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

Painful, disabling joint disease of the hip from: degenerative arthritis, rheumatoid arthritis, post-traumatic arthritis or late stage avascular necrosis.
Revision of previous unsuccessful femoral head replacement, cup arthroplasty or other procedure.
Clinical management problems where arthrodesis or alternative techniques are less likely to achieve satisfactory results.
Correction of functional deformity.
Treatment of nonunion femoral neck and trochanteric fracture of the proximal femur with head involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cementless use only.

For E-XPE Cemented Cup

Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, and painful hip dysplasia:
Inflammatory degenerative joint disease such as rheumatoid arthritis;
Correction of function deformity;
Revision procedures where other treatments or devices have failed;
Treatment of nonunion and femoral neck fractures of the proximal femur with head involvement that is unmanageable using other techniques.

This device is a single use implant and intended for cemented use only.

Device Description

For E-XPE Acetabular Components

The subject E-XPE Acetabular Components includes U-Motion II E-XPE Cup Liner and E-XPE Cemented Cup. U-Motion II E-XPE Cup Liner includes 0° and 20° hood designs, which are available in 28 mm, 32 mm, 36 mm and 40 mm inner diameter (ID). The 28 mm liners fit the acetabular cups with outer diameter (OD) ranging from 44-46 mm, the 32 mm liners fit the acetabular cups ranging from 46-50 mm, the 36 mm liners fit the acetabular cups ranging from 50-70 mm, and the 40 mm liners fit the acetabular cups ranging from 56-70 mm.

The E-XPE Cemented Cup is design for cemented use and assembled with a PMMA Spacer and an X-ray marking wire. The cement mantle is built within the outer surface of acetabular cup. The PMMA Spacer is designed for cement fixation with a uniform cement thickness and the X-ray marking wire is designed for X-ray image identification purpose. E-XPE Cemented Cups are available in a range of sizes to fit varying anatomical requirements.

For U-Motion II Acetabular Cup

The indication for use, materials, cup hole types, size distribution, sterilization method, safety and effectiveness of subject device are identical to predicate device (K122185) except the locking design. The subject device are available in sizes from 44 mm through 80 mm outer diameter in 2 mm increments.

AI/ML Overview

This is a medical device submission, specifically a 510(k) summary, for E-XPE Acetabular Components and U-Motion II Acetabular Cups. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel AI/software function. Therefore, the questions related to AI/software performance, such as sample size for test/training sets, expert qualifications, and MRMC studies, are not applicable to this document.

However, I can extract information regarding non-clinical performance tests conducted to establish safety and effectiveness for these medical implants.

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a table of pre-defined acceptance criteria with specific numerical targets. Instead, it lists the types of non-clinical tests performed to demonstrate safety and effectiveness and states that the "Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices." This implies that the devices met the expected performance benchmarks or were comparable to the predicate devices in these tests.

Acceptance Criteria (Implied)	Reported Device Performance
Performance comparable to predicate devices and market safety standards for hip implants in various non-clinical tests.	Performance data demonstrate the device is as safe and effective and is substantially equivalent to the legally marketed predicate devices. Specific quantitative results are not provided in this summary.
Compliance with bacterial endotoxin limits.	Bacterial endotoxin testing was conducted and met the endotoxin limit as specified in USP .

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in this 510(k) summary for any of the non-clinical tests. Medical device testing often uses specific numbers of samples based on industry standards, but these details are not provided here.
Data Provenance: The document does not specify the country of origin of the data. As these are non-clinical (laboratory) tests, the concept of "retrospective or prospective" as applied to clinical studies is not directly relevant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable. The document describes laboratory-based non-clinical performance tests for an orthopedic implant, not an AI/software device that requires expert ground truth labeling.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This question is not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI model training/testing, which is not the subject of this 510(k) summary.

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:

This question is not applicable. This is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable. This is not an AI/software device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This question is not applicable in the context of an AI/software device. For these orthopedic implants, the "ground truth" and "acceptance criteria" are implied by the established standards and performance expectations for medical devices of this type, which are assessed through the specified non-clinical tests (e.g., measuring locking strength, wear, impingement, material properties).

8. The sample size for the training set:

This question is not applicable. This is not a machine learning or AI device that requires a training set.

9. How the ground truth for the training set was established:

This question is not applicable. This is not a machine learning or AI device.

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.