FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; .
Rheumatoid arthritis; .
Correction of functional deformity; .
Revision procedures where other treatments or devices have failed; and, ●
Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with ● head involvement that are unmanageable using other techniques.

Device Description

The Accolade® HFx femoral stem is a tapered cobalt chrome stem. The Accolade® HFx femoral stem is collarless and flat bodied, and will be available in sizes 1 through 8. The proximal body is textured Is conaress and hit boured, and firm of a increase the surface area of the stem to accommodate a press-fit fixation.

AI/ML Overview

This document describes the Accolade® HFx Femoral Stem, a total hip joint replacement prosthesis. This submission is a 510(k) premarket notification, which aims to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically involve the rigorous clinical trials and statistical analyses found in AI device studies.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies are not applicable in this context. The 510(k) process for this device relies on demonstrating chemical, mechanical, and material equivalency through non-clinical testing, rather than studies of diagnostic accuracy or clinical effectiveness in the way an AI device would be evaluated.

Here's why each point isn't directly addressed by this document:

1. A table of acceptance criteria and the reported device performance: This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance metrics against pre-defined acceptance criteria, as would be done for an AI device. The "performance" being evaluated is primarily related to material properties, design, and intended use, which are deemed equivalent to the predicate.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. Clinical trials with test sets, as understood in AI device evaluation, are not part of a standard 510(k) pathway for a medical implant like a hip stem. Equivalence is usually shown through comparison of specifications, materials, and non-clinical bench testing.
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" to establish in the context of an AI-like diagnostic accuracy study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the AI sense, and thus no adjudication of results.
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 physical implant, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a hip stem's safety and effectiveness is established through its design, materials testing, and comparison to existing, cleared devices, not through diagnostic accuracy relative to a clinical outcome.
8. The sample size for the training set: Not applicable. This device is not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of the K051741 submission:

The Accolade® HFx Femoral Stem is a Class II device. The submission successfully demonstrated substantial equivalence to the predicate device, the Accolade® TMZF® femoral stem (K994366, cleared March 16, 2000). The determination of substantial equivalence was based on similarities in:

Intended Use: Both devices are for cementless fixation within the prepared femoral canal for conditions such as noninflammatory degenerative joint disease, rheumatoid arthritis, functional deformity correction, revision procedures, and specific types of proximal femur fractures.
Design: The Accolade® HFx is described as a tapered cobalt chrome stem, collarless and flat-bodied, with a textured proximal body to increase surface area for press-fit fixation, similar to the predicate.
Sterilization: Implied to be similar to the predicate device.

The FDA's decision to clear the device indicates their agreement that it is substantially equivalent to the predicate, and therefore as safe and effective as the legally marketed predicate device. No new "studies" in the AI or clinical trial sense were required or presented in this summary to prove performance against specific acceptance criteria.

Summary

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.