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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).
  The porous coated tibial baseplate is to be used uncemented (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 the Tibia baseplate and cemented to the prepared tibia.

The proposed devices are intended to be used for primary and revision total knee replacement.
The Pegged Tibial Baseplates offer additional torsional stability by adding pegs to the posterior end of the device. The material of the proposed Pegged Tibial Baseplates are Cobalt Chrome, CoCr (ASTM F75).
The ECiMa tibial inserts are machined from compression molded highly crosslinked polyethylene with Vitamin E (VE-XLPE) and attaches to the cobalt chrome tibial baseplate via dovetails and a retaining

The provided text describes a 510(k) premarket notification for the "Apex Knee™ System," a knee joint prosthesis. However, the document does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI-powered medical device.

The document is a submission for a physical medical device (a knee implant), not an AI device. Therefore, the questions related to AI device performance (e.g., number of experts for ground truth, MRMC studies, standalone algorithm performance, training set details) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device for a physical implant, primarily through material characterization, mechanical testing, and biocompatibility testing. The "acceptance criteria" discussed are mainly related to the performance standards for the implant materials and design, such as wear testing, strength testing, and sterility assurance levels.

Here's a breakdown of what is and is not in the provided text:

Information NOT Found (as it pertains to an AI device):

• 1. Table of acceptance criteria and reported device performance for an AI device: Not present. The acceptance criteria relate to mechanical and biological properties of the implant.
• 2. Sample size and data provenance for an AI test set: Not applicable. The "test set" refers to mechanical samples and animal models, not patient data for AI evaluation.
• 3. Number of experts and qualifications for AI ground truth: Not applicable. Ground truth for an AI device (e.g., image annotation) is not relevant here.
• 4. Adjudication method for an AI test set: Not applicable.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study for AI: Not applicable.
• 6. Standalone (algorithm only) performance for AI: Not applicable.
• 7. Type of ground truth for an AI device: Not applicable. Ground truth here refers to engineering specifications and biological response, not diagnostic labels for AI.
• 8. Sample size for an AI training set: Not applicable.
• 9. How ground truth for an AI training set was established: Not applicable.

What the document does provide regarding the physical device's "studies":

The document broadly mentions "non-clinical testing" conducted to demonstrate the safety and effectiveness and substantial equivalence of the modified Apex Knee™ System. These tests are the "study" proving the device meets its acceptance criteria (though not presented in the AI-specific format requested).

• Testing for Pegged Tibial Baseplates:
  • FEA (Finite Element Analysis) simulation
  • Peg location templating study
• Testing for ECiMa Tibial Inserts & Patellae:
  • Material characterization
  • PS (Posterior Stabilized) post strength testing
  • Insert disassembly strength testing
  • Wear testing
• Biocompatibility Testing for ECiMa material:
  • Intramuscular implantation in animal models
  • Implant toxicity and subcutaneous implantation in animal models
• Sterility: Validated sterilization process using ethylene oxide (EO) to a Sterility Assurance Level (SAL) of 10-6. Endotoxin testing via Limulus amebocyte lysate (LAL) on a quarterly rotating basis for product groups.

Conclusion:

This document is a regulatory submission for a physical knee implant and does not contain the specific information requested regarding AI device acceptance criteria and study methodologies. The "studies" mentioned are engineering and biological tests demonstrating the physical device's performance and safety.

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The OMNI 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 OMNI ARC™ Hip Stem is also intended for use in hemiarthroplasty when used with the Apex Bipolar Head. For further details, please refer to the Apex Bipolar Head Instructions for Use.

The proposed devices are intended to be used for primary and revision total hip replacement.

The OMNI ARC Anteverted Neck Hip Stem offers anteverted neck options (left and right orientations) to the monoblock stem system to meet the variety of patient anatomies expected in Total Hip Arthroplasty. This design is similar to the ARC Monoblock stem designs currently marketed.

The material of the proposed OMNI ARC Anteverted Neck Hip Stems are Ti-6Al-4V E.L.I (ASTM F136)

This document describes the regulatory submission for the "OMNI ARC Anteverted Neck Hip Stem." It is a 510(k) premarket notification, which means the manufacturer is seeking to demonstrate that their new device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness from scratch through extensive clinical trials.

