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The Surg Tech GENOLL™ system is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended for cemented use only.

The SurgTech GENOLL"Total Knee System is used for total knee arthroplasty in skeletally mature individuals. The system consists of a CoCr alloy Posterior Stabilized (PS) femoral component (10 sizes, Left and Right), a CoCr alloy tibial baseplate (10 sizes), a conventional polyethylene PS tibial bearing insert (5 sizes with 5 thicknesses each) and a conventional polyethylene patella (3 sizes). Instrumentation necessary for proper implantation is also included.

The provided text is related to an FDA 510(k) premarket notification for a medical device called the "SurgTech GENOLL™ Total Knee System." This document is a clearance letter, not a description of an AI/ML-based device or its performance study.

Therefore, none of the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, ground truth establishment, or clinical study methods can be found in the provided text.

The document explicitly states under section (b)(2) "Clinical testing:" that "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This indicates that the clearance was based on demonstrating equivalence to predicate devices through similarities in intended use, design, materials, packaging, sterilization, and mechanical performance, rather than through
clinical or AI/ML performance studies.

The acceptance criteria listed in the document are for non-clinical testing of the physical components (e.g., Baseplate Fatigue, Constraint, Contact Area, PS Post Fatigue, Tibial Insert/Baseplate Disassembly, Bacterial endotoxins), not for an AI/ML system's diagnostic or predictive performance.

In summary, the provided text does not contain the information needed to answer your request about acceptance criteria and study data for an AI/ML device.

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The SurgTech Bipolar Head system is intended for use for cases of:
• Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli and painful hip dysplasia.

• · Inflammatory degenerative joint disease such as rheumatoid arthritis.
• Correction of function deformity.
• · Revision procedures where other treatments or devices have failed.
  · Treatment of nonunion femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

The SurgTech Bipolar Head System is used for hip hemiarthroplasty in skeletally mature individuals. The system consists of a CoCr alloy shell (38-58mm outer diameters), a polyethylene bearing insert (22mm and 28mm inner diameters) and retaining ring, and CoCr alloy femoral heads (22mm and 28mm) in various offsets. Instrumentation necessary for proper implantation is also included.

The provided text is a 510(k) premarket notification for a medical device, the SurgTech Bipolar Head System. This type of regulatory submission in the US focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel safety and effectiveness through extensive clinical trials.

As such, the document does not describe acceptance criteria for a study or a study proving the device meets those criteria in the way one would expect for an AI algorithm or a device requiring new clinical efficacy data.

Here's an analysis based on the information provided, explaining why certain sections of your request cannot be fulfilled:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to predicate devices. This is achieved primarily through non-clinical testing comparing physical and mechanical characteristics. The document does not list specific numerical acceptance criteria (e.g., minimum accuracy score, sensitivity thresholds) because it's not a performance study of that nature.

Table of Acceptance Criteria and Reported Device Performance:

Explanation of Missing Information for an AI/Clinical Efficacy Study:

The following points cannot be addressed from the provided text because this is a 510(k) submission for a physical orthopedic implant, not an AI or diagnostic device that typically undergoes such efficacy studies.

1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. Clinical testing was not required or performed for this 510(k). The "test set" here refers to physical devices undergoing mechanical tests.
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. Ground truth for a physical implant's mechanical properties is typically established through standardized testing procedures, not expert consensus on medical images or diagnoses.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. This is not an AI device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical testing, the "ground truth" is adherence to established engineering standards and test methods (e.g., ASTM, ISO) for mechanical properties and biocompatibility.
7. The sample size for the training set: Not applicable. This device does not use a "training set" in the context of machine learning.
8. How the ground truth for the training set was established: Not applicable.

Summary from the Document:

• Non-clinical testing: The device underwent non-clinical testing for "Femoral Head/Bipolar Liner Pull Out/Lever Out," "Femoral Head/Femoral Stem Pull Off," "Range of Motion," and "Bacterial Endotoxins." These tests are typical for orthopedic implants to demonstrate mechanical integrity and biocompatibility.
• Clinical testing: "Clinical testing was not required to demonstrate substantial equivalence in this premarket notification." This explicitly states that no human clinical trials were conducted for this submission.
• Basis for Substantial Equivalence: The manufacturer believes the device is substantially equivalent based on "similarities in intended use, design, materials, packaging, sterilization and mechanical performance" to the identified predicate devices. The technological characteristics "do not raise any new questions of safety and efficacy."

In conclusion, the document describes a regulatory submission for a physical medical device (hip prosthesis) where substantial equivalence is demonstrated through non-clinical performance testing against predicate devices and adherence to established material and mechanical standards, not through clinical efficacy studies involving human subjects or AI-specific validation.

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