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The Ascent Knee Revision Femoral Stem is indicated for use in:

• 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
• 2. Correction of varus, valgus or posttraumatic deformity
• 3. Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
     This device is for Cemented Use Only

The Ascent Knee Revision Stems are similar to the previously cleared Performance Posterior Stabilized (PS) Total Knee System (K936274) used to ensure component placement and stability. The modifications made add a larger and smaller diameter size, decrease the slot width, and change the stem material. The distal diameter on stems sized 10 - 16 were also increased. Minor modifications were also made to the femoral locking screw.
There are sixteen new wrought titanium alloy (Ti-6Al-4v) Ascent Revision Stems available. Twelve of these sixteen have the same diameter and length as the previously cleared Performance PS Total Knee System (K936274). The larger diameter revision stem has been added to fit within larger canals. The smaller diameter revision stem has been added to fit within smaller canals.

This document discusses a 510(k) premarket notification for the "Ascent Knee Revision Femoral Stem." Due to the nature of 510(k) submissions, the data provided focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific study with acceptance criteria and performance metrics in the way one might find for a novel device with clinical trial data.

Based on the provided text, a direct table of acceptance criteria and reported device performance, or a detailed study proving the device meets specific acceptance criteria, is not present. The submission relies on demonstrating substantial equivalence to an existing, legally marketed device.

Here's an analysis of the provided information in the context of your request:

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

• Not Applicable in this context. The document is a 510(k) summary, which is a premarket notification aiming to demonstrate "substantial equivalence" to a predicate device rather than fulfilling specific, pre-defined acceptance criteria through a novel clinical study. The "performance" described is in comparison to the predicate, and detailed success/failure rates or specific outcome metrics against pre-set thresholds are not typically part of this type of submission.
• Implied "Acceptance Criteria": The implicit acceptance criterion for a 510(k) is that the new device is "as safe and effective" as a legally marketed predicate device. This is primarily demonstrated by showing that the new device has the same intended use, similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable/Provided. Since this is a 510(k) submission focused on substantial equivalence, there is no mention of a "test set" in the context of a prospective clinical study involving patients. The "test" is more about comparing the device's design, materials, and intended use to the predicate. The document describes modifications to an existing device (Performance P/S Knee femoral stem) and states the new stems "have the same diameter and length" or represent "larger and smaller diameter size" modifications. This implies engineering analysis and possibly bench testing, but not a patient-based test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable/Provided. As there is no clinical test set with patient data being evaluated for "ground truth," there is no mention of experts establishing such a truth. The regulatory review process involves FDA experts evaluating the submission.

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

• Not Applicable/Provided. No clinical test set with patient data is described, so no adjudication method is relevant here.

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. The device is a knee revision femoral stem, a physical implant, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not Applicable. The device is a physical implant. This question relates to AI/software performance, which is not relevant for this medical device.

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

• Not Applicable in the traditional sense. For a 510(k) for a physical implant, "ground truth" often refers to well-established engineering principles, material science data, and performance characteristics (e.g., wear, fatigue strength) compared to the predicate device, which has a proven track record of safety and effectiveness (its "ground truth" being its historical clinical outcomes). The clinical performance data of the predicate device (Performance P/S Knee femoral stem - K936274) serves as the "ground truth" that the new device is being compared against for substantial equivalence in safety and effectiveness.

8. The sample size for the training set

• Not Applicable/Provided. There is no "training set" in the context of machine learning or a clinical trial for this type of device submission.

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

• Not Applicable/Provided. As there's no training set, this question is irrelevant.

In summary:

The provided document is a 510(k) notification for a knee revision femoral stem. This regulatory pathway primarily involves demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing detailed clinical study results against specific acceptance criteria. The information you're asking for (acceptance criteria table, study sample sizes, expert ground truth, MRMC studies, etc.) is typically found in submissions for novel devices requiring clinical trials (e.g., PMA applications) or for AI/software as a medical device (SaMD). For this device, the "study" is the comparison against the predicate device through engineering analysis, material testing, and confirmation of similar intended use.

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