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The Power Tek II shaver system is a powered instrument for orthopedic applications including abrasion arthroplasty, synovectorny or intra-articular cutting and shaving. The device is intended for use in the knee, shoulder, wrist, temporal-mandibular joint, ankle, and elbow.

The Arthrotek Power Tek II arthroscopic shaver system is intended to provide a shaver unit that will meet the surgeon's needs and patient's needs for abrasion arthroplasty, synovectomy or intra-articular cutting and shaving. The system consists of four pieces. The Control Console houses the microprocessor, shaver driver, mode and speed controls, and operator display. A Remote Control allows the user to access all controls from the surgical field. The Footswitch allows the surgeon easy on/off and forward/reverse/oscillate selection and control. The Shaver Handpiece is capable of running from 400 to 12,000 rpm's, with linear suction control for debris aspiration.

The provided text is a 510(k) summary for the Power Tek II arthroscopic shaver console and handpiece. It details the device, its intended use, and claims substantial equivalence to a predicate device. However, it explicitly states:

"Clinical Testing: None provided as a basis of substantial equivalence."

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no clinical testing or performance data is presented in this document.

The document focuses on demonstrating substantial equivalence based on similarities in materials, process, and design to a legally marketed predicate device (The Integrated Endoscopy System 1000 K920800) and non-clinical validation testing.

Here's a breakdown of why the requested information cannot be extracted from this document:

1. A table of acceptance criteria and the reported device performance: Not available. No performance metrics or acceptance criteria are discussed as no clinical study was performed.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No clinical test set.
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 an arthroscopic shaver, not an AI diagnostic tool involving human readers. No such study would be relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No clinical data was used to establish substantial equivalence.
8. The sample size for the training set: Not applicable. No training set is relevant for this type of device and submission.
9. How the ground truth for the training set was established: Not applicable. No training set is relevant for this type of device and submission.

The "Non-Clinical Testing" section mentions:

• IEC 601-1 Safety Testing
• UL certification
• Electromagnetic Compatibility
• Software validation
• Cleaning and sterilization validation

However, these are regulatory and engineering validation tests, not clinical performance studies with acceptance criteria in the vein of diagnostic accuracy or treatment efficacy as implied by the request's format. The document does not provide specific performance metrics or acceptance criteria for these non-clinical tests.

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