(442 days)
The Cook-Swartz Doppler Flow Probe is for monitoring blood flow in vessels intraoperatively, and following reconstructive micro-vascular procedures, re-implantation, and free-flap transfers.
The Cook-Swartz Doppler Flow Probe contains a piezoelectric crystal transducer assembly at its distal end. The transducer is a 1 mm diameter disc and operates at 20 MHz. The transducer is attached to a silicone cuff (either 5 mm × 32 mm or 5 mm × 17.4 mm) that is designed to be secured around a blood vessel. Proximal to the cuff, braided wires connect the transducer to suture pads and to a proximal polyurethane-covered wire. The polyurethane-covered wire ends in a two-pin plug connector. The cuff is designed to be wrapped around the vessel to be monitored. The length of the cuff represents the circumference of the vessel that can be covered. The cuff is 5 mm wide regardless of length. The width of the cuff represents the length of the vessel that can be covered with the cuff.
The provided text describes a 510(k) premarket notification for the "Cook-Swartz Doppler Flow Probe." This document is primarily concerned with establishing substantial equivalence to a predicate device and does not contain the information typically found in an AI/ML medical device approval, such as acceptance criteria for algorithm performance, a study design for evaluating AI model accuracy, or details about training and ground truth establishment for an AI model.
The "Cook-Swartz Doppler Flow Probe" is a hardware device (a diagnostic ultrasonic transducer), not an AI/ML algorithm. Therefore, the questions regarding AI/ML specific information (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.
The document discusses device performance in terms of mechanical and biocompatibility testing, not AI model performance.
Based on the provided text, here's what can be extracted, acknowledging the limitations for AI/ML-specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it lists two types of tests conducted and concludes that the device "performs acceptably."
| Test Conducted | Reported Device Performance |
|---|---|
| Cuff detachment force | "Performed acceptably" (implies meeting internal criteria) |
| Suture pad attachment force | "Performed acceptably" (implies meeting internal criteria) |
2. Sample size used for the test set and the data provenance:
N/A for AI/ML performance testing. The document describes physical and biocompatibility testing of a hardware device. No specific sample sizes for these tests are mentioned, nor is data provenance in the context of clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
N/A. This device is a hardware probe, not an AI algorithm requiring expert-established ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
N/A. Not relevant for hardware device testing as described.
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:
N/A. This is not an AI-powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
N/A. This is a physical probe, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
N/A. Ground truth in the context of diagnostic performance (as an AI algorithm would have) is not applicable here. The "truth" for this device's performance is determined by its mechanical integrity (detachment/attachment forces) and biocompatibility, likely measured against established engineering or biological safety standards.
8. The sample size for the training set:
N/A. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
N/A. Not applicable as there is no training set for an AI model.
Summary of what the document does provide regarding device evaluation:
- Type of Device: Diagnostic ultrasonic transducer (hardware).
- Purpose of Study: To demonstrate substantial equivalence to a previously cleared predicate device (K022649). This is the primary "study" described, and it's a comparison of specifications and safety documentation.
- "Performance Data": Refers to physical testing (cuff detachment force, suture pad attachment force) and a biocompatibility assessment. The results of these tests "support the conclusion that the Cook-Swartz Doppler Flow Probe performs acceptably and does not raise new questions of safety and effectiveness."
- Biocompatibility Assessment: A comprehensive assessment covering 10 biological effects (Cytotoxicity, Sensitization, Irritation/intracutaneous reactivity, Acute systemic toxicity, Material-mediated pyrogenicity, Subacute/subchronic toxicity, Genotoxicity, Implantation, Chronic toxicity, Carcinogenicity). The conclusion was that materials "provide a reasonable assurance of safety with respect to biocompatibility."
§ 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.