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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 Alton PT Stabilizer and Stepper is designed to allow precision ultrasound probe alignment, precise prostate visualization and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate (or other) cancer. It is also used to allow precision ultrasound alignment and precise prostate visualization in cryotherapy treatments for prostate treatment.

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This document is a 510(k) summary for the ALTONTM PT Stepper and Stabilizing System, a medical device. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing performance data from a specific study against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets them cannot be extracted directly from the provided text.

Here is the information that can be extracted, along with explanations for what cannot be found:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the document. The 510(k) summary for this device focuses on demonstrating substantial equivalence by comparing its intended use, technological characteristics, and materials to previously cleared predicate devices, rather than presenting a performance study with acceptance criteria.

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

This information is not provided. As no specific performance study is detailed, there is no mention of a test set, sample size, or data provenance.

3. 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)

This information is not provided. There is no mention of a ground truth established by experts for a test set.

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

This information is not provided. There is no mention of a test set or an adjudication method.

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

This information is not provided. This device is a mechanical stepping and stabilization system for ultrasound probes in brachytherapy and cryotherapy, not an AI-based diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.

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

This information is not provided. This device is a mechanical instrument, not an algorithm, so a standalone performance study in the context of AI is not applicable.

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

This information is not provided. As no performance study requiring ground truth is detailed, this information is absent.

8. The sample size for the training set

This information is not provided. Not applicable to this type of device and submission.

9. How the ground truth for the training set was established

This information is not provided. Not applicable to this type of device and submission.

Summary of Device and Substantial Equivalence Claim:

The document describes the ALTON™ PT Stepper and Stabilizing System. This device is intended to allow precision ultrasound probe alignment, precise prostate visualization, and radioactive seed implantation in brachytherapy treatments, as well as precision ultrasound alignment and prostate visualization in cryotherapy treatments.

The substantial equivalence claim is based on:

1. Same intended use: The device has the same intended use as several predicate devices (e.g., K-972152 (DevMed), K-011581) (Amertek), K-864807 (Teknar), K-871413 (Civco), K-913293 (Mick Radio-Nuc.), K-963302 (Tayman Medical), K-972672 and K000960 by Barzell-Whitmeore).
2. Same technological characteristics: The technological characteristics are stated to be the same as the predicate devices.
3. Substantially equivalent materials: The materials used for the Alton™ are reported to be substantially equivalent (nearly identical with some) to those of similar products already on the market.

Conclusion:

The provided text constitutes a 510(k) summary demonstrating substantial equivalence for a medical device. It does not contain information about a specific study designed to meet pre-defined acceptance criteria, as is common for novel devices or those requiring a PMA. Instead, it relies on a comparison to existing, legally marketed predicate devices to establish safety and effectiveness.

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The DevMed is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate cancer.

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The provided text is a 510(k) summary for the DevMed™ Stepping and Stabilizing System, which is a device used for precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments, specifically for prostate cancer.

The document does not describe any acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market, which is the basis for 510(k) clearance.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment. The provided text explicitly states that the "510(k) 'Substantial Equivalence' Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed" and lists comparisons based on intended use, technological characteristics, and materials.

Key takeaway from the provided text: The DevMed™ Stepping and Stabilizing System was cleared based on its substantial equivalence to previously cleared devices, not on a study proving it meets specific performance acceptance criteria in the way a new medical device would typically be evaluated for efficacy or diagnostic performance.

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