Search Results

The intended use of the Dyna Camera 2 series collimator is to detect and image the distribution of high energy photons from an administered positron emitting radioactive agent in the human body. Same as predicate.

Not Found

This document describes the 510(k) summary for Park Medical Systems' 511 KeV collimator for their ISOCAM I and ISOCAM II nuclear imaging systems. The submission aims to demonstrate substantial equivalence to a predicate device, the Dyna camera 2 series high energy collimators, rather than proving the device meets specific acceptance criteria through a dedicated study with statistical endpoints.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a clinical trial or performance study with defined thresholds for sensitivity, specificity, etc. Instead, it presents a comparison table of technological characteristics and performance metrics against a predicate device to demonstrate substantial equivalence.

Note on Acceptance Criteria: The "acceptance criteria" here are implied by the substantial equivalence framework. The device is "accepted" if its performance and characteristics are comparable to a legally marketed predicate device, especially considering the NEMA NU 1-1994 standard for performance measurements. The specific numerical values for resolution are directly compared, and the new device generally performs within or better than the predicate's reported values, especially when adjusting for measurement distances.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a "test set" in the context of human data or a clinical study. The performance data (e.g., resolution) appears to be derived from device characterization measurements according to NEMA standards, not from a clinical test set involving patients or data sets. Therefore, there is no information on sample size for a test set or data provenance (country of origin, 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)

Not applicable. No "test set" with ground truth established by experts is described as this is a device performance characterization against a predicate, not a clinical diagnostic study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No "test set" requiring adjudication 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

Not applicable. This submission is for a physical medical device (collimator for a gamma camera) and does not involve AI or human reader performance studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm, but a physical component of an imaging system. The performance data presented (e.g., resolution) represents the standalone performance characteristics of the collimator itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance metrics like resolution (FWHM) would be based on physical phantom measurements according to the NEMA NU 1-1994 standard for performance measurements of scintillation cameras. This involves standardized radioactive sources and measurement setups to objectively quantify resolution.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device. The document describes a physical medical device and its characteristics.

9. How the ground truth for the training set was established

Not applicable. This is not a machine learning or AI device.

Ask a specific question about this device

The “ISOCAM II” manufactured by Park Medical Systems Inc. is a Single Photon Emission Computed Tomography (SPECT) gamma camera which is intended to image the distribution of radionuclides in the body by means of a single photon radiation detector. This system includes signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories. Same as ISOCAM II.

The ISOCAM II (Dual Head Gamma Camera) is a Single Photon Emission Computed Tomography (SPECT) gamma camera. This 510(K) is being submitted because of a modification to our ISOCAM II, more specifically, an additional collimator for the ISOCAM II, that allows better images. This modification changes the effectiveness of the ISOCAM II, therefore, we are submitting another premarket notification. The collimator is called MCAT™, which stands for Modular Coded Apperture Technology.

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the ISOCAM II with MCAT™:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states "better sensitivity and resolution measurements change the effectiveness of the ISOCAM II system." It then lists the specific values for the MCAT™ version, implying these are the performance goals and achievements.

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

The provided text does not contain information about a specific test set in terms of patient data or clinical trials for performance evaluation. The "study" described appears to be a technical comparison and verification of the device's physical and technical characteristics against a predicate device (the ISOCAM II without MCAT™).

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. Given the nature of the evaluation (technical performance metrics for a gamma camera), it's unlikely that traditional "ground truth" established by clinical experts in the context of diagnostic accuracy was involved in the same way it would be for AI algorithms. The performance metrics (sensitivity and resolution) are typically measured using physical phantoms and established scientific methodologies.

4. Adjudication Method

This information is not applicable to the type of evaluation described. There's no mention of a human-in-the-loop diagnostic task requiring adjudication.

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

A MRMC comparative effectiveness study was not conducted, or at least not described in this submission. The focus is on the technical specifications of the imaging equipment itself, not on comparing diagnostic outcomes with human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the device is a gamma camera, not an AI algorithm. The performance metrics listed are inherent to the machine's imaging capabilities.

7. Type of Ground Truth Used

The ground truth used for evaluating the performance metrics (sensitivity and resolution) would be based on physical measurements using standardized phantoms and radioactive sources. This is a common practice in imaging device evaluation to objectively quantify their technical capabilities. There are no mentions of expert consensus, pathology, or outcomes data being used for this specific evaluation.

8. Sample Size for the Training Set

This information is not applicable as the device is a gamma camera and not an AI algorithm that requires a training set.

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

This information is not applicable for the same reason as above.

Ask a specific question about this device