(87 days)
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.
| Acceptance Criteria (Implicitly, Performance of Predicate Device's 11mm probe) | Reported Device Performance (Model 1500's 12mm probes) |
|---|---|
| Counting Efficiency: Function of probe to source distance for 135I, 111In, and 99mTc (specific values not provided in summary) | Counting Efficiency: Demonstrated to be "functionally equivalent" except for predicted change due to crystal dimension, with "counts per second per unit area of detector surface" being the same. |
| Spatial Resolution: For 135I, 111In, and 99mTc (specific values not provided in summary) | Spatial Resolution: Demonstrated to be "functionally equivalent" to the 11mm probe. |
| Interchangeability: (Not applicable to predicate as it refers to new probes) | Interchangeability: Collimated and non-collimated versions of reusable, steam sterilizable detector probes can be used interchangeably with the Model 1500 control unit with the same disposable handle, without adjustments. |
| Material/Sterilization Equivalence: (Specifically for the 11mm EtO sterilizable probe) | Material/Sterilization Equivalence: Demonstrated for new 12mm reusable, steam sterilizable 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.
§ 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.