(41 days)
The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gammu ray emitting radionuctides in the body und store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, rudionuclide unatomical markers, component parts and accessories.
To detect or image the distribution of radionuclides in the baly or organ using the following technique(s).
(a) Planar Imaging: YES, 50-250 keV
(b) Whole Body Imaging: NO
(c) Tomographic Imaging (SPECT) for non Positron emitter: YES, 50-250 keV
(d) Positron imaging by coincidence: NO
(e) Positron imaging without coincidence: NO
(f) Other indication(s) in the device label, but not included in the above list: None
The COMPACT DIGITAL CARDIAC CAMERA nuclear imaging system has two rectangular fields of view detector heads.
The provided text describes a 510(k) premarket notification for a medical device called the "Compact Digital Cardiac Camera" (CDCC). However, it does not contain the detailed study information, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods typically associated with proving a device meets acceptance criteria.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Bi90 Digital Cardiac Camera) rather than conducting new performance studies to establish standalone acceptance criteria.
Therefore, many of the requested fields cannot be directly extracted from the provided text. I will fill in what can be inferred or explicitly stated, and note where information is missing.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance Study Information
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | The intended use and features of the Compact Digital Cardiac Camera must be substantially equivalent to the predicate device (Bi90 Digital Cardiac Camera), raising no new safety or effectiveness concerns. This includes having the same range of studies, identical hardware and software for detector heads, optimized for minimal room space, and the same range of automatic clinical motions. | The document concludes that the COMPACT DIGITAL CARDIAC CAMERA is substantially equivalent to the predicate device (Bi90 Digital Cardiac Camera). It states: "The intended use of the COMPACT DIGITAL CARDIAC CAMERA is the same range of studies to that of the Bi90 Digital Cardiac Camera. The detector heads are identical in hardware and software. The ganny of the COMPACT DIGITAL CARDIAC CAMERA is optimized for minimal room space and has the same range of automatic clinical motions of the Bi90 Digital Cardiac Camera." |
| Safety and Effectiveness | The device must be deemed safe and effective and certified to the same electrical safety standards as the predicate device by a third-party organization prior to use on patients. | "The COMPACT DIGITAL CARDIAC CAMERA has been deemed safe and effective and is certified to the same electrical safety standards as the predicule device by a third party organization prior to use on patients." |
| Intended Use Compatibility | Ability to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This includes accessories like signal analysis/display, patient/equipment supports, and radionuclide anatomical markers. It supports Planar Imaging (50-250 keV) and Tomographic Imaging (SPECT) for non-Positron emitters (50-250 keV). | The device's "Indications for Use" statement confirms these capabilities: "The intended use of the COMPACT DIGITAL CARDIAC CAMERA is to detect the location and distribution of gamma ray emitting radionuctides in the body und store data for analysis." It explicitly lists Planar Imaging (✓) for 50-250 keV and Tomographic Imaging (SPECT) (✓) for 50-250 keV. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. This 510(k) relies on substantial equivalence to a predicate device, not on new clinical performance data from a test set. There is no mention of a test set, data provenance, or study type (retrospective/prospective) for this device.
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)
- Not Applicable / Not Provided. No test set or ground truth establishment process is described for the CDCC. The "ground truth" for this submission is the established performance and safety profile of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No test set or adjudication process is described.
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. This device is a gamma camera, a hardware imaging system, not an AI-assisted diagnostic software. No MRMC study or AI component is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided. This is a hardware device; the concept of an "algorithm only" performance study in the context of AI does not directly apply here. Its performance is demonstrated through its hardware capabilities and comparison to the predicate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Substantial Equivalence to a Predicate Device. The "ground truth" for this 510(k) is the regulatory acceptance and established performance/safety profile of the legally marketed predicate device, the Bi90 Digital Cardiac Camera. The submission asserts that the CDCC's features, intended use, and safety standards match or are equivalent to this predicate, thus implying similar performance.
8. The sample size for the training set
- Not Applicable / Not Provided. No training set is mentioned as this is a hardware device submission focused on substantial equivalence, not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. (See point 8)
§ 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.