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The ICONACY I-Hip system is indicated for the following conditions: (1) a severely painful and/or disabled hip joint as a result of osteoarthritis, traumatic arthrius, theumatoid arthritis, or congenital hip dysplasia, (2) avascular necrosis of the femoral head, (3) acute traumatic fracture of the femoral head or neck, (4) failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement, (5) certain cases of ankylosis, (6) nonunions, correction of functional deformity, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The ICONACY I-Hip system consists of femoral stem and acetabular cup (i.e., shell) porous coated components intended for cementless, press-fit fixation

The ICONACY I-Hip consists of a collarless, tapered, forged titanium alloy femoral stem, mated to a cobalt chrome modular femoral head. This femoral construct articulates with an acetabular device assembly. The acetabular device assembly consists of a hemispheric titanium alloy cup (i.e., shell) coupled with a highly cross linked ultra-high molecular weight polyethylene (HXL-UHMWPE) liner. Forty percent of the femoral stem is circumferentially coated with a titanium coating designed to attain a cementless, press fit fixation. The acetabular cup is machined from forged Ti-6Al-4V ELI alloy. The cup has a threaded polar hole for insertion and two screw holes to permit the use of screws for adjunct fixation. The outer hemispheric surface of the cup has a titanium plasma spray coating for cementless, press fit fixation. A titanium locking ring is fixed into a groove on the cup to engage the groove in the HXL-UHMWPE liner. Standard instrumentation is used to implant the device.

The provided text describes a 510(k) submission for the ICONACY I-Hip System, a total hip replacement device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through clinical studies. Therefore, much of the requested information about device performance, study details, and ground truth establishment is not available in the provided text.

Here's an breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. No clinical test set or human subject data was used. The evaluation was based on nonclinical (bench) testing.

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

Not applicable. No expert-established ground truth for a test set was used, as no clinical testing was performed.

4. Adjudication Method for the Test Set

Not applicable. No clinical test set or adjudication process was described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A multi-reader multi-case comparative effectiveness study was not performed. The submission explicitly states "Clinical Testing: Clinical testing was not required for determining substantial equivalency with the predicate devices."

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

Not applicable. This device is a physical orthopedic implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for demonstrating substantial equivalence was derived from nonclinical (bench) testing results (e.g., measurements of material properties, mechanical performance under various loads, wear rates) compared against established performance characteristics of the predicate devices.

8. The Sample Size for the Training Set

Not applicable. There was no "training set" in the context of an AI/ML algorithm. The device's design and manufacturing processes are informed by engineering principles and existing knowledge of predicate devices.

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

Not applicable. As noted above, there was no "training set" for an algorithm. The design and manufacturing relied on established engineering standards and performance data from predicate devices.

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The Porous Plasma Spray (PPS) Ringloc + Acetabular System is intended to replace the natural acetabulum damaged by disease, trauma or revision of previous arthroplasty.

Indications For Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques.
5. Revision procedures where other treatment or devices have failed.

The Porous Plasma Spray (PPS) Ringloc + Acetabular System is intended for uncemented use only.

The Porous Plasma Spray (PPS) Ringloc + Acetabular System is a series of acetabular shells that incorporate the Ringloc + locking mechanism design of the predicate Regenerex Ringloc 4 Modular Acetabular Shells. The Porous Plasma Spray (PPS) Ringloc + Acetabular System shells are compatible with Biomet's M2a Ringloc® Acetabular Liners or the conventional Ringloc® UHMWPE liners that are currently on the market. The subject Porous Plasma Spray (PPS) Ringloc®+ Acetabular System shells are made of titanium alloy conforming to ASTM F-136 with a porous plasma spray outer surface coating of titanium alloy powder conforming to ASTM F-1580.

The provided text is a 510(k) summary for a medical device (Porous Plasma Spray (PPS) Ringloc+ Acetabular System). It does not describe a study to prove a device meets acceptance criteria related to an AI/ML algorithm or its performance.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for certain medical devices.

Therefore, most of the requested information regarding acceptance criteria, study design, ground truth, expert involvement, and sample sizes for AI/ML performance evaluation is not applicable to this document.

However, I can extract the following relevant information:

• Device Name: Porous Plasma Spray (PPS) Ringloc+ Acetabular System
• Purpose of filing: To demonstrate substantial equivalence to legally marketed predicate devices.
• Key finding related to "testing": "Since the locking mechanism of the subject and predicate devices is identical, no testing was required to demonstrate substantial equivalence of the Porous Plasma Spray (PPS) Ringloc + Acetabular System to the predicate Regenerex Ringloc + Modular Acetabular..."

Since no performance study in the context of AI/ML was conducted or described, I cannot fill in the requested table and details. The document explicitly states "no testing was required" due to the identical locking mechanism with the predicate device.

Ask a specific question about this device