(50 days)
The biocompatible ScanTac Strips will be used in diagnostic ultrasound imaging to couple sound waves between the patient's body and medical imaging electronics. ScanTac Strips are biocompatible, sterile, and, being solid, leave no residue. They are single use and disposable. ScanTac Strips are intended for use in sterile fields substituting for an ultrasound coupling gel or fluid, as currently used, in combination with a latex, polyurethane, polypropylene or other polymeric protective transducer cover.
The ScanTac Membrane is used for transcutaneous ultrasound imaging over wounds and to enhance imaging contact over difficult geometries. The ScanTac Membrane has a backing on one side that is removed prior to transcutaneous scanning. The Membrane is placed onto the patient, and is sufficiently adherent to remain in place during the scan due to the adhesive nature of the hydrogel. Either water or ultrasound scanning gel is used on the other side of the Membrane between the transducer and the Membrane.
ScanTacTM Membrane and ScanTac™ Strip
This document is a 510(k) premarket notification letter from the FDA regarding the "ScanTacTM Membrane and ScanTac™ Strip". It approves the devices for marketing, stating they are substantially equivalent to legally marketed devices. It also outlines the intended use of the devices.
Based on the provided text, there is no study described that proves the device meets acceptance criteria. The document is an FDA clearance letter, which indicates that the FDA has reviewed the submission and found the device substantially equivalent to an existing device, thus permitting its marketing. It does not contain details of a specific study performed by the manufacturer to establish acceptance criteria or device performance in the manner requested.
However, based on the information provided, we can infer some aspects related to what would be considered in such a submission, particularly for the "Acceptance Criteria" and "Reported Device Performance" for biocompatibility and sterility as these are explicitly mentioned in the "Indications For Use" section.
Here's an attempt to answer the questions based on the available text, along with explanations for unavailable information:
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A table of acceptance criteria and the reported device performance
The document does not contain a table of acceptance criteria or specific reported device performance metrics in the way one might expect from a clinical or performance study summary. However, it does state key characteristics of the devices that would have been evaluated as part of the substantial equivalence determination.
Acceptance Criteria (Implied from Indications for Use) Reported Device Performance (Implied from Device Description/Clearance) Biocompatibility ScanTac Strips are biocompatible. (Stated in Indications For Use) Sterility ScanTac Strips are sterile. (Stated in Indications For Use) Non-residue forming ScanTac Strips, being solid, leave no residue. (Stated in Indications For Use) Single-use and disposable ScanTac Strips are single use and disposable. (Stated in Indications For Use) Effective coupling for ultrasound imaging Intended for use in coupling sound waves between patient's body and medical imaging electronics. (Stated in Indications For Use) Adherence during scanning (Membrane) ScanTac Membrane is sufficiently adherent to remain in place during the scan. (Stated in Indications For Use) Transcutaneous imaging over wounds (Membrane) ScanTac Membrane is used for transcutaneous ultrasound imaging over wounds. (Stated in Indications For Use) Enhanced imaging contact over difficult geometries (Membrane) ScanTac Membrane is used to enhance imaging contact over difficult geometries. (Stated in Indications For Use) -
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided in the document. This is an FDA clearance letter and typically does not include the detailed test data or study design.
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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)
Not provided in the document. This information would be part of the detailed submission, not the clearance letter.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not provided in the document.
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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. The device is an ultrasound coupling agent/membrane, not an AI diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device (membrane/strip), not an algorithm or software.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not explicitly stated for performance, but for biocompatibility and sterility, the ground truth would likely be based on established international standards (e.g., ISO 10993 for biocompatibility, ISO 11137/11737 for sterility) and laboratory testing results.
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The sample size for the training set
Not applicable. This device is not an AI/machine learning model, so there is no "training set."
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How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.