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The OMNI TiN Coated Apex Knee™ is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented 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;
• · Revision procedures where other treatments or devices have failed;
  The Apex Knee™ Modular Tibial Augments with TiN coating are intended to be bolted to the TiN coated Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur System Augments are intended to be bolted to the TiN coated femoral component and cemented to the prepared femur.

The change that is the subject of this 510(k) is to add a thin coating of Titanium Nitride (TiN) to all surfaces of all CoCrMo substrate metal components (Femoral(s), Tibial Baseplate(s), and Revision Tibia Augments) as listed in the above Predicates. The purpose of the TiN coating is to substantially reduce release of CoCrMo metal ions into body fluids, bone or soft tissues.
There is no change to the fundamental scientific technology of the referenced OMNI Predicate Knee Systems (5) with the modifications in this 510(k) submission. This includes no changes to the substrate materials, design, sterilization, packaging, or method(s) of manufacture.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The text is a 510(k) premarket notification for a medical device called the "OMNI TiN Coated Apex Knee™ System."

While it discusses the device's indications for use, its description, predicate devices, and non-clinical testing performed on the Titanium Nitride (TiN) coating, it explicitly states:

"7. Clinical Testing: No clinical studies were performed."

This immediately indicates that there will be no information regarding:

• A table of acceptance criteria and reported device performance (as this would typically come from clinical or comprehensive performance studies).
• Sample sizes for test sets, data provenance, or details about training sets (as these are relevant to studies, especially those involving AI/ML or extensive clinical trials).
• Numbers of experts, their qualifications, or adjudication methods for ground truth (again, these are related to studies, particularly those involving human interpretation or AI model validation).
• MRMC studies, effect sizes for human readers, or standalone AI performance.
• Types of ground truth established.

The document focuses on demonstrating substantial equivalence to predicate devices through

• Indications for Use,
• Material changes (addition of TiN coating), and
• Non-clinical testing of the coating properties (Chemical Composition, Thickness, Hardness, Adhesion Strength, Surface Roughness, and Wear Resistance).

Therefore, I cannot fulfill your request based on the provided text, as the necessary information for describing acceptance criteria and a study proving device performance is not present.

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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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;
• Revision procedures where other treatments or devices have failed;
  The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
  The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Knee Revision Femur system augments are intended to be bolted to the femoral component and cemented to the prepared femur.

The Apex Knee™ Modular Tibia System is composed of a tibial baseplate that mates with a cap, keel or a stem. Additionally the baseplate may be used with tibial augments and pegs. The components are used together to form a prosthesis for implantation.

This document is a 510(k) summary for the Apex Knee™ Modular Tibia System. It outlines the device's description, indications for use, comparison to predicate devices, and non-clinical test summaries. It explicitly states that no clinical studies were performed for this submission.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, multi-reader multi-case studies, standalone performance, and ground truth for clinical studies cannot be provided, as none were conducted.

The acceptance criteria and study information provided in this document pertain exclusively to non-clinical testing.

Here's the information about the non-clinical tests mentioned:

Acceptance Criteria and Study Information for Non-Clinical Testing:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Note: The specific quantitative acceptance criteria for each test are not detailed in this summary but are standard for the cited ASTM methods.

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

• Sample Size: Not specified in the provided summary for any of the non-clinical tests.
• Data Provenance: The tests are described as being conducted "internally" or by a certified lab for the manufacturer, OMNI life science, Inc., based in East Taunton, MA, USA. The data is thus considered prospective as it was generated specifically for this submission.

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

• Not applicable. These are engineering/mechanical tests, not clinical evaluations requiring expert interpretation of ground truth data. The "ground truth" is determined by the physical properties and performance measured against the ASTM standard specifications.

4. Adjudication Method for the Test Set

• Not applicable, as these are technical performance tests, not clinical evaluations requiring human adjudication.

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

• No MRMC study was done. The document explicitly states: "No clinical studies were performed."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• Not applicable. This is a medical device (knee implant), not an algorithm or AI system.

7. Type of Ground Truth Used (Non-Clinical)

• Engineering specifications and recognized industry standards (ASTM): The "ground truth" for these non-clinical tests is adherence to the performance requirements outlined in the specified ASTM standards (e.g., F1929, F1800-07, F1814).

8. Sample Size for the Training Set

• Not applicable. This refers to a medical device, not a machine learning model.

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

• Not applicable. This refers to a medical device, not a machine learning model.

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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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;
• Revision procedures where other treatments or devices have failed;
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia Baseplate and cemented to the prepared tibia. The Apex Revision Knee System augments are intended to be bolted to the femoral component and cemented to the prepared femur.

