(113 days)
The Nextremity Solutions InCore® MPJ System is a three-part construct intended for internal fixation for First Metatarsophalangeal Joint Arthrodesis (also known as 1st MPJ Fusion).
The InCore MPJ System consists of a post and two headless compression screws. Posts are available with a 4.9mm diameter, in an 18mm length, and left orientations. Screws are available in a 2.7mm diameter and lengths of 16 to 52mm. The post is inserted into the metatarsal head and compression screws are inserted into the phalange and into the post to maintain apposition of the bones during fusion. A post plug screw is threaded into the top of the post after all components have been implanted to prevent tissue ingrowth into the post and facilitate removal, if needed. All implants are manufactured from color anodized Ti-6Al-4V alloy conforming to ASTM F-136. The system is provided with a set of accessory instruments designed for preparation of the implant site and insertion of the implants into bone.
The provided document (K200124) is a 510(k) summary for a medical device called the "InCore MPJ System," which is a bone fixation fastener. This document describes the device, its intended use, and the non-clinical testing performed to establish substantial equivalence to predicate devices.
It explicitly states:
- Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the InCore MPJ System to the predicate device.
Therefore, there is no information available within this document regarding acceptance criteria, device performance from a clinical study, sample sizes for test or training sets, expert roles, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment relevant to an AI/ML-based medical device.
The document covers:
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A table of acceptance criteria and the reported device performance: Not applicable, as this is a mechanical fastener, and performance is shown through mechanical testing against standards, not clinical metrics like sensitivity/specificity for an AI device. The document mentions "axial pull-out strength, torque to failure, and 3-point bend tests" conforming to ASTM standards, confirming strength and equivalence to predicate devices.
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Sample sized used for the test set and the data provenance: Not applicable in the context of clinical AI/ML studies. Mechanical testing was performed on "worst case compression screws" and "worst case constructs," but specific sample sizes for these mechanical tests are not detailed beyond "worst case."
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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.
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Adjudication method for the test set: Not applicable.
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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.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used: For mechanical testing, the ground truth is the performance against established ASTM F543-13 and ASTM F1264-16 standards for strength.
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The sample size for the training set: Not applicable.
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How the ground truth for the training set was established: Not applicable.
In summary, this document pertains to a traditional medical device (a mechanical implant) and relies on non-clinical, biomechanical testing for substantial equivalence, not clinical studies or AI/ML performance metrics.
§ 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.