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The intended use of the Mobile Rectangular Single Head Camera (MSR) is to detect the location and distribution of gamma ray enitting radionuclides in the body and store data for analysis. This device includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.

To detect or image the distribution of radionuclides in the body or organ using the following technique(s);
(a) Planar Imaging
(b) Whole Body Imaging
(c) Tomographic Imaging (SPECT) for non Positron emitter
(d) Positron imaging by coincidence
(e) Positron imaging without coincidence
(f) Other indication(s) in the device label, but not included in the above list None

The Mobile Rectangular Single Head Camera (MSR) nuclear imaging system has a single rectangular field of view detector heads. The intended use of the Mobile Rectangular Single Head Camera (MSR) is the same range of studies to that of the Rectangular Single Head Camera (SR). The detector head is identical in hardware and software. The gantry of the Mobile Rectangular Single Head Camera (MSR) is optimized for being attached to a mobile platform which is transported from location in a truck and has the same range of automatic clinical motions of the Rectangular Single Head Camera (SR).

This 510(k) submission (K032779) is for a medical device (Mobile Rectangular Single Head Camera - MSR) that is substantially equivalent to a predicate device (Rectangular Single Head Camera - SR). Therefore, it relies on comparison to the predicate device rather than a new study to meet acceptance criteria.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:

• The document does not describe a specific clinical test set or data provenance for this 510(k) submission.
• The argument for substantial equivalence is based on the device's technical specifications and intended use being identical or very similar to the predicate device, which would have undergone its own testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. As no new clinical test set was described, there's no mention of experts establishing ground truth for a new study. The safety and effectiveness are established through comparison to a certified predicate device.

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

• Not applicable. No new clinical test set was conducted or detailed.

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 MRMC comparative effectiveness study was done or described. This device is a gamma camera, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

• Not applicable. This device is a medical imaging system, not an algorithm, so a standalone algorithm performance test is not relevant.

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

• Not applicable. No new clinical study requiring ground truth establishment is described in this submission. The ground truth for the predicate device's original clearance would have been established at that time (likely through various validation methods relevant to gamma cameras).

8. The sample size for the training set:

• Not applicable. This submission concerns a physical medical imaging device, not a machine learning model, so there is no "training set."

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

• Not applicable, as there is no training set for this type of device.

Summary of the Study:

The "study" to prove the device meets acceptance criteria in this 510(k) submission is a comparison to a legally marketed predicate device (Rectangular Single Head Camera (SR), K982045).

The manufacturer, IS2 Medical Systems Inc., demonstrated that their new device, the Mobile Rectangular Single Head Camera (MSR), is substantially equivalent to the predicate by showing:

• Identical Intended Use: Both devices are used to detect the location and distribution of gamma ray-emitting radionuclides for analysis.
• Identical Detector Head: The hardware and software of the detector head are the same.
• Similar Gantry Functionality: Though optimized for mobility, the gantry provides the same range of automatic clinical motions as the predicate.
• Compliance with Safety Standards: The device is certified to the same electrical safety standards as the predicate device by a third-party organization.
• No New Concerns: The manufacturer concluded that these similarities mean no new safety or effectiveness concerns are raised compared to the predicate.

This approach, demonstrating substantial equivalence to a predicate, is a common pathway for medical device clearance through the 510(k) process when a new device does not raise new questions of safety or effectiveness.

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