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Joint replacement is indicated for patients suffering from disability due to:

• noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis of the natural femoral head;
• rheumatoid arthritis;
• correction of functional deformity;
• femoral fracture.

This device may also be indicated in the salvage of previously failed surgical attempts.

This device is to be used for uncemented applications.

This Traditional 510(k) is a line extension to the X-alt Highly Cross Linked Acetabular Liner with Vitamin E product line to expand femoral head compatibility within the system by making larger femoral heads compatible with smaller acetabular cups.

The provided text describes a medical device called "FMP Extended Liners" for hip joint replacement. However, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met.

Here's why and what information is missing:

• Acceptance Criteria and Device Performance (Question 1): The document states "All evaluations determined that the devices are substantially equivalent to the applicable predicate devices" after listing non-clinical tests (wear, impingement, push-out, lever-out, torsion, range of motion). This indicates that the device met the performance standards demonstrated by the predicate devices. However, the specific acceptance criteria (e.g., "wear not to exceed X mm^3/million cycles") and the reported device performance values for each test are not provided.

• Sample Size, Ground Truth, Adjudication, MRMC, Standalone, Training Set (Questions 2-9): The document explicitly states: "Clinical Testing: Clinical testing is not required." This means that no human-based studies (like those involving test sets, ground truth establishment, expert adjudication, or MRMC studies) were conducted or reported for this submission. The tests performed were non-clinical (mechanical and material tests). Similarly, there is no mention of a training set or how ground truth for a training set would be established, as algorithm-only performance (standalone) studies typically apply to software or AI/ML devices, not mechanical implants.

In summary, based on the provided text, I cannot answer questions 1-9 comprehensively because the submission focuses on demonstrating substantial equivalence through non-clinical laboratory testing, rather than clinical trials or AI/ML performance studies with specific acceptance criteria and performance metrics for such studies.

The information available is:

• Device Name: FMPT™ Extended Liners
• Tests Performed: Wear per ISO 14242-2/3, impingement per ASTM F2582-14, push-out, lever-out, torsion per ASTM F1820-13, and range of motion per ISO 21535:2009.
• Conclusion of Tests: "All evaluations determined that the devices are substantially equivalent to the applicable predicate devices."
• Clinical Testing: Not required.

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The MODULUS 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 Modulus Stems are intended for use with Co-Cr-Mo femoral heads and a compatible acetabular cup. When used in partial hip arthroplasty, the Modulus Stems are intended for use with the 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;
• osteoarthritis after femoral heads fractures; .
• correction of functional deformity; ●
• revisions in cases of good remaining femoral bone stock. ●

The Limacorporate Cemented Cup is intended for cemented use in hip arthroplasty where the acetabular socket needs reconstruction.

The Modulus femoral hip system consists of modular femoral hip prostheses, modular CoCrMo heads, cemented UHWMPE cups (for use in total hip arthroplasty) and bipolar heads (for use in partial or hemi-hip arthroplasty).

The Modulus femoral hip prosthesis consists of a femoral stem component and a femoral neck component combined by a Morse taper locking mechanism. A locking screw is provided to improve the security of fixation. The MODULUS femoral hip prosthesis is intended for cementless use in hip joint arthroplasty.

The femoral stem has a 5° conicity with a round finned section. It is made of Ti6A14V (ISO 5832-3, ASTM F1472) and is sandblasted. The stem is available in 11 sizes with diameters ranging from 16 to 26 mm with a 1 mm increment.

The femoral neck is available in two cervico-diaphyseal configurations (125° and 135°) and two lengths (42 and 48 mm). It is made of Ti6Al4V (ISO 5832-3, ASTM F1472). The proximal portion of the neck is highly polished while the distal portion is macroroughened.

Modular heads are manufactured from CoCrMo (ASTM F1537). They are characterized by a spherical shape and are used with an acetabular cup in total hip arthroplasty. The femoral heads are coupled with the MODULUS hip prosthesis by means of a 12/14 Morse taper. They are available in diameters of 28, 32 and 36 mm and in offset sizes S. M, L, XL.

Cemented cups are manufactured entirely of UHMWPE (ASTM F648, ISO 5834-2).

The acctabular cups are available in two different versions: standard and protruded. The standard version is hemispherical and is designed for use in deep acetabula. The protruded version has a lateral portion designed to resist dislocation.

An AISI 316-L stainless steel ring is inserted in the equatorial region to allow the evaluation of the device position through radiography.

