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The SMR Shoulder System is intended for partial or total, primary or revision shoulder joint replacement.

The SMR Anatomic Shoulder System is indicated for partial or total, primary or revision shoulder joint replacement in patients suffering from disability due to:

• non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
• inflammatory degenerative joint disease such as rheumatoid arthritis;
• treatment of acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
• . revision of a failed primary implant; in case of SMR Short Stems only if sufficient bone stock remains);
• cuff tear arthropathy (CTA Heads only);
• glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification (SMR TT Hybrid ● Glenoid only).

The SMR Reverse Shoulder System is indicated for primary, fracture or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder). The patient's joint must be anatomically suited to receive the selected implants and a functional deltoid muscle is necessary to use the device.

The SMR TT Hybrid Glenoid Reverse Baseplate must not be used in cases of excessive glenoid bone loss and/or when bone graft is needed.

The Modular SMR Shoulder System allows the assembly of components in various humeral and glenoid constructs. The constructs are intended for cemented and uncemented use as specified in the following table.

SMR Reverse Liners are made from LimaVit (cross-linked ultra-high molecular weight polyethylene with Vitamin E) conforming to ISO 5834-2, ASTM F648 and ASTM F2695. SMR Reverse Liners are coupled to SMR Reverse Humeral Bodies (K110598, K201905), with or without the use of the SMR Humeral Extension (K113523), and articulates with the SMR Glenosphere (K110598, K142139, K163397). SMR Reverse Liners have an articulating surface diameter of 36 mm and 40mm to articulate with the same diameter glenospheres respectively.

This document is a 510(k) summary for a medical device called the "SMR Reverse Liner." It describes the device, its intended use, and argues for its substantial equivalence to previously cleared devices.

Here's an analysis of the provided text in relation to acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state specific pass/fail acceptance criteria values for the device's performance. Instead, it broadly states that "Mechanical tests demonstrated that device performance fulfilled the intended use and that the devices is substantially equivalent to the predicate devices."

The reported device performance is qualitative, indicating that the device "fulfilled the intended use."

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

The document mentions "Mechanical testing was performed on worst case components or constructs." However, it does not specify the sample size (N) for these mechanical tests. It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as the testing is non-clinical/bench testing, not data derived from patients.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not applicable as the study is a non-clinical/mechanical testing study, not a study involving human data or expert review for ground truth establishment.

4. Adjudication Method:

This information is not applicable as the study is a non-clinical/mechanical testing study, not a study requiring adjudication of expert opinions.

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

This information is not applicable as the study is a non-clinical/mechanical testing study, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance Study:

A standalone performance study was done in the form of non-clinical mechanical testing. The device (SMR Reverse Liner) was tested directly for its mechanical properties (fatigue, wear, pull-out, torque-out, lever-out). The performance was compared to predicate devices for substantial equivalence.

7. Type of Ground Truth Used:

The "ground truth" for this non-clinical study is based on:

• Engineering Requirements/Standards: The device's performance must meet established mechanical properties deemed safe and effective for orthopedic implants. These are often guided by relevant ISO and ASTM standards (e.g., ISO 5834-2, ASTM F648, ASTM F2695 mentioned for materials).
• Predicate Device Performance: The performance of the SMR Reverse Liner is compared to that of the predicate devices to establish substantial equivalence.

8. Sample Size for the Training Set:

This information is not applicable as the study is a non-clinical/mechanical testing study, not a machine learning or AI-based study that would involve a "training set."

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 Delta Acetabular System is indicated for use in total hip arthroplasty 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;
• · Post-traumatic arthritis,
• · Correction of functional deformity;
• · Fractures, dislocation of the hip and unsuccessful cup arthroplasty;
• · Revisions in cases of good remaining bone stock;
• · Revision of previously failed total hip arthroplasty (Delta Multihole TT Pro only).

The Delta Acetabular System is intended for cementless use.

The Delta Multihole TT Pro Acetabular System consists of a Delta Multihole TT Pro cup, an acetabular liner and a modular femoral head. Bone screws can also be used to provide additional stability of the cup.

The Delta Multihole TT Pro cup is manufactured from titanium alloy; the Delta Multihole TT Pro liners are manufactured from cross-linked UHMWPE with Vitamin E and the femoral heads made of Biolox Delta ceramic or Cobalt Chrome Molybdenum alloy.

The design of shell is similar to the Delta TT Pro Acetabular System (K182099) and the G7 Acetabular System (Biomet, Inc., K140669) devices. The acetabular liners, the Biolox Delta heads, the CoCrMo heads and the bone screws are the same as those cleared in K182099. The Multihole TT Pro cup has a hemispherical design and provides holes in cranial and caudal aspects of the cup to provide additional cup stability by means of fixation screws. The Multihole TT Pro cup is coupled with a Delta TT Pro acetabular liner that is available in neutral, protruded and high wall versions.

This document describes the Delta Multihole TT Pro Acetabular System, a medical device for total hip arthroplasty, and its review by the FDA for substantial equivalence.

Based on the provided text, the device clearance was not based on studies involving AI or complex statistical analysis of human reader performance. Instead, it relied on non-clinical mechanical testing to demonstrate substantial equivalence to predicate devices. Therefore, many of the requested categories related to AI performance, human reader studies, and ground truth establishment for such studies are not applicable to this specific submission.

Here's the breakdown based on the provided text:

Acceptance Criteria and Device Performance

The provided document describes the acceptance criteria for this device as demonstrating substantial equivalence to existing predicate devices through non-clinical testing.

Study Details

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

   • Sample Size: Not applicable. The studies were non-clinical mechanical tests, not clinical studies with human subjects. The number of samples/units tested for the mechanical tests is not specified in the provided text, but these would be physical device units, not "data" in the sense of patient information.
   • Data Provenance: Not applicable. The tests were performed on the device itself, not on data from specific countries or patient populations. The tests are non-clinical (laboratory-based).

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

   • Not applicable. Ground truth for mechanical testing is established by engineering standards and measurement equipment, not by human experts interpreting clinical data.

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

   • Not applicable. This concept pertains to clinical image interpretation or diagnosis, not mechanical testing.

4. 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:

   • No. A MRMC study was not conducted. The document explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the Delta Multihole TT Pro Acetabular System to the predicate devices."
   • Effect size of human reader improvement with AI assistance: Not applicable as no such study was performed or required.

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

   • No. This device is a physical hip implant, not an algorithm or AI software. Therefore, standalone algorithm performance studies are not relevant.

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

   • The "ground truth" for the mechanical tests consists of the established engineering standards and requirements set forth in ASTM F1820-13 and ISO 7206-12:2016. Performance against these standards demonstrates "substantial equivalence" for the mechanical properties.

7. The sample size for the training set:

   • Not applicable. This is not an AI/machine learning device; there is no training set in this context.

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

   • Not applicable. There is no training set. The "ground truth" for the device's design and mechanical properties is based on established engineering principles and the performance of predicate devices, which the new device aims to match or exceed for relevant parameters.

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