Therefore, the typical questions about acceptance criteria for device performance, a study proving the device meets those criteria, sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set details are not applicable in the context of this 510(k) submission.

Here's why and what information is provided:

1. Acceptance Criteria and Reported Device Performance:

• Not Applicable in the traditional sense of a clinical performance study. The submission focuses on demonstrating substantial equivalence to a predicate device (K133381 OMNI ARC Monoblock Hip Stem).
• Performance is inferred through justification of equivalence. The "performance" assessment is based on demonstrating that the new design (anteverted neck options) does not introduce new risks and functions similarly to the predicate. The document states: "The proposed devices with modifications are substantially equivalent to the existing OMNI ARC Monoblock Hip Stem cleared in K133381 as the basic design, interface, fundamental technology, materials and intended use are the same."

2. Sample Size and Data Provenance:

• Not Applicable. No clinical test set data from patients is described or required for this type of 510(k) submission, as it relies on substantial equivalence to a known predicate rather than new clinical data.
• The "data" here refers to engineering evaluations and justifications, not patient data. The document mentions "HTR-082 ARC Monoblock Fatigue FEA Anteverted Neck" and "HTR-099 ARC Monoblock Anteverted Neck ROM" as justifications. These are likely finite element analysis (FEA) and range of motion (ROM) studies, which are engineering simulations/tests typically performed in vitro or computationally, not on patient samples.

3. Number of experts and qualifications for ground truth:

• Not Applicable. As no clinical test set data from patients is being evaluated for ground truth, there are no medical experts determining a "ground truth" for diagnostic or predictive performance. The "experts" would be the engineers and designers involved in proving equivalence through design, materials, and mechanical testing.

4. Adjudication Method:

• Not Applicable. No clinical data to adjudicate.

5. MRMC Comparative Effectiveness Study:

• Not Applicable. This is a medical device (hip stem), not an AI/diagnostic algorithm that would assist human readers in interpretation.

6. Standalone Performance:

• Not Applicable. No standalone algorithm performance is relevant for a physical implantable device.

7. Type of Ground Truth Used:

• Based on engineering principles and predicate device performance. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device (K133381 OMNI ARC Monoblock Hip Stem), combined with engineering analyses (like FEA) demonstrating that the modifications do not negatively impact these characteristics.

8. Sample Size for Training Set:

• Not Applicable. There is no "training set" in the context of a physical medical device. The "training" for the device's design is based on established biomechanical principles, material science, and the performance characteristics of the predicate device.

9. How Ground Truth for Training Set was Established:

• Not Applicable. See point 8.

In summary, for this specific 510(k) submission (K172467):

The manufacturer, OMNIlife Science, Inc., is seeking to market the "OMNI ARC Anteverted Neck Hip Stem" by demonstrating its substantial equivalence to an already legally marketed device, the "OMNI ARC Monoblock Hip Stem" (K133381). This type of submission relies on showing that the new device's design, materials, and intended use are fundamentally the same as its predicate and that any modifications (adding anteverted neck options) do not introduce new safety or effectiveness concerns.

Instead of clinical performance data, the submission relies on:

• Comparison of Indications for Use: The Indications for Use for the OMNI ARC Hip Stem are listed on page 2 and are expected to be similar or identical to the predicate device.
• Device Description Comparison: The new device offers anteverted neck options, but its design is "similar to the ARC Monoblock stem designs currently marketed." The material (Ti-6Al-4V E.L.I) is also stated.
• Justifications/Evaluations: The submission mentions specific justifications like "HTR-082 ARC Monoblock Fatigue FEA Anteverted Neck" and "HTR-099 ARC Monoblock Anteverted Neck ROM." These are engineering analyses (likely computational or bench testing) used to support the claim that the modifications do not introduce new risks regarding fatigue life or range of motion compared to the predicate. No clinical testing data is presented or required for a 510(k) based solely on substantial equivalence via design modifications and engineering justification.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

4. Adjudication method for the test set

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

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is a physical hip implant, not an AI software or diagnostic imaging tool. Therefore, MRMC studies are not relevant.