The Apex Revision Knee System includes the Revision Femoral Component, PS-R Insert, Retaining bolts, Femoral Augments and Femoral Stems. The Revision system is compatible with the previously cleared Modular Tibial Baseplates (K101994) and Patella component (K060192). The PS-R Insert has one level of medio-lateral constraint. The Revision Femoral component incorporates a proportionally sized box that is higher than the Apex PS Knee design (K102578). The Revision Femoral Component has the same bone cuts as the Apex CR Knee System and the Apex PS Knee System (K060192 and K102578). Size ranges, high flex and all other key design features of the Apex CR Knee System (K060192) have been retained in the Apex Revision Knee System. The Femoral Augments and Femoral Stems are available for use with the Revision Femoral Component.

The provided text describes the submission of the Apex Revision Knee System for 510(k) clearance. This is a medical device application, not an AI/ML device, and therefore the concepts of "acceptance criteria," "device performance," "sample size for test set," "data provenance," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "ground truth," and "sample size for training set" in the context of AI/ML models are not directly applicable.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an interpretation of the request using the information available and noting where AI/ML concepts do not apply:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The Apex Revision Knee System's acceptance criteria are framed within the context of demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance testing. The study supporting this is a series of in vitro mechanical and wear tests conducted according to recognized industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a mechanical medical device, the "acceptance criteria" are implied by adherence to specified ASTM and ISO standards for properties such as flexion range of motion, constraint, contact area, insert post strength, stem testing, augment testing, patello-femoral contact area and stability, and wear. The "reported device performance" is that these tests were conducted and the device "met the acceptance criteria." Specific numerical values for the criteria or performance are not detailed in this summary.

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

• Sample Size for Test Set: The document does not specify the exact number of samples (e.g., knee implants) used for each non-clinical test. It generally refers to "All samples tested."
• Data Provenance: The data provenance is from non-clinical, in vitro laboratory testing performed by the manufacturer, OMNIlife science, Inc. The country of origin of the data is not explicitly stated but is implicitly the United States, where the company is located. The tests are prospective in nature, as they are specifically conducted to support the 510(k) submission.

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

• This question is not applicable as the evaluation is based on objective, quantifiable engineering and material science performance test standards (ASTM, ISO) and FDA guidance documents, not on expert interpretation of medical images or patient data.
• The "ground truth" is defined by the requirements of the standards themselves (e.g., specific load conditions, displacement parameters, acceptable wear rates, etc.).

4. Adjudication Method for the Test Set

• This question is not applicable. There is no "adjudication method" in the sense of reconciling differing expert opinions, as the tests are objective mechanical assessments against pre-defined engineering standards. The pass/fail criteria are inherent in the test 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

• This question is not applicable. The device is a mechanical knee implant, not an AI/ML diagnostic or assistive tool for human readers. No MRMC study was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• This question is not applicable. The Apex Revision Knee System is a mechanical device, not an algorithm. Therefore, "standalone performance" in the context of AI/ML is not relevant.

7. The Type of Ground Truth Used

• The "ground truth" for this device's evaluation is defined by adherence to established engineering and materials science standards (e.g., ASTM F2083-08, ASTM F1223-03, ISO 14243-3, ISO 14243-2, ASTM F1877) and FDA guidance documents for total knee prostheses. These standards specify test methods, conditions, and performance requirements.

8. The Sample Size for the Training Set

• This question is not applicable. As a mechanical medical device, there is no "training set" in the context of machine learning. The device design is based on engineering principles and previous designs, not on statistical learning from a dataset.

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

• This question is not applicable for the same reasons as #8. There is no training set for this type of device. The "ground truth" for its development is based on established biomechanical knowledge, material science, and the performance characteristics of previously cleared predicate devices.

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The Apex Knee™ System is intended for use as a primary or revision total knee replacement. 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;
• Revision procedures where other treatments or devices have failed;

The porous coated femoral component may be used cemented or uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only.
The Apex Knee™ Modular Tibia System Tibial Augment are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.

The APEX PS Knee System includes a posterior stabilized Femur Component incorporating a proportionally sized box. The Femur Component has the same bone cuts as the Apex Knee™ System (K060192) with the addition of a cut for the Femur Component box. Femur Components will be available in both cemented and uncemented versions. Size ranges, high flex, and all other design features of the Apex Knee System are retained. The PS Insert has a medio-lateral constraint and utilizes the Apex Knee System Tibial Baseplate. For each PS Insert, a range of UHMWPE thicknesses are available to aid in obtaining the proper soft tissue balance across the knee joint.