Lock Bipolar Heads are modular prostheses characterized by an external shell made from CoCrMo (ASTM F1537) and by a conical liner made from UHMWPE (ASTM F648, ISO 5834-2). A retentive ring allows the shell to assemble with modular heads. Lock Bipolar heads are available in 13 sizes from 45 to 57 mm with a 1 mm increment.

The provided document, K112158, describes the Modulus Femoral Hip System. It is a 510(k) premarket notification, which means the manufacturer is seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing de novo safety and effectiveness. Therefore, the information provided focuses on comparative features and non-clinical testing, rather than an acceptance criteria study with clinical endpoints as might be seen for novel devices or PMAs.

Here's an analysis based on the provided text, addressing your points where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are largely implicit in a 510(k) submission. For medical devices seeking substantial equivalence, the "acceptance criteria" are often met by demonstrating that the device performs as well as, or better than, the predicate device in relevant non-clinical tests, or that any differences do not raise new questions of safety or effectiveness. Specific numerical thresholds for fatigue, pull-out, etc., are usually defined in the test protocols used by the manufacturer, which are not detailed in this summary.

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

• Test Set Sample Size: For the non-clinical testing, the document states "All mechanical testing was done on worst case components or constructs." This implies multiple samples of specific components were tested, but no specific number of samples (sample size) is provided for each test (fatigue, pull-out, range of motion simulation).
• Data Provenance: The testing was conducted by the manufacturer, Limacorporate S.p.A. (Italy). No information on country of origin of clinical data is relevant as no clinical testing was performed or deemed necessary. All data is prospective in the sense that it was generated for the 510(k) submission, not collected from existing patient records.

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

This point is not applicable to this submission. Since no clinical testing was performed, there was no "ground truth" to be established by clinical experts for a test set. The validation of the device relies on non-clinical mechanical testing and comparison to predicate devices, overseen by internal engineering and regulatory experts at the manufacturer, and subsequently reviewed by FDA experts.

4. Adjudication Method for the Test Set

This point is not applicable. No clinical test set requiring expert adjudication for ground truth was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of the Modulus femoral hip system to the predicate devices." MRMC studies are typically for evaluating human performance (e.g., radiologists interpreting images) with and without AI assistance, which is outside the scope of this device type and submission.

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

This question is not applicable as the device is a physical medical implant (hip system), not a diagnostic algorithm or AI system. Its "performance" is mechanical and clinical outcome-based in patients, not an algorithm's output.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance validation is primarily based on engineering standards, accepted mechanical test methods (e.g., for fatigue, pull-out), and the established safe and effective performance of its predicate devices. By demonstrating that its mechanical properties are comparable and meet relevant standards, and that its design and materials are substantially equivalent to predicates, it establishes its "ground truth" for safety and effectiveness in the context of a 510(k). No pathology or outcomes data from human subjects was used for this particular submission.

8. The Sample Size for the Training Set

This question is not applicable. This is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The design and manufacturing process are informed by engineering principles, material science, and prior successful designs (predicates).

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

This question is not applicable as there is no training set for an AI/ML algorithm.

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The FMP Constrained Liner is intended to replace a hip joint. The device is intended for primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered.

The constrained liner is first snapped into the shell and a ridge or lip around the outside of the liner engages a groove on the inside of the shell to provide a positive lock. The femoral head is inserted into the constrained liner and the locking ring secures the head into the liner.

The Constrained Liner consists of an UHMWPE insert conforming to ASTM F648 and a titanium alloy locking ring conforming to ASTM F620. The ID of the liners is 28 mm and the minimum thickness of the insert is 6 mm. The constrained liner is to be used in conjunction with the acetabular shells previously cleared in K973199, K974093, and K974095.

The provided document describes the acceptance criteria and the methods used to demonstrate that the FMP Constrained Liner meets these criteria. However, it does not detail a study in the context of an AI/ML device, as the document is for a physical medical device (hip prosthesis). Therefore, several requested points, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and data provenance, are not applicable.

Here's a summary based on the provided text, focusing on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not applicable. This document pertains to a physical medical device (hip prosthesis), not a data-driven AI/ML device. Performance is demonstrated through compliance with material and sterilization standards, and mechanical testing.
• Data Provenance: Not applicable.

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

• Not applicable. Ground truth for a physical device's performance is established through adherence to recognized engineering standards and physical testing, not expert consensus on data interpretation.

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 device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• The "ground truth" for this device is based on established engineering and medical standards (e.g., ASTM F136-98, ASTM F620-00, ASTM F648-00, ANSI/AAMI/ISO11137-94, EN552) for material properties and sterilization, and physical mechanical testing (lever-out testing).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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