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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 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 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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