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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 Ventraflo Catheter/Probe is a standard ventricular catheter with a laser Doppler blood perfusion probe embedded into the side wall of the Catheter. So when the catheter is placed within a brain ventrical the clinician will be able to use the catheter as a CSF drain . measure intracranial ventricular pressure. If connected to an external transducer and measure parenchymal blood flow simultaneously.

This 510(k) submission for the Vasamedics Ventraflo Blood Flow Monitoring Probe Kits is primarily focused on demonstrating substantial equivalence to predicate devices for its design, materials, and sterilization methods. It does not include a study that details acceptance criteria and device performance in the way typically expected for a software or AI-driven diagnostic device.

Therefore, many of the requested sections (1-9) cannot be filled with relevant information from the provided text, as the document does not describe a clinical performance study with acceptance criteria for device accuracy or effectiveness in measuring blood flow.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

Summary of Device and 510(k) Approach:

The Ventraflo Ventricular Catheter/Probe kit is a combination device. It integrates a laser Doppler blood perfusion probe into a standard ventricular catheter.

• Purpose: To allow simultaneous CSF drainage, intracranial ventricular pressure measurement, and parenchymal blood flow measurement (using the embedded probe).
• Predicate Device Strategy: The submission argues for substantial equivalence by breaking down the device into its components:
  • Laser Doppler Probe: Equivalent to Vasamedics' SUPR-434 Blunt Needle Probe (previously cleared in K951832).
  • Ventricular Catheter & Accessories: Equivalent to PS Medical "Becker Ventricular Catheter" and "PS Medical Ventriculostomy Kit" (products already in commercial distribution).
• Key Focus: Biocompatibility validation and sterilization validation are explicitly mentioned as crucial aspects of this submission, ensuring the new combined device is safe for human use.

Detailed Breakdown of Requested Information (Based on the Provided Text):

1. A table of acceptance criteria and the reported device performance

   • Not provided. The document does not describe any specific performance metrics (e.g., accuracy, sensitivity, specificity for blood flow measurement) or their corresponding acceptance criteria. The equivalence argument is based on the components having been cleared previously.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Not provided. There is no performance study described that would involve a test set of data.

3. 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 applicable. No test set or ground truth establishment relevant to device performance (e.g., blood flow measurement accuracy) is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. No test set or related adjudication method is 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

   • Not applicable. This device is a measurement tool, not an AI-assisted diagnostic. No MRMC study is described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This is a physical medical device (catheter with an embedded probe) used to measure blood flow, not a standalone algorithm. Its performance relies on the physics of laser Doppler measurements, not computational algorithms in the AI sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • Not applicable. As no performance study with ground truth for blood flow measurement is detailed, this information is not present. The "ground truth" for this 510(k) is primarily that the individual components (probe, catheter, accessories) have established safety and performance records or are substantially equivalent to marketed devices.

8. The sample size for the training set

   • Not applicable. No training set is mentioned as this is not a machine learning/AI device.

9. How the ground truth for the training set was established

   • Not applicable. No training set or ground truth establishment for a training set is mentioned.

Key Information from the Document that IS Provided:

• Intended Use: Extravascular monitoring of microcirculation blood flow in buried tissues, specifically, cerebral blood flow in patients at risk of cerebral ischemia.
• Biocompatibility: Materials are biocompatible. The probe part is equivalent to the Vasamedics SUPR-434 (Trimflo) probes (K951832). The ventricular catheter is silicone. All accessories are standard neurosurgery items.
• Sterilization: ETO sterilization, validated per AAMI guidelines using an overkill method to a sterility assurance level (SAL) of at least 1 x 10^-4. Residual levels target FDA 1978 guidelines.
• Predicate Devices:
  • Laser Doppler Probe: Vasamedics' SUPR-434 Single use Blunt Needle Probe (K951832).
  • Kit accessories and ventricular catheter: PS Medical "Becker Ventricular Catheter" and "PS Medical Ventriculostomy Kit".

In conclusion, this 510(k) submission relies on the substantial equivalence of its components to previously cleared devices, particularly for safety and efficacy in terms of material compatibility and sterilization. It does not present a new clinical performance study for the integrated device with specific acceptance criteria for blood flow measurement.

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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.

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The Single Use Probes are intended for extravascular monitoring of microcirculation blood flow in buried tissues. An example of this application is the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction, Another example is monitoring soft tissue microcirculation following reconstructive surgery, such as in oral and facial reconstruction. Yet another example is monitoring cerebral blood flow during and following neurosurgery for head trauma.

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 P-433 Needle Probe, Model PR-434 Implantable Prism Probe, and Model P-440 Implantable Soflex Probe are fiber optic probes designed for use with the BPM- These probes are labelled so as to be used for monitoring buried tissue, such as buried muscle following free muscle transfers and cerebral cortex following neurosurgical procedures. Permission to market the Model PR-434 and Model P-433 probes was granted by FDA on September 19, 1988 (Ref K875179). Permission to market the P-440 was granted by FDA on December 12, 1991 (Ref K912446).

The single use probes, SUP-440 Disposable Flat Probe, SUP-433 Disposable Right Angle Needle Probe, and SUPR-434 Disposable Blumt End Needle probe are also fiber optic probes designed for use with the BPM2 They connect to the BPM2 Probe Connector Port on the BPM front panel via a fiber optic interface cable. The tip of the SUP-440 Disposable Flat Profile Probe is similar to the P-440 Soflex Probe in that it includes the termination of the optical fiber which provides right angle light emission, and an outer encapsulation of soft, flexible material. The tip of the SUP-433 Disposable Right Angle Needle Probe and the SUPR-434 Disposable Blunt End Needle Probe are similar to the P-433 Needle Probe in that it includes the termination of the optical fiber in a stainless steel tube and similar to the PR-434 Implantible prism probe in that the probes provide right angle light emission.

This document is a 510(k) summary for a medical device. The information provided is insufficient to answer the request regarding acceptance criteria and a study proving the device meets those criteria, as it does not contain details about specific performance metrics, clinical studies, or acceptance targets.

The provided text focuses on:

• Device Name: Laserflo Blood perfusion Single Use Probes
• Predicate Device: Previous versions of similar probes and the BPM2 monitor
• Device Description: Physical characteristics and function of the probes as accessories to the BPM2 monitor.
• Intended Use: Clinical applications for monitoring microcirculation blood flow in buried tissues.

There is no mention of:

• Specific acceptance criteria (e.g., accuracy, precision, sensitivity, specificity, or correlation values).
• Any studies conducted to demonstrate the device meets performance claims or acceptance criteria.
• Details about sample sizes, data provenance, expert qualifications, or ground truth establishment.
• Comparative effectiveness studies (MRMC) or standalone algorithm performance.

Therefore, I cannot populate the requested table or answer the specific questions based solely on the provided text. The document is essentially a description of the device and its intended use, not a performance evaluation.

Ask a specific question about this device