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The SL-PLUS Stem is intended for advanced hip joint wear due to degenerative, posttraumatic or rheumatoid arthritis; fracture or avascular necrosis of the femoral head.

The SL-PLUS Lateralized Stem is intended for varus femur forms and trumpet shape of the proximal femur (champagne flute).

These stems are for uncemented use only. These devices are intended to aid the surgeon in relieving the patient of hip pain and restoring hip motion.

Subject of this premarket notification is the SL-PLUS Standard and Lateral Hip Stems. The overall design is based on the SL-PLUS Standard and SL-PLUS Lateralized Stem cleared in K001942 and K021178 respectively.

Currently, the SL-PLUS Standard Femoral Stems are of a double taper design and are manufactured from Ti-6Al-7Nb titanium alloy according to ASTM F1295-05 and ISO 5832-11. The primary stem SL-PLUS is available in 14 size options.

The SL-PLUS lateralized version is an additional 12 sizes, sizes 1 through 12, of lateralized stems to the SL-PLUS Stems, which were cleared for marketing by FDA on 7/25/00 (K001942). These stems allow for a larger offset from 6 mm (size 1) up to 8.5 mm (size 12) compared to the standard SL-PLUS Stem, thus giving the surgeon a further option to meet the patient's anatomy. The Caput Collum Diaphysis (CCD) angle is 123° compared to 131° for the standard SL-PLUS Stem. The material and surface characteristics remain unchanged for the lateralized stem as compared to the standard stem.

The provided text is a 510(k) summary for the Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stem. The primary purpose of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness through clinical trials and specific performance metrics with acceptance criteria, which is more common for novel or high-risk devices.

Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, or a study proving it meets such criteria in the way you've outlined. Instead, it focuses on comparing the new device to existing, cleared devices.

Here's a breakdown of what can be extracted and what is not present in relation to your questions:

1. A table of acceptance criteria and the reported device performance:

• Not present. This document does not list specific acceptance criteria (e.g., success rates, failure rates, specific measurement tolerances) or quantitative performance data from a dedicated study of the device. The "performance" is implicitly tied to its substantial equivalence to predicate devices that have already demonstrated safety and effectiveness.

2. Sample size used for the test set and the data provenance:

• Not present. There is no mention of a "test set" in the context of a study with human subjects, nor any data provenance, as this submission relies on equivalence to existing devices rather than a de novo clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not present. No ground truth establishment using experts for a test set is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not present.

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/Not present. This is a hip stem, not an AI diagnostic device. There is no mention of human readers or AI assistance.

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

• Not applicable/Not present. This is not an algorithm or AI device.

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

• Not present. The concept of "ground truth" as it applies to clinical diagnostics or AI performance studies is not relevant here. The "truth" in this submission relies on the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not present. There is no mention of a "training set" as this is not a machine learning device or a clinical study that would involve such.

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

• Not present.

Summary of what the document does provide regarding "performance" and "evaluation":

The "study" proving the device meets criteria is primarily a comparative analysis for substantial equivalence.

• Substantial Equivalence Information: The submission states that the "overall designs and the indications for use for the Smith & Nephew SL PLUS Standard and Lateral Femoral Stem are substantially equivalent to the PLUS Orthopedics SL-Plus and SL-Plus Lateralized Stems cleared for market under 510(k) Notifications K001942 and K021178, respectively."
• Technological Comparison: The document explicitly states: "The intended use, design, and materials of the Smith & Nephew SL PLUS Standard and Lateral Femoral Hip Stems are substantially equivalent to the previously cleared PLUS Orthopedics SL-Plus and SLR-Plus, and the SL-PLUS Lateralized Stems (K001942 & K021178). Design Control Activities have been completed and the results indicated that the subject device is safe and effective."

This means the "acceptance criteria" are effectively the characteristics and performance of the predicate devices (K001942 and K021178), and the "study" is the demonstration that the new device is sufficiently similar in terms of design, materials, and intended use, and has undergone internal "Design Control Activities" to ensure safety and effectiveness comparable to the predicates. Specific quantitative performance metrics are not typically required for this type of 510(k) submission where substantial equivalence to a well-established device type is being claimed.

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