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The Optetrak Logic Total Knee System is 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 Logic Total Knee System is indicated for cemented use only.

The proposed Optetrak Logic. Total Knee System half-size finned and trapezoidal tibial trays are modifications to the existing Optetrak Total Knee System Cruciate Retained Titanium Back Tibial. Components (K932776) and Optetrak Total Knee Trapezoidal Cemented Tibial Components (933610), respectively. The proposed Optetrak Logic Total Knee System tibial inserts and femoral components are modifications to the existing Optetrak Total Knee System Hi-Fiex Knee Components (K033883).

The predicate and proposed devices have the same intended use and basic fundamental scientific technology and share the following similarities:

• the same indications for use .
• similar design features .
• . incorporate the same materials
• the same shelf life .
• . are packaged and sterilized using the same materials and processes.

This document describes a 510(k) submission for the Exactech® Optetrak® Logic™ Total Knee System. 510(k) submissions, particularly for orthopedic implants like knee systems, typically rely on equivalence to predicate devices and engineering studies rather than clinical trials with human subjects to prove performance and safety. As such, the information requested about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and MRMC studies often does not apply in the context of a Special 510(k) for device modifications like this one.

Based on the provided text, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Not explicitly stated in the provided text. For a device like this, acceptance criteria would typically involve demonstrating mechanical and material equivalence to the predicate devices through engineering studies (e.g., fatigue testing, wear testing, mechanical strength, dimensional conformity to design specifications). The reported device performance would be that it meets these criteria, thereby establishing substantial equivalence.

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

Not applicable in the context of this 510(k) Preamble. This submission is for modifications to an existing knee system and relies on engineering studies, not clinical trials with "test sets" of patients.

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

Not applicable. Ground truth as typically understood for diagnostic or AI-based devices (e.g., consensus of radiologists on images) is not relevant for this type of implantable device submission. The "ground truth" here would be the established performance characteristics and safety profile of the predicate devices, and the engineering principles demonstrating the modified device performs equivalently.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" of patient data that would require medical expert adjudication in this type of submission.

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, not an AI diagnostic or assistance tool, so MRMC studies are not relevant.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices through their prior clearances and long-term clinical use. The new device demonstrates "substantial equivalence" to these predicates. The types of evidence used to demonstrate this include:

• Similar indications for use.
• Similar design features.
• Incorporation of the same materials.
• Same shelf life.
• Same packaging and sterilization processes.
• Results of engineering studies. These studies would confirm that the modifications do not adversely affect the mechanical performance, wear characteristics, or other critical safety and performance attributes compared to the predicate device.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. There is no "training set" for this device.

Summary of the Study and Acceptance Criteria from the Provided Text:

The provided document is a 510(k) Summary of Safety and Effectiveness for a Special 510(k). This indicates that the device being submitted (Exactech® Optetrak® Logic™ Total Knee System) involves modifications to existing, already cleared predicate devices.

The core of the submission relies on demonstrating Substantial Equivalence to the predicate devices. The study proving this is explicitly mentioned as:

• "Results of engineering studies referenced in this 510(k) submission demonstrate the proposed Optetrak Logic Total Knee System devices are substantially equivalent to cited cleared predicate devices."

The "acceptance criteria" are therefore implicitly that the results of these engineering studies confirm the modified device maintains the same safety and effectiveness profile as the predicate devices, despite the modifications. The specific details of these engineering studies (e.g., fatigue tests, wear tests, material property analyses) and their numerical acceptance thresholds are not provided in this summary document but would be reviewed by the FDA as part of the full submission.

The document highlights the basis for substantial equivalence:

• The same indications for use.
• Similar design features.
• Incorporate the same materials.
• The same shelf life.
• Are packaged and sterilized using the same materials and processes.

This document serves as a high-level summary, and the detailed engineering study reports would contain the specific acceptance criteria and detailed performance data.

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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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