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The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, theumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revious reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee Systems are indicated for cemented use only, except for the OPTETRAK Logic PS and CR Porous Femoral Components, which are indicated for cemented or cementless use.

One Logic femoral components are part of the Optetrak / Optetrak Logic device family and are for use in resurfacing femoral bone as part of tri-compartmental total knee arthroplasty employing modular components.

Cemented One Logic PS femoral components represent modifications to Optetrak Logic Total Knee System femoral components cleared per 510(k) submission K093360. Proposed cemented One Logic CR femoral components represent modifications to Optetrak Logic CR femoral components cleared per 510(k) submissions K111400 and K121307.

Porous-coated PS and CR One Logic femoral components represent modifications to porous PS and CR Optetrak Logic femoral components cleared per 510(k) submission K123687 and can be used in either press-fit or cemented applications.

One Logic femoral components operate using the same fundamental scientific technology, have the same intended use and Indications for Use statements, are offered in the same product size scopes, have the same device compatibility, and are implanted using the same instrumentation and surgical techniques as cited corresponding predicate Optetrak Logic femoral components.

This document is a 510(k) premarket notification for a medical device called "Optetrak One Logic Femoral Components." It's an FDA submission, and as such, it does not contain the kind of detailed study data, acceptance criteria, or ground truth information typical for an AI/ML device performance evaluation as outlined in your request.

The information provided pertains to a traditional medical device (knee replacement components), not an AI-powered diagnostic or predictive tool. Therefore, many of the requested categories are not applicable.

Here's why many of your specific questions cannot be answered from this document:

• AI/ML Device: The device described is a physical knee implant, not an AI/ML software or system. Therefore, concepts like "test set," "training set," "experts to establish ground truth," "adjudication method," "MRMC comparative effectiveness," "standalone performance," and "effect size of human readers with/without AI assistance" are not relevant.
• Acceptance Criteria for Performance: For a mechanical device like this, acceptance criteria typically relate to material properties, mechanical strength, wear resistance, and biocompatibility, rather than diagnostic accuracy metrics (e.g., sensitivity, specificity). The document mentions "mechanical patellofemoral constraint testing," but it doesn't specify the acceptance criteria for this test or the detailed results against those criteria. It only states that the testing was performed and supports substantial equivalence.
• Study Details: The document refers to "engineering studies" and "testing", but it does not provide detailed study protocols, results, or statistical analyses that would allow for a breakdown of sample sizes, data provenance, ground truth establishment, or performance metrics in the way you've requested for an AI/ML device.

However, I can extract the following limited information that is somewhat related to your request, keeping in mind the context of a physical medical device:

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

This document does not provide a table of acceptance criteria and reported device performance in the manner you've requested for an AI/ML device (e.g., sensitivity, specificity, accuracy against a threshold). For a physical implant, acceptance criteria would typically involve engineering specifications (e.g., material strength, wear rates, fatigue life).

The document states: "This submission includes results for mechanical patellofemoral constraint testing." and "Results of engineering studies referenced in this 510(k) submission demonstrate proposed One Logic devices are substantially equivalent to cited cleared predicate Optetrak Logic devices." This indicates that the device met its performance criteria by demonstrating substantial equivalence to predicates through these engineering tests, but the specific numerical acceptance criteria and performance metrics are not detailed in this summary.

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

• Sample Size for Test Set: Not applicable in the context of an AI/ML test set. For mechanical testing of a physical device, sample sizes would refer to the number of components tested for strength, wear, etc. This information is not detailed in this summary.
• Data Provenance: Not applicable in the context of an AI/ML test set. The "data" here would be mechanical test results from laboratory settings, typically performed by the manufacturer.

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

Not applicable. "Ground truth" in this context would be defined by engineering specifications and material science standards for the physical implant, not by expert consensus on diagnostic images or data.

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

Not applicable. Adjudication methods are used for resolving disagreements among human reviewers of diagnostic data, which is not relevant for mechanical testing of an implant.

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

Not applicable. This is an AI/ML specific study type, not relevant for a physical knee implant.

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

Not applicable. This is an AI/ML specific performance metric, not relevant for a physical knee implant.

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

Not applicable in the AI/ML sense. For this device, the "truth" is established by adherence to engineering design specifications, material standards, and performance in standardized mechanical tests, as well as clinical experience with predicate devices.

8. The sample size for the training set:

Not applicable. This is an AI/ML specific concept.

