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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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