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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.

The OPTETRAK Comprehensive Knee Systems are contraindicated in patients with active infection, patients without sufficient bone stock to allow appropriate insertion and fixation of the prosthesis, patients without sufficient soft tissue integrity to provide adequate stability, patients with either mental or neuromuscular disorders that do not allow control of the knee joint, and patients whose weight, age, or activity level might cause extreme loads and early failure of the system.

The proposed Exactech Optetrak® Proximal Tibial Spacer (PTS) is a titanium alloy spacer that assembles with the Optetrak® Tibial Tray and the Optetrak® Tibial Insert prostheses to replace the correct amount of joint space. This allows a combined tibial insert/tibial tray thickness comparable to the thickness provided by larger tibial inserts, while maintaining the function and performance of the predicate Optetrak Knee tibial insert/tibial tray assembly. The proposed Optetrak PTS is intended to take the place of inserts larger than 15mm by mating with the thinner inserts (ranging from 9mm to 15mm) to achieve the same total thickness.

Here's a breakdown of the acceptance criteria and the study information for the Exactech Optetrak® Proximal Tibial Spacer, based on the provided 510(k) summary:

This device is a Class II medical device, and the submission is a 510(k) premarket notification. 510(k) submissions typically do not involve clinical trials with human readers or standalone algorithm performance studies in the way AI/ML devices do. Instead, they focus on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, many of the requested categories (like MRMC studies, number of experts, training set size, etc.) are not applicable in this context.

The "study" that proves the device meets the acceptance criteria is primarily non-clinical performance data demonstrating substantial equivalence.

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

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 for Test Set: Not applicable in the context of clinical images or patient data. The "test set" here refers to the specific components of the device that underwent mechanical testing. The document does not specify the exact number of spacers tested, but rather refers to "mechanical tests and engineering analyses."
• Data Provenance: Not applicable. The data is from in-vitro mechanical testing and engineering analyses, not human patient data or images.

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)

• Number of Experts: Not applicable. Ground truth for mechanical performance is established through recognized engineering standards and test methodologies, not expert interpretation of clinical data. This would be determined by qualified engineers and material scientists.
• Qualifications of Experts: Not specified, but implied to be qualified engineers/scientists conducting and interpreting the mechanical tests.

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

• Adjudication Method: Not applicable. This concept applies to human interpretations of clinical data, not mechanical testing.

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, an MRMC comparative effectiveness study was not done. This type of study is not relevant for a prosthetic device demonstrating substantial equivalence via mechanical testing. This device is not an AI/ML imaging device where "human readers" would be involved in interpreting outputs.

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

• Standalone Performance Study: No, a standalone performance study in the context of an algorithm or AI was not done. The performance demonstrated is the standalone mechanical integrity of the device itself.

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

• Type of Ground Truth: The ground truth for this device's performance is based on recognized industry standards and engineering principles for permanent implants. This includes material property specifications, dimensional tolerances, biomechanical load testing parameters, and adherence to established sterilization protocols. The "predicate devices" serve as the benchmark for this ground truth performance.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is a physical implant, not an AI/ML algorithm that requires a "training set" of data.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for a physical implant.

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The Optetrak® HI-FLEX Asymmetric Posterior-Stabilized Cemented Femoral Components (herein referred to as the Optetrak® HI-FLEX PS Femoral Components) and Optetrak® HI-FLEX Posterior-Stabilized Tibial Inscrts (Herein referred to as the HI-FLEX PS Tibial Inserts) are intended to be used with an Optetrak® Tibial Tray to replace the patient's distal fomur and proximal tibia during primary or revision total knee arthroplasty. The Optetrak® HI-FLEX PS Femoral components are intended for use when needed to closely match the geometry of the patient's resected distal femur and allows for more flexion than the standard Optetrak® components.

The Optetrak® HI-FLEX PS Tibial Insert is intended for use with the Optetrak® HI-FLEX PS Femoral components to afford the patient a higher degree of flexion than the standard Optetrak " femoral/tibial insert combination.

The proposed components are intended for use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) must be sacrificed.

All proposed femoral components are intended for cemented use only.

The OPTETRAK® Total Knee Systems are indicated for use in skeletally mature individuals undergoing primary surgery for total knce replacement due to osteoarthritis, osteonecrosis, theurnatoid 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.

