(32 days)
The Axis Charcot Fixation System in diameters of 4.5 to 8.5mm is indicated for reconstruction procedures, non-unions and fusions of bones in the foot and ankle including the metatarsals, cuneiforms, cuboid, navicular, calcaneus and talus; specific examples include: medial and lateral column fusion resulting from neuropathic osteoarthropathy (Charcot).
The Axis Charcot Fixation System consists of 5.5, 6.5 and 7.5mm cannulated, titanium alloy fixation beams and accessories used for midfoot reconstruction. The modified device adds additional sizes, 4.5 and 8.5mm cannulated, titanium alloy fixation beams, previously cleared under Extremity Medical's 4.5 to 8.5 Screw System (K171018). The additional sizes offer the surgeon options for placement based on patient anatomy.
The provided text is a 510(k) summary for the Axis Charcot Fixation System, a medical device. It does not include information about AI/ML device performance, acceptance criteria, or studies involving human readers, as it describes a bone fixation system.
Therefore, most of the requested information cannot be extracted from this document as it pertains to AI/ML device evaluation.
However, based on the provided text, I can infer the following:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner typical for AI/ML performance. Instead, it refers to "engineering analyses evaluating mechanical strength" and "pullout strength". The performance determined was "substantially equivalent to the predicate devices for the intended use."
| Acceptance Criteria (Inferred from testing type) | Reported Device Performance |
|---|---|
| Mechanical strength of the smallest beam diameter (4.5mm) is substantially equivalent to predicate. | Demonstrated substantial equivalence to predicate devices. |
| Pullout strength of the shortest, smallest beam diameter is substantially equivalent to predicate. | Demonstrated substantial equivalence to predicate devices. |
| The largest beam diameter (8.5mm) is no worst case than the predicates. | No additional safety and effectiveness concerns presented. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and not provided. The testing described is mechanical, not involving patient data or a "test set" in the context of an AI/ML device.
3. 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)
This information is not applicable and not provided. The "ground truth" for this device would be established through engineering standards and physical measurements, not expert consensus on medical images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and not provided. Mechanical testing does not involve adjudication.
5. 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 such study was performed or is relevant to this device. This device is a physical bone fixation system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. This device is a physical bone fixation system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is based on engineering standards and physical measurements of mechanical properties (strength, pullout force).
8. The sample size for the training set
This information is not applicable and not provided. There is no AI/ML model being "trained" for this device.
9. How the ground truth for the training set was established
This information is not applicable and not provided. There is no AI/ML model being "trained" for this device.
In summary, the provided document describes a 510(k) submission for a physical medical device (bone fixation system) and does not contain information related to AI/Machine Learning device performance or ground truth establishment in the context of diagnostic or interventional AI.
§ 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.