(57 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Intra-operative (Specify), Extra Corporeal/ Other (specify)
The three intraoperative probe accessories, Sled, Finger and Handle function with the AU4 ultrasound system's intraoperative probe, cleared via K953819. The intraoperative accessories consist of three kinds of plastic brackets attached to the ultrasound intraoperative transducer. The material used in the brackets has been tested following ISO 10993 / EN 30993. The biocompatibility tests required are attached.
The provided document is a 510(k) premarket notification for accessories (Sled, Finger, Handle) for an ultrasound transducer. It focuses on demonstrating substantial equivalence to predicate devices, material biocompatibility, and sterilization methods. This type of submission typically does not involve a study to prove device performance against acceptance criteria in the way that an AI/software device would, as it's for physical accessories with a different regulatory pathway and different types of "performance" to demonstrate.
Therefore, I cannot extract the information you requested regarding acceptance criteria and a study proving device performance in the context of an AI/software device. The document describes:
- Device Function: The accessories "function with the AU4 ultrasound system's intraoperative probe" and allow the surgeon to "position the probe more easily inside the body."
- Performance Evaluation: The "performance" in this context is primarily related to material biocompatibility and effective sterilization, rather than diagnostic accuracy or clinical outcomes.
Here's how I can address your request based on the provided document, interpreting "acceptance criteria" and "study" in the context of this specific type of device (physical accessories):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: Meet ISO 10993 / EN 30993 for External Communicating Device (Class A - limited, ≤ 24 hours). Specific tests: Cytotoxicity, Sensitization, Irritation. | Passed: Material (polyurethane resin 6090 black) tested by Biolab in accordance with ISO10993. |
| Sterilization: Compatibility with recommended sterilizing solution and ability to be properly sterilized. | Compatible: Instructions provided for use with Cidex Activated Dialdehyde Solution (Johnson & Johnson). |
| Functionality: Function with the AU4 ultrasound system's intraoperative probe to facilitate probe positioning. | Claimed: "The three intraoperative probe accessories... function with the AU4 ultrasound system's intraoperative probe," and "the surgeon is able to position the probe more easily inside the body." (Note: this is a functional claim, not an explicit performance metric like sensitivity/specificity). |
| Dimensions: Adherence to specified dimensions for Sled, Finger, and Handle. | Provided: Dimensions listed for Sled (47.43 mm X 22.70 mm), Finger (Irregular), and Handle (104.96 mm X 13.78 mm). (Implied to meet intended design, no explicit "testing" details provided for this.) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of AI/software performance studies. The "testing" referred to for this device is physical material testing.
- For Biocompatibility, the "sample" would refer to the material itself (polyurethane resin 6090 black). The tests were performed by Biolab, an Italian laboratory. This is a retrospective assessment of the material's properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of device. Ground truth, in the AI/software context, typically refers to expert labels or definitive diagnoses. Here, "ground truth" for biocompatibility is established by international standards (ISO 10993 / EN 30993) and laboratory testing protocols.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among multiple human readers on diagnostic tasks, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. These studies are conducted to compare human reader performance with and without AI assistance, which is outside the scope of physical ultrasound probe accessories.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance assessment was not done. This concept applies to AI algorithms operating independently, which is not relevant for physical accessories.
7. The Type of Ground Truth Used
The "ground truth" used related to the device's safety is based on international standards and laboratory test results for biocompatibility (ISO 10993 / EN 30993 testing for cytotoxicity, sensitization, irritation) and compatibility with sterilization solutions.
8. The Sample Size for the Training Set
Not applicable. This device is a physical accessory, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this 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.