(91 days)
Indications for use of this implant are:
- Hallux limitus or hallux rigidous. .
- Painful hallux valgus. .
- . Revision of failed previous surgery.
- Painful arthritis. .
The Metal Hemi Toe implant is a cobalt chrome alloy, one piece implant to supplement first metatarsal phalangeal joint arthroplasty. The implant is designed to replace the base of the proximal phalanx and provide a smooth articular surface for the adjacent metatarsal head. Primary fixation of the grit-blasted version of the device is via a press fit. This is consistent with the description and intended use of the Swanson Titanium Great Toe Implant. The titanium plasma spray coated version of this device is intended for use with bone cement.
This 510(k) submission for the Futura Biomedical Metal Hemi Toe Implant is a premarket notification for a medical device seeking substantial equivalence to a predicate device. As such, it does not contain a study with detailed acceptance criteria and performance metrics in the way a clinical trial or a machine learning device study would. Instead, the "acceptance criteria" here refer to demonstrating substantial equivalence to a legally marketed predicate device based on technological characteristics and intended use.
Here's an analysis based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use: | |
| Must be equivalent to the predicate device. | The Metal Hemi Toe implant's intended use is to supplement the first metatarsal phalangeal joint arthroplasty, replacing the base of the proximal phalanx and providing a smooth articular surface. This is stated to be consistent with the description and intended use of the Swanson Titanium Great Toe Implant. |
| Indications for use: Hallux limitus or rigidus, painful hallux valgus, revision of failed previous surgery, painful arthritis. These indications are provided without direct comparison to the predicate, but implied to be equivalent. | |
| Technological Characteristics: |
- Design
- Material composition
- Fixation method
- Sizing | Design: Anatomic design to minimize complications (joint instability, shortening, painful/limited ROM), thin inferior aspect for flexor brevis tendon.
Material: Cobalt Chrome Alloy (main difference from predicate, which is Titanium).
Fixation: Press fit for grit-blasted version, bone cement for titanium plasma spray coated version.
Sizing: Offered in sizes that fit within the size range of the Swanson Titanium Great Toe Implant.
Both are one-piece, single-stemmed, press-fit into intramedullary canal, with a curved articular surface. |
| Safety and Effectiveness:
Material differences should not adversely affect safety and effectiveness. | Cobalt Chrome is widely used in metallic implants, commonly favored as an articular surface, and has a 40-year history.
Referenced studies on metallic hemi toe implants using Cobalt Chrome (Townley and Taranow) or Titanium (Leavitt et al.), and general orthopedic implant use.
ASTM standards (F 67, F 75) exist for both Titanium and Cobalt-Chromium-Molybdenum for surgical implant applications.
Conclusion: Material difference (Cobalt Chrome vs. Titanium) does not adversely affect safety and effectiveness. |
| Predicate Device Performance (Implied Baseline): Implied that the predicate device (Swanson Titanium Great Toe Implant) is safe and effective when marketed. | Not explicitly stated as "performance" in numerical terms, but the predicate's long-standing market presence and FDA clearance (K864492) serve as the benchmark for safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This submission does not describe a "test set" in the context of a statistical study with a specific sample size. The device approval is based on a comparison of its design, materials, and intended use against a legally marketed predicate device, rather than a clinical trial with a "test set" of patients.
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, in this context, refers to the established safety and effectiveness of the predicate device and the accepted scientific and engineering principles for implant materials. There's no mention of a ground truth established by a panel of experts for a specific dataset within this document. The FDA's review process itself involves expert evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No "test set" or adjudication method for interpreting outcomes of a clinical study are 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 a premarket notification for a physical medical implant, not an AI/software device. Hence, no MRMC study, human readers, or AI assistance is relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this 510(k) submission is primarily:
- Regulatory Precedent: The established safety and effectiveness of the predicate device (Swanson Titanium Great Toe Implant, K864492), as determined by its prior FDA clearance and market history.
- Scientific and Engineering Consensus: The widely accepted knowledge and standards regarding the biocompatibility, mechanical properties, and clinical performance of implant materials like Cobalt Chrome and Titanium, supported by published literature (e.g., Townley and Taranow, Leavitt et al.) and ASTM standards (F 67, F 75).
8. The sample size for the training set
Not applicable. This is a device approval based on substantial equivalence, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, there is no description of how its ground truth was established.
§ 888.3730 Toe joint phalangeal (hemi-toe) polymer prosthesis.
(a)
Identification. A toe joint phalangeal (hemi-toe) polymer prosthesis is a device made of silicone elastomer intended to be implanted to replace the base of the proximal phalanx of the toe.(b)
Classification. Class II.