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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 Interface™ Acetabular System is designed to be used in hip arthroplasty. The specific indications for use include -

• . 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 Interface Acetabular System is intended for cementless and single use implantation only.

The OMNI Interface Acetabular System consists of acetabular cups/shells that are made of titanium alloy, standard and crosslinked ultra high molecular weight polyethylene shell inserts and femoral heads that are used with compatible femoral hip stems for primary and revision total hip replacement. The shells are available in “no hole” and “3-hole” configuration and a size range from 46-76 mm and X size (48x-58xmm).

The provided document is a 510(k) summary for the OMNI Interface™ Acetabular System, which is a medical device (hip implant). It is not an AI/ML device, and therefore the concepts of acceptance criteria for an algorithm, study design for AI models, ground truth, expert adjudication, or MRMC studies are not applicable.

The document discusses the substantial equivalence of the OMNI Interface™ Acetabular System to predicate devices. Substantial equivalence in this context means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Here's an interpretation of the relevant information provided, framed as closely as possible to your request, but adapted for a non-AI medical device:

The "acceptance criteria" for a medical device like the OMNI Interface™ Acetabular System are typically related to its physical and mechanical performance, biocompatibility, and intended use as compared to existing, cleared devices. The "study that proves the device meets the acceptance criteria" refers to the testing and comparison performed to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not an AI device, there are no "performance metrics" in the sense of sensitivity, specificity, etc. The acceptance criteria relate to the device's characteristics and its ability to function as intended without raising new safety or effectiveness concerns compared to a predicate device.

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

This information isn't directly applicable as it's not an AI model. For mechanical medical devices, testing typically involves simulating physiological conditions using specific numbers of samples (e.g., a certain number of implants tested for fatigue or range of motion).

• Test Set (for mechanical testing): The document mentions "The results of testing for the proposed use of OMNI Interface Acetabular System with the Paragon Stem met the performance requirements for range of motion per ISO 21535." It also states "compatibility and mechanical testing." The specific sample sizes for these mechanical tests are not provided in this summary but would have been part of the full 510(k) submission.
• Data Provenance: Not applicable in the AI sense. The "data" here would be the results of laboratory mechanical and material tests conducted on the physical devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This concept is not applicable to this type of medical device submission. "Ground truth" in the context of AI refers to expert-labeled data for training and evaluating an algorithm. For a hip implant, the "truth" is established by manufacturing standards, preclinical mechanical testing, material specifications, and comparison to the performance of existing legally marketed predicate devices. No human experts are "labeling" data for an outcome here in the AI sense.

4. Adjudication Method:

Not applicable. Adjudication methods (like 2+1, 3+1) are used in AI studies to resolve disagreements among human labelers establishing ground truth. For a hip implant, material properties and mechanical performance tests have objective outcomes measured by equipment.

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

Not applicable. MRMC studies are used to evaluate how an AI algorithm affects the performance of human readers (e.g., radiologists interpreting images). This device is a physical implant, not an interpretive algorithm.

6. Standalone Performance:

Not applicable. "Standalone performance" refers to the algorithm's performance without human intervention. This device is a component of a total hip replacement, which is entirely reliant on human surgeons for implantation and human patients for its function. The closest equivalent would be the mechanical performance of the device components themselves, which is implicitly what the "testing" section refers to.

7. Type of Ground Truth Used:

Not applicable in the AI sense. For this device, "truth" is established by:

• Engineering design specifications.
• Conformity to international standards (e.g., ISO 21535 mentioned for range of motion).
• Material science properties.
• Biocompatibility assessments.
• Demonstration of substantial equivalence to predicate devices which have a known history of safe and effective use.

8. Sample Size for the Training Set:

Not applicable. This device does not use a training set as it is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. No training set exists for this device.

