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The intended use of the CardioSPECT SC and the CardioSPECT D90 is to detect the location and distribution of gamma ray emitting radionuclides in the human body and store the data for analysis as the same equivalent device, K013353.
Intended use is to detect & image the distribution of radionuclides in the body, when the radiopharmaceutical is administered in the body.

The SC and D90 are scintillation detector, Nal, systems with PMT a) light gathering capacity. The D90 has two (2) detectors and the SC has one detector both with the ability to rotate these detectors around the patient. The system uses a collimator on each detector to permit spatial image resolution of the gamma photons emitted from the patient. The collimators lock in place. There is no built-in radioactive scanning source and none is required. The SC and D90 are capable of both Planar (Class I) and SPECT or ECT (Class ii) operation. The acquisition/processing computer is a presently approved system sold and supported by NC Systems, Inc. but manufactured by Segami Corporation. This application is for the ECT device-qamma camerasystem(s) and not the previously approved computer.

Here's an analysis of the provided text regarding the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list numerical acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the CardioSPECT SC and D90 devices. Instead, the primary acceptance criterion is substantial equivalence to the predicate device, the NC Systems, Inc. QUAD (K013353).

The reported device performance is that the CardioSPECT SC and D90:

• "perform well or better than the legally marketed device identified in paragraph 3.(a) of this section." (paragraph 6.g)
• are "safe and as effective" as the legally marketed predicate device (paragraph 6.g).

Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for the Test Set and Data Provenance:

• Sample Size: The document states that "The clinical tests submitted were performed on, and clearly identified, the SC and D()." It further specifies that "The subjects were adults who were under the care of a physician licensed to perform these procedures." However, the exact number of subjects or cases used in the clinical test set is not provided.
• Data Provenance: The document does not specify the country of origin for the clinical data. It states the manufacturing site is in Budapest, Hungary, but this doesn't directly indicate where the clinical studies were conducted. The study was conducted on "adults who were under the care of a physician licensed to perform these procedures," implying a prospective clinical study rather than retrospective data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not provide information on the number of experts used to establish ground truth or their qualifications. It only mentions that the subjects were "under the care of a physician licensed to perform these procedures," but this doesn't detail the "ground truth" establishment process for evaluating the device's performance against clinical reality.

4. Adjudication Method for the Test Set:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• Was it done? The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The comparison is between the new devices (SC and D90) and a predicate device (QUAD) in terms of their overall safety and effectiveness, rather than evaluating human reader performance with and without AI assistance.
• Effect size: Since an MRMC study with AI assistance was not described, there is no information provided on the effect size of how much human readers improve with AI vs. without AI assistance.

6. Standalone Performance Study (Algorithm only without human-in-the-loop):

The document describes the device as an "Emission Computed Tomography System" (Gamma Camera-SPECT), which is inherently a medical imaging device rather than an AI algorithm. The tests were performed on the device itself. Therefore, a standalone algorithm-only performance study in the context of AI is not applicable to this type of medical device as presented. The "clinical tests" described represent the device's standalone performance in acquiring and imaging radionuclide distribution.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for the clinical tests. Given that it's an imaging device for detecting radionuclide distribution, it's highly probable that the ground truth would have been established through clinical assessment/diagnosis by physicians, potentially combined with other diagnostic imaging modalities or patient outcomes, but this is not detailed. It mentions subjects "under the care of a physician licensed to perform these procedures," suggesting clinical correlation.

8. Sample Size for the Training Set:

The document does not specify a training set sample size. This is consistent with the type of device (SPECT system) which doesn't typically undergo machine learning training in the same way an AI algorithm would. Its performance is based on the physics of gamma detection and image reconstruction.

9. How the Ground Truth for the Training Set Was Established:

As there's no mention of a traditional "training set" for a machine learning model, the document does not provide information on how ground truth for a training set was established. The device's performance relies on its engineering specifications and physical characteristics tested through non-clinical and clinical evaluations, not on learning from a labeled dataset.

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NeuroSpect QUAD is intended to detect and obtain planar and SPECT images of the distribution of a gamma emitting radionuclide administered in the body.

Gamma Camera NeuroSpect QUAD Gamma Camera Emission Computed Tomography System. The NeuroSpect QUAD nuclear imaging system had four (4) rectangular field of view detector heads.

The provided text is a 510(k) summary for the NeuroSpect QUAD Gamma Camera. Rather than detailing acceptance criteria and a study proving device performance against those criteria, this document primarily asserts substantial equivalence to a predicate device.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from the provided text.

Explanation:

The 510(k) summary focuses on demonstrating that the NeuroSpect QUAD Gamma Camera is "substantially equivalent" to an existing, legally marketed predicate device (the Picker Prism 3000). For devices in this category, the primary requirement is to show that the new device is as safe and effective as the predicate device. This is often achieved through comparison of features, intended use, and adherence to safety standards, rather than conducting new clinical trials with specific performance acceptance criteria.

The document explicitly states:

• "This 510(k) Premarket Notification has been prepared to demonstrate that the NeuroSpect QUAD Gamma Camera... is substantially equivalent to the Picker Prism 3000..."
• "The intended use of the two devices is identical."
• "The NeuroSpect QUAD has been deemed safe and effective and is certified to the same electrical safety standards as the predicate device by a third party organization prior to use on patients."
• "a matrix was constructed comparing the features and intended use of the NeuroSpect QUAD with the predicate device."
• "We conclude that the NeuroSpect QUAD is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised."

These statements indicate a comparison-based approach rather than a performance-based study against predefined acceptance criteria.

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