(205 days)
The BRM Extremities NewPrim device is intended for use in:
- Hallux rigidus or hallux limitus;
- Painful rheumatoid arthritis;
- Hallux abducto valgus associated with arthritis;
- Unstable or painful joint from previous surgery
The NewPrim system is a double-stemmed, constrained, silicone prosthesis, intended to be implanted to replace the osteo-cartilaginous heads of the first metatarsophalangeal joint. The implant is designed to act as a joint spacer between the resected head of the first metatarsal and base of the proximal phalanx.
The provided text is a 510(k) summary for the BRM Extremities NewPrim System, a toe joint polymer constrained prosthesis. This document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for medical devices in the US.
The document does not contain information about a clinical study with acceptance criteria, human readers, or ground truth for evaluating the device's performance in the context of diagnostic accuracy or clinical outcomes. Instead, it describes bench testing conducted to support substantial equivalence.
Therefore, many of your requested points cannot be answered based on the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document mentions two types of bench testing:
| Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Static Tensile Testing | The subject device should demonstrate static strength substantially equivalent to the reference predicate (K023562). | "Static tensile testing demonstrated that the static strength of the subject device is substantially equivalent to that of the reference predicate (K023562)." (Specific numerical values for acceptance or performance are not provided in this summary, but the conclusion of substantial equivalence is stated.) |
| Fatigue Testing | The NewPrim spacer should perform as intended in fatigue displacements more extreme than expected with physiologic implant displacement. | "Results of fatigue testing demonstrated that the NewPrim spacer performs as intended in fatigue displacements more extreme than expected with physiologic implant displacement." (Again, specific numerical values for acceptance or performance are not provided, but the conclusion of proper performance is stated.) |
| LAL Testing | Compliance with LAL testing requirements for orthopedic devices per AAMI ST-72. | "Additionally, the NewPrim System is in compliance with LAL testing requirements for orthopedic devices per AAMI ST-72 testing." (Demonstrates compliance with a safety standard for endotoxins.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for any of the bench tests.
- Data Provenance: This is bench testing, not clinical data from patients. The manufacturer is BRM Extremities, located in Milano, Italy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes requiring human expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study assessing diagnostic accuracy or clinical outcomes requiring human expert ground truth.
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 a prosthesis, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a prosthesis, not an AI diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench tests, the "ground truth" would be the predefined engineering specifications and comparison to the predicate device's measured performance for mechanical characteristics and compliance with a standard for LAL testing. It's not a clinical "ground truth."
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device that requires a training set.
§ 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.