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

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

7. The type of ground truth used

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

8. The sample size for the training set

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

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

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

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The 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 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 proposed devices are intended to be used for primary and revision total knee replacement.
The Revision Tibia Baseplates offer enhanced torsional stability by adding keels to the posterior end of the device. This design is similar to keeled stem designs currently marketed.
The retaining bolt modifications offer additional bolt sizes that allow the cleared tibial inserts to lock into the proposed longer Revision tibial Baseplate.
The material of the proposed Revision Tibial Baseplate is Cobalt Chrome, CoCr (ASTM F75). The material if the proposed retaining bolts is Ti-6Al-4V E.L.I (ASTM F136)

This document describes the regulatory submission for the Apex Revision Knee System (K163332), a medical device. The information provided heavily emphasizes substantial equivalence to a predicate device (K153437) rather than providing detailed acceptance criteria and a study demonstrating the device meets those criteria in a traditional sense (e.g., performance metrics, statistical analysis).

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific acceptance criteria in the form of performance metrics (e.g., accuracy, sensitivity, specificity) or a study with reported performance values. Instead, the basis for approval is "substantial equivalence" to a predicate device.

The study presented is a justification of substantial equivalence, not a performance study against specific acceptance criteria. The "reported device performance" is essentially that it is considered "as safe, as effective, and performs as well as or better than the legally marketed predicate."

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

• Sample Size: Not applicable in the traditional sense of a clinical or performance study with a test set of data. The "test set" here refers to the new proposed components and their interaction with existing components.
• Data Provenance: Not applicable. The "study" is a series of justifications and evaluations rather than a data-driven test.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not mentioned, as this was not a study involving human interpretation or subjective assessment.

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

• MRMC Study: No. This device is a mechanical knee prosthesis, not an AI-assisted diagnostic tool.

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

• Standalone Performance: No. This device is a physical implant.

7. The Type of Ground Truth Used

The "ground truth" here is the established safety and effectiveness of the legally marketed predicate device (K153437). The new device is deemed equivalent because its modifications do not introduce new risks. The justifications listed are:

• "KTR-116 Tray Fatigue FEA" (Finite Element Analysis) - This indicates an engineering simulation was performed for fatigue, but the results or a direct comparison to acceptance criteria are not provided in this summary.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is not a machine learning model.

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

• Ground Truth Establishment: Not applicable.

Summary of Device Acceptance and Study:

The acceptance of the Apex Revision Knee System (K163332) is based on the demonstration of substantial equivalence to a previously cleared predicate device (K153437). The "study" is less of a traditional performance study and more of a technical justification.

Acceptance Criteria (Implied by Substantial Equivalence):

Key takeaways from the document regarding the "study":

• This was a Special 510(k) submission, used when modifications to a legally marketed device do not significantly alter its safety or effectiveness.
• The manufacturer explicitly states that "Testing was not conducted" in a hands-on sense for comparing the new device against the predicate. Instead, "justifications were written" and the devices were "evaluated."
• The primary justification is that the modifications (additional baseplate and retaining bolt types) maintain the "basic design, interface, fundamental technology, materials and intended use" of the cleared predicate device.
• The listed "study" is "KTR-116 Tray Fatigue FEA", which is a Finite Element Analysis for fatigue. This is a computational simulation, not a physical study with a test set of real-world data or human subjects. The details of the FEA results or acceptance criteria for fatigue are not included in this summary document.
• The "ground truth" for demonstrating equivalence is the established safety and effectiveness profile of the predicate device (K153437).

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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 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). 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 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 the femoral component and cemented to the prepared femur.

The proposed devices are intended to be used for primary and revision total knee replacement.

The fluted femoral stems and the keeled femoral stems are slight modifications of the existing designs. The femoral stems offer enhanced press-fit implantation and torsional stability by adding longitudinal raised ribs similar to most stems designs currently marketed.

The notched 10mm posterior femoral augment has been created to increase the product offerings when using posterior augments. The new notched augment will allow a 10mm distal augment and 10mm posterior augment to be used together.

