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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 using other techniques.
5. Revision of previously failed total hip arthroplasty.

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

Resolve Modular Revision Hip Stem is a modular stem optimized for femoral primary or revision surgery. It consists of three main components:
(1) Resolve Proximal Component (two types: With Hole or No Hole, each available with HA/Ti plasma spray or Ti plasma spray coating)
(2) Resolve Distal Stem (four types: Taper Stem, Clothespin Stem, Clothespin With Hole Stem, and Interlocking Stems. Taper Stem is uncoated; others are available with HA/Ti plasma spray or Ti plasma spray coating. Clothespin With Hole Stem and Interlocking stem provide holes for additional Distal Interlocking Screw fixation.)
(3) Resolve Distal Interlocking Screw (used with Resolve Clothespin With Hole Stem and Interlocking stem)

Resolve Modular Revision Hip Stem can be used with "United" metallic femoral heads (K994078, K022520, K111546, K122504, K152439, K162957, K221675) or ceramic femoral heads (K103497, K112463, K122185).

All components are manufactured from Ti-6Al-4V alloy (ASTM F136). The coatings (HA/Ti plasma spray and Ti plasma spray) comply with ASTM F1580 and ASTM F1185, ISO 13779-6. Proximal components have standard and high offset designs.

Based on the provided FDA 510(k) Clearance Letter for the "Resolve Modular Revision Hip Stem," it's crucial to understand that this document pertains to a physical medical device (an orthopedic implant), not a software-based medical device or AI/ML algorithm.

Therefore, the concepts of "acceptance criteria for an AI/ML algorithm," "test set," "ground truth establishment," "expert adjudication," "MRMC studies," and "standalone performance" do not apply to the information contained within this 510(k) filing.

The 510(k) process for a physical device like this hip stem primarily focuses on demonstrating substantial equivalence to existing legally marketed predicate devices through:

• Indications for Use Comparison: Showing the device is intended for the same medical purposes.
• Technological Comparison: Demonstrating similar fundamental scientific principles, materials, design, and operating conditions.
• Non-Clinical (Bench) Testing: Conducting a series of engineering and materials tests to ensure the device meets specified mechanical and material performance standards, and that it is as safe and effective as the predicate devices.
• No Clinical Studies (unless specifically required): The letter explicitly states "No clinical studies were required or provided," which is common for devices demonstrating substantial equivalence through bench testing.

There is no "AI/ML algorithm" or "software performance" to describe acceptance criteria or study results for in this context.

Instead, I can extract and present the relevant information about the acceptance of this physical medical device based on the given 510(k) letter.

Acceptance Criteria and Study for the Resolve Modular Revision Hip Stem (Physical Device)

The "acceptance criteria" for a physical device in a 510(k) submission are not typically presented as a table of accuracy metrics. Instead, they are demonstrated by meeting various engineering and material standards, and by showing that the device performs similarly (or better) than the predicate devices in specified non-clinical tests. The "study" refers to the non-clinical (bench) testing performed.

1. Table of "Acceptance Criteria" (represented by tests aligned with regulatory standards) and "Reported Device Performance" (implied compliance or successful test outcomes):

Explanation of "Reported Device Performance": The document states: "Based on the design rationale of the Subject device, the following tests were conducted to evaluate the safety and effectiveness of the subject device, and the test results indicated that this device is safe and effective." This implies that the device successfully met the requirements and specifications of each listed test and standard, thus demonstrating its safety and effectiveness. Specific numerical performance values are not typically included in the summary letter itself but would be detailed in the full submission.

2. Sample Size and Data Provenance:

• Sample Size: Not explicitly stated for each test (e.g., number of stems tested for fatigue). These are typically engineering bench tests on a representative sample of device components or full devices.
• Data Provenance: The tests are non-clinical (bench tests), meaning they were conducted in a laboratory setting, not with human patient data. The manufacturer, United Orthopedic Corporation, is based in Taiwan.

3. Number of Experts and Qualifications for Ground Truth:

• This concept is not applicable as this is a physical device clearance based on non-clinical bench testing, not an AI/ML algorithm requiring expert review for ground truth establishment.

4. Adjudication Method:

• Not applicable for a physical device and non-clinical bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Not applicable. This is a clearance for a physical orthopedic implant. The letter explicitly states: "No clinical studies were required or provided." MRMC studies are typically performed for imaging-based AI/ML devices to assess human reader performance with and without AI assistance.

6. Standalone Performance (Algorithm Only):

• Not applicable as there is no algorithm. The performance documented is the standalone mechanical and material performance of the physical implant itself through a series of bench tests.

7. Type of Ground Truth Used:

• For the physical device, the "ground truth" for acceptance is based on established engineering standards (e.g., ISO, ASTM) and regulatory guidance (FDA guidance documents) for mechanical, material, and biological compatibility properties of orthopedic implants. Compliance with these predetermined, objective standards serves as the "ground truth" for safe and effective performance.

8. Sample Size for Training Set:

• Not applicable. This is not a "training set" in the context of AI/ML. The device's design and manufacturing processes are developed based on extensive engineering principles, materials science, and prior knowledge from predicate devices.

9. How Ground Truth for Training Set was Established:

• Not applicable. As there is no AI/ML training set, the concept of establishing ground truth for it does not apply. The "ground truth" for the device's design and material selection would be established through decades of orthopedic research, biomechanical principles, and clinical experience with similar implants.

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