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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Functional Equivalence to Predicate Device (Model 1000 GEN 1B)	Counting efficiency of the 11 mm GEN 1C probes was found to be functionally equivalent to the counting efficiency of the predicate 19 mm Model 1000 GEN 1B probe.

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.

Summary

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K962319

510(k) SUMMARY

Neoprobe Corporation's Model 1000 GEN 1C Portable Radioisotope Detector and Accessories

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Submitter Neoprobe Corporation 425 Metro Place North Suite 400 Dublin, OH 43017-1367 (614) 793-7500 Phone: (614) 793-7520 Facsimile:

SEP 1 3 1996

Contact Person Susan D. Tiedy-Stevenson Director of Regulatory Affairs Neoprobe Corporation (301) 620-9416 Phone: (301) 620-1438 Facsimile:

June 14, 1996 Date Prepared:

Name of Device and Name/Address of Sponsor

Neoprobe Model 1000 GEN 1C Portable Radioisotope Detector and Accessories

Neoprobe Corporation 425 Metro Place North Suite 400 Dublin, OH 43017-1367 (614) 793-7500 Phone: (614) 793-7520 Facsimile:

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Common or Usual Name

Radioisotope detector and accessories

Classification Name

Nuclear uptake probe and accessories

Predicate Device

Neoprobe Model 1000 GEN 1B Portable Radioisotope Detector and Accessories (K942580)

Intended Use

Technological Characteristics and Substantial Equivalence

Device Description

Safety and Effectiveness

The GEN 1C is substantially equivalent to its predecessor, the Model 1000 GEN 1B, which received premarket clearance in 1995 (K942580). The GEN 1C is identical to the predicate device in general intended use, design, and principle of operation. The only differences between the GEN 1C and the predicate device are the use of a singlepiece aluminum probe cap rather than a probe cap comprised of multiple parts, addition of a smaller (11 mm) detector probe, and use of a two millimeter radioactive

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encapsulated area (check source) with the existing 19 mm probe and with the 11 mm detector probe. These minor differences raise no new issues of safety or effectiveness because the modified device continues to perform identical functions in the same manner as the predicate device.

Performance Data

Neoprobe has conducted laboratory studies to demonstrate the functional equivalence of the 11 mm GEN 1C probes to the predicate Model 1000 GEN 1B probe. These tests included: (1) a comparison of the counting efficiencies of six randomly selected 11 mm GEN 1C probes using a calibrated source of 129; (2) measurement of the counting efficiency of a representative probe as a function of probe-to-source distance for 1251, 1111In, and 900Tc; and (3) measurement of the spatial resolution of the probe with and without collimation for the three nuclides. In summary, the counting efficiency of the 11 mm GEN 1C probes was found to be functionally equivalent to the counting efficiency of the predicate 19 mm Model 1000 GEN 1B probe.

Regulation Number and Section

§ 892.1320 Nuclear uptake probe.

(a)
Identification. A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.