The device modifications to the femoral components presented in this Special 510(k) represent changes to the Optetrak® Asymmetric (AK), Posterior-Stabilized, Cemented Femoral Components (K032606) and the Optetrak® B-Series Postcrior-Stabilized Femoral Component (K010434). These changes represent a combination of

1. The condyle, anterior cam, asymmetric flange and PCL stabilizing box geometries of the Optetrak® AK Femoral components, and
2. The Posterior condyle radius and cam geometries of the Optetrak® B-Series Femoral Component

The device modifications to the tibial insert components presented in this Special 510(k) represent changes to the Optetrak® Posterior-Stabilized Tibial Inserts (K011976 and K933610) and changes to the Optetrak® B-scries Tibial Inserts (K010434). These changes represent a combination of:

1. The articulating surfaces, mating geometry and anterior spine geometry of the Optetrak® Posterior-Stabilized Tibial Inscrts, and
2. The posterior portion of the spine and the posterior scallops of the Optetrak® B-Series Tibial Insert Component

No changes were made to the patellar or tibial tray components of the Optetrak® Total Knec System.

The Exactech Optetrak® Total Knee System Line Extension-Optetrak® HI-FLEX Knee Components is a medical device. The provided text is a 510(k) premarket notification for this device, outlining its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are not explicitly stated as numerical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance criteria are based on demonstrating substantial equivalence to legally marketed predicate devices. The performance data presented focuses on verifying the implant's mechanical adequacy for anticipated in vivo loading.

Note: While not explicitly stated as "acceptance criteria," these are the aspects evaluated for a 510(k) submission to demonstrate that the new device is as safe and effective as a legally marketed device.

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

The document does not specify a "test set" in the context of clinical data or patient outcomes for this 510(k) submission. The performance assessment primarily relies on "Verification and Validation analyses" which are typically engineering tests, mechanical simulations, and material characterizations.

• Sample Size for Test Set: Not applicable as no clinical test set data is described. The "sample" would refer to the components tested in engineering analyses. The specific number of components or iterations for these tests is not provided in the summary.
• Data Provenance: Not applicable for clinical data. For the engineering analyses, the provenance would be internal to Exactech, likely conducted in a laboratory setting. The country of origin of such data is not specified but presumed to be the USA where Exactech is located. The study is a retrospective analysis of the design modifications and their compliance with established engineering and manufacturing standards, as opposed to a prospective clinical trial.

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

Not applicable. This 510(k) submission is for a line extension of an orthopedic implant, focusing on mechanical performance and substantial equivalence, not on diagnostic accuracy requiring expert interpretation of results. The "ground truth" for mechanical performance would be established by engineering specifications, material properties, and biomechanical standards, not by expert consensus on clinical images or patient outcomes.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical test set involving human interpretation that would require an adjudication method.

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 knee implant (hardware), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is irrelevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this submission is based on engineering specifications, biomechanical testing standards, material science principles, and comparison to the established performance of predicate devices. The verification and validation analyses would have used these objective measures to confirm the safety and performance of the modified components.

8. The Sample Size for the Training Set

Not applicable. This device 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

Not applicable. As there is no "training set" for an AI model, the concept of establishing ground truth for it does not apply.

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The Optetrak Femoral components are intended to replace the patient's distal femur during primary or revision total knee arthroplasty. The Optetrak® Asymmetric Femoral components are intended for use when needed to more closely match the geometry of the patient's resected distal femur. This change results in separate components for the right and left knees. The Asymmetric, Cruciate-Retaining Cemented components and the Asymmetric, Cruciate-Retaining, Porous-Coated Femoral Components are intended for use in total knee arthroplasty procedures in which the Posterior Cruciate Ligament (PCL) is preserved.

The Optetrak® Size 6 Posterior-Stabilizing, Cemented Femoral Component and Asymmetric, Posterior-Stabilizing Femoral components are intended to replace the function of the PCL during a total knee arthroplasty in which the PCL must be sacrificed.

All proposed femoral components are intended for cemented use only.

The OPTETRAK® Total 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.

The device modifications presented in this Special 510(k) represent changes to the posterior stabilized, cruciate-retaining cemented, and cruciate-retaining porous coated femoral components of the Optetrak® Total Knee System (K932690, K933494, K935726, K011976). These changes include:

1. Modification of the patellar flange to create an asymmetric femoral component
2. Addition of a larger size posterior-stabilized, cemented (symmetric) femoral component

No changes were made to the tibial or patellar components of the Optetrak® Total Knee System.

The differences in design features between the proposed Optetrak AK Femoral and predicate Optetrak® Femoral include the following:

1. Changes to the anterior flange to make the component asymmetric by:
   a. Tilting the flange laterally, and
   b. Angling the proximal edge of the flange medially.
2. Adjustments to the patella groove edges by:
   a. Increasing the edge radii resulting from the intersections of the patella groove and the trochlear condyles to smooth the edges, and
   b. Slightly lowering the profile height of the medial trochlear condyle in the proximal area as a result of the tilting of the flange.

