(42 days)
The intended use of the device here in question, i.e. the Care Wise C-Trak Automatic Analyzer, remains unchanged from the intended use of prior predicate Care Wise and other portable radioisotope detectors. The Care Wise C-Trak Automatic Analyzer is designed- as are all similar devices - to detect and quantify nuclear 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 Care Wise C-Trak Automatic Analyzer consists of a battery-powered analyzer designed to operate a hand held probe, display the data from the detected radiation, and display and control the system's operating parameters.
Based on the provided text, the device in question, the "Care Wise C-Trak® Automatic Analyzer," is a portable radioisotope detector. The document describes its intended use and establishes its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed study with acceptance criteria for a new clinical performance claim. Therefore, much of the requested information cannot be found in the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be found in the provided text. The document asserts the device's function (to detect and quantify nuclear radiation) but does not define specific performance metrics or acceptance criteria for that function. It relies on the substantial equivalence to predicate devices, implying that if the predicate devices meet performance standards, this device, being equivalent, also meets them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be found in the provided text. There is no mention of a specific test set, patient data, sample size, or study design (retrospective/prospective).
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)
- Cannot be found in the provided text. No ground truth establishment related to a test set is discussed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be found in the provided text. There is no mention of an adjudication process.
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
- Cannot be found in the provided text. This device is a radioisotope detector, not an AI-assisted diagnostic tool for image interpretation by human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable to this device type and is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be found in the provided text. While the device "detects and quantifies nuclear radiation" automatically, the document doesn't provide performance data for this "standalone" functionality or describe a specific study for it. The focus is on substantial equivalence, implying its performance is comparable to existing devices.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be found in the provided text. Since no specific study with a test set is outlined, the type of ground truth used is not mentioned.
8. The sample size for the training set
- Not applicable / Cannot be found in the provided text. This device is a physical instrument for radiation detection, not a machine learning or AI model that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable / Cannot be found in the provided text. As this is not an AI/ML device requiring a training set, the establishment of ground truth for such a set is not relevant and not discussed.
Summary of available information related to "study" and "demonstration of effectiveness":
The primary "study" or justification for the device's effectiveness and safety, as described in this 510(k) summary, is its substantial equivalence to predicate devices.
- Predicate Devices:
- Documentation for Substantial Equivalence:
- Page 65A of Volume 17 of the Journal of Nuclear Medicine, January 1976 (enclosed as Attachment V).
- NeoProbe promotional literature (enclosed as Attachment VI).
- Safety Aspects Mentioned:
- Comprehensive shielding of high voltage sites.
- Operation only from internal batteries (eliminates electrical current leakage risks).
- Designed for safe operation in an operating room environment, provided flammable anesthetic gases are not used.
In essence, the document confirms the device's regulatory clearance based on its similarity to existing, approved devices, rather than presenting a new, dedicated performance study with defined acceptance criteria.
§ 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.