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The Responsive Orthopedics Total Hip Arthroplasty System is indicated for cementless use only in the following cases:

• · Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and
  · Nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The Responsive Orthopedics Total Hip Arthroplasty System Acetabular screws are indicated for supplemental fixation of Responsive Orthopedics Acetabular Cup.

The Responsive Orthopedics Total Hip Arthroplasty (RO THA) System is a total hip system that allows for the restoration of alignment, stability and range of motion, and alleviates pain, by replacing the articulating surfaces of the hip joint. The system includes both femoral and acetabular components. The implants are available in a variety of sizes to accommodate varying patient anatomy.

The provided text describes a 510(k) premarket notification for a medical device, the "Responsive Orthopedics Total Hip Arthroplasty System." However, this document primarily focuses on the substantial equivalence of the subject device to predicate devices based on indications for use, technological characteristics, materials, and performance bench testing.

Crucially, the document does NOT contain information about a study proving the device meets acceptance criteria related to clinical performance, particularly in the context of AI/algorithm performance with human involvement or standalone performance (e.g., accuracy, sensitivity, specificity, or reader improvement). The performance data mentioned refers exclusively to bench testing of the physical properties and durability of the hip implant components.

Therefore, I cannot fulfill most of your request as the information is not present in the provided document. The document discusses mechanical, material, and assembly testing for a physical orthopedic implant, not an AI or algorithmic device that would typically involve acceptance criteria, test sets, expert adjudication, or MRMC studies for clinical performance on data.

Here's what I can extract from the provided text regarding the closest relevant sections (Performance Data and Acceptance Criteria for bench testing), and explanations for why other sections cannot be answered:

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

The document broadly states: "The subject devices met the pre-determined acceptance criteria for all tests. Therefore, design verification testing determined that the subject devices are substantially equivalent to the predicate devices."

However, it does not provide a specific table detailing:

• The exact numerical acceptance criteria for each test (e.g., "Fatigue life must exceed X cycles at Y load").
• The specific numerical results obtained for each test (e.g., "Femoral Stem Fatigue Test result: Z cycles at Y load").

It only lists the types of performance bench tests conducted:

Regarding the sections typically relevant to AI/Algorithm performance studies for medical devices:

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to physical components undergoing bench testing, not a dataset of patient images/records.
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 for an AI/algorithm (e.g., disease presence in an image) is not relevant to the described mechanical/material testing of a hip implant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used in clinical studies or expert reviews of data, not for bench testing of physical properties.
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 type is for evaluating the impact of AI assistance on human performance (e.g., radiologists interpreting images). The device described is a physical hip implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context would be related to the physical properties measured during bench testing (e.g., the actual force applied, the measured fatigue cycles until failure), established by engineering standards and measurement tools.
8. The sample size for the training set: Not applicable. There is no "training set" in the context of testing a physical medical device. This concept applies to machine learning models.
9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) clearance letter and summary for a physical medical device (a hip replacement system), not a software or AI-based device. Therefore, the detailed information sought regarding acceptance criteria and study designs for AI/algorithm performance (e.g., involving clinical data, expert readers, MRMC studies) is not present and is not relevant to the type of device described. The "performance data" discussed refers exclusively to bench testing for the physical and mechanical properties of the implant components.

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The Responsive Orthopedics Total Knee Arthroplasty System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

• · noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis;
• · inflammatory degenerative joint disease including rheumatoid arthritis;
• · correction of functional deformity:
• · revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The Responsive Orthopedics Total Knee Arthroplasty System is for cemented use only.

The Responsive Orthopedics Total Knee Arthroplasty System is a total knee system for the restoration of alignment, stability and range of motion, and alleviation of pain, by replacing the articulating surfaces of the knee joint. The system includes femoral, tibial and patellar components available in cruciate retaining, ultra-conforming cruciate sacrificing, medial-pivot cruciate sacrificing and posterior stabilizing versions.

This document is a 510(k) summary for the Responsive Orthopedics Total Knee Arthroplasty System. It serves as a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a predicate device already legally marketed. As such, it focuses on demonstrating equivalence rather than proving novel efficacy or meeting specific acceptance criteria based on clinical outcomes.

Therefore, many of the requested items related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity, expert ground truth, MRMC studies) are not applicable to this type of device submission. This device is a prosthetic implant, and its performance is evaluated through bench testing to ensure mechanical properties and safety are comparable to existing, legally marketed devices.

Here's a breakdown of the information that can be extracted or deduced from the provided text, addressing the closest relevant points:

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

This document does not present "acceptance criteria" or "reported device performance" in the typical sense of a diagnostic or AI device's clinical efficacy. Instead, it relies on demonstrating substantial equivalence to predicate devices through various bench tests that ensure the mechanical integrity and safety of the knee implant. The "acceptance criteria" here are implicitly the standards set by the predicate devices and the relevant ASTM standards for mechanical performance. The "reported device performance" is that it passed these tests.

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

• Sample size for test set: This is not applicable in the context of clinical testing for diagnostic performance. For the bench tests, the "sample size" would refer to the number of physical device components tested, but this specific number is not provided in the summary.
• Data provenance: Not applicable to this type of bench testing. The testing is performed on physical prototypes of the device.

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

Not applicable. Ground truth as established by experts (e.g., radiologists) is for diagnostic devices where human interpretation is involved. This device is a mechanical implant subjected to engineering tests.

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

Not applicable. Adjudication methods are relevant for clinical studies, particularly for diagnostic accuracy, which is not the focus of this 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

Not applicable. This is not an AI/diagnostic device.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable. The "ground truth" for this device's performance is compliance with established engineering and material standards (e.g., ASTM F1800, F648, F1223, F2083, F1814) and demonstrating mechanical properties comparable to the predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. This device does not involve a machine learning "training set".

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