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The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cup are intended for uncemented fixation and single use implantation. The Apex Acetabular Cup liners, standard and ApeX-LNK Poly, are intended for use with the Apex Modular Acetabular Cup, in combination with the Apex Modular, Apex K2, Apex K2 mid length or Apex K1 Hip in total hip replacement procedures. The acetabular cup inserts are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for 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

Non hooded (0 deg neutral) and Hooded (10 deg) +4mm offsets for use with 28, 32, 36, 40mm Apex Modular heads.

The provided text describes a 510(k) summary for the Interface Acetabular System, Acetabular Insert. The documentation primarily focuses on the device's design, materials, indications for use, and a comparison to predicate devices, along with non-clinical testing.

Here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document does not specify the exact number of samples used for each non-clinical test (ROM analysis, artificial aging, push-out & lever-out). It only states "All samples tested."
• Data Provenance: Not applicable in the context of this device and testing. The tests are in vitro mechanical/material tests, not data derived from human subjects or clinical settings based on a specific country of origin or retrospective/prospective nature.

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 explicitly states, "No clinical studies were performed." The "ground truth" for the non-clinical tests would be the performance standards defined in the ASTM and ISO standards, which are engineering specifications, not expert medical consensus.

4. Adjudication method for the test set:

• This information is not applicable as there were no clinical studies involving human readers or subjective interpretations of data that would require an adjudication method. The testing involved objective physical measurements against established engineering standards.

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:

• No, an MRMC comparative effectiveness study was not done. This is a medical device (hip insert), not an AI diagnostic or image analysis tool. The document explicitly states, "No clinical studies were performed."

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

• This information is not applicable. This device is a mechanical implant, not an algorithm.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" was established by engineering performance standards specified by ASTM F2003-02 (extreme artificial aging) and ISO-21535-2007 (ROM analysis), along with industry-standard "Push-out & Lever-out Test" criteria.

8. The sample size for the training set:

• This information is not applicable as no clinical studies or AI/machine learning models were involved in the evaluation of this device.

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

• This information is not applicable as no clinical studies or AI/machine learning models were involved.

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The Apex ARC Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for 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 Apex ARC Hip Stem consists of a curved, rectangular tapered stem, and modular necks that connect to the tapered hole in the stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. Three neck sizes are offered, with a neutral, 8 degree, and 12 degree varus-valgus angle, respectively. The necks are compatible with the modular heads that are part of the Apex Modular and Apex K2 hip systems (K000788, K012918, and K073150) and may be used with head diameters and offsets up to a maximum offset of +7 mm. These configurations allow the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The Apex ARC Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110, K062489, and K073150) for total hip arthroplasty.

The provided document describes the 510(k) Summary for the Apex ARC™ Hip Stem (K090845). This is a medical device submission to the FDA, and as such, it focuses on demonstrating "substantial equivalence" to predicate devices rather than proving performance against specific acceptance criteria through a traditional clinical study with defined endpoints as would be expected for a novel AI/software device.

Therefore, the requested information elements (acceptance criteria, study details, sample sizes, expert ground truth, MRMC, standalone performance) are not directly applicable in the context of this device's submission type and the information provided. Traditional clinical trials with acceptance criteria and statistical analysis are typically not required for Class II devices demonstrating substantial equivalence through non-clinical testing.

However, I can extract the relevant information regarding the non-clinical tests conducted which serve a similar purpose to demonstrating the device's functional integrity and safety, and compare them to the general characteristics of the predicate devices.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a mechanical implant, "acceptance criteria" are not explicitly defined in terms the performance metrics commonly associated with AI/software (e.g., sensitivity, specificity, AUC). Instead, the device's "performance" is demonstrated through non-clinical mechanical and material testing based on recognized international and ASTM standards. The acceptance criterion for these tests is generally successful completion of the test without failure, meeting the requirements of the specified standard, and demonstrating equivalence to predicate devices.

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

• Sample Size: Not specified in terms of number of physical devices tested for each non-clinical test. For mechanical tests, representative samples are typically used to meet the requirements of the standards. For material properties, it refers to the composition. The document doesn't detail the number of physical units tested.
• Data Provenance: The tests are non-clinical, meaning they were performed in a laboratory setting, not on human subjects. No country of origin is specified for the testing, but the submitter (OMNI life science, Inc.) is based in E. Taunton, MA, USA. This is a prospective assessment for market clearance, meaning the tests were conducted specifically for this submission.

