(66 days)
The Hand Biomechanics Lab, Inc. Digit Widget is intended for use in treating PIP joint flexion contractures with an associated loss of range of motion.
The Digit Widget is an external fixation system designed to effect rotation of an injured or diseased finger, to help regain, maintain, or increase the range of motion of the proximal interphalangeal (PIP) joint. It utilizes standard small diameter bone pin (Kirschner wire) fixation techniques and procedures for placement. The device acts about the PIP joint and allows some adjustability to permit fine tunive to the joint's axis. During treatinent, the surgeon or hand therapist (under order from the physician) may be required to periodically adjust the torque provided by the traction mechanism, by changing or adding orthodontic elastic can be removed temporarily to permit active range of motion exercise. The Digit Widget traction device is made from plastic and materials. Fixation pins (Kirschner wires) are made from implant grade stainless steel. An included wrist splint is made of neoprene and nylon, with Velcro attachment provisions. All components are designed for single use only.
The Digit Widget 510(k) summary explicitly states:
Clinical Tests: None
This means that no studies were conducted to prove the device meets specific acceptance criteria. Therefore, most of the requested information cannot be provided from the given document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not defined in the document.
- Reported Device Performance: Not reported as no clinical tests were performed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable as no clinical tests were performed.
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 as no clinical tests were performed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical tests were performed.
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 MRMC study was done, as no clinical tests were performed. The device is also an external fixation device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable as this is a physical medical device, not an algorithm. No standalone performance study was performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable as no clinical tests were performed.
8. The sample size for the training set
- Not applicable as no clinical tests were performed and no machine learning algorithm is involved.
9. How the ground truth for the training set was established
- Not applicable as no clinical tests were performed and no machine learning algorithm is involved.
Conclusion from the document:
The regulatory clearance for the Digit Widget (K992970) was based on substantial equivalence to predicate devices (specifically, the Proximal Interphalangeal (PIP) Joint External Fixation device (Compass® Proximal Interphalangeal Joint Hinge) marketed by Smith Nephew Richards). This means the FDA determined the new device was as safe and effective as a legally marketed predicate device, without requiring new clinical performance data. The submission explicitly states "Clinical Tests: None."
§ 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.