(102 days)
The RTS® Lesser MTP Implant is intended for use in the treatment of:
- · Partial or complete dislocation of the lesser metatarsophalangeal joint
- · Pain associated with either rheumatoid or osteoarthritis
- · Repair of unsuccessful arthroplasties of the lesser metatarsophalangeal joint
- · Stiffness at the lesser metatarsophalangeal joint associated with joint disease
- · Hammertoe deformity where the proximal phalanx is dorsally located on the metatarsal in a fixed contracture state.
The In2Bones USA RTS® Lesser MTP Implant is a one-piece device manufactured from Medical Grade Silicone Elastomer. The implant is available in three sizes. The associated sterile instruments are made of medical grades of stainless steel and polymer materials
This document is a 510(k) premarket notification for the RTS® Lesser MTP Implant System, which is a medical device. As such, the information provided does not include the detailed acceptance criteria and study data typically associated with software or AI device performance. The focus of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through clinical studies in the same way an AI/software device would.
However, I can extract the information related to performance testing that was conducted to support the substantial equivalence claim for this physical implant.
1. A table of acceptance criteria and the reported device performance
Since this is a physical implant and not a software/AI device, the "acceptance criteria" are not reported in terms of metrics like sensitivity, specificity, or AUC. Instead, the acceptance criteria are implicitly met by demonstrating that the device performs equivalently to the predicate devices in terms of its physical and material properties and its ability to withstand standard sterilization, cleaning, and packaging processes.
| Acceptance Criteria Category (Implied) | Reported Device Performance |
|---|---|
| Cleaning Validation | Validations were performed on the cleaning of the implants and associated surgical instruments. |
| Packaging Validation | Validations were performed on the packaging of the implants and associated surgical instruments. |
| Sterilization Validation | Validations were performed on the sterilization of the implants and associated surgical instruments. |
| Biocompatibility | Not explicitly detailed in the summary, but implied by "Medical Grade Silicone Elastomer" and comparison to predicate devices made of similar materials. |
| Mechanical Performance | Engineering analysis including Finite Element Analysis was also performed. |
| Substantial Equivalence | The device was demonstrated to be substantially equivalent to predicate devices based on indications, materials, and geometry. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of human subjects or patient data. The performance testing refers to bench and in-vitro tests for cleaning, packaging, sterilization, and engineering analysis (Finite Element Analysis). Therefore, information on sample size, country of origin, or retrospective/prospective nature is not applicable in the way it would be for a clinical AI study.
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. Ground truth for clinical outcomes in a human study is not established here. The "ground truth" for the engineering performance and material properties would be established by standard engineering and material science methodologies, not by expert medical consensus in the way an AI diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there is no human "test set" or clinical adjudication process described.
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 not an AI device, and no MRMC study was conducted.
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)
For the performance testing mentioned (cleaning, packaging, sterilization, engineering analysis), the "ground truth" would be established by:
- Validated laboratory protocols and standards: For cleaning, packaging, and sterilization.
- Engineering principles and material science data: For Finite Element Analysis, comparing results against established material properties and design specifications.
- Predicate device characteristics: The fundamental "ground truth" for substantial equivalence is the existing legally marketed predicate device, whose safety and effectiveness have already been established.
8. The sample size for the training set
Not applicable. This is a physical implant, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
Summary of Device Performance (from the document):
The document states: "The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified." This overarching statement serves as the conclusion for meeting "acceptance criteria" in a 510(k) context. The specific tests performed were:
- Validations for cleaning of implants and surgical instruments.
- Validations for packaging of implants and surgical instruments.
- Validations for sterilization of implants and surgical instruments.
- Engineering analysis, including Finite Element Analysis.
The device is concluded to be substantially equivalent to the predicate devices (OsteoMed Metatarsophalangeal Flexible Stabilizing Rod System and Integra Lesser Metatarsal Phalangeal Implant) based on similar indications, materials (Medical Grade Silicone Elastomer), and geometry.
§ 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.