The difference in design between the proposed size 6 femoral component and the predicate femoral components consists of a size increase in the overall geometry of the component. resulting in:

1. An increase in the overall anterior-posterior dimension of four (4) millimeters
2. An increase in the overall medial-lateral dimension of five (5) millimeters

The provided text describes a Special 510(k) submission for a line extension of the Exactech® Optetrak® Total Knee System, specifically for Optetrak® Femoral Components. This submission is for modifications to existing devices, not for a new medical imaging or diagnostic device that would involve an AI algorithm with specific acceptance criteria related to accuracy, sensitivity, or specificity.

Therefore, the document does not contain the information required to answer your request. The "acceptance criteria" discussed are related to demonstrating substantial equivalence to predicate devices for mechanical performance and design changes, rather than clinical performance metrics for an AI-powered diagnostic tool. The "study" mentioned refers to "Verification and Validation analyses" for implant performance, which are likely mechanical and design tests, not clinical studies with human participants, ground truth establishment, or statistical performance metrics.

Specifically, the following information is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not specify quantitative clinical acceptance criteria or performance metrics in terms of accuracy, sensitivity, specificity, or similar.
2. Sample size used for the test set and the data provenance: No information about a clinical test set, its sample size, or data provenance is provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable as there is no clinical test set with an associated ground truth based on expert review.
4. Adjudication method for the test set: Not applicable.
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, as this is not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• The sponsor and contact information (Exactech Inc.).
• The device name and its classification.
• The legally marketed predicate devices for substantial equivalence comparison.
• The intended use, indications, and contraindications of the Optetrak Femoral components.
• Specific device modifications:
  • Modification of the patellar flange to create an asymmetric femoral component.
  • Addition of a larger size posterior-stabilized, cemented (symmetric) femoral component.
• A general statement about "PERFORMANCE DATA SUMMARY": "Verification and Validation analyses were conducted to verify that the implant performance would be adequate for anticipated in vivo loading." The conclusion is that the modified components are "substantially equivalent" to the predicate devices.

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The Molded Metal-back Tibial components are intended to replace the patient's proximal tibia during primary or revision total knee arthroplasty. This device has been designed to substitute for the posterior stability of the Posterior Cruciate Ligament (PCL) and is intended for cemented application.

The OPTETRAK® Total 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 materials and design, the proposed Molded Metal-back Tibial components are a combination of:

1. The articulating surfaces of the Exactech Optetrak Tibial Tray Insert components (K933610 and K011976)

2. The tibial stem of the Cemented Finned Tibial Tray components (K932776 and K011976).

The device modifications presented in this Special 510(k) represent changes to the posterior stabilized, modular tibial insert and finned tibial tray components of the Optetrak Total Knee (K932776, K933610 and K011976). No changes were made to the femoral or patellar components of this system.

The proposed device modifications involve:

1. Modification to the portion of the modular assembly distal to the proximal articulating surface and proximal to the distal finned stem.

2. Revised cement fixation undercuts on the distal portion of the component

3. Integration of geometric undercuts to form a mechanical interlock between the UHMWPE and metallic portions of the component

4. A change in material of the finned stem portion from titanium alloy to cobaltchromium (CoCr)

No modifications have been made to the articular surface of the UHMWPE that interfaces with the femoral components. Nor have any configuration changes been made to the finned stem portion of the tibial bone interface.

There have been no changes to the material of the predicate Optetrak Total Knee bearing surface. Like the predicate Optetrak Total Knee tibial inserts, the proposed bearing surface is manufactured of Ultra-High Molecular Weight Polyethylene (UHMWPE) conforming to ASTM F648.

This document describes a Special 510(k) submission for a line extension to the Exactech Optetrak Total Knee System, specifically for "Molded Metal-back Tibial Components." The application focuses on demonstrating substantial equivalence to previously cleared predicate devices through design modifications and performance testing.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for any "test set" in the context of clinical testing with human subjects or a defined dataset for AI/algorithm performance. The evaluation is primarily based on functional testing of the implant, design comparisons to predicate devices, and material specifications.

The data provenance is prospective functional testing conducted by the manufacturer, Exactech, Inc. There is no indication of retrospective or prospective clinical human data, nor is there any mention of country of origin for such data.

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

This information is not applicable and not provided in the document. The evaluation is focused on the mechanical and material properties of a prosthetic device, not on interpreting images or making diagnoses that would require expert-established ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI algorithms, which are not described here.