The acceptance criteria and study proving the device meets them for the Apex PS Knee™ System are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The device's performance was evaluated through a series of non-clinical tests as listed above. The provided document states, "All samples tested met the acceptance criteria." This indicates that for each specific test, the Apex PS Knee™ System demonstrated performance within the predefined limits or adherence to the specified standards, thereby proving the device meets its acceptance criteria.

Detailed Information on the Study:

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: The document does not specify the exact sample size for each non-clinical test. It generally states, "All samples tested met the acceptance criteria," implying that a sufficient number of samples were tested to demonstrate compliance with the standards.
• Data Provenance: The tests are non-clinical, likely laboratory-based. The country of origin of the data is not explicitly stated, but given the submitter is OMNIlife science, Inc. in E. Taunton, MA, USA, the testing was likely conducted in the US or by US-affiliated labs. The nature of these tests makes them prospective in that they are conducted specifically to evaluate the new device against established standards.

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)

• This question is not applicable to this type of submission. The "ground truth" for non-clinical performance criteria of a medical device like a knee implant is established by recognized national and international engineering standards (e.g., ASTM, ISO) and FDA guidance documents, not by individual expert consensus on specific cases. The tests are designed to objectively measure physical and mechanical properties.

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

• This question is not applicable as the evaluation involves objective physical and mechanical tests against predefined standards, not subjective clinical assessments requiring adjudication.

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

• This question is not applicable. The submission is for a knee implant, a physical medical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers or AI assistance are not relevant to this submission.

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

• This question is not applicable. This is a physical medical device, not an algorithm or software.

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

• The "ground truth" for the non-clinical tests are the specified engineering and performance criteria established by national and international standards (ASTM F2083-08, ASTM F1223-03, ISO 14243-3, ISO 14243-2, ASTM F1877, ISO 21536, ISO 7207-2, ISO 21534) and relevant FDA Guidance Documents. These standards define acceptable ranges or behaviors for various mechanical and material properties of knee prostheses.

8. The sample size for the training set

• This question is not applicable. There is no "training set" in the context of this submission, as it's for a physical device undergoing non-clinical mechanical and material testing, not a machine learning model.

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

• This question is not applicable for the reason stated above.

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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 Modular™ Ceramic Femoral Heads are intended for use in combination with the Apex Modular Hip Stem as the femoral component in total hip replacement procedures. This ceramic head is intended to articulate with a polyethylene or metal-backed polyethylene acetabular cup or bipolar component. 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 Modular Hip System BIOLOX® delta Femoral Head is composed of an alumina matrix composite, the femoral heads include diameters ranging from 28mm to 40mm with various offsets.

Here's a breakdown of the acceptance criteria and study information for the APEX Modular Hip System BIOLOX® delta Femoral Head, based on the provided document:

This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific, independent performance acceptance criteria through clinical studies. Therefore, the "acceptance criteria" here are implicitly linked to the performance characteristics of the legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for a medical implant, the "acceptance criteria" are not explicit performance metrics in the way one might find for a diagnostic device (e.g., sensitivity, specificity). Instead, they are related to demonstrating that the new device is as safe and effective as the predicate devices, primarily through design, material, and mechanical property comparisons. There are no direct "reported device performance" metrics in terms of clinical outcomes, but rather a demonstration of comparable mechanical performance.

• Influence of diameter and neck length on burst strength of BIOLOX delta ball heads with taper type 12/14, per ISO-7206-10 setup.
  (These tests aimed to show comparable mechanical integrity and performance to the predicate BIOLOX forte heads.) |
  | Biocompatibility | Residuals of sterilization agents must be within acceptable limits (e.g., ETO residuals). | ETO Residuals per ANSI/AAMI/ISO 10993-7. (Indicates compliance with biocompatibility standards for ETO sterilization). |

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

• Sample Size for Test Set: Not applicable in the context of this 510(k) submission. There was no "test set" of patient data used. The testing was non-clinical, focusing on device components. The specific number of femoral heads or tapers tested in the mechanical studies is not provided, only the types of tests performed.
• Data Provenance: The data is from non-clinical bench testing (mechanical and material characterization). There is no patient data, so country of origin or retrospective/prospective status is not applicable.

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

• Not applicable. There was no "ground truth" derived from human experts for a clinical test set. The ground truth for the non-clinical tests would be the established chemical, physical, and mechanical properties of the predicate materials and devices, as defined by relevant ISO standards and material specifications. The expertise would lie with the engineers and scientists conducting the testing and comparing the results against these established standards.

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical test set requiring expert adjudication.

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 hip implant device, not a diagnostic imaging device involving human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This device does not involve algorithms or AI.

