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The major intended use of the Amertek Sure-Point Tracker™ is the same as that of its unmodified predecessors cleared in K011581 and K972152: to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer. The Amertek Sure-Point Tracker 100 also allows data from the use of probe location indicators to be fed directly into the brachytherapy planning program, such as that of Varian.

Like other basic stabilizers and steppers (e.g. Barzell-Whitmore Omnistand; Tayman Accuquide; Teknar, Proscan), this device is applicable in other surqical procedures or specialties which require accurate instrument fixation, such as cryosurgery, biopsy, and remote afterloading equipment (HDR) such as that used with the Nucletron device.

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The provided text describes a 510(k) premarket notification for the Amertek™ Sure-Point Tracker System. This device is described as a "Stepping and Stabilization Device, and template" for use with ultrasound probes, specifically for brachytherapy treatments (e.g., prostate cancer) and other surgical procedures requiring accurate instrument fixation.

However, the document does not contain specific acceptance criteria, a study that proves the device meets those criteria, or any of the detailed information requested in your prompt (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details).

Instead, the submission states that the device is "substantially equivalent" to predicate devices already cleared for marketing. This means the FDA's decision was based on the device having the same intended uses, similar technological characteristics, and comparable materials as existing devices, rather than on new performance studies with specific acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria or details about a study proving the device meets them, as this information is not present in the provided text. The submission explicitly states:

• "We have not found a specific guidance document on this subject, but believe we have complied fully with general guidance documents and usual practices in preparing premarket notifications." (Page 1)
• The "510(k) 'Substantial Equivalence' Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:
  1. These products have the same intended uses, as the classified device and those cleared for marketing as equivalent to it by the 510(k) process...
  2. The technological characteristics for this product are the same as those for the predicate devices and those currently on the market.
  3. Descriptive information provided shows that the materials from which Amertek™ is made are substantially equivalent those of similar products, used for identical purposes, currently on the market." (Page 0)

The lack of such detailed performance study information is common in 510(k) submissions where substantial equivalence is claimed based on similarity to predicate devices, rather than novel performance claims requiring new clinical or analytical studies.

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