(253 days)
Locking Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
The proposed device, Locking Bone Screw, is made of Titanium Alloy (6Al-4V ELI) that meets ASTM F136 - 08e1 Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) which is intended to be used with Orthmed Locking Compressing Bone Plate for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.
Here's the breakdown of the acceptance criteria and study information based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Bench Tests) | Reported Device Performance (Summary) |
|---|---|
| ASTM F543-07 compliance | Met design specifications and demonstrated similar performance to predicate device |
| Substantial Equivalence to predicate device (K081513) | Determined to be Substantially Equivalent (SE) |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document states "Bench tests were conducted to verify that the proposed device met all design specifications," but does not provide details on the number of screws or conditions tested.
- Data Provenance: The tests are non-clinical (bench tests) and were performed by the manufacturer, Changzhou Orthmed Medical Instrument Co., Ltd. The document does not specify the country of origin for the data beyond that. The nature is non-clinical, so "retrospective or prospective" does not apply in the typical sense; these are controlled laboratory tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a non-clinical bench test study for a bone screw. Ground truth in the context of expert consensus or medical diagnosis is not relevant here. The "ground truth" is adherence to engineering standards (ASTM F543-07) and performance metrics typically measured in mechanical testing (e.g., torque, bending strength, fatigue).
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 are typically used for clinical studies involving interpretation of medical images or patient outcomes, not for mechanical bench tests of a bone screw. Performance is measured objectively against engineering standards.
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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:
- No. This is a non-clinical bench test for a bone screw. It does not involve human readers or AI assistance.
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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 medical device (bone screw), not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests was established by adherence to a recognized international standard (ASTM F543-07) and by demonstrating "similar performance" to a legally marketed predicate device (Merete 3.5mm Locking Screws, K081513). This means the device's mechanical properties and functionality were measured against defined engineering specifications and compared to an existing, approved device.
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The sample size for the training set:
- Not Applicable. This is a physical medical device (bone screw) and not an AI/ML algorithm that requires a training set.
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How the ground truth for the training set was established:
- Not Applicable. As this is not an AI/ML algorithm study, there is no training set or associated ground truth.
§ 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.