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

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Congenital dislocation;
• Revision procedures where other treatments or devices have failed;
• Femoral neck and trochanteric fractures of the proximal femur.

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

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

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

4. Adjudication Method:

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

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

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

6. Standalone Performance:

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

7. Type of Ground Truth Used:

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

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

8. Sample Size for the Training Set:

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

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

Not applicable. No training set exists for this device.

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The Apex Interface™ Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for uncemented fixation and single use implantation, and may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur.

The Interface Acetabular System, Acetabular Shell is composed of titanium alloy (ASTM F136), coated with sintered unalloyed titanium beads. The shells are designed for cementless use. The two versions of the shells include a "no hole" and a "3 hole" version (plus an apical hole in both versions). The cup system includes titanium alloy cancellous bone screws (in separate sterile packaging) for optional supplemental fixation of the "3 hole" shell. The Shell uses plastic inserts manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648-00), machined from compression molded sheet, and sterilized using ethylene oxide.

The provided document is a 510(k) premarket notification for a medical device, specifically the Apex Interface Acetabular System, Acetabular Shell. For this type of device, the acceptance criteria are primarily based on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves non-clinical performance testing and a comparison of design features, materials, and intended use. Clinical studies, and thus the specific types of studies and criteria outlined in your request, are generally not performed for 510(k) submissions unless specifically deemed necessary by the FDA.

Based on the provided text, here's a breakdown of the information you requested, highlighting what is implicitly or explicitly stated:

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

For a 510(k) submission like this, "acceptance criteria" generally refers to demonstrating that the new device is as safe and effective as the predicate device. This is achieved through a combination of comparing design, materials, and non-clinical testing. The "reported device performance" is essentially the determination of substantial equivalence based on these comparisons.

The Apex Interface Acetabular System is manufactured, packaged, and sterilized using equivalent materials and processes. The subject device(s) is also substantially equivalent to its predicate(s) based on comparison of design features, intended use, and indications for use. The fundamental scientific technology of the modified device(s) has not changed relative to the predicate device(s). The safety and effectiveness of the devices has not changed relative to the predicate devices. The safety and effectiveness of the Interface Acetabular System is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

(FDA's conclusion: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices...") |
| Material Equivalence | The Interface Acetabular System, Acetabular Shell is composed of titanium alloy (ASTM F136), coated with sintered unalloyed titanium beads. The Shell uses plastic inserts manufactured from ultra high molecular weight polyethylene (UHMWPE, ASTM F648-00), machined from compression molded sheet, and sterilized using ethylene oxide. (Implicitly, these materials are equivalent to or acceptable for the predicate device's function). |
| Design Feature Equivalence | Comparison of design features (e.g., standard sizes 46-76mm and x-sizes 48x-58x mm; "no hole" and "3 hole" versions with apical hole; titanium alloy cancellous bone screws) against the predicate device (K031110 Apex Modular Acetabular Cup), demonstrating substantial similarity. |
| Intended Use and Indications for Use Equivalence | The Apex Interface™ Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures... This prosthesis is intended for uncemented fixation and single use implantation... (These were found to be substantially equivalent to the predicate). |
| Non-Clinical Performance (if applicable) | No additional testing required per dFMEA. (This indicates that based on a design FMEA, existing test data, and comparison to the predicate, no new specific non-clinical tests were deemed necessary to prove substantial equivalence). |

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

• Sample Size: The document explicitly states: "No clinical studies were performed." Therefore, there is no "test set" in the context of human clinical data. The evaluation was based on non-clinical aspects and comparison to the predicate.
• Data Provenance: Not applicable as no clinical data was used.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable as no clinical studies were performed and thus no "ground truth" established by experts in a clinical test set. The substantial equivalence determination is made by the regulatory body (FDA) based on the manufacturer's submission and predicate comparison.

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

• Not applicable as no clinical studies were performed.

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

• Not applicable. This device is a passive implant (acetabular shell) and does not involve AI or human readers for diagnostic interpretation. No MRMC study was conducted.

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

• Not applicable. This device is a passive implant; there is no algorithm or standalone performance in the context of AI.

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

• Not applicable as no clinical studies were performed. The "ground truth" for a 510(k) in this context is implicitly the established safety and effectiveness of the predicate device, against which the new device is compared.

8. The sample size for the training set

• Not applicable as no machine learning/AI training was involved for this passive implant device.

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

• Not applicable as no machine learning/AI training was involved.

