(90 days)
The Ortho Development Balanced Knee™ Tibial Tray Pegged is indicated for patients suffering from severe knee pain and disability. Specific indications include femoral, tibial and patellar replacement due to degenerative bone disease such as rheumatoid arthritis or osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyles, pseudo-gout, or complications from a previous prosthesis. This device is intended for cemented use only.
The Balanced Knee™ Tibial Tray Pegged is intended for single use in primary total knee replacement only. Indications include:
- Loss of joint configuration and joint function; .
- Osteoarthritis of the knee joint; .
- Rheumatoid arthritis of the knee joint; .
- Post-traumatic arthritis of the knee joint; ♥
- Moderate valgus, varus, or flexion deformities.
The Ortho Development Balanced Knee™ Tibial Tray Pegged serves as an additional option to the tibial tray configurations currently offered in the Ortho Development Balanced Knee™ System, K994370, which include the tibial tray nonporous and the tibial tray porous.
The devices are manufactured from forged Ti-6AI-4V ELI alloy and coated with CP Materials: Titanium per ASTM standards.
The Tibial Tray Pegged functions to provide restoration of function as a replacement for Function: diseased and arthritic knees as part of the Ortho Development Balanced Knee™ System.
The provided document is a 510(k) premarket notification for a medical device (Ortho Development Balanced Knee™ Tibial Tray Pegged). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new, comprehensive study to establish specific performance acceptance criteria from scratch.
Therefore, the document does not contain the kind of direct clinical study data, acceptance criteria, or performance evaluation that would typically be found for novel device approvals or AI/software-as-a-medical-device (SaMD) clearances.
However, I can extract information related to the device's characteristics and how its equivalence was "proven" for its specific regulatory pathway.
Here's a breakdown based on the information provided, outlining what is and isn't available:
Description of Acceptance Criteria and the Study that "Proves" Device Meets Them
1. Table of Acceptance Criteria and Reported Device Performance:
Since this is a 510(k) submission, "acceptance criteria" are primarily related to demonstrating substantial equivalence to a predicate device across various technological characteristics. Performance is assessed through comparison to the predicate, rather than against independent, pre-defined metrics.
| Parameter Examined for Equivalence | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|---|
| Design | Must be identical or similar such that any differences do not adversely affect safety or effectiveness. | Identical: Same profile, keel geometry, and locking mechanism for UHMWPE insert. Same surface finish specifications. |
| Similar: Proposed device has pegs on the distal surface in place of screws on the tibial tray porous (a design difference noted, but deemed not to adversely affect use). | ||
| Materials | Must be identical or similar, meeting established standards and having a safe clinical history. | Identical: Ti-6Al-4V ELI Alloy and porous coating used for both. Meets or exceeds ASTM standards. Common to orthopedic products with extensive safe clinical history. |
| Manufacturing Process | Must be identical or similar. | Identical: Both machined from near-net forgings; both porous coated using the same material specification and process. |
| Biocompatibility | Materials must meet or exceed ASTM standards and have an extensive safe clinical history. | Identical: Materials used meet or exceed ASTM standards, are common to orthopedic products, and have extensive safe clinical history. |
| Pyrogenicity | Not expected to be labeled as nonpyrogenic if not required by USP (for orthopedic products). | Identical: Neither device labeled as nonpyrogenic, consistent with USP XXII, NF18 (1995 edition) which states "These requirements do not apply to orthopedic products." |
| Sterility | Must achieve a Sterility Assurance Level (SAL) of 10⁻⁶ or better through validated terminal sterilization processes. | Identical: Both terminally sterilized by gamma radiation. Processing and dose mapping conducted according to ANSI/AAMI/ISO 11137-1994. Products accepted for release as sterile through a validated dosimetric release program designed to provide an SAL of 10⁻⁶ or better (citing ANSI/AAMI/ISO 11137-1994, ANSI/AAMI ST32-1991, and ISO/TR 13409-1996). |
| Intended Use | Must be equivalent (or very similar) to the predicate device. | Equivalent: Intended for patients with severe knee pain and disability, including degenerative bone diseases (rheumatoid arthritis, osteoarthritis), traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis, pseudogout, or complications from previous prostheses. Intended for cemented use only. (Similar to the predicate's intended use as part of the Balanced Knee™ System). |
| Conclusions | Device is substantially equivalent to the predicate device and does not raise new questions of safety or effectiveness. | FDA concluded the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. |
Regarding aspects typically relevant to AI/SaMD studies:
2. Sample size used for the test set and the data provenance:
- This document describes a medical device (implant) and not an AI or software product. Therefore, there is no "test set" of data or data provenance in the context of an algorithm or model evaluation. The "test" is a regulatory comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" establishment in this context, as it's a hardware device comparison.
4. Adjudication method for the test set:
- Not applicable.
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, as this is not an AI/software product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is not an AI/software product.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this submission is the safety and effectiveness of the legally marketed predicate device, to which the new device is compared for substantial equivalence.
8. The sample size for the training set:
- Not applicable. This is not an AI/software product.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/software product.
Summary for this specific document:
The Ortho Development Balanced Knee™ Tibial Tray Pegged met its "acceptance criteria" by demonstrating substantial equivalence to an already legally marketed predicate device (the Balanced Knee™ System). This "study" was primarily a comparison of technological characteristics (design, materials, manufacturing, biocompatibility, pyrogenicity, sterility, and intended use) between the new device and the predicate. No clinical studies or AI algorithm evaluations were performed or deemed necessary for this specific 510(k) pathway, as explicitly stated: "Clinical data and conclusion were not needed for this device."
§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.