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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 head;
• Rheumatoid arthritis;
• · Correction of functional deformity;
• Femoral fracture

This device may also be indicated in the salvage of previously failed surgical attempts. The EMPOWR Dual Mobility™ system has the additional indication of joint replacement due to dislocation risks.

The constrained acetabular component is indicated for primary or revision 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 who all other options to constrained acetabular components have been considered.

The ceramys™ femoral head system represents the latest generation of prosthetic femoral heads used in hip arthroplasty.

The ceramys™ femoral head system is applicable for use in total hip arthroplasty and the prosthetic replacement of femoral neck fractures. It offers a femoral head design with a reproducible surgical technique carefully developed to enable consistent and accurate implantation.

The ceramys™ femoral head system is composed of ceramys™ femoral heads, ceramys™ choice sleeved femoral heads, and ceramys™ choice sleeves. The ceramys™ femoral head system consists of alumina toughened zirconia ceramic heads and titanium adapter sleeves that connect to femoral stems using a 12/14 taper. The ceramys™ choice femoral heads and sleeves can be used with a well fixed stem in revision hip arthroplasty. The femoral head spherical diameter will be offered as 28, 32, 36, 40, and 44 mm and the femoral head center is offered in 4 increments ranging from -4 to +8 mm.

The provided text describes a 510(k) premarket notification for the ceramys™ femoral head system. This notification is for a medical device and not an AI/ML software. Therefore, the requested information regarding acceptance criteria and study details for an AI/ML device is not explicitly present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device through:

• Biocompatibility testing: Conducted according to FDA guidance and ISO standards for permanent implantation.
• Performance testing: A comprehensive list of tests performed to FDA recognized standards and internal protocols specific to the ceramys™ femoral head system. These tests cover mechanical properties, material composition, and other performance aspects relevant to the physical device.

Key points from the document regarding the device and its testing:

• Device Name: ceramys™ femoral head system
• Regulation Number: 21 CFR 888.3353 (Hip Joint Metal/Ceramic/Polymer Semi-Constrained Cemented Or Nonporous Uncemented Prosthesis)
• Regulatory Class: Class II
• Intended Use/Indications for Use: Joint replacement for patients with noninflammatory degenerative joint disease (osteoarthritis, avascular necrosis), rheumatoid arthritis, functional deformity, femoral fracture, and salvage of failed surgical attempts.
• Comparison to Predicate: The subject device is compared to the BIOLOX® delta Ceramic Femoral Head (K082844). While diameters and offsets are similar, the ceramic material formulation is different.
• No AI/ML Component: The submission does not mention any AI/ML components or software in the device description or testing.
• No Clinical Studies or Animal Studies: The document explicitly states "No animal data submitted" and "No clinical data submitted."

Therefore, it is not possible to extract the requested information about acceptance criteria or studies related to AI/ML device performance from this document. The acceptance criteria for this device would be embedded within the specific standards listed for performance testing (e.g., ISO 7206-10:2018, ASTM F1875-14) and would relate to the physical and mechanical properties of the femoral head system, not to an AI's diagnostic or predictive accuracy.

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

• · degenerative, post-traumatic or rheumatoid arthritis;
• · avascular necrosis of the femoral condyle;
• · post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
• · moderate valgus, varus or flexion deformities;
• · treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. All devices are intended for cemented applications except for the 3DKNEE™ Porous Coated Femur, EMPOWR Porous™ Knee Femur and EMPOWR Porous™ Knee Tibia which are intended for cementless applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Varus / Valgus Constrained (VVC) Tibial Insert and accessory is a line extension to the EMPOWR Knee platform (cleared via K143242), to include a more constrained tibial insert component that provides additional internal / external and varus / valgus rotational stability, which provide surgeons with comprehensive surgical solutions to address a variety of patient demographics and surgeon preferences.

The provided text is a 510(k) summary for the EMPOWR VVC Tibial Insert, a medical device. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that clinical testing was not required. As such, the information typically found in a study proving the device meets acceptance criteria, an MRMC study, or a standalone algorithm performance study is not present. The document focuses on mechanical testing.

Here's the breakdown of what can and cannot be extracted from the provided text regarding acceptance criteria and studies:

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

The document lists "Non-Clinical Testing" that was performed, implying that the results of these tests met certain acceptance criteria, but the specific numerical acceptance criteria and the detailed reported performance values are not provided. The conclusion states, "All testing has determined that the device is substantially equivalent to the predicate devices," which implies that the device did meet the acceptance criteria, whatever they were.

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

This information is not provided in the document. The Non-Clinical Testing section describes types of mechanical tests but does not specify sample sizes for these tests or data provenance beyond "All testing has determined that the device is substantially equivalent to the predicate devices."

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 the document describes mechanical, non-clinical testing, not a study involving human experts or ground truth establishment in a clinical sense.

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

This information is not applicable as the document describes mechanical, non-clinical testing.

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 information is not applicable. The device is a medical implant (Tibial Insert), not an AI-powered diagnostic or assistive tool for human readers. Additionally, the document explicitly states: "Clinical Testing: Clinical testing was not required."

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

This information is not applicable. The device is a physical medical implant, not a standalone algorithm.

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

For the non-clinical tests, the "ground truth" would be established by engineering standards, manufacturing specifications, and the performance characteristics of the predicate devices. The document implies that the device's performance met these engineering and substantial equivalence criteria. No clinical "ground truth" (like pathology or outcomes data) was used or required.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is a physical medical device undergoing mechanical testing, not a machine learning model.

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

This information is not applicable for the same reason as point 8.

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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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