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The Apex Knee ™ Modular Tibia System is intended for use as a primary or revision total knee replacement. This prosthesis may be used for the following conditions, as appropriate:
• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• Revision procedures where other treatments or devices have failed
The porous coated femoral component may be used cemented or uncemented (biological fixation). The porous coated tibial baseplate component may be used uncemented (biological fixation). All other femoral, tibial baseplate and patellar components are indicated for cemented use only. The Apex Knee™ Modular Tibia System Tibial Augments are intended to be bolted to the Tibia baseplate and cemented to the prepared tibia.

The Modular Tibial Baseplate is offered in sizes 1 thru 6 and is a symmetrical design. It is 5mm thick, and accepts Tibial Stems and Augment Blocks on its inferior surface. Modular Tibia Stems are available from 9-17mm diameter in lengths of 75,100 or 150mm. The stem mates to the Modular Tibial Baseplate via a Morse taper connection, secured by a Locking Bolt. Modular Tibia Augments are available in, size 1 thru 6. Each Augment is 4mm thick, and may be placed on either the medial or lateral side of the baseplate. They may be stacked up to three high in equal or descending sizes to create either a uniform or stepped lateral profile. Bone cement should not be used between stacked augments. Once stacked the augments must be secured to the tibial tray using a locking bolt of appropriate length to match the height of the augment stack. The Tibial tray (tibial baseplate) - augment assembly is then cemented to the prepared tibia.

Here's a breakdown of the acceptance criteria and study information for the Apex Knee ™ Modular Tibia System based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text details non-clinical performance testing rather than clinical performance (e.g., diagnostic accuracy metrics). The acceptance criteria are implicit in that the samples must meet the standards.

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

The document does not specify the exact sample size for each non-clinical test (Augment Attachment Strength, Fretting Analysis, Stem Attachment, and Tray/Augment Attachment Strength).
The data provenance is from non-clinical bench testing, not human subjects. Therefore, details like country of origin for data or retrospective/prospective classification are not applicable.

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

This information is not applicable. The ground truth for this device (a knee implant system) is established through adherence to engineering standards and physical properties as assessed by bench testing, not expert interpretation of diagnostic images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 refer to resolving discrepancies in human expert assessments, which is not relevant for non-clinical bench testing.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This type of study would involve human readers and is relevant for diagnostic or AI-assisted medical devices, not for assessing the mechanical properties of an orthopedic implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The Apex Knee ™ Modular Tibia System is a physical orthopedic implant, not a software algorithm or AI device. Therefore, a "standalone algorithm performance" study is irrelevant in this context. The standalone performance relates to the mechanical integrity and functionality of the implant itself, which was assessed through the non-clinical tests.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation was adherence to specified ASTM (American Society for Testing and Materials) standards for mechanical and material properties. This is a type of engineering and material science ground truth, not clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

This information is not applicable. As a physical orthopedic implant, there is no "training set" in the context of machine learning or AI. The design and manufacturing processes are informed by engineering principles, material science, and prior successful designs.

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

This information is not applicable. There is no "training set" for physical implant devices in the way there is for AI/ML algorithms. The design and manufacturing are based on established engineering principles, material properties, and successful predicate device designs, all of which are validated through non-clinical testing.

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The Apex Hip System is intended for primary or revision total hip replacement. The femoral hip stems and acetabular cup are intended for uncemented fixation and single use implantation. These prostheses may be used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Congenital dislocation; Revision procedures where other treatments or devices have failed; Femoral neck and trochanteric fractures of the proximal femur.

Apex Modular Head sizes 28, 32, 36, and 40 mm with a + 10.5mm offset

Here's an analysis of the provided text regarding the acceptance criteria and study for the Apex Modular Heads, +10.5mm offset:

Acceptance Criteria and Device Performance Study for Apex Modular Heads, +10.5mm offset

This submission (K101575) is for a medical device seeking substantial equivalence to previously cleared predicate devices. Therefore, the "acceptance criteria" are primarily established by demonstrating equivalency to the predicate devices through non-clinical testing, rather than defining novel performance thresholds for clinical outcomes.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for substantial equivalence based on non-clinical testing, the "acceptance criteria" are implicitly met by demonstrating that the subject device's performance is comparable to or better than previously cleared predicate devices for relevant mechanical and material properties. The device performance is reported as meeting the specified standards, thereby indicating compliance with the implicit acceptance criteria for safety and effectiveness in comparison to the predicates.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in terms of number of physical units tested beyond the mention of "tests were conducted." For mechanical and material testing, sample sizes are typically defined by the specific ASTM/ISO standards referenced (e.g., minimum number of specimens for fatigue testing). The provided text indicates that the tests were conducted, implying adequate sample sizes were used as required by the standards.
• Data Provenance: Not explicitly stated (e.g., specific country or lab). The tests are described as "Non-Clinical Test Summary," meaning they were laboratory-based and not derived from human subjects. The reference to ISO and ASTM standards suggests internationally recognized testing protocols. Retrospective or prospective designations are not applicable as these are non-clinical lab tests.

