(58 days)
The Phantom Sof-Thread Soft Tissue Interference Screw is intended to be used to provide interference fixation of soft tissue grafts in ACL reconstruction.
The Phantom Sof-Thread Screw is a resorbable, cannulated, interference screw with widely spaced, rounded threads and a conical tip, designed for use with soft tissue grafts. The Sof-Thread Screw is available in 4 diameters, 7. 8, 9 and 10mm, and one length, 25mm.
This is a 510(k) premarket notification for a medical device (Phantom Sof-Thread Soft Tissue Interference Screw), not an AI/ML software device. Therefore, the information requested regarding acceptance criteria, study details, ground truth, and training sets for AI/ML performance evaluation is not applicable and cannot be extracted from this document.
The document describes the device, its intended use, and establishes substantial equivalence to predicate devices based on design and mechanical testing in cadaver bone.
Here's a breakdown of the relevant information provided in the document, which pertains to traditional medical device clearance, not AI/ML:
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Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is "substantial equivalence" to legally marketed predicate devices. This is demonstrated by comparing design, materials, and mechanical performance.
- Reported Device Performance:
- Mechanical Testing: "Mechanical testing in cadaver bone has shown that the average insertion torque and pull-out strength of the Phantom Sof-Thread Screw are comparable to those of the Linvatec BioScrew."
- Comparison to Predicate: The Phantom Sof-Thread Screw has comparable insertion torque and pull-out strength to the Linvatec BioScrew, which is a legally marketed device.
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Sample Size for Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a number of cases or subjects in a traditional clinical trial sense. The "mechanical testing in cadaver bone" implies a sample of cadaver bones and screws, but the specific number (e.g., how many screws, how many bones) is not provided.
- Data Provenance: The testing was conducted "in cadaver bone," indicating an ex vivo setting. Country of origin is not specified.
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Number of experts used to establish ground truth & qualifications: N/A for this type of device and study. Ground truth in this context is based on direct physical measurements of mechanical properties.
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Adjudication Method: N/A. No human interpretation requiring adjudication is involved.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This is not an AI/ML device, nor is it a diagnostic device where human reader performance would be the primary endpoint.
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Standalone (algorithm-only) performance: Not applicable. There is no algorithm.
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Type of ground truth used: For the mechanical testing, the ground truth is the direct physical measurement of "average insertion torque" and "pull-out strength" in cadaver bone.
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Sample size for the training set: Not applicable. There is no AI/ML model, hence no training set.
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How the ground truth for the training set was established: Not applicable.
In summary, the provided document is for a traditional surgical implant, not an AI/ML device. Therefore, most of the requested information regarding AI/ML performance evaluation is not present. The device demonstrated substantial equivalence through mechanical testing in cadaver bone comparing its performance (insertion torque and pull-out strength) to a legally marketed predicate device.
§ 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.