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

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

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

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

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

Here's a summary of the available information:

1. Acceptance Criteria and Reported Device Performance:

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

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

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

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

4. Adjudication method for the test set:

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

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

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

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

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

7. The type of ground truth used:

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

8. The sample size for the training set:

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

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

• Not applicable.

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The Apex ARC™ 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 (Cobait 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 Apex Hip System ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiathroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
• Femoral neck and trochanteric fractures of the proximal femur;
• Osteonecrosis of the femoral head;
• Revision procedures where other treatments or devices for these indications have failed.

The Apex ARC Hip Stem consists of a curved, rectangular tapered stem with a distal slot, and modular necks that connect to the tapered hole in the stem. The larger size stems have a lateral feature referred to as a lateral t-flange. The T-flange is reduced in size on the smaller stem sizes (size 1 and 2), and further reduced to no t-flange on the smallest (subject) size 0 stem. The femoral stems are manufactured from titanium alloy and the modular necks are manufactured from cobalt chromium alloy. The Apex ARC Hip Stem is available with and without HA coating.

The necks are compatible with the Cobalt Chromium and Ceramic modular heads, and may be used with head diameters and offsets up to a maximum offset of +7 mm. The Apex ARC Hip Stem may be used in conjunction with the Apex Interface™ Acetabular System (Shells and Inserts) for total hip arthroplasty.

Here's an analysis of the provided text regarding the Apex ARC™ Hip Stem, focusing on acceptance criteria and the study proving conformance.

Important Note: The provided document is a 510(k) Pre-market Notification for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving efficacy or meeting specific acceptance criteria through extensive clinical studies as one might find for a novel drug or a high-risk device requiring a PMA.

Description of Acceptance Criteria and the Study Proving the Device Meets Acceptance Criteria

The document states that the Apex ARC™ Hip Stem (specifically the new Size 0) is substantially equivalent to its predicate devices (Apex ARC Hip Stem K090845 and K111193). The primary method used to demonstrate this substantial equivalence, and thus "meet acceptance criteria," is through non-clinical testing and comparison of design features, materials, and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for substantial equivalence based on a new size of an existing device, the "acceptance criteria" are not explicitly defined as pass/fail thresholds for clinical outcomes, but rather demonstrate that the new size performs comparably to the predicate device in relevant biomechanical tests.

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

• Sample Size for Test Set: Not explicitly stated as this is a non-clinical mechanical and material testing summary. For such tests, the sample size typically refers to the number of individual test articles (e.g., hip stems) subjected to each specific test. This information is usually detailed in the full test reports, which are not provided here.
• Data Provenance: The testing was "conducted," implying laboratory testing. The country of origin for the data is implied to be within the scope of the submitter, OMNIlife science, Inc., based in East Taunton, MA, USA, and adherence to international standards (ISO, ASTM). The data is prospective in the sense that the new size 0 was manufactured and then tested.

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

• Not Applicable. For non-clinical, biomechanical testing of a medical device, "ground truth" is established by relevant engineering standards (ISO, ASTM) and the objective measurements obtained from properly calibrated testing equipment. There is no expert consensus involved in establishing the "ground truth" for the mechanical properties of a hip stem.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies or image-based diagnostic studies where human interpretation of data is involved. Here, the "study" is a series of non-clinical tests with objective, quantitative outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC comparative effectiveness study was conducted.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Not Applicable. This device is a physical hip stem, not a software algorithm or AI-driven diagnostic tool. Therefore, the concept of "standalone algorithm performance" does not apply.

7. The Type of Ground Truth Used

• For the non-clinical tests (Fatigue Strength, ROM Evaluation), the "ground truth" is defined by established engineering standards and specifications (ISO 7206 series, ASTM 2068-09, ISO 21535) for hip implant performance. The device's measured performance against these standards constitutes the "ground truth" for its mechanical properties. There is no pathology, outcomes data, or expert consensus used for the "ground truth" in this context.

8. The Sample Size for the Training Set

• Not Applicable. This report does not involve machine learning or AI, 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, there is no ground truth establishment for it.

Summary of the Study Proving Device Acceptance Criteria:

The "study" proving the Apex ARC™ Hip Stem (Size 0) meets its "acceptance criteria" (which in this 510(k) context means demonstrating substantial equivalence) is a non-clinical testing program.

This program involved:

• Fatigue Strength Testing: Performed according to international standards ISO 7206-6, ISO-7206-4, ISO 7206-8, and ASTM 2068-09. This testing assesses the material's ability to withstand repeated stress without failure, simulating the forces experienced during daily activity.
• Range of Motion (ROM) Evaluation: Performed according to ISO 21535. This evaluates the articulation capabilities of the hip stem in conjunction with other components to ensure proper biomechanical function and prevent impingement.

The conclusion drawn from these studies is that the "addition of one new stem size for the Apex ARC Hip Stem, in our opinion, is substantially equivalent to the predicate device." This implicitly means that the new size 0 performed comparably to the predicate devices and met the relevant performance standards for hip stems. No clinical studies were performed to support this submission.

