(185 days)
The probes kits are intended for extravascular monitoring of microcirculation blood flow in buried tissues, specifically, in monitoring cerebral blood flow in patients at risk of cerebral ischemia.
The Model BPM2 is a Laser Doppler Blood Perfusion Monitor, which is used to measure microcirculatory blood flow in a variety of clinical applications. Permission to market the BPM2 was granted by FDA on February 13, 1990 (Ref. K896515). The Model SUPR-434 Blunt Needle Probe is a single use fiber optic probe designed for use with the BPM2. These probes are labeled so as to be used for monitoring buried tissue, such as brain parenchyma during and following neurosurgical procedures. Permission to market the Model SUPR-434 ( Note: the SUPR-434 Blunt needle probes model names have since been changed to Trimflo 4314, 4316, 4364 and 4366) was granted on March 21, 1996 (Ref. K951832).
The provided text K961368 is a 510(k) summary for a medical device (Single Use Laser Doppler Probe Kits). It describes the device, its intended use, and argues for substantial equivalence to a predicate device. However, it does not contain any information about a study proving the device meets acceptance criteria, nor does it mention specific acceptance criteria with corresponding performance metrics.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on establishing substantial equivalence based on the device being largely the same as existing, cleared devices (the probes themselves) with minor changes (addition of accessories, packaging as a kit, and ETO sterilization). It highlights biocompatibility and sterilization processes, but these are described as general adherence to standards (e.g., AAMI guidelines for sterilization, FDA guidelines for residual levels) rather than a specific study with measured performance against predefined acceptance criteria for the device's primary function.
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).