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

This information is not applicable and not provided. This document pertains to a knee prosthesis and does not involve AI or human "readers" of medical images or data.

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

This information is not applicable and not provided. This document describes a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device appears to be based on:

• Validated engineering principles and functional testing standards: The performance data summary mentions "Functional testing was conducted to verify that the implant performance would be adequate for anticipated in vivo loading." This implies comparison against established biomechanical standards and expected performance in the human body.
• Material specifications: Conformance to ASTM F648 for UHMWPE.
• Design characteristics of legally marketed predicate devices: The primary method of showing substantial equivalence is by demonstrating that the new device's design, materials, and functional performance are similar to or equivalent to existing, cleared devices (K933610, K011976, K932776).

There is no mention of expert consensus, pathology, or outcomes data as a ground truth for the technical evaluation presented in this 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable and not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

This information is not applicable and not provided. As there is no training set mentioned, this question is irrelevant to the provided document.

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The Offset Tibial Tray components are intended to replace the patient's proximal tibia during primary or revision total knee arthroplasty. The Optetrak Offset Tibial Tray is intended for use when the tibial intramedullary (IM) canal is offset from the tibial plateau.

The OPTETRAK® Total 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.

The device modifications presented in this Special 510(k) represent changes to the Tibial Tray Components of the Optetrak Total Knee System (premarket notifications #K933610 and #K011976). No changes were made to the other components of the Optetrak Total Knee System.

The proposed device modifications involve offsetting the distal portion of the tray's stem in the sizes 0, 1 Delta, 1, 2, 3, 4 and 5. This is done in order to accommodate varying patient anatomies.

No modifications have been made to the mating features of the Tibial Tray in order to maintain the full mating capabilities with all tibial inserts, augmentation components and stem extensions of the predicate Optetrak Total Knee System

The proposed offset design incorporates modified screws for attachment of the Constrained Condylar Tibial Inserts and the Tibial Stem Extensions.

There have been no changes to the material of the predicate Optetrak Tibial Tray components. Like the predicate Optetrak Tibial Tray components (#K933610 & #K011976), the proposed tray components are manufactured from titanium alloy (Ti 6 Al 4V) conforming to ASTM F-136.

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

Acceptance Criteria and Device Performance for the Exactech® Optetrak® Total Knee System Line Extension - Offset Tibial Tray Special 510(k)

This document describes a Special 510(k) submission for modifications to an existing device, the Optetrak Total Knee System. The primary modification involves offsetting the distal portion of the tibial tray's stem. For such submissions, the acceptance criteria are typically met by demonstrating that the modified device is substantially equivalent to the predicate device and that the modifications do not negatively impact its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify a sample size for a test set in the context of clinical data for the Offset Tibial Tray. This is because the submission is a Special 510(k) for a device modification, relying heavily on predicate device equivalence and bench testing rather than new clinical trials.

The data provenance for the "Functional testing" is not explicitly stated (e.g., country of origin, retrospective or prospective), but it would be laboratory-based (bench testing), not clinical.

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

This information is not applicable or provided in the context of this Special 510(k) submission. The "ground truth" here is established through mechanical testing standards and comparison to the predicate device's performance, not by expert review of patient data.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Since the primary performance data comes from functional (bench) testing, there would be no need for an adjudication method as typically applied to expert-reviewed clinical or imaging data.

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

There was no MRMC comparative effectiveness study done, as this is a mechanical medical device (a knee implant), not an AI-powered diagnostic tool. The concept of "human readers" and "AI assistance" is not relevant to this device.

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

This is not applicable or provided. This device is a mechanical implant, not an algorithm, so a "standalone algorithm" performance assessment is irrelevant.

7. The Type of Ground Truth Used

For this Special 510(k) submission concerning a mechanical device modification, the "ground truth" for demonstrating safety and effectiveness is primarily based on:

• Mechanical performance standards and established engineering principles: Ensuring the modified implant can withstand anticipated in vivo loads.
• Material specifications: Conformance to ASTM standards (ASTM F-136 for Ti 6 Al 4V).
• Demonstrated performance of the predicate device: The new design is compared to the known and accepted performance of the legally marketed predicate Optetrak products.

Thus, the ground truth is derived from bench testing results and material compliance, not pathology, patient outcomes, or expert consensus on clinical data for the modified component itself.

8. The Sample Size for the Training Set

This information is not applicable or provided. As this is a mechanical medical device, there is no "training set" in the context of machine learning or AI. The design and testing are based on engineering principles and predicate device data.

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

This information is not applicable or provided for the same reasons as in point 8.

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