7. The Type of Ground Truth Used

• The "ground truth" in this context is the performance and material specifications of legally marketed predicate devices and the adherence to recognized industry standards (e.g., ISO for mechanical testing, ANSI/AAMI/ISO for ETO residuals). The goal was to demonstrate that the new device meets or exceeds the performance characteristics of its predicates.

8. The Sample Size for the Training Set

• Not applicable. There was no "training set" in the context of machine learning or clinical trials. This is a physical medical device.

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

• Not applicable. As there was no training set, there was no ground truth for one.

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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 Apex Hip System is intended for primary and revision total hip replacement. The femoral hip stem 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 K1 Hip in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. These prostheses may be used for total 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.

ApeX-LNK Poly™ Acetabular Cup Liners are manufactured of compression molded, cross-linked and stabilized ultrahigh molecular weight polyethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 40 mm diameter, with various offsets.
Apex Modular Heads have a standard tapered bore that corresponds to the mating taper on the modular neck (ASTM F1636). Various industry standard head diameters are included to allow use of a wide range of acetabular cups, at the discretion of the orthopaedic surgeon.

Here's an analysis of the provided text, focusing on acceptance criteria and study details.

Analysis based on the provided document:

The provided document is a 510(k) premarket notification for ApeX-LNK Poly™ Acetabular Cup Liners and Apex Modular Heads. It is a regulatory submission for medical devices, primarily focused on demonstrating substantial equivalence to predicate devices, rather than establishing numerical performance acceptance criteria through clinical studies in the way an AI/software device would.

Therefore, the requested information categories (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance) are not applicable in the context of this medical device submission. These categories are typically relevant for AI/ML-based diagnostic or screening devices where performance is measured against a ground truth from human expert interpretation or pathology.

This document demonstrates equivalence through design, materials, manufacturing processes, and in some cases, performance testing (often mechanical bench testing) to ensure safety and effectiveness are comparable to legally marketed devices. It does not involve "performance metrics" in the sense of diagnostic accuracy (sensitivity, specificity) or human reader improvement with AI.

Here's a breakdown of the relevant information from the document, acknowledging the difference in context:

1. Table of Acceptance Criteria (for Substantial Equivalence) and Reported Device Performance

For this type of device, "acceptance criteria" are primarily established by the requirements for demonstrating substantial equivalence to a legally marketed predicate device. The "performance" is judged by meeting these equivalence criteria and by ensuring the device functions as intended and is safe.

• ApeX-LNK Poly™ Acetabular Cup Liners: Used with Apex Modular Acetabular Cup, with Apex Modular, Apex K2 Hip, articulating with metal (cobalt chromium) or ceramic (alumina) femoral head for conditions like degenerative joint disease, rheumatoid arthritis, functional deformity, congenital dislocation, revision procedures, and fractures.
• Apex Modular Heads: Used in total hip replacement, compatible with various acetabular cups. |
  | Operating Principle ("ball-in-socket" cobalt chromium-UHMWPE articular bearing components) | Meets Predicate: "Same operating principle: 'ball-in-socket' cobalt chromium-UHMWPE articular bearing components" |
  | Materials (UHMWPE for liners, wrought cobalt chromium for heads as per specific ASTM standards) | Meets Predicate: "Same materials as predicates: the ApeX-LNK Acetabular Cup Liners are manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648) with identical specifications and processing parameters as the predicate ApeX-LNK Acetabular liners; the Apex Modular Heads are manufactured from the same material as the predicate Apex Modular Heads (wrought cobalt chromium per ASTM F1537)" |
  | Basic Design (UHMWPE liners, cobalt chromium heads, identical modular interface dimensions, surface finish, taper dimensions, locking features) | Meets Predicate: "Same basic design: UHMWPE liners, cobalt chromium heads; identical modular interface dimensions and specifications as the predicates, including surface finish, taper dimensions, and locking features"
• Liner Engagement: 19° taper and PE locking ring (same as ApeX-LNK predicate K073150).
• Liner Options: Neutral and 10° hooded (same as ApeX-LNK predicate K073150).
• Taper Design (Heads): Identical (size "N" bore in ASTM F1636-95) (same as Apex Modular Femoral Heads predicate K000788).
• Offsets (Heads): -3.5, +0, +3.5, +7 (same as Apex Modular Femoral Heads predicate K000788). |
  | Shelf Life (5 years from date of manufacture) | Meets Predicate: "Same shelf life: 5 years from date of manufacture." |
  | Packaging & Sterilization (ETO, SAL 10^-6^) | Meets Predicate: "Packaged and sterilized using the same materials and processes: ETO, SAL 10^-6^*."
• Packaging: Paper board box, Foil outer pouch, Double Tyvek inner pouch (same as ApeX-LNK predicate K073150 and Apex Modular Femoral Heads predicate K000788). |
  | Functional Equivalence (demonstrated via performance testing, design comparisons, functional analysis) | Meets Predicate: "Performance testing, design comparisons, and functional analysis conducted on these devices demonstrate that they are equivalent to the predicate devices." (Specific details of any new performance testing are not provided in this summary, but would typically involve mechanical tests for wear, fatigue, static strength, etc., to support the safety and effectiveness of the new sizes, not a clinical study comparing outcomes to a "ground truth" established by experts). The modifications are limited to the addition of a 40mm size head and a 40mm ID liner. |