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The Apex All Poly Tibia is intended for use as part of 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 Apex All Poly Tibia is for use only with the Apex Knee™ System Femoral and Patella components. The Apex All Poly Tibia is indicated for cemented use only.

The Apex All Poly Tibia is used as part of a primary or revision cemented total knee implant using established total knee arthroplasty procedures. The All Poly Tibia is intended for use with bone cement, single use implantation and for use only with the Apex Knee™ System Femoral and Patella components.

The device is machined from compression molded Ultra High Molecular Weight Polyethylene (UHMWPE per ASTM F648). This device is a semi-constrained monoblock tibia and designed for posterior cruciate substitution.

The provided text describes a 510(k) premarket notification for the "Apex All Poly Tibia" device, which is part of the "Apex Knee™ System." The submission aims to demonstrate substantial equivalence to legally marketed predicate devices. The information focuses on non-clinical testing for the device.

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "All samples tested met the acceptance criteria." however, it does not specify the sample sizes used for any of the non-clinical tests (FEA Contact Stress Testing, Peg Stiffness Analysis, Cement Mantle Stress Analysis, FEA Abrasive Wear, or Insert Contact Pressure and Contact Area Testing).

The data provenance is not explicitly stated beyond being non-clinical tests typically conducted in a lab environment. There is no mention of country of origin of the data, or if it's retrospective or prospective.

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

Since these are non-clinical engineering tests (FEA, stiffness, wear, contact pressure), the concept of "ground truth" established by human experts in the typical clinical sense (like radiologists reading images) does not apply. The "ground truth" for such tests would be based on established engineering principles, material properties, and test standards (e.g., ASTM F2083-08). The document does not mention any human experts establishing ground truth for these specific non-clinical tests.

4. Adjudication Method for the Test Set

Not applicable. As these are non-clinical engineering tests with objective measurements against defined acceptance criteria (implicitly derived from engineering standards or predicate device performance), there is no mention of an adjudication method involving human interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable to this submission. The device is a physical knee implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

• Engineering principles and simulations: For FEA Contact Stress, Peg Stiffness, Cement Mantle Stress, and FEA Abrasive Wear.
• Standardized test methods: Specifically, ASTM F2083-08 for Insert Contact Pressure and Contact Area Testing.
• Comparison to predicate device specifications/performance: While not explicitly detailed as "ground truth," the overall goal of the 510(k) is to demonstrate substantial equivalence to predicate devices, implying that the performance of the new device should be within acceptable limits relative to the predicates.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning model. Therefore, 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 a physical medical device.

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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 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 Apex Hip System ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:

• · Femoral neck and trochanteric fractures of the proximal femur;
• · Osteonecrosis of the femoral head;
• Revision procedures where other treatments or devices for these indications have failed.

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 height of the anterior and posterior lateral protrusions (Lateral T-Flange) was reduced on Size 1 and 2 ARC Hip Stems. Three new neck sizes are offered, Long Neutral, Long 8 ° Varus/Valgus and Anteverted. The necks are compatible with the Cobalt Chromium and Ceramic modular heads, and may be used with head diameters and offsets up to a maximum offset of +7 mm. The Apex ARC Hip Stem may be used in conjunction with the Apex Interface™ Acetabular System (Shells and Inserts) for total hip arthroplasty.

The Apex Hip System ARC™ Hip Stem is a medical device and the provided text describes its acceptance criteria and the study conducted to prove it meets them.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Apex Hip System ARC™ Hip Stem are based on demonstrating substantial equivalence to a predicate device (Apex ARC Hip Stem - K090845). This equivalence is primarily shown through non-clinical performance testing.

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

The document states, "Non-Clinical Test: The following tests were conducted." It then lists fatigue strength testing and ROM evaluation. However, the exact sample size (number of devices or components tested) for these non-clinical tests is not specified in the provided text.

The data provenance is from non-clinical laboratory testing performed on the device itself (or its components) according to specified ISO and ASTM standards. No human or animal data is involved; thus, there is no country of origin or retrospective/prospective distinction in the typical sense.

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

Not applicable. This device is a mechanical implant, and the acceptance criteria for performance are based on engineering standards and physical testing, not subjective expert assessment of medical images or patient outcomes as would be the case for an AI device.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in AI studies where human experts disagree on interpretations. For mechanical performance testing of an implant, the results are objective measurements against defined standards, not subject to 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 hardware medical device (hip stem), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and assessments of human reader improvement with AI assistance are irrelevant.

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, so "standalone performance" in the context of AI does not apply.

7. The type of ground truth used

The "ground truth" for this device's performance is established by objective measurements against recognized industry standards (ISO and ASTM) for mechanical properties (fatigue strength) and range of motion. The predicate device's performance under these same standards effectively sets the benchmark for "ground truth" for demonstrating substantial equivalence.

8. The sample size for the training set

Not applicable. This section usually refers to the data used to train an AI model. Since this is a physical medical device, there is no "training set" in this context. The manufacturing and design process follows established engineering principles and quality systems; it's not "trained" on data.

