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The Master stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Master Stems are intended for use with Co-Cr-Mo or ceramic femoral heads and cemented cups, or with Co-Cr-Mo or ceramic femoral heads and Delta TT Acetabular System. When used in partial hip arthroplasty, the Master stems are intended for use with Lock Bipolar Heads.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• rheumatoid arthritis;
• treatment of femoral head and neck fractures;
• revisions in cases of good remaining femoral bone stock.

The Master femoral stem is a monolithic, collarless, tapered wedge shaped stem intended for press-fit uncemented partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Limacorporate CoCrMo alloy femoral heads (K112158) or Biolox Delta ceramic femoral heads and with either a Limacorporate Cemented Cups or Limacorporate Delta TT Acetabular System cup. When used in partial hip arthroplasty. the Master" femoral stem is used with a Limacorporate CoCrMo alloy femoral heads coupled with a Lock Bipolar Head (Limacorporate K112158).

The Master® femoral stem is made of Ti6Al4V conforming to ASTM F1472 – ISO 5832-3. The proximal 1/2 of the stem has a plasma sprayed coating of titanium alloy (ASTM F1472 - ISO 5832-3). The stem has a tapered rectangular section and the distal anterior and posterior surfaces have a vertical groove for rotational stability. The stem provides a neck with a 12/14 conical taper to couple to Limacorporate CoCrMo allov or Biolox Delta ceramic femoral heads and the necks are mirror-polished and lowered to reduce accidental abrasion and contact between the stem neck and the acetabular cup. The Masters stem is available 13 sizes in both standard and lateralized versions with different CCD angles.

The Biolox Delta ceramic head is a femoral ceramic head with a female 12/14 taper for coupling to the male 12/14 taper of the femoral stem. The Biolox Delta ceramic heads are available in diameters of 28, 32, and 36 mm in three (3) neck lengths (S, M, L); the 36 mm diameter head is also available with a XL neck length.

This document describes a 510(k) premarket notification for a medical device called the Master® Femoral Stem. It is not a study report that details acceptance criteria and device performance. The information provided is primarily for regulatory clearance based on substantial equivalence to predicate devices, rather than a detailed performance study with acceptance criteria.

Therefore, most of the requested information cannot be extracted directly from this document. However, I can still provide the limited information that is present and indicate where the document does not contain the requested details.

Here's an analysis of the provided text in relation to your questions:

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

This document does not specify quantitative acceptance criteria or provide a table of reported device performance values. It focuses on demonstrating substantial equivalence to predicate devices through material and design similarities, and non-clinical testing already performed on those predicate devices.

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

The document explicitly states: "Non-Clinical Testing: ...the tests provided in K140975 and K141327 are therefore applicable...". It does not report new non-clinical test data or sample sizes for a "test set" in the context of a new performance study for the Master® Femoral Stem. The tests referenced are from previous 510(k) clearances (K140975 for the Master Femoral Stems and K141327 for the Minima S Hip Stem and Biolox Delta Heads). No information on data provenance (country of origin, retrospective/prospective) is provided for these referenced tests.

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

This information is not applicable as there is no mention of a "test set" or ground truth established by experts in this regulatory submission.

4. Adjudication method for the test set

This information is not applicable as there is no mention of a "test set" or adjudication in this regulatory submission.

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

This is not applicable. The device is a physical orthopedic implant (femoral stem) and not an AI-powered diagnostic or decision support system. Therefore, no MRMC study or AI-related effectiveness analysis would be conducted.

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

This is not applicable. The device is a physical orthopedic implant and does not involve any algorithm or AI components.

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

This is not applicable. The document refers to non-clinical testing (material properties, design specifications, etc.) rather than a study requiring ground truth established by medical experts or pathology for diagnostic accuracy.

8. The sample size for the training set

This is not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This is not applicable. There is no mention of a "training set".

Summary of available information related to performance/testing:

The document primarily relies on the concept of substantial equivalence for regulatory clearance. This means that the device is considered safe and effective because it is very similar to legally marketed predicate devices, and the differences do not raise new questions of safety or effectiveness.

Key points:

• Non-Clinical Testing: The submission states that non-clinical testing was deemed sufficient and refers to tests provided in previous 510(k) clearances (K140975 and K141327) for predicate devices. It emphasizes that since the materials, design, femoral head sizes, and acetabular components are the same as described in these predicate clearances, "no new issues of safety and effectiveness are introduced."
• Clinical Testing: The document explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence."

Therefore, this document does not present a standalone study with specific acceptance criteria and reported device performance for the Master® Femoral Stem itself. Instead, it leverages the existing regulatory clearances and associated testing of its predicate devices to demonstrate equivalence.

