(88 days)
Indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; angular deformity; impaired function and stability; pain; impaired toe length ratio. Implants are single use only.
This submission describes the OsteoMed Interphalangeal Flexible Stabilizing Rod System intended for indications commonly found in the interphalangeal joints; semi-rigid or rigid hammertoe deformity; anqular deformity; impaired function and stability; pain; impaired toe length ratio. OsteoMed Interphalangeal Flexible Stabilizing Rod Implants are intended for single use only.
The OsteoMed Interphalangeal Flexible Stabilizing Rod System is a stemmed flexible implant specifically designed for replacement of the interphalangeal joints of the lesser toes. It is constructed of medical grade silicone elastomer. The OsteoMed Interphalangeal Flexible Stabilizing Rods are offered in diameters of 2.0mm through 2.5mm. Drills and sizers will also be a part of the system.
The provided document is a 510(k) summary and FDA clearance letter for a medical device, the OsteoMed Interphalangeal Flexible Stabilizing Rod System. This type of document is generally used for demonstrating substantial equivalence to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics as might be found for a novel device requiring clinical trials.
Therefore, this document does not contain the information requested in the prompt regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Explanation:
The 510(k) summary explicitly states: "Equivalence for this device is based on similarities in intended use, material, design and operational principle to the Sgarlato Laboratories Shaw-Ship Rod, Hammer Toe Implant." It also notes: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices, OsteoMed believes that the OsteoMed Interphalangeal Flexible Stabilizing Rod System does not raise any new safety or effectiveness issues."
This indicates that the clearance was based on substantial equivalence to an already legally marketed device, not on a new study demonstrating specific performance metrics against pre-defined acceptance criteria as would be required for a device for which no predicate exists or for a higher-risk classification device. The FDA letter confirms the substantial equivalence determination.
§ 888.3720 Toe joint polymer constrained prosthesis.
(a)
Identification. A toe joint polymer constrained prosthesis is a device made of silicone elastomer or polyester reinforced silicone elastomer intended to be implanted to replace the first metatarsophalangeal (big toe) joint. This generic type of device consists of a single flexible across-the-joint component that prevents dislocation in more than one anatomic plane.(b)
Classification. Class II.