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The Quantix/OR Blood Flow Monitor is intended for invasive and noninvasive diagnostic blood flow measurements.

The Quantix/OR™ Blood Flow Monitor with Flexible Probe and Vessel Stabilizer is a dualbeam, angle independent, pulse-wave Doppler ultrasound system for the invasive and noninvasive blood vessel flow measurements. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/ORTM Flexible Probe technology utilizes ultrasound Doppler methods to obtain real-time measurements according to the definition of blood flow volume to target blood vessels. By definition, blood flow is the product of velocity cross-sectional area. In other words, the volume blood flow is calculated by deriving flow velocity from the Doppler shift frequency using the basic standard formula and then multiplying the velocity by the cross-sectional area of the blood vessel.

This device is a Quantitative Flow Monitor, not an AI/ML device. Therefore, the requested information pertaining to AI/ML device studies (such as sample size for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is not applicable or cannot be extracted from the provided text.

The provided text describes a 510(k) premarket notification for the Quantix/OR™ Blood Flow Monitor, a medical device for measuring blood flow. The submission focuses on demonstrating substantial equivalence to predicate devices, which is the standard for 510(k) clearances. This type of submission typically relies on comparing technological characteristics and intended use, rather than detailed performance studies with acceptance criteria in the way an AI/ML device would.

Here's an analysis based on the information available in the text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format typically used for AI/ML device evaluation (e.g., sensitivity, specificity, AUC). The submission's core argument is substantial equivalence to predicate devices rather than meeting specific performance thresholds in a clinical study for a novel algorithm.

The "performance" is implicitly deemed equivalent to the predicate devices due to similar technological characteristics and intended use.

2. Sample Size Used for the Test Set and Data Provenance:
Not applicable as this is not an AI/ML device and no such test set is described.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable as this is not an AI/ML device.

4. Adjudication Method for the Test Set:
Not applicable as this is not an AI/ML device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is not an AI/ML device.

7. The type of ground truth used:
Not applicable in the context of an AI/ML device's ground truth. However, for a traditional medical device, ground truth for performance claims (if any were made beyond equivalence) would typically be established through recognized measurement standards or validated clinical methods. The document does not describe such studies for this device.

8. The sample size for the training set:
Not applicable as this is not an AI/ML device.

9. How the ground truth for the training set was established:
Not applicable as this is not an AI/ML device.

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The Neoprobe® Model 1500 Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. It is indicated for external and intraoperative detection of radioactivity in body tissues or organs, such as bowel, bone, lymphatics, and red blood cells, where radiopharmaceuticals are administered.

The Neoprobe® Model 1500 Portable Radioisotope Detector ("Model 1500") consists of (1) a microcomputer-based control unit: (2) a 12 mm collimated detector probe tip, a 12 mm non-collimated detector probe tip, and a 19 mm noncollimated probe tip, all of which are reusable, steam sterilizable and contain a cadmium zinc telluride crystal gamma ray detector; (3) a disposable sterile probe handle with an attached polypropylene cable; (4) a check source disk containing a known quantity of 1201; and (5) a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings.

Based on the information provided in the 510(k) summary (K971167) for the Neoprobe Model 1500 Portable Radioisotope Detector, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device is seeking substantial equivalence to predicate devices, particularly the Neoprobe Model 1000 GEN 1C. Therefore, the "acceptance criteria" are implicitly the functional performance characteristics of the predicate device, especially its 11mm EtO sterilizable detector probe, and the "reported device performance" are the measurements obtained for the new Model 1500's 12mm probes.

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

The summary describes laboratory studies to demonstrate functional equivalence.

• Sample Size: Not explicitly stated as a number of probes or trials. It refers to general testing of "the cleared 11 mm and the new 12 mm collimated and non-collimated probe tips." This implies testing of at least one of each type of probe.
• Data Provenance: The studies were laboratory studies conducted by Neoprobe Corporation. No specific country of origin for the data is mentioned, but it can be inferred to be from the company's location (Dublin, OH, USA). The studies are inherently prospective as they were specifically designed and executed for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This type of information is not applicable to the described study. The study focused on technical performance characteristics (counting efficiency, spatial resolution) of the device itself, rather than diagnostic accuracy requiring expert interpretation of clinical data. The "ground truth" for these measurements would be physical standards and known radioactive sources.

