(28 days)
The Extremity Medical Suture Anchor is intended for the fixation of soft tissue to bone in shoulder. foot/ ankle, knee, hand/wrist, and elbow in the following procedures:
Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair. Capsular Shift of Capsulolabral Reconstruction.
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Mid-foot reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy.
Knee: Medial Collateral Ligament Repair. Lateral Ligament Repair. Patellar Tendon Repair. Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis.
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction.
The Extremity Medical Suture Anchor is an implantable device manufactured from Titanium Alloy (6AL-4V ELI, per ASTM F136). The suture anchor is preloaded with two or three sutures depending on the size of the anchor. The suture material is Size #2 Teleflex Force Fiber. The device is recommended to be used for the repair of soft tissue to bone. The suture anchor and sutures are assembled to an inserter which is used to screw the anchor into bone. The product is provided pre-packaged and sterile via EtO sterilization.
The provided document is a 510(k) premarket notification for the Extremity Medical Suture Anchor, a medical device used for the fixation of soft tissue to bone. The document does not describe the acceptance criteria or the study that proves the device meets the acceptance criteria in the manner requested. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Here's an analysis based on the information provided in the document, highlighting why the requested information about AI/algorithm performance and ground truth is not applicable or present:
The device in question, the "Extremity Medical Suture Anchor," is a physical implantable device, not an AI or algorithmic medical device. Therefore, many of the requested categories related to AI performance, ground truth, training sets, and expert adjudication are not relevant to this type of medical device submission.
However, I can extract information related to the physical device's testing:
Device Acceptance Criteria and Performance (as applicable for a physical medical device):
| Acceptance Criteria (Implied) | Reported Device Performance (Implied from substantial equivalence) |
|---|---|
| Equivalent Indications for Use | The modified Suture Anchor and predicate devices are equivalent in terms of indications for use. |
| Equivalent Design | The modified Suture Anchor and predicate devices are equivalent in terms of design. |
| Equivalent Material Mechanical Properties | The modified Suture Anchor and predicate devices are equivalent in terms of material mechanical properties. |
| Satisfactory Pull-out Strength | Bench testing, including pull-out strength, was performed and compared to the predicate device. (The report implies satisfactory performance by concluding substantial equivalence, but specific numerical criteria or results are not provided.) |
Explanation Regarding AI/Algorithm-Specific Questions:
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. This is a physical medical device. The "test set" in this context refers to bench testing of the physical implant, not a data set for an algorithm.
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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. There is no "ground truth" to establish for an AI algorithm. Bench testing for pull-out strength would involve engineering and materials science experts and validated testing methodologies, but not clinical "ground truth" in the AI sense.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Again, this is for a physical device, not an AI algorithm.
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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 device is not an AI diagnostic tool that human readers would interact with.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable. This is a physical implantable device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. The "ground truth" for a physical device's performance relies on validated engineering tests (e.g., ASTM standards for mechanical properties) and comparison to predicate devices, not clinical or pathological ground truth in the context of diagnostic algorithms.
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The sample size for the training set:
- Not Applicable. This is a physical device, no training data for an algorithm.
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How the ground truth for the training set was established:
- Not Applicable. This is a physical device, no training data or ground truth for an algorithm.
Summary of what the document does state regarding testing:
- Study Type: Non-clinical bench testing was performed.
- Specific Tests: Pull-out strength testing was explicitly mentioned.
- Comparison: The results of the bench testing were compared to the predicate device (K083151 - Suture Anchor from Extremity Medical).
- Clinical Testing: "No clinical testing was performed."
- Conclusion: The submission concludes that the modified Suture Anchor is "substantially equivalent" to its predicate device based on indications for use, materials, design, and test data (including the unspecified pull-out strength results) and principles of operation. This "substantial equivalence" is the regulatory criterion met, rather than specific performance metrics against pre-defined acceptance criteria, which are not detailed in this summary.
§ 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.