testing Summary" indicates mechanical, insertion/removal, biocompatibility, and bacterial endotoxin testing were performed. These tests would involve a specific number of device samples, but this detail is not provided.
• Data Provenance: Not applicable in the context of clinical image data for AI. The data provenance here refers to the source of the materials and manufactured devices used for the described non-clinical tests. No geographical or retrospective/prospective data details are relevant to this type of device submission.

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

• Not applicable. This submission does not involve diagnostic image interpretation or clinical expert-established ground truth. The "ground truth" for this device is based on laboratory-measured physical properties and biological responses to materials.

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

• Not applicable. No clinical expert adjudication was performed as part of this non-clinical testing.

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, an MRMC comparative effectiveness study was not done. This device is a bone staple, not an AI-assisted diagnostic tool. The submission explicitly states: "No clinical or animal data were required to support the substantial equivalence."

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

• Not applicable. There is no AI algorithm being evaluated.

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

• For this device, the "ground truth" for performance is based on objective measurements derived from standardized mechanical testing protocols (e.g., tensile strength, shear strength, insertion/removal forces) and biocompatibility testing standards (e.g., ISO 10993 for cytotoxicity, sensitization, irritation) and bacterial endotoxin assays. There is no "expert consensus" or "pathology" as would be seen in diagnostic imaging.

8. The sample size for the training set:

• Not applicable. There is no AI model or "training set" involved.

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

• Not applicable. There is no AI model or "training set" involved.

In summary, this FDA 510(k) submission for a bone staple system is for a conventional medical device and therefore does not include any information related to AI/ML performance testing. The "study that proves the device meets the acceptance criteria" refers to a battery of non-clinical, bench-top mechanical tests and biocompatibility assays, rather than a clinical study evaluating diagnostic accuracy or reader performance.

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