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The Symmetric(TM) Total Knee System consists of single use components intended for total knee arthroplasty with the following indications:

1. Rheumatoid arthritis,
2. Post-traumatic arthritis,
3. Osteoarthritis,
4. Degenerative arthritis in older patients whose age, weight, and activity level are compatible with an adequate long-term result.
5. Failed osteotomies, unicompartmental replacement, or total knee replacement.
   All components are for cemented use only.

The Femoral components are cobalt chromium alloy (ASTM F75). Tibial articular inserts and patellar components are UHMWPE (ASTM F648). Tibial trays, metaphyseal and revision stems, femoral and tibial wedges and cones, and screws (K961157), are titanium (ASTM F1472). Coated cobalt chromium and titanium components feature a coating of plasma sprayed titanium (ASTM F1580).
The purpose of this 510(k) is to submit an additional sterilization method of a flexible bag system. Other descriptive details remain unchanged from the predicate.

This document is a 510(k) premarket notification for a medical device called the "Symmetric™ Total Knee System." It's important to note that this submission is for an additional sterilization method for an existing device, not for a new AI/software-driven device. As such, the information typically requested for AI device studies (like sample sizes, ground truth, expert adjudication, MRMC studies, standalone performance, training set details) does not apply to this specific submission.

Therefore, I cannot provide a table of acceptance criteria for AI performance or details of a study proving a device meets AI-specific criteria, as this document pertains to a physical orthopedic implant and its sterilization process, not an AI or software-based medical device.

Here's a breakdown of what the document does provide, and why the requested information isn't present:

Device: Symmetric™ Total Knee System (a knee joint prosthesis)
Purpose of 510(k): To submit an additional sterilization method (flexible bag system) for the device. The core device itself was previously cleared under K080199.

Missing Information (and why it's not applicable here):

1. Table of acceptance criteria and reported device performance: This document doesn't define acceptance criteria for AI performance. The "performance data" mentioned (Section VII) refers to "full sterilization qualification of the flexible bag sterilization vendor," not clinical or AI performance.
2. Sample size, data provenance for a test set: No test set for AI performance is discussed.
3. Number of experts and qualifications for ground truth: Not applicable, as there's no AI ground truth to establish.
4. Adjudication method for the test set: Not applicable.
5. MRMC comparative effectiveness study: Not applicable. Human readers are not using AI assistance with a knee implant.
6. Standalone performance study: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

What the document does state regarding the study (sterilization-related):

• Study: "The full sterilization qualification of the flexible bag sterilization vendor is included in the submission." (Section VII. Performance Data)
• Conclusion: "The technological characteristics/features and performance characteristics for the Symmetric Total Knee System are substantially equivalent to the legally marketed predicate device. This 510(k) is submitted for the addition of the flexible bag chamber sterilization method." (Section VIII. Conclusions)

In summary, this document is about changes to the manufacturing process (sterilization) of a physical medical implant, not the evaluation of an AI or software algorithm.

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The ACTIVE TM Screw Bone Screw is intended for implantation into prepared bone during orthopaedic surgery when the surgeon determines the need for additional fixation: bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ACTIVE™ Screw Bone Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ACTIVE ™ Screw Bone Screws subjected to this premarket notification are 4.5 mm diameter screws available in 5 mm length increments from 20 to 50 mm. The screws are manufactured from titanium alloy and have an expandable thread crest. The implants are single use only devices.

The ACTIVE ™ Screw Bone Screw consists of a screw shank in conjunction with a spiral helical thread crest component. With the spiral helical thread component, the screw has the ability to expand an additional 1 mm after implantation.

The ACTIVE TM Screw Bone Screw is made of wrought titanium 6AI-4V ELI (ASTM F136) and is available in a 4.5 mm diameter size from 20 mm to 50 mm and will be provided non-sterile, and is to be steam sterilized by the end user. Resterilization of screws upon contamination is not recommended.

The provided document describes a 510(k) premarket notification for the "ACTIVE™ Screw Bone Screw" and contains information about its performance testing. However, it does not present acceptance criteria in a quantitative, pass/fail manner with specific numerical targets. Instead, it describes general compliance with existing standards and acceptable results.

Here's a breakdown of the information based on the request:

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria are not explicitly stated in the document, I will infer them from the reported testing methods and positive outcomes.

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

• Sample Size for Test Set: The document does not explicitly state the specific number of screws or tests conducted for each performance evaluation (torsion, pullout, torque in/out, bone interaction). It refers to "testing" as a general activity.
• Data Provenance: The studies were pre-clinical bench tests. The data is generated from laboratory testing of the device itself, not from human subjects or retrospective/prospective clinical data. Therefore, notions of "country of origin of the data" or "retrospective/prospective" do not apply in the typical sense; the tests were conducted by the manufacturer, Intelligent Implant Systems, LLC.

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

This question is not applicable to the type of safety and effectiveness testing described in the document. The "ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F543-07) and objective physical measurements rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods like "2+1" or "3+1" are relevant for clinical studies where subjective assessments (e.g., image interpretation) require reconciliation; this document describes objective mechanical performance 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

This question is not applicable. The device described is a bone screw, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or evaluation of AI assistance for human readers is irrelevant to this device.

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

This question is not applicable. The device is a physical bone screw, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is based on:

• Engineering Standards: Specifically, ASTM F543-07 for bone screw testing methods.
• Physical Measurements: Objective measurements of torsional strength, breaking angle, axial pullout strength, and force exerted.
• Comparative Performance to Predicate Devices: Damage from removal was compared directly to that of "traditional (predicate) bone screw[s]."

8. The Sample Size for the Training Set

This question is not applicable. As a physical medical device (bone screw), there is no "training set" in the context of machine learning or AI models. Performance is evaluated through physical testing.

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

This question is not applicable, as there is no training set for this device.

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