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510(k) Data Aggregation
(77 days)
The Doubleplay™ Suture Anchor is intended for fixation of suture to bone in orthopaedic procedures in the shoulder, foot/ankle, knee, hand/wrist, elbow and pelvis.
The Doubleplay™ Suture Anchor is a bioabsorbable device manufactured from Bilok®, a composite mixture of poly-L-lactic acid (a synthetic bioabsorbable polymer) and calcium phosphate (bone void filler material). It may be supplied with sutures with or without pre-attached needles.
The provided text describes a 510(k) submission for the Doubleplay™ Suture Anchor, a bioabsorbable device used for fixation of suture to bone in orthopedic procedures. Here's a breakdown of the information requested based on the supplied text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a medical device (suture anchor), not an AI device. Therefore, the concept of "acceptance criteria" in the context of sensitivity, specificity, or AUC for an algorithmic diagnostic output does not directly apply. Instead, the "acceptance criteria" implicit in this 510(k) submission are that the device demonstrates substantial equivalence to legally marketed predicate devices in terms of its characteristics, intended use, safety, and effectiveness.
| Acceptance Criteria (Implicit for Substantial Equivalence Determination) | Reported Device Performance (from K061949 Summary) |
|---|---|
| Material Composition | The Doubleplay™ Suture Anchor is manufactured from Bilok®, a composite mixture of poly-L-lactic acid and calcium phosphate. This material has been used in other bone site applications for approximately eight years with no reported incidents of material-related adverse events. |
| Technological Characteristics | "The Doubleplay™ Suture Anchor has the same technological characteristics as the predicate devices and any differences do not raise concerns concerning safety and effectiveness." |
| Intended Use / Indications | "The Doubleplay™ Suture Anchor is intended for fixation of suture to bone in orthopaedic procedures." The indications, contraindications, risks, and potential adverse events are stated to be the same as the identified predicate devices. |
| Non-Clinical Testing | "Test data supplied demonstrates that the Doubleplay™ Suture Anchor is substantially equivalent to the predicate devices and any differences do not raise concerns concerning safety and effectiveness." (Specific test results are not provided in the summary) |
| Resorption Profile (for bioabsorbable material) | Implant studies show the material is not resorbed in less than 12 months, which is greater than the expected bony healing period (typically 12 weeks) and tissue-to-bone healing period (typically 6-8 weeks). |
| Overall Safety and Effectiveness | "No new concerns have been identified regarding safety and effectiveness of the new device." |
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not mention a "test set" in the context of an algorithm's performance evaluation. The "testing" referred to is primarily non-clinical (e.g., mechanical, material characterization) and potentially clinical experience with the material used.
- No specific sample size for an algorithmic "test set" is provided as this is not an AI device.
- Data provenance for the clinical experience with the material is stated as general "implant studies" and "other bone site applications" over approximately eight years. The country of origin and whether these were retrospective or prospective studies are not specified in this summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This is not an AI device, and the concept of "ground truth" established by experts for an algorithmic test set is not relevant to this submission.
4. Adjudication Method for the Test Set
Not applicable. There is no algorithmic test set or adjudication process described in this context.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI device, and no MRMC study comparing human readers with or without AI assistance is mentioned.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a medical device (suture anchor), not an algorithm.
7. Type of Ground Truth Used
Not applicable in the context of an AI device's performance evaluation. For a physical device like a suture anchor, "ground truth" would be related to clinical outcomes, biomechanical performance, biocompatibility, and material properties, which are assessed through various non-clinical and clinical (in a broader sense, relating to material history) studies rather than expert consensus on diagnostic images.
8. Sample Size for the Training Set
Not applicable. This is not an AI device, and therefore, there is no "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.
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