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The PLUS Orthopedics Cemented Hip Stem is intended for treating patients who are candidates for total hip arthroplasty because the natural femoral head has been subject to disease or trauma. It is also intended to treat previously failed hip arthroplasties. This device is intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

This is a cemented hip stem fabricated from forged cobalt-chromium-molybdenum alloy (CoCrMo) that conforms to ASTM F799. It has a trapezoidal proximal body cross section, tapering both lateral to medial and proximal to distal. The proximal body has a cobra flange along the lateral aspect that helps to apply compressive stresses to the cement. It has a "standard 12/14" Morse type taper to accept modular heads and a neck/shaft angle of 129°. It also has a calcar collar that extends medially only.

The distal stem is conical in shape, tapering proximal to distal end the stem quickly necks down to accept a PMMA distal centralizer is four flanged and is utilized to assure that the distal stem is centered in the femoral canal and a uniform cement mantle is obtained. The distal stem bas four flutes or grooves that increases torsion stability when implanted in cement.

Shallow holes are drilled into the proximal body into which 3m PMMA spacers are pressed. These spacers assure a 3mm cement mantle around the medial, anterior and posterior surfaces.

Here's an analysis of the provided text regarding the acceptance criteria and study for the PLUS Orthopedics Cemented Hip Stem:

Analysis of Acceptance Criteria and Study Design

The provided 510(k) summary for the PLUS Orthopedics Cemented Hip Stem is an application for market clearance based on substantial equivalence to predicate devices, not a clinical trial demonstrating efficacy against specific acceptance criteria. Therefore, the information typically found in a study proving a device meets acceptance criteria (like specific performance metrics, sample sizes, expert involvement, and ground truth establishment) is largely absent.

Instead, the documentation focuses on:

• Design Equivalence: Demonstrating that the new device is substantially equivalent in design, materials, and intended use to already legally marketed devices.
• Nonclinical Testing: Primarily engineering analysis to ensure it can withstand similar loads as predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) summary. This submission relies on engineering analysis and comparison to predicate devices, not a clinical test set.
• Data Provenance: The engineering analysis would be conducted internally or by a contracted lab. The predicate device data is from previously cleared devices, which would have undergone their own evaluation, but no new patient data is presented here.

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

• Not applicable. There was no "test set" in the sense of patient data requiring expert ground-truthing. The "truth" in this context is established by engineering principles and the known performance of predicate devices.
• The "experts" involved would be the engineers and designers who conducted the analyses and compared the device to the predicate, and potentially regulatory reviewers at the FDA.

4. Adjudication Method for the Test Set

• Not applicable. No clinical test set.

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

• Not applicable. This device is a hip stem, a medical implant, not an imaging analysis AI or diagnostic tool.

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

• Not applicable. This device is a hip stem, not an algorithm.

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

• The "ground truth" for this 510(k) is primarily established regulatory clearance of predicate devices combined with standard engineering principles and material specifications (e.g., ASTM F799 for the CoCrMo alloy, and mechanical testing results that show cyclic load resistance).

8. The sample size for the training set

• Not applicable. This is a hardware implant, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not applicable. See point 8.

In summary: The provided document is a 510(k) premarket notification for a medical device (hip stem) seeking clearance based on substantial equivalence. It does not contain information typically found in a study demonstrating a device meets specific performance acceptance criteria through clinical or even extensive in-vitro testing against a "ground truth" in the way an AI diagnostic device would. The core "proof" is the detailed comparison to existing, legally marketed predicate devices and confirmation of equivalent design characteristics and performance in simulated (engineering) conditions.

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