4. Adjudication Method for the Test Set

This is not applicable. There was no human interpretation or diagnostic decision-making involved in the laboratory performance tests that would require adjudication. The measurements were objective physical science tests.

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

No, an MRMC comparative effectiveness study was not done. This device is a radioisotope detector, not an AI-powered diagnostic tool. The submission focuses on the hardware's functional equivalence.

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

Yes, in essence. The laboratory studies directly assessed the performance of the device's detector probes (counting efficiency, spatial resolution) independently of a human operator, making it a "standalone" performance evaluation of the hardware components. There is no "algorithm" in the sense of artificial intelligence.

7. The Type of Ground Truth Used

The ground truth used for these laboratory studies would be based on:

• Known Radioactive Sources: Standardized sources of 135I, 111In, and 99mTc with known activities and decay characteristics.
• Physical Measurement Standards: Accurate measurement tools for distance and physical arrangements to determine spatial resolution.
• Engineering Specifications: Comparison against expected physical and engineering principles for gamma ray detection.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device's submission. The device is a hardware instrument, not a machine learning model that requires training data.

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

This is not applicable as there is no training set for this hardware device.

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The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector is an electronic device intended to detect and quantify gamma radiation. The GEN 1C in indicated for external and intraoperative detection of radioactivity in body tissues or organs in medical procedures where gamma emitting isotopes are administered.

The Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector ("Model 1000") consists of a microcomputer-based control unit, a cadmium zinc telluride gamma ray detector probe, a cable used to connect the probe to the control unit, a check source containing a known quantity of 129 I, and a chrome-plated Teflon-lined lead noise adjustment fixture used for periodic verification that the system continues to meet factory calibration readings. The detector probe is available in two sizes: (1) a detector probe with a 19 mm external diameter and a detector diameter of 15 mm; and (2) a detector probe with an 11 mm external diameter and a detector diameter of 7 mm. Optional accessories include a detector probe collimator and a detector probe shield.

Here's a breakdown of the acceptance criteria and study information for the Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided text is a 510(k) summary, which generally focuses on demonstrating substantial equivalence to a predicate device rather than defining new, specific acceptance criteria with numerical targets. The "acceptance criteria" here is implicitly "functional equivalence" to the previously cleared device.

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

• Sample Size (Test Set): Six randomly selected 11 mm GEN 1C probes were used for counting efficiency comparison. A "representative probe" was used for distance-function and spatial resolution measurements.
• Data Provenance: The studies were described as "laboratory studies." No information is given regarding the country of origin or whether the data was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. This device is a radioisotope detector, and the performance assessment described is based on physical measurements of counting efficiency and spatial resolution using calibrated radioactive sources, not interpretation of data by human experts to establish a "ground truth" in the diagnostic sense.

4. Adjudication Method for the Test Set

• Not applicable. See point 3.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a radioisotope detector, and its performance is evaluated based on its physical detection capabilities, not its assistance to human readers in interpreting clinical cases.

6. Standalone Performance Study

• Yes, a standalone performance evaluation was conducted. The "laboratory studies" described measured the performance characteristics (counting efficiency, spatial resolution) of the device itself (the 11 mm GEN 1C probes) without human interaction for interpretation.

7. Type of Ground Truth Used

• The "ground truth" in this context refers to known physical properties and measurements. This includes:
  • Calibrated radioactive sources: Such as 129I, 111In, and 99mTc, with known activity and emission characteristics.
  • Geometric setups: Controlled distances and configurations for spatial resolution measurements.
  • Predicate device's performance: The Model 1000 GEN 1B probe's performance served as a benchmark for "functional equivalence."

8. Sample Size for the Training Set

• Not applicable. This device is a hardware radioisotope detector. There is no mention of a "training set" in the machine learning sense. The device's operation is based on established physical principles of radiation detection, not learned algorithms.

9. How Ground Truth for the Training Set Was Established

• Not applicable. See point 8.

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