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

This question is not applicable to this 510(k) summary. For mechanical devices, "ground truth" typically relates to objective physical measurements or material properties as defined by engineering standards, not expert consensus as in diagnostic imaging. The "experts" involved would be the engineers and technicians conducting and validating the tests, adhering to the specified ISO and ASTM standards. Their qualifications are inherent in the rigorous nature of these testing facilities.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical findings, not for objective mechanical test results. The results of the non-clinical tests are binary (pass/fail compliance with the standard).

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 total hip replacement device, not an AI/software diagnostic tool, and therefore no MRMC study was performed.

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.

7. The type of ground truth used

The "ground truth" for this device's evaluation is primarily based on engineering standards (ISO, ASTM) for mechanical performance and material properties. This includes objective measurements of fatigue strength, fretting potential, disassembly strength, torsional strength, range of motion, and material composition. Biocompatibility (ETO residuals) is also assessed against established standards.

8. The sample size for the training set

Not applicable. This is a physical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device.

In summary: The Apex ARC™ Hip Stem, a Class II medical device, demonstrates its safety and effectiveness for market clearance by showing substantial equivalence to existing predicate devices (Apex K2™ Hip System and Aesculap Metha® Hip System) through a detailed comparison of design, materials, and intended use, and by successfully completing a series of non-clinical mechanical and material tests according to recognized international standards (ISO, ASTM) and FDA guidance documents. No clinical studies or AI-related evaluations were performed for this submission.

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The Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• e 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 Interface™ Acetabular Cup Liners are manufactured of compression molded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 28 mm, 32 mm or 36 mm diameter. The subject device adds an option for a 20° elevated rim that was not previously offered.

The provided text describes a 510(k) premarket notification for the "Interface™ Acetabular Cup Liners." This submission focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a study of the device's clinical performance against specific acceptance criteria in the manner of a clinical trial for an AI/ML medical device.

Therefore, the specific information requested about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets (relevant to AI/ML device studies) is not applicable to this 510(k) submission for a physical orthopedic implant.

Here's why and what information is available:

• Nature of the Device: The Interface™ Acetabular Cup Liners are physical medical devices (orthopedic implants) used in total hip replacement procedures. They are not an AI/ML algorithm or software that performs diagnostic or prognostic functions.
• Regulatory Pathway (510(k)): A 510(k) submission demonstrates "substantial equivalence" to a legally marketed predicate device. This typically involves comparing design, materials, manufacturing processes, intended use, and performance characteristics (often mechanical testing for implants) to established, safe, and effective devices. It does not generally require new clinical trials or performance studies against predefined clinical acceptance criteria in the same way an AI/ML device would.

What is provided in the document and how it relates to "acceptance criteria" for a physical device:

The "acceptance criteria" in this context are primarily the demonstration of substantial equivalence to predicate devices. The study proving this involves detailed comparisons rather than a clinical performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are implicitly meeting the design, material, and functional equivalence to the predicates. The "reported device performance" is the comparison showing these equivalences.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a clinical study involving a test set of patient data. The "test" is the comparison of device characteristics to predicates.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the clinical sense, is not established for this type of submission. The "ground truth" is the established safety and effectiveness of the predicate devices.

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 an orthopedic implant, not an AI-assisted diagnostic tool.

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 in the context of AI/ML. For this 510(k) submission, the "ground truth" (or basis of comparison) is the known safety and effectiveness profiles of the predicate devices (Interface™ (K031110), ApeX-LNK Poly™ (K062489 and K073150), and Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners) as determined by their prior FDA clearances and long-standing use in the market.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) premarket notification that demonstrates substantial equivalence for a physical medical device (acetabular cup liners). The "study" proving it meets "acceptance criteria" involves a detailed comparison of its design, materials, and intended use against already cleared predicate devices. The concepts of test sets, training sets, expert ground truth, and AI-assisted performance are not relevant to this type of regulatory submission.