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

• Not applicable. For this type of mechanical and material performance testing, "ground truth" is established by adherence to recognized international standards (ISO, ASTM) and the results obtained from the tests themselves using calibrated equipment. There is no concept of expert consensus for establishing ground truth in this context, unlike clinical studies involving image interpretation or diagnosis.

4. Adjudication Method for the Test Set

• Not applicable. As described above, the "test set" refers to the mechanical and material testing of the device components. Adjudication methods (like 2+1, 3+1) are employed in clinical studies, particularly in situations where there is subjective human interpretation or diagnostic agreement required (e.g., radiology reads).

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

• No. The document explicitly states: "No clinical studies were performed." Therefore, no MRMC comparative effectiveness study was conducted. This device is seeking clearance based on substantial equivalence to predicate devices through non-clinical performance data and material specifications.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not applicable. This device is a physical medical implant (hip prosthesis), not a software algorithm or AI-powered diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. Type of Ground Truth Used

• Engineering and Material Standards Compliance, and Mechanical Test Results: The "ground truth" for this device's performance is established by demonstrating compliance with recognized international standards (ISO, ASTM) for mechanical properties, material composition, and manufacturing processes relevant to hip implants. The results of the non-clinical tests (ROM, FEA, Fatigue Strength) serve as the evidence to support this compliance and demonstrate substantial equivalence to the predicate devices.

8. Sample Size for the Training Set

• Not applicable. This device is a physical medical implant and does not involve AI or machine learning algorithms that require a "training set."

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

• Not applicable. No training set was used or required for this device.

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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 devices or treatments for these indications have failed.

The Apex Hip System Bipolar Head consists of a factory assembled Ultra High Molecular Weight Polyethylene (UHMWPE) liner in a cobalt chrome outer shell and UHMWPE retention ring with a Ti-6Al-4v spring. These bipolar heads include outer diameters ranging from 38 to 60 mm, in 1 mm increments, to properly fit the patient anatomy. The smaller bipolar heads (38 to 42 mm) have an inner diameter that mates with a 22 mm diameter femoral head; the larger bipolar heads (43 mm to 60 mm) have an inner diameter that mates with a 28 mm diameter femoral head. The Apex Hip System Bipolar Head may be used in conjunction with an Apex Hip System femoral stem (K060072) for hemiarthroplasty.

The provided document does not describe a study involving an AI or algorithmic device, nor does it include acceptance criteria and performance data in the typical sense of a software-based medical device.

Instead, the document is a 510(k) Premarket Notification for a medical implant: the OMNI life science Apex Hip System Bipolar Head. This submission demonstrates substantial equivalence to a predicate device, as required by the FDA for certain medical devices.

Therefore, many of the requested categories are not applicable to the information contained in this document.

Here's an analysis based on the document:

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

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

• Test Set Sample Size: Not specified in the document for the non-clinical tests. These would typically be a small number of physical samples for mechanical testing.
• Data Provenance: Not explicitly stated, but assumed to be from OMNI life science, Inc.'s internal testing labs or contracted labs. The document indicates the submitter's location as E. Taunton, MA, USA, and the contact's location as Raynham, MA, USA, suggesting testing was conducted in the US.
• Retrospective or Prospective: Not applicable as these are bench tests on physical devices, not data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This document describes non-clinical bench testing of a physical implant, not a study requiring expert-established ground truth for data. The "ground truth" here is the physical performance of the device against engineering specifications.

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

• Not applicable. No adjudication method is relevant for the described non-clinical bench tests. The results of these tests are objective measurements.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed." This is a device for physical implantation, not an AI or imaging diagnostic device that would involve human readers.

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

• Not applicable. This is a physical medical implant, not an algorithm or AI device.

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

• For the non-clinical tests, the "ground truth" is defined by engineering specifications and established test methods (e.g., ASTM standards for UHMWPE, internal specifications for push-out/lever-out forces, and sterilization standards).

8. The sample size for the training set

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

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

• Not applicable. This is a physical medical implant, not an AI device.

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

• Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; .
• . Rheumatoid arthritis;
• Correction of functional deformity; .
• Congenital dislocation; ●
• Revision procedures where other treatments or devices have failed. .

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

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

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

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

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

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

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

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

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

4. Adjudication method for the test set:

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

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

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

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

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

7. The type of ground truth used:

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

8. The sample size for the training set:

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

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

• Not applicable. See point 8.

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