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The ESOP® S/C Femoral Stem is a device intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there exists sufficient sound bone to seat the prosthesis. This device is intended for cementless application.

Device Description

The ESOP® S/C Femoral Stem consists of a ceramic head, left and right configuration metaphysary parts in various size diameters, and diaphysary parts in various sizes. The ESOP® S/C instrumentation system is utilized for proper implantation of the device.

AI/ML Overview

The provided text describes the 510(k) summary for the ESOP® S/C Femoral Stem, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials with specific acceptance criteria related to disease detection or diagnosis, as would be common for AI/ML-based diagnostic devices.

Therefore, the information required in your request regarding acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance is not applicable to this particular document. This is a premarket notification for a traditional orthopedic implant, not an AI/ML-driven diagnostic tool. The "performance data" mentioned refers to engineering and materials testing, not diagnostic accuracy.

Here's a breakdown of why many of your requested fields are not present or applicable:

Acceptance Criteria and Reported Device Performance (Table): This document does not present acceptance criteria in terms of diagnostic metrics (e.g., sensitivity, specificity, AUC) or human reader performance. Its "performance" refers to the mechanical and material characteristics of the implant.
Sample Sized used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of diagnostic data for this type of device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant here.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This is not a diagnostic device requiring human reader interpretation or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
The type of ground truth used: Not applicable in the diagnostic sense. The "ground truth" for an orthopedic implant's performance is established through material science testing, mechanical testing, and clinical follow-up over time (not typically part of the 510(k) summary itself, but post-market surveillance).
The sample size for the training set: Not applicable. There's no training set for an AI/ML model for this device.
How the ground truth for the training set was established: Not applicable.

However, I can extract the information that is relevant to the nature of this submission, focusing on the equivalence argument and basic device characteristics:

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

The "acceptance criteria" for a 510(k) submission like this are generally defined by demonstrating "substantial equivalence" to a predicate device in terms of:

Intended use
Technological characteristics (materials, design)
Performance (mechanical, biocompatibility, sterilization, etc.)

Since no specific numerical acceptance limits for "performance" are provided in the document (other than meeting general engineering standards), I will describe the approach.

Acceptance Criteria Category	Description (as implied/stated in 510(k))	Reported Device Performance
Intended Use	Must be the same as or very similar to predicate devices.	"The ESOP® S/C Femoral Stem is intended for use in degenerative and inflammatory arthritis of the hip joint, trauma, non-acute femoral neck fracture, revision of previously failed hip arthroplasties, and idiopathic avascular (osteo) necrosis where radiographic evidence shows there exists sufficient sound bone to seat the prosthesis. This device is intended for cementless application." (Stated to have the same intended use as predicate devices).
Technological Characteristics	Design features, materials (ceramic head, metaphysary parts, diaphysary parts, hydroxylapatite coating) must be similar to or justified as equivalent to predicate devices.	"The ESOP® S/C Femoral stem design includes: 2 ceramic heads with short, medium, or long necks; 10 left and right configuration metaphysary parts in various size diameters with a 10° relief to the lateral side of the metaphys for ease of insertion into the femoral canal; and 7 diaphysary parts in various sizes which are to be screwed into the extremitv of the metaphyseal part." (Stated that predicate devices may incorporate some or all of these features).
Performance Data	Testing to characterize materials, coatings, and overall device performance under defined laboratory conditions. (Specific metrics not detailed in summary, but generally includes mechanical strength, fatigue, biocompatibility, etc.)	"Testing conducted to characterize the materials, the hydroxylapatite coating, and the performance characteristics of the device under defined laboratory conditions was provided to support a finding of substantial equivalence."
Safety and Effectiveness	Demonstrated through substantial equivalence to predicate devices, without raising new questions of safety or efficacy.	"The ESOP® S/C Femoral Stem is substantially equivalent to predicate device in terms of intended use, safety, and effectiveness."

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

Sample Size: Not applicable in the context of diagnostic data. The "testing" mentioned refers to engineering and material characterization tests. The dimensions and specifications of the various parts (2 ceramic heads, 10 metaphysary parts, 7 diaphysary parts) define the "sample space" of the product, but not a data test set.
Data Provenance: Not explicitly stated for performance testing, but the submitter is "Fournitures Hospitalieres" located in Quimper, France. The testing would have been conducted by them or a contracted lab. No mention of retrospective or prospective data in a clinical sense.

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. This is not a diagnostic device requiring expert interpretation of clinical data for ground truth.

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

Not applicable.

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 is not an AI/ML diagnostic device and does not involve human readers interpreting data enhanced by AI.

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

Not applicable. This is a physical orthopedic implant.

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

For the "performance data" referenced, the 'ground truth' would be established through scientific and engineering standards, physical measurements, and established material testing methodologies. For example, fatigue testing would have a 'ground truth' based on cycles to failure under specific load conditions, measured against established standards for implants. Biocompatibility testing results (e.g., ISO standards) would form part of this. There is no clinical outcomes data or pathology reference provided in the 510(k) summary itself to form a "ground truth" for clinical performance, as that is typically beyond the scope of a 510(k) unless specifically required for novel claims.

8. The sample size for the training set

Not applicable. No AI/ML model training is involved.

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

Not applicable.

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