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

Not applicable. This is an AI/ML specific concept.

In summary, this document is an FDA 510(k) clearance letter for a conventional medical device (knee implant components) and does not contain the detailed performance study information, acceptance criteria, or ground truth methodologies that would be relevant for an AI/ML-powered device.

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The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.

The proposed Optetrak Logic 17mm & 19mm Thick Inserts are modifications to Optetrak Logic ultra high molecular weight polyethylene (UHMWPE) tibial insert components cleared per 510(k)s K093360. K110547. K111400. K121307, and K123342.

This submission proposes adding 17mm and 19mm tibial insert options to the existing 9mm-15mm range of Optetrak Logic insert thicknesses. The 17mm and 19mm thick inserts will be provided across the current component size range (size 0 through size 6). Like the predicate devices, the proposed inserts are used in total knee arthroplasty (TKA) with metal femoral components and tibial trays. The thicker inserts are proposed for both posterior-stabilized (Logic PS, Logic PSC) and cruciate-retaining (Logic CR. Logic CRC) product options.

The provided text describes a 510(k) submission for Exactech® Optetrak Logic® 17mm & 19mm Thick Inserts, which are modifications to existing tibial inserts for total knee arthroplasty (TKA). The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical performance data.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document mentions "engineering studies" and "non-clinical performance data" but does not specify sample sizes for the test set or directly refer to a "test set" in the context of clinical data or human subjects. The evaluation is focused on the device's mechanical properties. The data provenance is non-clinical testing performed by the manufacturer,Exactech, Inc.

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

This information is not applicable as the provided text describes non-clinical engineering testing. There is no mention of human experts establishing ground truth for a clinical test set.

4. Adjudication Method for the Test Set:

This information is not applicable as the assessment is based on non-clinical engineering tests, not on human interpretation or clinical adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for a medical device modification, and the provided text focuses on engineering studies, not clinical effectiveness studies involving human readers and interpretations.

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

This information is not applicable. The device is a physical medical implant (tibial insert), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical performance data is derived from the results of mechanical and physical testing (e.g., anterior/posterior liftoff/dissociation testing) designed to assess the locking stability of the tibial inserts. This is based on established engineering principles and test methods for medical devices.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a physical medical implant and does not involve a "training set" in the context of machine learning or AI.

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

This information is not applicable as there is no "training set" for this type of medical device submission.

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The OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.

The proposed Optetrak Logic Porous Femoral Component devices represent modifications to existing Optetrak Logic Total Knee System (K093360) and Optetrak Logic CR Knee System femoral components (K111400 and K121307) used in total knee arthroplasty. The only difference between proposed Optetrak Logic Porous Femoral Components and predicate Optetrak Logic femoral components is the addition of a beaded, sintered cobalt-chrome coating to specific non-articulating areas of the subject devices, similar to the coating added to predicate Optetrak Porous Coated Cruciate Retaining Femoral Component devices cleared per 510(k) K935726 and predicate Exactech Posterior Stabilized Porous Femoral Component devices cleared per 510(k) K935773.

Both predicate and proposed devices share the following similarities:

• the same indications for use .
• . the same materials
• . the same basic fundamental scientific technology
• . the same device compatibility
• the same materials and processes used for packaging and sterilization .

Here's an analysis of the provided text regarding the acceptance criteria and study for the Exactech® Optetrak Logic® Porous Femoral Component:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document describes material and mechanical testing, not a clinical study with patients. Therefore, the concept of "test set" in terms of patient data or clinical outcomes doesn't directly apply here.

• Mechanical Testing (e.g., Shear fatigue testing): Sample size of n=5 was used for shear fatigue testing per ASTM F1160-05.
• Other Mechanical Tests (Shear strength, Tensile strength): The document states "All test samples exceeded..." for shear and tensile strength, implying multiple samples were tested, but the exact count isn't specified beyond "all test samples."
• Data Provenance: The tests are reported as "engineering studies" and "cadaver lab evaluation," indicating laboratory-based data and potentially pre-clinical/bench testing. There is no mention of country of origin for this data or if it's retrospective or prospective in a clinical sense. The cadaver lab evaluation is a type of prospective pre-clinical test.

