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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."

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."

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The COOK- Swartz Doppler Flow Probe and Monitor System is intended 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 is supplied sterile and intended for one time use

The Modified COOK-Swartz Doppler Flow Probe is intended for monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures. The COOK-Swartz Doppler Flow Probe is supplied sterile, and nonpyroqenic and is intended for one-time use. Reasonable assurance of biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing.

The provided document is a 510(k) summary for a Special 510(k) Device Modification for the COOK-Swartz Doppler Flow Probe. This type of submission is for modifications to a legally marketed device and primarily focuses on demonstrating substantial equivalence to the predicate device, rather than providing extensive de novo clinical study data to demonstrate novel performance against acceptance criteria.

Therefore, the document does not contain the detailed information typically found in a clinical study report that establishes acceptance criteria and then proves the device meets those criteria.

Here's a breakdown of what can be extracted and what is missing, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not present in the document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (COOK-Swartz Doppler Flow Probe D.C. #K964001) based on intended use, material composition, and method of operation. It does not provide specific performance metrics or acceptance criteria for the modified device.

2. Sample Size Used for the Test Set and Data Provenance

This information is not present in the document. Since it's a 510(k) for a device modification showing substantial equivalence, a formal "test set" with a specified sample size for performance evaluation in the way a de novo clinical study would isn't typically included in this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not present. The document doesn't describe a study involving expert panels for ground truth establishment.

4. Adjudication Method

This information is not present. No adjudication method is mentioned as there is no description of a study involving multiple readers or complex diagnostic interpretations requiring consensus.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not present. There is no mention of an MRMC study or any comparison of human readers with and without AI assistance. The device in question is a Doppler flow probe, which is a diagnostic tool, not an AI-assisted diagnostic software.

6. Standalone (Algorithm Only) Performance Study

This information is not present. The device is hardware (a probe), not a standalone algorithm. Therefore, "algorithm-only" performance is not applicable.

7. Type of Ground Truth Used

This information is not present. Given that the submission is for a device modification demonstrating substantial equivalence to a predicate, a new "ground truth" establishment for performance validation is not usually required or detailed in this type of submission summary.

8. Sample Size for the Training Set

This information is not present. The document does not describe the development of an algorithm that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not present, as no training set or ground truth for an algorithm is mentioned.

Summary of the Document's Approach:

The provided document (K022649) is a Special 510(k) Device Modification for the COOK-Swartz Doppler Flow Probe. The core of this submission is to demonstrate substantial equivalence to a previously cleared predicate device (COOK-Swartz Doppler Flow Probe D.C. #K964001).

The argument for equivalence is based on:

• Intended Use: "monitoring blood flow through vessels in patients intraoperatively and during reconstructive vascular procedures." (The modified device also adds "and following reconstructive micro-vascular procedures, re-implantation, and free flap transfers" which is also aligned with the predicate's expanded indications as K964001's indications include "monitor blood flow intraoperatively, during intraoperative neuro-vascular procedures, and following reconstructive micro-vascular procedures, re-implantation and free flap transfer.")
• Material Composition: "biocompatibility of the body fluid/tissue contacting materials comprising the device is provided by their established history of use in medical product manufacturing."
• Method of Operation: Implied to be similar as it's a modification to an existing device.
• Manufacturing: "manufactured according to specified process controls and a Quality Assurance Program, undergoing packaging and sterilization procedures similar to the currently marketed and distributed COOK-Swartz Doppler Flow Probe D.C. #K964001."

No new clinical data, performance criteria, or "proof of meeting acceptance criteria" in the sense of a novel functional claim are presented in this summary. The FDA's letter explicitly states: "We have determined the device is substantially equivalent... You may, therefore, market the device, subject to the general controls provisions of the Act." This confirms that the modification was deemed equivalent without requiring new, extensive performance studies detailed in this summary.

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