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MicroPort total hip systems are intended 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:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;

2. inflammatory degenerative joint disease such as rheumatoid arthritis;

3. correction of functional deformity; and,

4. revision procedures where other treatments or devices have failed.

The subject MicroPort Orthopedics (MPO) CoCr femoral heads are spherical in shape and manufactured from low carbon cobalt chromium molybdenum alloy. The outer surface of the subject devices articulates against a polyethylene acetabular liner. The subject femoral heads possess an outer articulating surface finish of ≤3μin. The subject femoral heads are provided sterile. The proposed MPO femoral heads fill a gap in the current CoCr head offering. MicroPort CoCr heads are currently offered with short (S), medium (M), long (L) and extra-long (XL) offset for 32mm and 36mm diameter heads. The proposed new product offering in extra short (XS) and extra - long (XXL) offset will bring the CoCr heads offering into alignment with the current market presence of 32mm and 36mm heads.

The sole purpose for this traditional 510(k) is to seek clearance for the additional offering (XS and XXL) of the CoCr femoral heads in 32mm and 36mm sizes.

The provided text describes the 510(k) summary for MicroPort CoCr Femoral Heads, focusing on substantial equivalence to predicate devices rather than proving a device meets specific clinical performance criteria for an AI/ML algorithm. Therefore, many of the requested elements for describing an acceptance criterion for an AI/ML device and the study proving it cannot be extracted from this document.

The document primarily focuses on mechanical testing and material compatibility to demonstrate substantial equivalence for a medical device (hip implant components). It does not involve any Artificial Intelligence/Machine Learning (AI/ML) components, nor does it conduct studies that would establish "ground truth" through expert consensus or measure the effect size of AI assistance on human readers.

Below is a breakdown of what can be extracted and what cannot, based on the provided text:

What Can Be Extracted (Pertaining to Device Acceptance/Testing in General):

• Acceptance Criteria (General): While not explicitly stated as "acceptance criteria" for an AI/ML device, the document implies acceptance based on meeting mechanical testing requirements as outlined in various ASTM and ISO standards for hip joint prostheses, and non-pyrogenicity endotoxin testing (20 EU/device). The overarching "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
• Reported Device Performance (Mechanical/Biological):
  • Mechanical Testing: "The mechanical testing verifies that the subject components are substantially equivalent to the predicate devices currently on the market and have met all mechanical testing requirements based on the worst case construct testing." Specific numerical performance metrics (e.g., wear rate, torque values) are not provided in this summary, only that they met requirements.
  • Non-Pyrogenicity Endotoxin Testing: "Testing was successfully performed and it was confirmed that the subject implants meet the 20 EU/device testing limit." This explicitly mentions meeting a specific numerical limit.
• Device Type: MicroPort CoCr Femoral Heads (hip implant components).
• Study Type: Non-clinical (mechanical and biological bench testing).

What Cannot Be Extracted (Specific to AI/ML Device Acceptance Criteria and Study Design):

Most of the requested information is not applicable to this document as it describes a physical medical device (hip implant components) and not an AI/ML algorithm or software as a medical device.

1. A table of acceptance criteria and the reported device performance (for AI/ML): Not applicable. The document describes mechanical/biological acceptance, not AI/ML performance metrics like sensitivity, specificity, AUC, etc.
2. Sample sized used for the test set and the data provenance: Not applicable in the context of AI/ML. The "test set" here refers to physical implant samples for mechanical/endotoxin testing, not a dataset for AI evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no "ground truth" in the AI/ML sense (e.g., expert-annotated images) for this type of device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for this device would be physical properties and biocompatibility, verified by standard testing methodologies.
8. The sample size for the training set: Not applicable. There is no AI training set.
9. How the ground truth for the training set was established: Not applicable. There is no AI training set.

Summary Table (Limited to Applicable Information):

Details Not Applicable to This Device (No AI/ML):

• Sample Size (Test Set): Not a "data set"; refers to physical samples for lab tests. Data provenance, experts for ground truth, adjudication, MRMC studies, standalone performance, and AI-specific ground truth are not relevant for this physical device.
• Training Set: Not applicable as there is no AI/ML component.

Therefore, the provided document does not contain the information needed to describe acceptance criteria and a study proving an AI/ML device meets those criteria. It describes the regulatory clearance process for a traditional, physical medical device.

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The OMNI Anseris Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System. The Apex Interface™ Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as appropriate:

• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Congenital dislocation;
• Revision procedures where other treatments or devices have failed;
• Femoral neck and trochanteric fractures of the proximal femur.
  The OMNI Anseris Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

The OMNI Anseris Stem is a "fit and fill" femoral stem with a tapered conical design and is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface™ Acetabular System.

This document is a 510(k) premarket notification for a medical device called the "OMNI Anseris Hip Stem." It details the manufacturer's claim of substantial equivalence to existing predicate devices, rather than proving the device meets acceptance criteria through a standalone study of its performance in a clinical setting.

Therefore, the information typically found in a study proving acceptance criteria for an AI/algorithm-based device (like sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or ground truth establishment) is not present in this document because it describes a physical implantable device, not a software algorithm.

