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The intended use of the Mobile Compact Digital Cardiac (MCDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device resides on a mobile platform and includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.

The Mobile Compact Digital Cardiac Camera (MCDCC) is a gamma camera system. It includes a detector head, gantry, and resides on a mobile platform. It includes accessories such as signal analysis and display equipment supports, radionuclide anatomical markers, component parts and accessories.

This document is a 510(k) summary for the Mobile Compact Digital Cardiac Camera (MCDCC). It does not contain acceptance criteria or the results of a study that proves the device meets specific performance criteria.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Compact Digital Cardiac Camera, K033199). This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device and does not introduce new questions of safety or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from the given text.

Here's why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing design features and intended use to a predicate device.
2. Sample sized used for the test set and the data provenance: No performance testing data is presented, and thus no sample sizes or data provenance are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant to a substantial equivalence claim, as no new performance study is being presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set or expert adjudication is described for performance evaluation.
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 device is a gamma camera, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a medical imaging system, not an algorithm being tested in isolation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no new performance study with ground truth establishment is detailed.
8. The sample size for the training set: Not applicable as this is not an AI/ML device that undergoes training.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The core of this 510(k) is the statement: "The Mobile Compact Digital Cardiac Camera (MCDCC) has been deemed safe and is certified to the same 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 Mobile Compact Digital Cardiac Canera (MCDCC) with the predicate device. We conclude that the Mobile Compact Digital Cardiac Camera (MCDCC) is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised." This indicates a comparison study of design and function, not a clinical performance study with specific acceptance criteria.

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The intended use of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) is to detect the location and distribution of gamma ray emitting 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.

The Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) manufactured by IS2 Medical Systems Inc., is substantially equivalent to the Mobile Single Rectangular Camera (MSR). The detector head is identical in hardware and software. The gantry of the Mobile Single Circular Camera (MSC) and the Mobile Digital Cardiac Camera (MDCC) are optimised for being attached to a mobile platform which is transported from location to location in a truck and have the same range of automatic clinical motions of Mobile Single Rectangular Cumera (MSR).

This 510(k) summary (K033956) is for the Mobile Single Circular Camera (MSC) and Mobile Digital Cardiac Camera (MDCC). This submission is a declaration of substantial equivalence to a predicate device, the Mobile Single Rectangular Camera (MSR) (K032779). As such, it does not involve new clinical studies with acceptance criteria and device performance evaluation in the typical sense of a novel device. Instead, the focus is on demonstrating that the new devices are essentially the same as the predicate in terms of safety and effectiveness, despite some mechanical differences.

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

1. A table of acceptance criteria and the reported device performance

Since this is a substantial equivalence claim for a device with the same hardware and software as a predicate, there are no specific performance acceptance criteria or reported performance values from a new study presented in this 510(k) summary. The acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate device, which would have already met its own performance specifications.

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

No new test set or clinical data is mentioned or used for this 510(k) submission as it relies on substantial equivalence to a predicate 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. No new test set requiring expert ground truth establishment was conducted for this substantial equivalence claim.

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

Not applicable. No new test set requiring adjudication was conducted for this substantial equivalence claim.

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 device is a gamma camera, not an AI-powered diagnostic tool, and the submission does not mention any MRMC studies or AI assistance.

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

Not applicable. This device is a gamma camera, not an algorithm, and the submission does not describe any standalone performance studies of an algorithm.

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

Not applicable. No new ground truth was established as the submission relies on the substantial equivalence to a predicate device. The predicate device's performance would have been established against appropriate ground truths for medical imaging devices (e.g., phantom studies, clinical correlation, etc. as per the standards applicable at the time of its clearance).

8. The sample size for the training set

Not applicable. The submission does not describe any machine learning or AI components requiring a training set. The device is a medical imaging hardware system with associated software for signal analysis and display.

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

Not applicable. No training set for machine learning was involved.

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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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To DETECT AND IMAGE THE DISTRIBUTION of THE GAMMA EMITTING RADIONUCLIDE IN THE PATIENT 'S BREAST AND THE SURROUNDING AREA AND TO STORE THE IMAGES WHEN THE RADIONUCLIPE IS ADMINISTERED INTO THE PATIENT 'S Bo Dy-THE

The BCC nuclear imaging system has two rectangular fields of view detector heads.

The provided text is a 510(k) summary for the BCC Planar Scintillation Camera, indicating it is a device for detecting gamma ray emitting radionuclides in the body. The submission aims to demonstrate substantial equivalence to a predicate device, the NuCamma Bi90 camera, rather than presenting a de novo study with acceptance criteria and performance data.

Therefore, the document does not contain information about:

• Specific acceptance criteria and reported device performance in a table.
• Sample sizes for test sets, data provenance, number of experts for ground truth, or adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance studies.
• The type of ground truth used.
• Sample size for training sets or how ground truth for training sets was established.

Instead, the submission focuses on proving the substantial equivalence of the BCC device to the predicate device, NuCamma Bi90. The key arguments for substantial equivalence are:

• Intended Use: The BCC performs a reduced range of studies compared to the NuCamma Bi90, but the studies it does perform are identical to those the NuCamma Bi90 can perform. The specific intended use mentioned is "to detect the location and distribution of gamma ray emitting radionuclides in the body and store the data for analysis," with a focus on imaging the breast and surrounding area when a radionuclide is administered.
• Hardware and Software: The detector heads are described as identical in both hardware and software.
• Safety and Effectiveness: The BCC is stated to have 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."
• Gantry Optimization: The gantry of the BCC is optimized for clinical study of the breast, which means it does not have the same range of automatic motions as the NuCamma Bi90, implying a specialized, rather than less capable, design for its specific intended use.

