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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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