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The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation, with the option of using a porous coated femoral component for uncemented or cemented fixation. This prosthesis may be used for 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. .

The Apex Knee System Porous Coated Femoral Components are part of the Apex Knee System for primary or revision total knee replacement. These cobalt chrome femoral components have a sintered porous coating (ASTM F1377). Fixation of the femoral component is achieved using either PMMA bone cement or by biological fixation via tissue ingrowth into the porous coating. The Apex Knee System consists of a range of sizes of femoral components with a deep patellar groove, dome shaped UHMWPE patella resurfacing components, UHMWPE tibial inserts, cobalt chrome tibial trays, and a titanium alloy bolt for locking the tibial insert to the tibial tray. This modular configuration allows the surgeon user to choose a combination of femoral and tibial tray component sizes to appropriately fit the anatomy of the patient, and to use a tibial insert with a sizefor-size match to the femoral component. There are two different articular geometries for the tibial insert, a cruciate retaining ("CR") design, which allows retention of the posterior cruciate ligament, and an ultra-congruent posterior cruciate substituting ("Ultra") design. For each tibial insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.

The provided text describes a 510(k) premarket notification for the Apex Knee System Porous Coated Femoral Components. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than conducting new clinical studies to prove performance against specific acceptance criteria. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set details will not be explicitly found in this document.

However, I can extract the relevant information from the document that addresses the comparison to predicate devices, which is the basis for this 510(k) clearance.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The "reported device performance" is the claim of equivalence.

• Apex Knee System (K060192) for cemented components
• Sigma Cruciate-Retaining Porocoat® Femoral Components (K062654) for porous coated components |
  | Identical Intended Use | Indications for Use are identical to the predicate Apex Knee System, with the added option of uncemented fixation for the porous coated femoral component. |
  | Similar Design Features | Similar design (asymmetric femur, anatomic patella groove, metal-backed UHMWPE tibial component, patella design) to predicate devices. The key difference is the addition of a porous coating. |
  | Similar Materials | Femoral component: Cobalt chrome.
  Porous coating: Sintered cobalt chrome (same as DePuy predicate and Sponsor's K031110) |
  | Same Manufacturing, Packaging, Sterilization Methods | Identical to the predicate Apex Knee System (K060192). |

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

• Not applicable. This submission is a 510(k) premarket notification, which relies on demonstrating substantial equivalence to existing predicate devices rather than new clinical testing against a specific test set. No new clinical study data or patient samples are presented for this purpose in the document. The 'test set' in this context would be the comparison against specifications and characteristics of the predicate devices.

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

• Not applicable. As this is a 510(k) based on substantial equivalence, there is no "test set" in the sense of clinical data requiring expert review for ground truth. The evaluation is against the features and performance of predicate devices as described in their own 510(k)s or regulatory clearances.

4. Adjudication method for the test set:

• Not applicable. No clinical data test set requiring adjudication is presented.

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 device is a total knee replacement prosthesis, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader improvement with AI is irrelevant to this submission.

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

• Not applicable. This device is a total knee replacement prosthesis and does not involve an algorithm or AI component.

7. The type of ground truth used:

• Not applicable in the conventional sense of a clinical study. The "ground truth" for this 510(k) hinges on the established characteristics, performance, and regulatory clearances of the legally marketed predicate devices. The "truth" is that the new device is functionally and materially similar enough to the predicates to warrant substantial equivalence.

8. The sample size for the training set:

• Not applicable. This device is a physical medical implant, not an AI model requiring a training set.

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

• Not applicable. See point 8.

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The Apex HCLA Acetabular Cup Liners are intended for use with the Apex Modular™ Acetabular Cup, in combination with the Apex Modular, Apex K2™, or Apex K61™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for 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 Apex HCLA™ Acetabular Cup Liners are manufactured of compression molded, cross-linked and stabilized ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 28 mm diameter, with various offsets.