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The Master stems are indicated for use in partial or total hip arthroplasty and are intended for press-fit (uncemented) use. When used in total hip arthroplasty, the Master Stems are intended for use with Co-Cr-Mo femoral heads and cemented cups or with Co-Cr-Mo femoral heads and Delta TT Acetabular System. When used in partial hip arthroplasty, the MasterSL stems are intended for use with Lock Bipolar Heads.

Hip arthroplasty is intended for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

• · non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis and hip dysplasia;
• · rheumatoid arthritis;
• · treatment of femoral head and neck fractures;
• · revisions in cases of good remaining femoral bone stock.

The Master femoral stem is a monolithic, collarless, tapered wedge shaped stem intended for press-fit uncemented partial or total hip arthroplasty. When used in total hip arthroplasty the stem is coupled to a Limacorporate Femoral Heads (K112158) and used with either a Limacorporate Cemented Cups (K112158) or Limacorporate Delta TT Acetabular System cup (K112898). When used in partial hip arthroplasty the Master" femoral stem is coupled to a Limacorporate Femoral Heads (K112158) and used with a Lock Bipolar Head (Limacorporate K112158).

The Master" femoral stem is made of Ti6A14V alloy conforming to ASTM F1472 - ISO 5832-3; the proximnal 1/2 of the stem a plasma sprayed coating of titanium alloy (ASTM F1472 - ISO 5832-3). The stem has a tapered rectangular section and the distal anterior and posterior surfaces have a vertical groove for rotational stability. The stem provides a neck with a 12/14 conical taper to couple to Limacorporate Femoral Heads and the necks are mirror-polished and lowered to reduce accidental abrasion and contact between the stem neck and the acetabular cup. The Master stems is available 13 sizes in both standard and lateralized versions with different CCD angles.

Here's an analysis of the provided text regarding the MasterSL Femoral Stem, focusing on acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for MasterSL Femoral Stem

Disclaimer: The provided document is a 510(k) summary for a medical device (femoral stem). This type of submission primarily focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing and comparison of design, materials, and intended use, rather than setting and meeting quantitative performance acceptance criteria through clinical studies typical for AI/software devices. Therefore, the tables below will reflect the nature of this submission.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a prosthetic implant, the "acceptance criteria" are related to compliance with recognized standards and similarity to predicate devices, rather than specific performance metrics (e.g., sensitivity, specificity) common in software or diagnostic device submissions.

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

• Sample Size for Test Set: Not applicable. This submission relies on non-clinical (bench) testing and comparison to predicate devices, not human or animal clinical trials. The "test set" in this context refers to the physical devices subjected to fatigue and ROM testing. The number of physical units tested is not specified in this summary.
• Data Provenance: Not applicable for a traditional "test set" as understood in a clinical study. The non-clinical tests were performed by the manufacturer, Limacorporate S.p.A. The origin is therefore the manufacturer's testing facilities in Italy.

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

• Number of Experts: Not applicable. For non-clinical, bench testing of a medical implant, "ground truth" is established by adherence to recognized international standards (e.g., ISO, ASTM) and engineering principles, rather than expert consensus on a test set. The results of the physical tests themselves serve as the outcome.
• Qualifications of Experts: Not applicable in the context of human expert review for "ground truth." The expertise involved would be in biomedical engineering, materials science, and quality assurance to conduct and interpret the non-clinical tests.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since there's no clinical "test set" requiring expert review or labeling, there's no adjudication method in the sense of resolving discrepancies among human reviewers. Test results are typically evaluated against pre-defined criteria from the relevant standards.

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

• MRMC Study Done: No. An MRMC study is relevant for evaluating the impact of a diagnostic or AI-assisted device on human interpretation (e.g., radiologists reading images). This submission is for a prosthetic hip stem and does not involve human readers interpreting data.
• Effect Size of Human Readers' Improvement with AI vs. Without AI: Not applicable.

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

• Standalone Study Done: Not applicable. This device is a physical implant, not a software algorithm. Therefore, "standalone algorithm performance" is not relevant. The "performance" is inherent in the physical properties of the implant itself.

7. Type of Ground Truth Used

• Type of Ground Truth: For the non-clinical testing, the "ground truth" is defined by international engineering standards (e.g., ISO 7206-4, ISO 7206-6 for fatigue) and material specifications (e.g., ASTM F1472, ISO 5832-3 for Ti6A14V alloy). The tests simulate physiological conditions and material requirements. For the overall submission, the ground truth for substantial equivalence is the performance and characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This is not an AI/ML device that requires a training set. The design of the MasterSL Femoral Stem is based on established engineering principles, clinical experience with similar implants, and perhaps internal design iterations, rather than machine learning from data.

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

• How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device.

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