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

Not applicable. As there is no training set for a physical device, this question is not relevant.

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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 (biological fixation). All other femoral, tibial baseplate, and patellar components are indicated for cemented use only.
  The Apex Knee™ Modular Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.

The posterior stabilized system offers a femoral component and two tibial inserts (PS (K102578) and PS-C (subject device)) offering different levels of constraint. The PS-C Insert post is approximately 1 mm larger than the PS Insert (K102578). The slightly larger post is designed to produce more varus/valgus and internal/external rotational constraint.

The provided text describes a 510(k) summary for the Apex PS Knee System PS-C Insert and its comparison to a predicate device, the Apex PS Knee System, PS Insert (K102578). The document focuses on demonstrating substantial equivalence through non-clinical testing rather than clinical studies using patient data. Therefore, many of the requested categories related to clinical study design, such as sample size, expert ground truth, and reader studies, are not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly met by demonstrating that the subject device's performance characteristics are either identical to or within acceptable variations of the predicate device, as determined by specific ASTM standards. No explicit numerical "acceptance criteria" are stated for performance metrics in the table; rather, the subject device's design and mechanical properties are compared to the predicate.

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

• Sample Size: Not specified in terms of number of devices or units tested. The document refers to "the following tests were conducted," implying a sufficient number of samples were used for the mechanical tests to be representative and meet the requirements of the ASTM standards.
• Data Provenance: Not applicable as no clinical data (patient data) was used. The tests were non-clinical, likely bench testing performed by the manufacturer or a contract lab.

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

• Not Applicable: No clinical studies were performed, and thus no "ground truth" based on expert medical evaluation of patient data was established for a test set. The "ground truth" for non-clinical testing refers to the accepted standards (ASTM F2083-08, ASTM F1223-03) and FDA guidance.

4. Adjudication Method for the Test Set

• Not Applicable: No human review or adjudication of clinical outcomes was involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No: No MRMC study was performed. The evaluation was based on non-clinical, mechanical testing.

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

• Not Applicable: This device is a mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Standards and Guidance: The "ground truth" or reference for performance was established by recognized industry standards (ASTM F2083-08, ASTM F1223-03) and FDA guidance documents specific to knee joint prostheses. These standards define the methods and expected performance characteristics for evaluating such devices.

8. The Sample Size for the Training Set

• Not Applicable: No training set was used as this involved mechanical testing of a physical device, not an AI or algorithm.

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

• Not Applicable: No training set was used.

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The Apex Hip System K1™ 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 prosthesis 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 Apex Hip System K1 Femoral Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head.

The Apex Hip System Bipolar Head is intended for use in combination with an Apex Hip System femoral stem for uncemented primary or revision hemiarthroplasty of the hip. This prosthesis may be used for the following conditions, as appropriate:
• Femoral neck and trochanteric fractures of the proximal femur;
• Osteonecrosis of the femoral head;
• Revision procedures where other treatments or devices for these indications have failed.

The Apex K1™ Hip Stems are rectangular in cross-section and tapered in the proximal-to-distal direction. The K1 Hip Stem is offered in 12 sizes and two neck offsets for each size. Standard necks have a 135 degree angle and lateralized (Lat) necks have a 130 degree angle. Sizes 7 to 12 also offer a Lat + offset with a 127 degree angle.

The provided text is a 510(k) Summary for the Apex K1™ Hip System, a medical device for hip replacement. It outlines the device's characteristics, intended use, and a comparison to a predicate device. However, it explicitly states: "No clinical studies were performed."

Therefore, it is impossible to provide the requested information about acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth, as no clinical study was conducted for this device.

The document indicates that the device's substantial equivalence to a legally marketed predicate device (K060072 - Apex K1™ Hip Stem) was established through non-clinical testing.

Here's a summary based on the provided text, highlighting the absence of clinical study data:

Absence of Clinical Study Data:

The provided 510(k) Summary explicitly states: "No clinical studies were performed." Therefore, the device performance against acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment, which are typically derived from clinical studies, cannot be detailed.

Instead, the device's substantial equivalence was demonstrated through non-clinical testing and comparison to an existing predicate device.

Non-Clinical Test Summary:

The following non-clinical tests were conducted:

• Fatigue Strength Testing: Performed according to ISO 7206-6, ISO-7206-4, ISO 7206-8, and ASTM 2068-09.
• ROM (Range of Motion) evaluation: Performed per ISO 21535.

Predicate Device Comparison:

The Apex K1™ Hip Stem (subject device, sizes 0, 0 Lat, 1, 1 Lat, and 7 thru 12 Lat +) was found to be substantially equivalent to the predicate device (Apex K1™ Hip Stem, Sz 2 to 12, K060072) based on the following:

Since no clinical studies were performed, the specific details requested for clinical performance acceptance criteria, study design, and ground truth establishment cannot be provided from this document. The basis for acceptance for this device was its substantial equivalence to a previously cleared predicate device, supported by the mentioned non-clinical engineering and material testing.

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