This document describes a 510(k) premarket notification for a medical device (Apex HCLA™ Acetabular Cup Liners), not an AI/ML-driven device or study. Therefore, the information requested in the prompt, which is typically relevant for AI/ML device evaluations (e.g., acceptance criteria for algorithm performance, sample sizes for training/test sets, expert ground truth, MRMC studies, standalone performance), is not applicable to this submission.

The document primarily focuses on establishing "substantial equivalence" of the Apex HCLA™ Acetabular Cup Liners to legally marketed predicate devices based on similarities in design, intended use, material, and manufacturing methods. It does not involve any performance evaluation against acceptance criteria in the context of an AI/ML model.

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The Apex K1™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for 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 Apex K1 Hip Stem consists of a rectangular tapered stem, and modular heads that connect to the tapered trunion on the neck. Four configurations are available for each size: standard and long lengths, each with standard and lateraliz ed necks. These configurations allow the user to choose a combination of stem and head components to appropriately fit the anatomy of the patient. The Apex K1 Hip Stem may be used in conjunction with the Apex Modular™ Acetabular Cup (K031110) for total hip arthroplasty.
The femoral stems are manufactured from titanium alloy, and can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems.

The provided 510(k) summary for the Apex K1™ Hip Stem does not describe acceptance criteria, a study that proves the device meets specific acceptance criteria, or performance metrics in the way typically expected for AI/software-as-a-medical-device (SaMD) devices.

This document is for a medical implant (a hip stem), and the regulatory submission process for such devices focuses on demonstrating substantial equivalence to a legally marketed predicate device primarily through:

• Comparison of design and materials: Ensuring the new device has similar characteristics.
• Bench testing: Addressing mechanical properties, fatigue, and biocompatibility.
• Performance data: Often derived from established standards for orthopedic implants.

Therefore, many of the specific questions about acceptance criteria, sample sizes for test sets, expert ground truth, MRMC studies, and standalone performance for AI are not applicable to this type of device submission.

Here's an attempt to answer the questions based on the provided text, highlighting where the information is not present or relevant to this type of device:

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

The document does not provide a table of acceptance criteria or specific performance metrics (like sensitivity, specificity, accuracy) typically associated with AI/SaMD. The "performance" for a hip stem is generally implied by its design, materials, and mechanical properties, which are shown to be substantially equivalent to predicate devices.

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. This is a physical medical implant. There is no "test set" in the context of data for an algorithm. The "testing" involved would be mechanical and biocompatibility bench tests, not data analysis.

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. This is a physical medical implant. The determination of "ground truth" (e.g., successful performance or safety) comes from engineering standards, material science, and clinical experience with similar implants, rather than expert consensus on data interpretation.

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

Not applicable. See point 3.

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 medical implant, not an AI or software device that assists human readers.

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

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

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

The "ground truth" for this device's safety and effectiveness is established through:

• Engineering design principles.
• Material testing to industry standards (e.g., for fatigue, strength).
• Biocompatibility testing.
• Demonstration of substantial equivalence to predicate devices with a history of safe and effective use.
• No specific "ground truth" is explicitly mentioned in the document in the context of data for an algorithm.

8. The sample size for the training set

Not applicable. This is a physical medical implant, not an AI/software device that uses a training set.

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

Not applicable. See point 8.

Summary regarding the provided document:

The 510(k) summary for the Apex K1™ Hip Stem focuses on demonstrating substantial equivalence to predicate devices (SL-Plus® and SLR-Plus® hip stems, and Apex K2™ Hip System) based on:

• Intended Use: Identical or very similar.
• Design Features: Comparison of coated status, modularity (head vs. neck), surface finish, stem shape, etc.
• Materials: Comparison of titanium alloys, head materials, and coatings.

