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The NEO Total Knee System components are indicated for use in skeletally mature individuals, with severe knee pain and disability, undergoing surgery for total knee replacement due to:

• · Osteoarthritis, rheumatoid arthritis, post-traumatic arthritis, moderate deformities and femoral condyle osteonecrosis.
• . Failed osteotomies, failed partial knee replacement, or failed total knee replacement whose age, weight and activity level are compatible with an adequate long-term result.
• . Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities. .
  The Neo Total Knee System components are indicated for use only with cement and are single use devices.

The NEO Total Knee System was cleared for marketing in April 2012, under 510(k) #K120313. The predicate knee system includes a cruciate retaining (CR) femoral component design, tibial trays, CR tibial inserts for use with intact posterior cruciate ligament(PCL), and patellar components. The subject 510(k) adds ultra congruent (UC) tibial inserts for use when the PCL is sacrificed. There are no changes to materials or to system component size offering.
The Neo Knee System CR femoral components, when used with the mating Neo Knee System CR and UC articular surfaces, are designed to achieve flexion at high angles and provide a clinical ROM up to 150 degrees.

The provided document is a 510(k) summary for the NEO Total Knee System - Line Extension. This document does not describe a study involving an AI/CADeX device. Instead, it describes a medical device (a knee implant) and its performance through mechanical and material testing, not a clinical or comparative effectiveness study involving human readers or AI.

Therefore, many of the requested categories in the prompt do not apply to this document. I will answer the questions that can be addressed based on the provided text, and explicitly state when a question is not applicable.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating "substantial equivalence" to legally marketed predicate devices. This is achieved by showing that the new components (ultra congruent tibial inserts) perform comparably to or within acceptable limits for a total knee replacement system. The performance criteria are related to the mechanical and material integrity of the implant components.

Study Proving Device Meets Acceptance Criteria:

The study referenced is a series of "Performance Testing" and a comparison of "Technological Characteristics" to predicate devices. This is a non-clinical, benchtop, and analytical comparison study as typically used for 510(k) submissions for medical devices like implants.

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

   • Sample Size: Not specified in the document. For benchtop mechanical testing, typical sample sizes might be N=5 or N=10 per test condition, but this is not mentioned.
   • Data Provenance: Not specified, but likely from laboratory testing conducted by the manufacturer or a contracted lab. The terms "retrospective" or "prospectively" do not apply to this type of mechanical testing.

2. 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 submission describes the mechanical and material performance of an orthopedic implant, not a diagnostic device that requires expert interpretation for a ground truth. The "ground truth" here is the physical measurement of performance against established standards or predicate device performance.

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

   • Not applicable. As above, this does not involve human interpretation or adjudication for a diagnostic task.

4. 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. No MRMC or AI study was performed. This is a 510(k) for a physical implant, not an AI/CADeX device.

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

   • Not applicable. No algorithm or AI device is described.

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

   • The "ground truth" for this type of device is based on engineering and material science principles, established mechanical testing standards (e.g., ISO or ASTM for implants), and performance data from legally marketed predicate devices. The goal is to demonstrate that the new component (UC tibial inserts) performs equivalently or acceptably within the established parameters for total knee systems.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not applicable. As there is no training set mentioned, this question does not apply.

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