(53 days)
The BioPoly Great Toe Hemiarthroplasty implant is intended to replace the distal metatarsal surface of the great toe of patients with degenerative and post-traumatic arthritis in the presence of good bone stock along with the following clinical conditions: hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The device is a single use implant intended to be used with bone cement.
The BioPoly Great Toe Hemiarthroplasty Implant is a hemi-arthroplasty device specifically designed to restore the articular surface of the first metatarsal bone in patients with degenerative and post-traumatic arthritis.
The implant is comprised of BioPoly (UHMWPE/hyaluronic acid) direct compression molded onto a Ti-6Al-4V stem. A porous stem option is available, which additionally contains OsteoSync™ Ti, a porous titanium (CP Ti) material.
The provided text describes a 510(k) premarket notification for the BioPoly Great Toe Hemiarthroplasty Implant. This document focuses on the substantial equivalence of the device to existing predicate devices, rather than an AI/ML medical device. Therefore, a table for "acceptance criteria and reported device performance" as typically understood for AI/ML devices (e.g., sensitivity, specificity, AUC) and other details about an AI/ML study are not applicable or extractable from this document.
However, I can extract the performance testing summaries for the device as described, which demonstrate its mechanical and material properties.
Performance Testing Summary for BioPoly Great Toe Hemiarthroplasty Implant (Not an AI/ML device)
| Test Category | Acceptance Criteria (General Description) | Reported Device Performance (Summary) |
|---|---|---|
| Mechanical Testing | ||
| Initial Fixation | Meet predetermined acceptance criterion & exceed predicate strength | Met the predetermined acceptance criterion and exceeded the predicate fixation strength. |
| Shear Testing | Meet predetermined acceptance criterion | Met the predetermined acceptance criterion. |
| Fatigue Testing | Meet predetermined acceptance criterion | Met the predetermined acceptance criterion. |
| Wear Testing | Meet predetermined acceptance criterion | Significantly less wear of the BioPoly material compared to predicate materials (CoCrMo and Silastic) against cartilage. Significantly less cartilage wear when articulating with BioPoly than with CoCrMo or Silastic. |
| BioPoly Material Testing | ||
| Tensile & Impact Strength | Meet or exceed ASTM F648 Type 1 (impact) and Type 2/3 (tensile) requirements | Met or exceeded the Type 1 (impact strength) and Type 2 / 3 (tensile) requirements per ASTM F648. |
| Fatigue Crack Propagation | (No specific criterion mentioned, but conducted) | Conducted per ASTM E647. |
| Density Testing | Meet ASTM F648 Type 1 requirements | Met the Type 1 requirements per ASTM F648. |
| Oxidative Index Testing | (No specific numerical criterion) | Showed no measurable oxidative index ("non-detectable") per ASTM F2102. |
| Morphology Testing | (No specific criterion mentioned, but for full consolidation) | Showed full consolidation of the BioPoly material per ASTM F648. |
| Creep Testing | (No specific criterion, but for consistency with control) | Showed no difference between BioPoly material and UHMWPE control creep strain and creep modulus per ASTM D2990. |
| Coefficient of Friction (against cartilage) | (No specific numerical criterion) | Significantly lower than that of CoCrMo, silicone, and UHMWPE. |
| Pin on Disc (POD) Testing | (No specific criterion, but for wear rate) | Wear rate of BioPoly material against cobalt chrome is significantly less than that of UHMWPE control. |
| Enzyme Degradation Testing | (No specific criterion, but for stability) | BioPoly material in its final form is not degraded in the presence of hyaluronidase enzyme. |
| Bacterial Endotoxin | Meet predetermined acceptance criteria (LAL method) | Measured levels were , USP , EP 2.6.14, and JP 4.01). |
Non-Applicable Sections for this Device (as it is not an AI/ML medical device):
The following information is specifically requested for Artificial Intelligence/Machine Learning (AI/ML) medical devices and is not applicable to the BioPoly Great Toe Hemiarthroplasty Implant, which is a physical implant, not a software device that relies on AI/ML algorithms for its function. Therefore, the document does not contain information on these points:
- Sample size used for the test set and the data provenance: Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
§ 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.