The document states: "Substantial equivalence is claimed to the SL-Plus® and SLR-Plus® hip stems distributed by Plus Orthopedics (K001942 and K021178), and the Apex K2™ Hip System (K041950)." This is the core "study" and "acceptance criteria" mechanism for this type of device – proving that it is sufficiently similar to devices already on the market that have been deemed safe and effective. The FDA's letter confirms this "substantial equivalence determination."

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The Apex Modular™ HA Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for 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 Apex Modular™ HA Hip Stem consists of three modular components, with various sizes available for each component: the porous coated femoral stem, a modular neck that connects to the proximal end of the femoral stem, and a modular head that connects to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex Modular HA Hip Stem may be used in conjunction with the Apex Modular Acetabular Cup (K031110) for total hip arthroplasty. The femoral stems (and modular necks) are manufactured from titanium alloy. The Apex Modular HA stems can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular and Apex K2 hip systems. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray, with an optional hydroxyapatite (HA) coating on top of the titanium coating. As in the predicate Apex Modular stem, the alignment pin in the stem is manufactured from wrought cobalt chromium alloy.

The provided document is a 510(k) premarket notification for the Apex Modular™ HA Hip Stem. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, this document does not contain information on acceptance criteria, a study proving the device meets those criteria, or any of the detailed study parameters requested in the prompt (e.g., sample sizes for training/test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance).

The 510(k) process for this type of medical device (hip prosthesis) primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices, rather than conducting new clinical trials or performance studies with specific quantitative acceptance criteria in the manner requested for AI/software devices. The "study" mentioned here is the comparison to predicate devices, and the "acceptance criteria" is essentially the demonstration of substantial equivalence.

Therefore, I cannot fulfill your request for a detailed table and description of the study and its parameters because the necessary information is not present in the provided text. The document focuses on regulatory approval through substantial equivalence, not on the quantitative performance validation typical for AI/software.

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The Apex K2™ Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for uncemented fixation and single use implantation. This prosthesis may be used for 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 Apex K2™ Hip Stem consists of a rectangular tapered stem, modular necks that connect to the proximal end of the stem, and the modular heads that connect to the tapered trunion on the neck. This configuration allows the user to choose a combination of stem, neck, and head components to appropriately fit the anatomy of the patient. The various neck sizes allow for several length and lateral offset options for a given stem size. Several offset options are also available for the heads to allow further refinement of the lengths and offsets. The Apex K2 Hip Stem may be used in conjunction with the Apex Modular Acetabular Cup (K031110) for total hip arthroplasty.
The femoral stems (and modular necks) are manufactured from titanium alloy. The Apex K2 stems can be used with the cobalt chromium alloy heads and the alumina ceramic heads that are part of the Apex Modular hip system. The proximal metaphyseal region of each size femoral stem is circumferentially coated with unalloyed titanium applied by plasma spray, the same coating method used by the predicate Apex Modular hip stem. As in the predicate Apex Modular stem, the alignment pin in the stem is manufactured from wrought cobalt chromium alloy.

The provided text describes a 510(k) premarket notification for the Apex K2™ Hip Stem, seeking to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria with performance metrics. The information focuses on device description, intended use, and comparison to predicate devices. As such, the requested details regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not available in the provided text.

Specifically:

• Acceptance Criteria and Reported Device Performance: This information is not explicitly stated in terms of quantitative performance metrics for the Apex K2™ Hip Stem. The document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and intended use.
• Sample size used for the test set and data provenance: No test set is described. The document pertains to a 510(k) submission, not a clinical study on the Apex K2™ Hip Stem with a specific test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical test set with corresponding ground truth is detailed.
• Adjudication method for the test set: Not applicable.
• 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 document is for a hip stem, not an AI or diagnostic imaging device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

The document indicates that "Performance testing of the modularity was completed as per the relevant FDA guidance documents" and "Performance testing of the plasma sprayed unalloyed (CP) titanium coating was completed as per the relevant FDA guidance documents." This suggests engineering and material testing were performed, but the specific acceptance criteria and results of these tests are not detailed in the provided text. The submission is primarily about establishing substantial equivalence through comparison of features and characteristics to existing predicate devices.

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