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The Restoration® Modular System is intended for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. Examples of specific indications for use of the Restoration® Modular System include, non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, revision procedures where other treatments or devices have failed, and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Restoration® Modular Hip System is a modular hip system comprised of different proximal body styles and three distal stem designs, which are affixed with the use of a locking bolt. These individual components are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal stem to better fit the patient. This submission modifies the existing Restoration® Modular Bowed Plasma Stem to create a line extension called the Restoration® Modular Bowed Plasma Trislot Stem. The subject components are for use with the previously cleared Restoration® Modular Distal Stem components.

The provided text describes a Special 510(k) Premarket Notification for a line extension to the Restoration® Modular Hip System, specifically the Restoration® Modular Bowed Plasma Trislot Stem. This is a submission for a medical device (hip prosthesis) and the document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing de novo performance criteria for a new type of device or an AI/software as a medical device.

Therefore, the requested information about acceptance criteria and the study proving the device meets them (especially those related to AI/software performance, ground truth, experts, and training sets) is not applicable to this type of regulatory submission.

Here's why and what information is relevant from the provided text:

Key Takeaways from the Document:

• Device Type: This is a physical medical device (femoral hip prosthesis components), not an AI/software-based diagnostic or therapeutic device.
• Regulatory Path: It's a "Special 510(k) Premarket Notification" for a "line extension." This path is used for modifications to a manufacturer's own legally marketed device where the modification does not affect the intended use or the fundamental scientific technology of the device. The primary goal is to demonstrate substantial equivalence to the predicate device.
• Proof of Equivalence: The document states: "Mechanical testing and analysis demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength. In addition, the intended use, material, manufacturing methods, packaging, and sterilization of the predicate and new components are identical."

Answer to the specific questions (modified for context):

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

   • Acceptance Criteria for Substantial Equivalence (Implicit): The device (Restoration® Modular Bowed Plasma Trislot Stem) must demonstrate equivalent mechanical strength, intended use, material, manufacturing methods, packaging, and sterilization to its predicate devices (Restoration® Modular Bowed Plasma Stem and other Restoration® Modular Distal Stem components).
   • Reported Device Performance: "Mechanical testing and analysis demonstrates substantial equivalence of the new components to the predicate devices in regards to mechanical strength." The document does not provide specific quantifiable performance metrics (e.g., fatigue life numbers, stress data) in this summary, but asserts that the testing showed equivalence.

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

   • Not applicable in the context of an AI/software device. For a physical device like a hip implant, "sample size" usually refers to the number of components tested in mechanical studies (e.g., fatigue or tensile tests). This specific information (number of components tested) is not detailed in the summary. Data provenance is not a typical concern for this type of mechanical testing.

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. "Ground truth" established by experts is relevant for diagnostic or AI systems. For mechanical testing of an implant, the "ground truth" is determined by established engineering standards and physical measurements, not expert human interpretation.

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

   • Not applicable. This relates to expert review for diagnostic accuracy, not mechanical 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:

   • Not applicable. This study design is specifically for evaluating diagnostic AI or image interpretation systems.

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

   • Not applicable. This device is a physical implant, not an algorithm.

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

   • Not applicable. As noted above, the "ground truth" for demonstrating substantial equivalence for a mechanical implant would be established through engineering measurement against established performance standards and predicate device data.

8. The sample size for the training set:

   • Not applicable. This concept pertains to machine learning models, not physical devices.

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

   • Not applicable. This concept pertains to machine learning models, not physical devices.

In summary, this document is a regulatory submission for a physical hip implant. The "study" referenced is mechanical testing and analysis, which determined that the new components are "substantially equivalent" to predicate devices, thereby meeting the regulatory requirement for market clearance. The detailed specifics of those mechanical tests (e.g., number of samples, specific loads, quantifiable results) are not provided in this summary but are implicit in the FDA's clearance decision.

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The Restoration™ Modular System is intended to be used for primary or revision total hip arthroplasty, as well as in the presence of severe proximal bone loss. The stems are intended to be used with Howmedica Osteonics femoral heads, unipolar and bipolar components, and acetabular components. These femoral stems are designed to be press fit into the proximal femur.

The 2 Piece Modular Hip Stem, hereby referred to as the Restoration™ Modular System, is a modular system comprised of a proximal body, distal stem, and locking bolt. These three individual components utilizing a modular junction are assembled by the surgeon in the operating room or in situ to allow independent sizing of the proximal body and distal This system is designed so that all proximal components will be able to mate with stem. all distal components, thus affording optimal flexibility. The Restoration™ Modular System components will be fabricated from Titanium (Ti6Al-4V) Alloy. The Cone and Broached body components as well as the Porous Stems will be offered with plasma spray or plasma spray and hydroxylapatite coatings.

The Restoration™ Modular System is a medical device designed for hip arthroplasty. The provided text outlines a 510(k) summary for a device modification to a 2-piece modular revision stem system. The study conducted to demonstrate its performance focuses on mechanical properties rather than AI/human reader performance.

Here's a breakdown of the requested information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on the mechanical strength and integrity required for femoral hip prostheses, as dictated by relevant international standards.

Note: The document does not explicitly state numerical acceptance criteria, but rather general compliance with "defined performance values" and substantial equivalence to a predicate device.

2. Sample Size and Data Provenance for the Test Set

• Sample Size: The document mentions "A series of fatigue tests were performed" and "Most severe case' components/assemblies were tested." However, it does not specify the exact number of samples (sample size) used for the test set.
• Data Provenance: The study was conducted by Howmedica Osteonics Corp., a US-based company. The nature of these tests (fatigue tests on physical components) implies a prospective generation of data in a laboratory setting rather than retrospective analysis of patient data. There is no information on country of origin of data in terms of patient data, as this is a mechanical test.

3. Number of Experts and Qualifications for Ground Truth of Test Set

• Not Applicable: This study is a mechanical performance study of a prosthetic device, not a study evaluating diagnostic accuracy based on expert interpretation of medical images or clinical outcomes. Therefore, there were no human experts used to establish a ground truth for a test set in the traditional sense of a clinical or diagnostic study. The "ground truth" here is the physical performance of the device against engineering standards.

4. Adjudication Method for the Test Set

• Not Applicable: As this is a mechanical performance study, there was no adjudication method for a test set involving human interpretation or consensus. The performance is objectively measured against pre-defined engineering parameters and standards (ISO 7206-4 and ISO 7206-6).

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

• No: The document explicitly states, "A series of fatigue tests were performed to ensure the integrity of the Restoration™ Modular System." This is a mechanical engineering study, not an MRMC study comparing human readers with and without AI assistance. Therefore, no effect size for human readers improving with/without AI assistance is reported.

6. Standalone Performance Study (Algorithm only without human-in-the-loop)

• Not Applicable: This device is a physical medical implant, not a software algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop) performance" does not apply. The study focuses on the standalone mechanical performance of the device itself.

7. Type of Ground Truth Used for the Test Set

• Engineering Standards and Predicate Device Performance: The ground truth for the test set's performance was established by "defined performance criteria" derived from ISO 7206-4 and ISO 7206-6 (international standards for hip joint prostheses) and by comparison to the mechanical properties of a legally marketed predicate device (Restoration™ Modular (2 Piece Modular System) (K013106)).

8. Sample Size for the Training Set

• Not Applicable: This is a mechanical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model. The design and testing are based on engineering principles and material science.

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

• Not Applicable: As there is no training set for an AI model, there is no ground truth established for a training set. The device design itself is based on established engineering principles for biomechanics and material compatibility.

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