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

The patient should be skeletally mature.
The patient's condition should be due to one or more of the following:
1. Osteoarthritis.
2. Rheumatoid arthritis.
3. Tumor conditions involving the upper third of the femur or of the Acetabular.
4. Ankylosing spondylitis.
5. Psoriatic arthritis.
6. Old osteomyelitis with a long infection-free period and a normal WBC, ESR and C-reactive protein.
7. Non union of femoral neck fracture or avascular necrosis of the femoral head.
8. Post-traumatic fracture/dislocation of the hip.
9. Revision of an unsuccessful arthrodesis with either poor positioning or pain in the hip, or where low back pain or knee pain is becoming disabling.
10. Revision of an unsuccessful cemented or un-cemented hip replacement, providing sufficient bone stock is present.
11. Revision of a previous unsuccessful femoral osteotomy, Girdlestone resection, cup arthroplasty or hemi arthroplasty.

Device Description

The Equator Plus™ Acetabular Cup System is comprised of two units the first is a coated outer shell manufactured from titanium alloy (Ti-6A1-4V). The second unit is a ultra high molecular weight polyethylene (UHMWPE) liner force fitted into an outer cobalt chrome metal dome casing. The UHMWPE liner is provided as a single pre-assembled component. The Equator Plus™ Acetabular Cup System is to be used as part of a modulary total hip replacement system in a cementless application.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Equator Plus™ Acetabular Cup System, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (an acetabular cup system), which primarily focuses on demonstrating substantial equivalence to predicate devices through testing and material qualification. It does not present a clinical study or performance data in the way one would for an AI/algorithm-based diagnostic or assistive device. Therefore, many of the requested fields related to clinical performance, ground truth, expert review, and AI specific metrics (like MRMC or standalone performance) will be answered as "Not Applicable" or "No information provided," as these types of studies are not relevant to the approval process described in this document for an orthopedic implant.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness (demonstrated to be substantially equivalent to predicate devices)	"Testing and materials qualification have demonstrated that the differences in the Equator Plus™ Acetabular Cup System do not raise any new issues of safety and effectiveness."
Compliance to Standards	"SUMMANT of TED III. has provided analytical and mechanical testing to Portland Orthopaedics, Ltd. Has proved and compliance to standards for the Equator Plus™ Acetabular Cup System."
Clinical Indications for Use	Device's indications for use were reviewed and deemed acceptable by the FDA (implicitly meeting the criteria for the specified patient conditions).

Explanation: In the context of this 510(k), acceptance criteria for orthopedic implants are typically centered around demonstrating substantial equivalence to already approved predicate devices. This is achieved through:

Material compatibility and strength: Ensuring the chosen materials (titanium alloy, UHMWPE, cobalt chrome) meet industry standards and perform as expected under physiological conditions.
Mechanical performance: Testing to ensure the components (shell, liner, interface) can withstand loads and stresses encountered in the body, resist wear, and maintain structural integrity. This is often done via analytical and mechanical testing, comparing results to those of predicate devices or established standards.
Biocompatibility: Ensuring the materials are safe for implantation and do not elicit adverse biological responses.
Design validation: Confirming that the device design facilitates proper surgical implantation and long-term function.

The document states that "Testing and materials qualification have demonstrated that the differences in the Equator Plus™ Acetabular Cup System do not raise any new issues of safety and effectiveness" and that the device has "proved and compliance to standards." This is the general statement of performance proving it met the (implied) acceptance criteria for substantial equivalence. Specific quantitative performance metrics (e.g., tensile strength values, wear rates) are not provided in this summary but would have been part of the detailed testing report submitted to the FDA.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: No information provided. This type of device approval relies on mechanical and analytical testing of the device itself and its components, not on a "test set" of patient data or images.
Data Provenance: No information provided for clinical data, as it was not a clinical study. Mechanical and analytical testing data would originate from laboratory settings.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. Ground truth, in the sense of clinical diagnoses or image interpretations by experts, is not relevant for this type of device submission.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Not applicable. (No clinical test set as described for an AI/algorithm device).

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

No. This is an orthopedic implant, not an AI-assisted diagnostic or imaging device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used

For the testing described, the "ground truth" would be established engineering and material science standards and specifications (e.g., ASTM standards for mechanical testing, ISO standards for biocompatibility, material properties of the chosen alloys and polymers). These define the expected performance thresholds and material characteristics. The device's performance against these standards constitutes its "truth" for this approval process.
No "expert consensus," "pathology," or "outcomes data" in the typical clinical study sense were used as ground truth for initial device approval, as this is a pre-market notification demonstrating substantial equivalence through physical testing, not a clinical trial proving efficacy and safety in patients.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an orthopedic implant approval. Device design and material selection are based on engineering principles and established medical knowledge, not machine learning training.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

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.