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The SBi Carpal Fusion Plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.

The SBI Carpal Fusion Plate is a low profile single piece construct designed to fit over the dorsal aspect of the carpal bones in the hand. The plate has spherical holes or slots that accommodate screws for fixation. The plate and screws are fabricated from implantable grade stainless steel.

The provided text is a 510(k) summary for a medical device called the "SBI Carpal Fusion Plate." This document type primarily focuses on establishing substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way an AI/ML clinical study would.

Therefore, the information typically requested for a clinical study of an AI/ML device (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this 510(k) summary for a physical orthopedic implant.

Here's a breakdown based on the content available:

1. A table of acceptance criteria and the reported device performance

• Not applicable. This 510(k) summary does not define specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) for the SBI Carpal Fusion Plate in the clinical study context. Instead, it demonstrates substantial equivalence to existing devices. Performance is implied to be similar to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. No clinical test set data is presented in this 510(k) summary. The submission relies on material safety, biocompatibility, and mechanical testing to demonstrate substantial equivalence, rather than a clinical performance study with a test set of patient data.

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)

• Not applicable. No clinical test set with ground truth established by experts is discussed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No clinical test set requiring adjudication is discussed.

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 is a medical device (plate and screws), not an AI/ML-driven diagnostic tool. Therefore, MRMC studies are not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. Clinical performance ground truth is not typically established for this type of device through clinical studies described in 510(k) summaries in the same way it is for diagnostic algorithms. For an implant, "ground truth" might pertain to established biomechanical properties, material compatibility, or surgical outcomes observed over time, which are implicitly covered by its substantial equivalence to predicate devices and adherence to relevant standards.

8. The sample size for the training set

• Not applicable. No training set for an algorithm is relevant here.

9. How the ground truth for the training set was established

• Not applicable. No training set for an algorithm is relevant here.

Summary of the K062903 510(k) based on the provided text:

This 510(k) submission establishes the substantial equivalence of the SBI Carpal Fusion Plate to other legally marketed devices.

• Manufacturing: rms Company, Minneapolis, MN.
• Submission By: Small Bone Innovations, New York, NY.
• Device Name: SBI Carpal Fusion Plate.
• Classification: Class II, 21 CFR 888.3030 - Plate, Fixation, Bone.
• Predicate Device: Documentation provided demonstrates substantial equivalence to other legally marketed devices (specific predicate not named in this excerpt but usually required in the full submission).
• Device Description: Low profile, single-piece construct designed for dorsal aspect of carpal bones, with spherical holes/slots for screws. Fabricated from implantable grade stainless steel.
• Intended Use: Fusion of carpal bones (capitate, hamate, lunate, triquetrum) to address pain/loss of function due to osteoarthritis, post-traumatic arthritis, fractures, failed partial wrist fusions, carpal instability, or rheumatoid arthritis. Used with screws.
• Material: Implantable grade stainless steel.

The FDA's review concluded that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market under general controls. This type of submission relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to a legally marketed predicate device. It does not typically involve clinical performance studies with the types of acceptance criteria and data metrics requested for AI/ML devices.

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