The submission concludes that a matrix comparing the features and intended use of the BCC with the predicate device led to the conclusion that the BCC is substantially equivalent and raises no new safety or effectiveness concerns.

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To detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the 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

The NuCamma Rx nuclear imaging system has a rectangular field of view. The system does not include data analysis capability. The data is stored and available for transmission to, or retrieval by, existing commercially available data analysis software and accompanying computer equipment.

This document is a 510(k) Premarket Notification for the NuCamma Rx gamma camera system. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria through novel testing.

Therefore, many of the requested elements (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance studies, and training set details) are not typically found in a 510(k) submission that relies on equivalence to a predicate device. The information provided mainly covers the device's intended use and a qualitative comparison to the predicate.

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with quantitative performance metrics for the NuCamma Rx itself. Instead, it claims substantial equivalence to a predicate device based on its intended use and general safety/effectiveness. The key "performance" aspect is its ability to perform certain imaging techniques within a specified energy range.

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. The submission for NuCamma Rx relies on demonstrating substantial equivalence to a predicate device (ISOCAM I gamma camera) rather than conducting a new clinical performance study with a test set of patient data. Therefore, there is no mention of a specific sample size, data provenance, or whether the study was retrospective or 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. As stated above, no new clinical performance study on a test set was performed for this 510(k) submission.

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

Not applicable. No test set was used for a new clinical performance study.

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 device is a gamma camera system, not an AI-assisted diagnostic tool. There is no mention of AI or MRMC studies in the document.

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

Not applicable. This device is a gamma camera, not an algorithm, and the submission does not describe standalone performance testing in the context of an algorithm.

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

Not applicable. No new clinical performance study with defined ground truth was conducted for this 510(k) submission. The safety and effectiveness are established through substantial equivalence to a predicate device already on the market.

8. The sample size for the training set

Not applicable. No algorithm training was performed or described for this device.

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

Not applicable. No algorithm training was performed or described for this device.

Summary of the document's approach:

The core of this 510(k) submission is to demonstrate that the NuCamma Rx is "substantially equivalent" to a previously cleared predicate device (ISOCAM I gamma camera). This approach means the manufacturer doesn't need to perform extensive new clinical studies to prove safety and effectiveness from scratch. Instead, they compared the NuCamma Rx's intended use, technological characteristics, and safety certifications to the predicate device.

The "study that proves the device meets the acceptance criteria" in this context is the qualitative comparison (a "matrix was constructed comparing the features and intended use") and the certification to electrical safety standards, all aimed at establishing substantial equivalence to the predicate device. The FDA's letter confirms that, based on this comparison, the device is deemed substantially equivalent.

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To detect the location and distribution of gamma ray and positron emitting radionuclides in the body and store the 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): Planar Imaging, Whole Body Imaging, Tomographic imaging (SPECT) for non Positron emitter.

The NuCamma R* nuclear imaging system has a round field of view. The system does not include data analysis capability. The data is stored and available for transmission to, or retrieval by, existing commercially available data analysis software and accompanying computer equipment.

The provided text does not contain detailed information regarding acceptance criteria or a specific study that proves the device meets such criteria. It primarily focuses on the 510(k) submission for the NuCamma R* Gamma Camera, demonstrating its substantial equivalence to a predicate device (ISOCAM I).

Here's an analysis of the information that is present, and an explanation of why many of your requested items cannot be fulfilled from the provided text:

Lack of Specific Acceptance Criteria and Performance Study:

The document is a 510(k) submission summary, which primarily aims to establish substantial equivalence to a legally marketed predicate device, rather than providing detailed performance data against specific acceptance criteria. This means:

• No specific quantified acceptance criteria are listed. The approval hinges on demonstrating equivalence in intended use, technological characteristics, and safety and effectiveness concerns compared to the predicate device.
• No detailed performance study results are provided. The document mentions a "matrix was constructed comparing the features and intended use of the NuCamma R* with the predicate device," but it doesn't elaborate on the methodology or specific outcomes of this comparison in a way that aligns with a typical performance study against acceptance criteria.

Therefore, the following points cannot be answered from the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How the ground truth for the training set was established

Information that can be extracted or inferred:

While a detailed performance study isn't available, the document does touch upon the basis for the FDA's decision, which suggests some implicit "acceptance criteria" are being met through substantial equivalence.

1. A table of acceptance criteria and the reported device performance:

As explained, no explicit table is provided. The acceptance, in this context, is primarily based on substantial equivalence to the predicate device (ISOCAM I).

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

• Not applicable/Not provided. The document does not describe a "test set" in the context of clinical performance evaluation with patient data. The evaluation appears to be a technical comparison and safety assessment against a predicate device.

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

• Not applicable/Not provided. No "ground truth" establishment by experts for a test set is described.

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 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. This is not an AI device, and no MRMC study or AI assistance 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 gamma camera, not an algorithm, so "standalone performance" in this context is not what is being assessed as an algorithm.

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

• Not applicable/Not provided. No explicit ground truth is mentioned regarding clinical performance data. The basis for approval is substantial equivalence to the predicate device, relying on its established safety and effectiveness.

8. The sample size for the training set:

• Not applicable/Not provided. As there is no mention of an algorithm or AI component, there would be no "training set."

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

• Not applicable/Not provided. As above, no training set information is available.

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