(28 days)
The SURE-POINT MIDLINE Stepping and Stabilization System is indicated for use to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy procedures. A specific application is the treatment of prostate cancer.
The Sure-Point Midline Stepping and Stabilization System is comprised of three Components - the Midline Stepping Head, the Midline Articulated Arm and the Midline Patient Board. The System is placed on a procedure table utilizing the patient's weight for proper stabilization. The Sure-Point Midline Stepping Head is mounted onto the Midline Articulated Arm which in turn is connected to the patient board using mating "dovetail connections", clamps and screws. During a brachytherapy procedure, the Stepping Head serves to securely hold an ultrasound transducer and template, while the Midline Articulated Arm's locking knob facilitates precise three dimensional placement of radioactive seed implantation.
The provided text describes a 510(k) premarket notification for the SURE-POINT® MIDLINE Stepping and Stabilization System. This device is described as a "Stepping and Stabilization Device" used for "precision ultrasound probe alignment and radioactive seed implantation in brachytherapy." The text explicitly states that it has the "same fundamental scientific technology as the predicate device" and that "appropriate design verification and validation activities...were conducted."
However, it does not contain any information about specific acceptance criteria or a study proving the device meets those criteria. The document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria. This type of submission typically relies on comparing the technological characteristics and intended use to an already legally marketed device.
Therefore, most of the requested information cannot be extracted from the provided text.
Here is a breakdown of what can and cannot be answered based on the provided document:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not specify any quantitative acceptance criteria or report device performance data. It states that "appropriate design verification and validation activities...were conducted" but provides no details on these activities or their outcomes.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No information about a test set, sample size, or data provenance is present.
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)
- Cannot be provided. No information about a test set or ground truth establishment is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information about a test set or adjudication methods is present.
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
- Cannot be provided. The device is a "Stepping and Stabilization System," not an AI-assisted diagnostic tool. An MRMC study is not relevant here, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Cannot be provided. Not applicable as this is a physical medical device for positioning, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No information about ground truth is present.
8. The sample size for the training set
- Cannot be provided. No information about a training set is present.
9. How the ground truth for the training set was established
- Cannot be provided. No information about a training set or ground truth establishment is present.
Summary of available information as per the prompt's request:
The document is a 510(k) summary for a physical medical device used for precision alignment during brachytherapy. It declares that "appropriate design verification and validation activities" were conducted to support its substantial equivalence to a predicate device. However, it does not include any of the detailed performance study information specifically requested regarding acceptance criteria, test sets, ground truth establishment, or multi-reader studies.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.