Regarding the other requested points:

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

  • N/A. This is a medical device 510(k) submission, not a study evaluating an AI/ML diagnostic algorithm. "Test sets" in the context of this document refer to mechanical testing of physical device components, not data for an AI model.

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

  • N/A. Ground truth from experts is not applicable here. Mechanical tests typically compare physical measurements or observed failures against engineering specifications, often established by material science experts or engineers.

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

  • N/A. Not applicable for a device 510(k) 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:

  • N/A. This is not an AI/ML device.

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

  • N/A. This is a physical medical device (hip implants), not an algorithm.

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

  • N/A in the context of AI. For this device, the "ground truth" for demonstrating safety and effectiveness relies on established engineering principles, material science data from ASTM standards, and performance characteristics (e.g., strength, wear resistance) that are comparable to previously approved, equivalent predicate devices.

• 8. The sample size for the training set:

  • N/A. This is not an AI/ML device.

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

  • N/A. This is not an AI/ML device.

In summary: The provided document is a regulatory submission for a physical medical device. It demonstrates substantial equivalence to predicate devices based on design, materials, intended use, manufacturing processes, and fundamental operating principles. The concepts of "acceptance criteria" and "studies" as typically applied to AI/ML software performance (e.g., diagnostic accuracy, reader studies) are not relevant to this document. The "study" here is the entire 510(k) submission process, which involves demonstrating that the new device is as safe and effective as a legally marketed one, often supported by detailed engineering and mechanical testing data (which is not fully detailed in this summary document).

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The Apex Knee System Tibial Baseplate Augment is intended for use with the Apex Knee System as a primary or revision total knee replacement. This knee replacement system is intended for cemented 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: .
• Revision procedures where other treatments or devices have failed. .

The Augments are used as optional spacers and are cemented below the Tibial Tray using PMMA bone cement.

The Tibial Baseplate Augment is available in the following Sizes:
• Size 1 x 8mm
• Size 2 x 8mm
• Size 3 x 8mm
• Size 4 x 8mm
• Size 5 x 8mm

This document describes the 510(k) submission for the OMNI life science Apex Knee System Tibial Baseplate Augment. It is a premarket notification to demonstrate substantial equivalence to previously marketed devices, not a study proving device safety and effectiveness through clinical trials with specific acceptance criteria as might be expected for an AI/clinical diagnostic device. Therefore, much of the requested information regarding AI device evaluation is not applicable here.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (sensitivity, specificity, accuracy, etc.) because this is a mechanical medical device (a knee implant component). Instead, the acceptance criteria are related to mechanical and material properties and a demonstration of substantial equivalence to predicate devices.

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

This information is not applicable. The device is a mechanical implant, and its evaluation does not involve "test sets" or "data provenance" in the way an AI diagnostic device would. The "performance testing" and "bench testing" mentioned are likely mechanical tests performed in a lab setting, not on patient data.

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)

This is not applicable. Ground truth for mechanical device performance is established through engineering specifications, material properties, and physical testing, performed by engineers and technicians, not clinical experts establishing diagnostic ground truth from patient data.

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

This is not applicable. Adjudication methods are used for resolving disagreements in expert opinions, typically in diagnostic or clinical trial settings. Mechanical testing results are objective measurements.

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

This is not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is an implant, not an AI diagnostic tool.

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

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

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

The "ground truth" for this device's acceptance is based on engineering specifications, material standards, and the results of the bench testing demonstrating mechanical integrity, fit, and function as being equivalent to legally marketed predicate devices. This is a regulatory pathway (510(k)) focused on demonstrating substantial equivalence, rather than proving clinical efficacy through extensive outcomes data, which would typically be required for a PMA application.

8. The sample size for the training set

This is not applicable. There is no AI model or "training set" involved in the development or evaluation of this mechanical device.

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

This is not applicable, as there is no training set for an AI model.

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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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