The femoral Locking Bolt functions similarly to the tibial locking bolt. It was designed for femoral use for enhanced fixation of the stem to the femur.

The current tibial peg offers additional torsional stability when added to the modular tibial baseplate. The proposed revision tibial Peg is a slight modification of that existing tibial peg and is improved in size and torque strength. The Augment Peg Bolt is similar to the tibial peg and can be used to add additional torsional stability to the modular tibia baseplate when augments are used.

The material of each new component is titanium alloy Ti-6Al-4V E.L.I (ASTM F136)

The provided document is a 510(k) premarket notification for a medical device called the "Apex Revision Knee System." It details the device's indications for use, its description, and the manufacturer's assertion of substantial equivalence to previously cleared devices.

Crucially, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria for artificial intelligence (AI) or software-based medical devices.

This 510(k) is for a physical medical device (a knee prosthesis), not a diagnostic AI system or a decision support software. The "study" referenced in the document (KTR-102 Femur Stem Bolt Testing Justification, KTR-100 Revision Knee Fluted Stem FEA Comparison, etc.) are engineering justifications and comparisons to existing predicate devices, primarily through finite element analysis (FEA) and design comparisons, not clinical trials or performance assessments against specific numerical acceptance criteria for an AI system.

Therefore, I cannot fulfill your request for the tables and study details related to AI device performance based on the provided text. The information you are seeking (AI acceptance criteria, human reader improvement with AI, ground truth establishment, sample sizes for training/test sets, expert qualifications, etc.) is simply not present in this type of regulatory submission for a physical orthopedic implant.

If you have a document describing an AI medical device, please provide that, and I would be happy to assist with your request.

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The OMNI ARC Monoblock 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 (Coball 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; .
• י Revision procedures where other treatments or devices have failed;
• . Femoral neck and trochanteric fractures of the proximal femur.

The OMNI ARC Monoblock Hip Stem is also intended for use in hemiathroplasty 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 OMNI ARC Monoblock Hip Stem consists of a curved, rectangular tapered stem that combines the neck and stem into a single piece design. The OMNI ARC Monoblock Hip Stem is intended for use as the femoral component of a primary or revision total hip replacement when used with the Apex Interface Acetabular System. The Apex Interface Acetabular System articulates with the Apex Modular Femoral Head (Cobalt Chromium or Ceramic). The femoral hip stem is intended for uncemented fixation and single use implantation. These prostheses may be used for hip arthroplasty to treat the following conditions, as appropriate:

Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur. The OMNI ARC™ Monoblock 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 provided text focuses on the 510(k) summary for the OMNI ARC Monoblock Hip Stem, primarily establishing substantial equivalence to predicate devices through material similarity and performance testing. It does not contain the detailed setup and results of a clinical study or a study involving human readers and AI assistance for diagnostic accuracy. Therefore, many of the requested sections regarding acceptance criteria and study particulars cannot be filled using the provided information.

However, based on the provided text, we can infer some "acceptance criteria" related to mechanical performance and report the device's stated performance in those areas.

Here's an attempt to answer your questions based solely on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing of the device components, not a clinical test set with patient data. Therefore, this question is not applicable to the information provided. The study mentioned is primarily an engineering performance evaluation.

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 as the document describes mechanical testing, not a study requiring expert clinical interpretation for ground truth.

4. Adjudication method for the test set

This question is not applicable as the document describes mechanical testing, not a study requiring adjudication of clinical findings.

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 such MRMC study is mentioned in the provided 510(k) summary. The document describes mechanical performance testing of a hip stem, not a diagnostic AI device.

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

This question is not applicable. The device is a physical hip stem, not an algorithm.

7. The type of ground truth used

For the mechanical tests, the "ground truth" would be the specifications and requirements defined by the ISO standards (ISO 7206-6, ISO 7206-4, ISO 21535). The device's performance was compared directly against these established engineering standards.

8. The sample size for the training set

This question is not applicable as the device is a physical medical implant, not an AI algorithm requiring a training set.

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

This question is 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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