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1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; 2) rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatment or devices have failed; 5) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The predicate to the Modular Reach Hip - the Mallory-Head Modular Hip - was previously cleared in K921274. The proximal portion of the predicate has been modified by removing A/P and lateral fins and adding an optional proximal collar. The modified and predicate devices are made of the same material (Ti-6Al-4V), both are porous coated, and intended for noncemented use.

The modified device, the Modular Reach Hip, can be used with any Biomet modular distal component. As with the predicate, the proximal body and the distal stem are joined by means of a Morse locking taper. Additional fixation is achieved through a locking screw inserted through the driving platform and engaging with the stem taper.

The predicate and the Modular Reach Hip utilize Biomet Type I taper modular heads which are taper-fit on to the stem at the time of surgery.

The provided text is a 510(k) summary for a medical device called the "Modular Reach Hip." This document is from 1999 and primarily focuses on establishing "substantial equivalence" to a predicate device (the Mallory-Head Modular Hip) rather than providing detailed clinical study data with specific acceptance criteria and performance metrics described in the prompt.

Therefore, much of the requested information regarding acceptance criteria, specific study designs, sample sizes, expert involvement, and ground truth establishment cannot be found within this document. This type of information is typically found in pre-market approval (PMA) applications or more extensive clinical trial reports, which are not usually part of a 510(k) submission focused on substantial equivalence.

Here's what can be extracted and what is not available from the provided text:

Description of Acceptance Criteria and Study to Prove Device Meets Criteria

No explicit acceptance criteria or a dedicated study proving the device meets those criteria are detailed in this 510(k) summary.

The primary "study" implicitly referenced is the comparison to the predicate device (Mallory-Head Modular Hip) to establish substantial equivalence. The modifications described (removing A/P and lateral fins, adding an optional proximal collar) are structural changes, and the document asserts that the modified device uses the same materials, is porous coated, and intended for non-cemented use, similar to the predicate. The "study" is more akin to demonstrating that these modifications do not alter the fundamental safety and effectiveness of the device beyond what was demonstrated for the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

• Device uses the same material (Ti-6Al-4V) as the predicate.
• Both are porous coated.
• Both are intended for non-cemented use.
• Can be used with any Biomet modular distal component.
• Proximal body and distal stem joined by Morse locking taper.
• Additional fixation through a locking screw.
• Utilizes Biomet Type I taper modular heads. |

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

• Sample Size for Test Set: Not mentioned. 510(k)s for orthopedic implants like this often rely on mechanical testing, material characterization, and comparison to predicate devices, rather than a clinical "test set" as one might find for diagnostic AI. If any mechanical testing was performed to support the modifications, the sample size is not disclosed.
• Data Provenance: Not mentioned.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This document pre-dates and does not involve the type of expert-driven ground truth establishment typically required for AI/diagnostic devices. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate device. The FDA's review process itself involves experts within the agency.

4. Adjudication Method for the Test Set

• Not Applicable. No explicit "test set" in the context of diagnostic performance or expert adjudication is described.

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

• No. This is a clearance for a hip implant, not a diagnostic imaging device. MRMC studies are not relevant for this type of device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This is a hardware device (hip implant), not a software algorithm.

7. Type of Ground Truth Used

• The "ground truth" implicitly used for this 510(k) is the established safety and effectiveness profile of the predicate device, the Mallory-Head Modular Hip, as previously cleared under K921274. The submission aims to demonstrate that the modified device (Modular Reach Hip) is substantially equivalent to this predicate.

8. Sample Size for the Training Set

• Not Applicable. There is no "training set" in the context of an AI algorithm for this device. For mechanical devices, design and manufacturing processes are iterative, but not termed as "training."

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

• Not Applicable. As there is no training set mentioned, this question is not relevant.

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