(32 days)
This submission describes an external fixation clamp to used to provide a hybrid construct combining the pin fixation of the Monotube® External Fixation System with the Ring and wire fixation of the Monticelli/Spinelli Circular External Fixation This device is intended to provide stabilization of open System. and/or unstable fractures and where soft tissue injury precludes the use of other fracture treatments such as IM rodding or casting.
The Monotube® Tube to Ring Clamp is designed to connect the Ring of a Monticelli/Spinelli Circular Frame to a Monotube® Tube. The Clamp provides for anqulation between the circular frame and the tube of the external frame system. The Clamp is manufactured from Stainless Steel and Aluminum.
The provided text describes a mechanical device, specifically an external fixation clamp. It is not an AI/ML powered medical device, nor does it involve any form of AI or machine learning. Therefore, the detailed information requested regarding acceptance criteria and a study to prove the device meets those criteria (including sample sizes, data provenance, expert involvement, MRMC studies, standalone performance, training sets, etc.) is not applicable to this submission.
The original submission for the Monotube® Tube to Ring Clamp (K961618) is for a 510(k) premarket notification, which demonstrates substantial equivalence to a predicate device. This process primarily relies on comparing the new device's intended use, materials, design, and operational principles to legally marketed devices.
However, I can extract the information that is relevant from the provided text, even though it doesn't fit the AI/ML framework.
1. A table of acceptance criteria and the reported device performance:
The provided text does not specify quantitative acceptance criteria or detailed performance metrics in a tabular format. It mentions a "Testing... presented within the submission" that compared the performance of the Monotube® Hybrid Frame versus a Monticelli/Spinelli Hybrid Frame. Without access to the full submission, specific acceptance criteria (e.g., minimum tensile strength, fatigue life) and their corresponding reported values cannot be extracted.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The text states: "Testing of this device is presented within the submission. Testing was preformed to compare the performance of the Monotube® Hybrid Frame versus a Monticelli/Spinelli Hybrid Frame using components of the Hoffmann External Fixation System."
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text.
- Retrospective/Prospective: Not specified, but generally, mechanical testing is done prospectively in a controlled laboratory setting.
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 is not applicable as the device is mechanical and not interpreted by human experts in the manner of diagnostic AI. Testing would involve engineering or biomechanical experts to design and conduct tests, and interpret raw data (e.g., stress-strain curves, displacement).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Mechanical testing does not involve adjudication of expert opinions.
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:
Not applicable. This device is not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a mechanical clamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For a mechanical device, the "ground truth" would generally be established by:
- Engineering specifications and design requirements.
- Material properties data (e.g., tensile strength, yield strength, fatigue limits of stainless steel and aluminum).
- Biomechanical principles and expected loads in vivo.
- Performance metrics derived from standardized mechanical tests (e.g., ASTM standards for fracture fixation devices), which would be the "true" or "correct" performance characteristics.
The text vaguely refers to "performance" comparison, implying that the ground truth for comparison would be the established performance characteristics of the predicate Monticelli/Spinelli Hybrid Frame.
8. The sample size for the training set:
Not applicable. There is no training set for a mechanical device.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for a mechanical 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.