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

• Cadaver Lab Evaluation: A "surgeon" determined the prototype was implanted without difficulty. The number of surgeons and their specific qualifications (e.g., years of experience, specialization) are not specified. This 'ground truth' is subjective, based on surgical ease of use.
• Other Tests: For the material and mechanical tests, the "ground truth" is established by the ASTM standards themselves (e.g., ASTM F1854-09, ASTM F1044-05). These standards define the test methods and performance metrics, and the measurements are objective laboratory results. There is no mention of human experts establishing ground truth for these quantitative measurements beyond the technicians conducting the tests according to standard protocols.

4. Adjudication Method for the Test Set:

Not applicable in the context of these engineering and cadaver lab tests. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for ambiguous cases or diagnostic disagreement between multiple human readers or between human readers and AI. The tests performed are objective measurements against defined standards or surgeon's subjective assessment of implantability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This submission focuses on material and mechanical equivalence for a modified medical device, not on assessing the diagnostic or clinical effectiveness of an AI system.

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

Not applicable. This submission is for a physical medical device (femoral component for knee replacement), not an algorithm or AI system.

7. The Type of Ground Truth Used:

• Material and Mechanical Tests: The ground truth is objective, quantitative measurements derived from standardized laboratory tests (e.g., ASTM standards) and compared against pre-defined performance acceptance criteria suggested by FDA guidance.
• Cadaver Lab Evaluation: The ground truth is a subjective expert assessment by a surgeon regarding the ease of implantation.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" as this is not an AI/machine learning device. The device's design is based on existing predicate devices and engineering principles, not statistical learning from a dataset.

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 OPTETRAK Comprehensive Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems. They are also indicated for revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present. In the USA, the OPTETRAK Comprehensive Knee System is indicated for cemented use only.

The proposed Optetrak Logic CRC Tibial Insert devices represent modifications to existing Optetrak Logic CR Knee System components cleared per 510(k) K111400 and 510(k) K121307. Both proposed and predicate devices are made from the same materials using the same processes and are compatible with the same Optetrak Logic tibial trays and femoral components.. Compared to predicate Logic CR inserts; the proposed Logic CRC inserts are designed to provide additional stability in the absence of a fully functioning PCL.

Here's a breakdown of the acceptance criteria and the study proving the device meets it, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document only provides comparative performance against predicate devices, indicating the changes introduced by the new design. It doesn't define explicit pass/fail thresholds for each constraint measure as "acceptance criteria" but rather presents the observed increases as the performance that justifies equivalence. The ultimate acceptance criterion is the determination of "substantial equivalence" to the predicate.

Study Details

2. Sample Size and Data Provenance

• Sample Size for Test Set: n=5 (This likely refers to the number of devices tested in the engineering study).
• Data Provenance: Not explicitly stated beyond "engineering studies" and "cadaver lab testing." The engineering studies are likely laboratory tests conducted by the manufacturer. Cadaver lab testing would involve human cadavers.

3. Number and Qualifications of Experts for Ground Truth (Test Set)

• Number of Experts: Not explicitly stated, but referred to as "surgeon experts" (plural).
• Qualifications of Experts: "Surgeon experts." Specific years of experience or specialty (e.g., orthopedic surgeon) are not provided.

4. Adjudication Method (Test Set)

• Adjudication Method: Not specified. The document only states that "Devices were also evaluated by surgeon experts during cadaver lab testing." How their evaluations were combined or reconciled is not detailed.

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

• Was an MRMC study done? No. The document describes engineering studies and cadaver lab testing, not a comparative effectiveness study involving human readers (e.g., surgeons interpreting images with and without AI).

6. Standalone (Algorithm Only) Performance

• Was a standalone study done? Not applicable. This device is a physical knee implant, not an algorithm or AI system. The "performance" relates to the mechanical properties of the device itself.

7. Type of Ground Truth Used

• Type of Ground Truth:
  • Engineering Study: Based on objective measurements according to ASTM F1223-08 to characterize constraint. The "ground truth" here is the measured mechanical output of the device under specific test conditions.
  • Cadaver Lab Testing: Expert evaluation by surgeons. This would be based on clinical judgment and experience with the device in a simulated anatomical environment.

8. Sample Size for Training Set

• Sample Size for Training Set: Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set. The design was likely developed through iterative engineering and simulation, not "training" in the AI sense.

9. How Ground Truth for Training Set was Established

• How Ground Truth was Established: Not applicable, as there is no "training set" in the context of this physical device. The design was likely refined based on engineering principles, biomechanical understanding, and potentially feedback from prior designs or clinical experience.

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