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The Sure-Point™ HDR Needle Template is designed to allow precision ultrasound probe alignment, placement and position retention of HDR needles in cancer treatments. It was designed to work with commercially available high dose rate remote afterloaders. A specific application is the treatment of prostate (or other) cancer.

Template for Seeding Device: Probe Stabilization Device. Applicator for Remote Controlled Afterloading Brachytherapy.

This FDA 510(k) summary for the "Sure-Point™ HDR Needle Template" (K031273) does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

This document is a declaration of substantial equivalence to existing predicate devices. This means that the manufacturer is asserting their device is as safe and effective as devices already on the market, based on similar intended use, technological characteristics, and materials.

Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes, ground truth information, or details about comparative effectiveness studies, because this information is not present in the provided text.

Here's what I can infer from the document:

• Device Type: This is a physical medical device (a template for brachytherapy needles), not an AI/software device that would typically have performance metrics like sensitivity, specificity, or AUC.
• Approval Basis: Substantial equivalence, not based on a new performance study demonstrating effectiveness against specific acceptance criteria.
• Study Data: No study data is mentioned, as is common for many 510(k) submissions of physical medical devices demonstrating substantial equivalence.

If you have a document describing a performance study for an AI/software device, I would be happy to analyze it according to your prompt.

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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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The Amertek Template is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer.

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The provided text is a 510(k) summary for the Amertek™ Brachytherapy Template, a device designed to assist in brachytherapy treatments. It focuses on establishing substantial equivalence to existing predicate devices rather than presenting a performance study with acceptance criteria and results.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study to prove the device meets them. The summary primarily addresses:

• Device identification and classification
• Substantial equivalence claims based on intended use, technological characteristics, and materials compared to predicate devices.
• Indications for Use.

There is no mention of:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance.
3. Number of experts, their qualifications, or adjudication methods for ground truth.
4. MRMC studies or effect sizes.
5. Standalone algorithm performance.
6. Type of ground truth used.
7. Sample size for training sets or how their ground truth was established.

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