However, I can extract the information related to the device's non-clinical testing which serves as the "study" proving it meets specific engineering/physical acceptance criteria.

Here's the information parsed from the provided text, focusing on the nearest equivalent to your request:

Acceptance Criteria and Device Performance for OMNI Anseris Hip Stem (Non-Clinical Testing)

This document describes the non-clinical testing performed to demonstrate substantial equivalence of the OMNI Anseris Hip Stem to predicate devices. The "acceptance criteria" here refer to meeting specific engineering and performance standards for a hip implant, rather than clinical performance metrics of an AI algorithm.

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

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated in terms of individual units tested, but the document refers to "the results of testing of the proposed Anseris Hip Stems." For mechanical testing, this typically refers to a specific number of samples required by the standard (e.g., n=6 or more for fatigue testing). The document does not specify the exact number of physical stems tested.
• Data Provenance: The testing was carried out by the manufacturer, OMNIlife Science. The data is internal to the company's testing processes as part of their 510(k) submission. There is no mention of country of origin of data in a clinical sense, nor is it retrospective or prospective as it's mechanical testing of a physical device.

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

• Not Applicable. This is a physical device being cleared through substantial equivalence to existing predicate devices based on non-clinical (mechanical and material) testing. There is no "ground truth" derived from expert consensus like in an AI/imaging study. The "ground truth" here is the pass/fail criteria of established international and industry standards (ISO, ASTM).

4. Adjudication method for the test set

• Not Applicable. As there are no human readers or interpretations of data akin to an AI study, there's no adjudication method. The tests are designed to provide objective, quantifiable results against predefined engineering specifications.

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 a physical hip implant, not an AI software or diagnostic imaging tool. Therefore, MRMC studies are not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm. The "standalone performance" is the performance of the hip stem in a mechanical testing environment.

7. The type of ground truth used

• For the non-clinical testing, the "ground truth" refers to compliance with established international and industry standards for hip implants, such as ISO 7206-6, ISO 7206-4, ISO 21535, and ASTM F2996-13, as well as biocompatibility standards (e.g., SAL of 10-6 for sterility, endotoxin limits).

8. The sample size for the training set

• Not Applicable. There is no "training set" as this is not an algorithm undergoing machine learning.

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

• Not Applicable. As there is no training set, there is no ground truth for it.

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The OMNI Skirted Heads are intended for use in combination with the NOVAE® Dual Mobility Acetabular Cup and are indicated for total hip replacement, which includes:
• Osteoarthritis
• Femoral neck fracture
• Dislocation risk
• Osteonecrosis of the femoral head
• Revision procedures where other treatments or devices have failed and if bone reconstruction so permits.

SUNFIT TH, NOVAE E TH and COPTOS TH are intended for press-fit use and NOVAE STICK is indicated for cemented use.

The OMNI Skirted Heads are intended to be used in the primary/revision total hip replacement procedures in combination with the SERF Dual Mobility Acetabular Cup. These femoral heads are manufactured from cobalt chromium (CoCr) and are designed to be used with the SERF Dual Mobility Acetabular cup. These heads offer a skirted feature and when used with the Dual Mobility cups, the skirt extends over the exposed femoral taper and reduces the contact between the SERF polyethylene liner and machined surface of the K1 stem trunnion. SERF obtained clearance to use the OMNI K1 stem with its Dual Mobility NOVAE Acetabular Cup under K111572. In this submission, OMNI proposes two sizes for these skirted heads – 28mm+7 and 22mm+3.5 diameter and neck length respectively.

This is not an AI/ML device and as a result, the acceptance criteria and study information points outlined in the request are not applicable. The device is the OMNI Skirted Heads, which are part of a hip joint prosthesis. The provided document is a 510(k) premarket notification for this medical device, demonstrating its substantial equivalence to previously marketed devices.

However, I can extract information relevant to the device's performance testing and justification for substantial equivalence.

Here's a summary of the available information:

1. Acceptance Criteria and Reported Device Performance:

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

• Test Set: The document mentions "Range of Motion testing was conducted." It does not specify the exact sample size for this testing.
• Data Provenance: Not explicitly stated, but it's internal testing conducted by the manufacturer (OMNIlife Science) to support their 510(k) submission.

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

• Not applicable/provided. This device is a mechanical implant, and its performance criteria are based on engineering and material standards (e.g., ISO 21535), not expert interpretation of outputs.

4. Adjudication method for the test set:

• Not applicable. Performance is based on objective measurements against engineering standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No, this type of study is not applicable as this is a mechanical medical device, not an AI/ML-driven diagnostic or assistive tool.

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

• Not applicable, as this is not an algorithm or AI device.

7. The type of ground truth used:

• Engineering Standards and Specifications: The "ground truth" for this device appears to be the requirements of relevant ISO standards (e.g., ISO 21535 for Range of Motion) and the performance characteristics of predicate devices.

8. The sample size for the training set:

• Not applicable, as this is not an AI/ML device that requires a training set.

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

• Not applicable.

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