(119 days)
"This device is intended to be used for diagnostic brain imaging."
a modification of a gamma camera system. This device includes a gamma camera system, xenon delivery system, xenon probe, system interface, and the necessary software.
This 510(k) notice for the "Xenon Option to the Prism 3000 System" is highly deficient in providing the detailed information requested for a modern medical device clearance. The document is from 1996, and regulatory requirements and best practices for demonstrating device performance have evolved significantly since then.
Therefore, much of the requested information cannot be extracted directly from the provided text because it simply doesn't exist in this summary. I will answer each section to the best of my ability based on the provided text, and explicitly state when information is not present.
Acceptance Criteria and Study Details for "Xenon Option to the Prism 3000 System"
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Effective in diagnosing brain anomalies | "Clinical tests have shown that the Xenon option is effective in diagnosing brain anomalies." |
| Performance in accordance with development specifications | "The product will perform in accordance with the development specifications." |
| Substantial equivalence to legally marketed devices | "The Xenon option... is substantially equivalent to legally marketed devices." (Implied acceptance by comparison to predicate) |
| Electrical safety (IEC-601 certification) | "The Xenon option will be certified to electrical safety standards (IEC-601) by a third party organization prior to use on human patients." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The document only mentions "Clinical tests have shown..." without providing any details on the number of patients or scans included.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided. The document states the device will be "operated by trained health care professionals," but does not detail how the ground truth for the clinical tests was established or by whom.
4. Adjudication Method for the Test Set
- Not specified. There is no mention of adjudication methods for determining ground truth in the clinical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, with Effect Size.
- No, an MRMC study is not mentioned or implied. The document refers to "Clinical tests" and a "matrix... comparing the Xenon option to a predicate device," but this is a device-to-device comparison for substantial equivalence, not a human reader comparative effectiveness study. No effect size for human readers with or without AI assistance is provided, nor is AI a component of this 1996 device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done.
- Not applicable in the modern sense. This device is a gamma camera system with a xenon option, not an AI algorithm. Its performance is inherently linked to human operation and interpretation. The "clinical tests" described would be evaluating the overall system performance, not an isolated algorithm.
7. The Type of Ground Truth Used
- Not specified. The clinical tests evaluated "diagnosing brain anomalies," implying a clinical diagnosis as the ground truth, but the specific method (e.g., expert consensus based on other imaging, pathology, clinical follow-up, etc.) is not detailed.
8. The Sample Size for the Training Set
- Not applicable / Not specified. This device predates the common use of machine learning models requiring "training sets" in the way we understand them today for regulatory submissions. The device is a hardware system with associated software, not an AI model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Not specified. As there is no mention of a "training set" in the context of an AI model, the method for establishing its ground truth is not relevant to this document.
Summary of Deficiencies and Context:
This 510(k) summary reflects the regulatory landscape of 1996. It focuses heavily on "substantial equivalence" to a predicate device and relies on general statements about clinical effectiveness and adherence to specifications. Modern 510(k) submissions, especially for devices involving advanced software or AI, would require significantly more detailed information regarding study design, sample sizes, ground truth establishment, reader performance, and statistical analysis to demonstrate safety and effectiveness.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.