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The intended use of the MyoLIGHT system is to perform Nuclear imaging procedures for detection and imaging of single photon radioisotope tracer uptake in the patient body for clinical diagnostic purposes.

The MyoLIGHT system is a dedicated Gamma Camera for nuclear cardiology, highperformance dual-head nuclear medicine imaging system. It is based on the following legally marketed device: CARDIOSPECT D90 - K021823. Modifications include reduced gantry size, adapted patient table, detectors moving in an enclosed space on a fixed radius and set at 90 degrees, integrated patient table, integrated acquisition station and operator console, and built-in cardiac gating circuitry.

This document is a 510(k) summary for the GE Medical Systems F.I. Haifa MyoLIGHT device, a dedicated Gamma Camera for nuclear cardiology.

1. Acceptance Criteria and Reported Device Performance:

The document states that the MyoLIGHT device is a modification of a legally marketed predicate device, CARDIOSPECT D90 (K021823). The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to the predicate device in terms of safety and effectiveness.

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

The document mentions "Bench and images data" but does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective).

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

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

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

The document does not specify an adjudication method.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable as this is not an AI-assisted device in the context of the provided document. The study focuses on demonstrating equivalence of the MyoLIGHT system to a predicate device.

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

A standalone performance evaluation (algorithm only) was not explicitly detailed as such. The "Bench and images data" likely refers to technical performance assessment of the system, not an algorithm's performance independent of human interaction for interpretation.

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

The document does not specify the type of ground truth used. The statement "Bench and images data show that the MyoLIGHT images are similar to the CARDIOSPECT D90 (K021823) images" suggests a comparison against the imaging characteristics or output of the predicate device, rather than a clinical ground truth like pathology.

8. The sample size for the training set:

There is no mention of a training set as this device is not described as involving a learning algorithm. The study focuses on comparing a modified device to a predicate.

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

Not applicable, as there is no training set mentioned.

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The Apex XL-4 is intended for use as an acquisition of Nuclear Medicine SPECT and Planar Gamma Camera images.

The APEX XL-4 is a Gamma Camera - SPECT Imaging System. It is intended to acquire nuclear medicine gamma camera output data for previously-approved Elscint APEX Gamma Camera systems. This acquisition is performed in the same manner as the corresponding components of the equivalent device, K021823. The detector electronics, mechanical components, software, and the manufacturing specifications of the applicant system (the APEX XL-4) are substantially equivalent to the CardioSPECT SC, the legally marketed device.

The provided document for K033001 describes the Photon2 APEX XL-4, a gamma camera - SPECT imaging system. This 510(k) submission is for demonstrating substantial equivalence to a predicate device, not for establishing novel performance criteria through a new clinical study. Therefore, the information requested about specific acceptance criteria, device performance tables, sample sizes for test sets, expert involvement, and comparative effectiveness studies as typically presented for AI/ML device submissions is not applicable in this context.

This 510(k) relies on demonstrating that the new device has substantially equivalent specifications, safety, effectiveness, and intended use as the legally marketed predicate device, the NC Systems, Inc. CardioSPECT SC (K021823). The document primarily focuses on comparing technical specifications and intended use.

Here's a breakdown of what can be extracted from the document based on your request, with an emphasis on what is not present:

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

• Not Applicable. This type of table is typically found in submissions for novel devices or those with new performance claims where specific metrics (e.g., sensitivity, specificity, AUC) are being established against a defined ground truth. For a substantial equivalence claim for a gamma camera, the acceptance criteria are generally met by demonstrating that the device meets existing performance standards and is comparable to the predicate device across various technical and functional specifications. The document states: "The conclusion of tests performed and clinical images obtained demonstrate that the subject device (APEX XL-4) is as safe and effective as the legally marketed device (CardioSPECT SC)." However, no specific performance metrics or acceptance criteria are presented in a table form.

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. The document does not describe a specific "test set" in the context of an AI/ML algorithm evaluation. The "tests performed and clinical images obtained" mentioned are likely part of the validation process to ensure the device performs as expected and similarly to the predicate, but detailed information about the number of patients/cases, their origin, or study design (retrospective/prospective) is not provided.

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. Since there's no described "test set" and ground truth establishment in the context of AI/ML performance evaluation, there's no mention of experts or their qualifications for this purpose.

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

• Not Applicable/Not Provided.

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 hardware system, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with AI assistance is not relevant to this submission.

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

• Not Applicable. This is a hardware device; no standalone algorithm performance is being evaluated.

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

• Not Applicable/Not Provided. As there is no "test set" requiring ground truth for performance evaluation in the AI/ML sense, no specific type of ground truth is mentioned. The comparison is based on the technical specifications and functional equivalence to the predicate device.

8. The sample size for the training set

• Not Applicable/Not Provided. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable/Not Provided.

Summary of the study that proves the device meets the acceptance criteria (as understood in a 510(k) for a hardware device):

The "study" presented is primarily a comparison of specifications and intended use between the APEX XL-4 and its predicate device, the NC Systems, Inc. CardioSPECT SC (K021823). The document states:

• "The intended use of the applicable components in the two devices is identical."
• "The specifications for each device are compared in Section C." (This section is referenced but not provided in the input, but implies detailed technical comparison).
• "The labeling for each device are equivalent."
• "The conclusion of tests performed and clinical images obtained demonstrate that the subject device (APEX XL-4) is as safe and effective as the legally marketed device (CardioSPECT SC)."

This demonstrates that the device achieves substantial equivalence by meeting the implied "acceptance criteria" of being functionally and technically similar to a device that has already been cleared by the FDA for safety and effectiveness. The proof is in the direct comparison of the new device to the predicate across various attributes including design, materials, performance claims, and intended use as outlined in Section 6.0 "Determination of Substantial Equivalence." There is no detailed clinical study described with patient cohorts or statistical performance endpoints in the provided text.

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