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To obtain Nuclear Medicine images based on high-energy photons from an administered positron-emitting radioactive agent in the human body.

The VPC-94 high-energy (511 KeV) collimators and cart is an option for the Apex VariCam and Millennium VG gamma camera (K953801). It comprises two high-energy collimators and a collimator cart.

The provided text describes a 510(k) submission for a medical device and its substantial equivalence to a predicate device. However, it does not contain specific details about acceptance criteria, a detailed study proving performance against those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

The document states: "Bench data and Clinical data show that the VPC-94 option achieves its intended use," but it does not elaborate on the nature or results of these studies.

Therefore, much of the requested information cannot be extracted from the provided text.

Here's a breakdown of what can be inferred or directly stated, along with what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The studies are referred to generally as "Bench data and Clinical data."

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: Not specified.

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

• MRMC Study: Not mentioned or described. This submission is for a collimator for 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

• Standalone Performance: Not applicable/not discussed in the context of this device (a collimator). The device itself (collimator) is a physical component, not an algorithm.

7. The type of ground truth used

• Type of Ground Truth: Not specified. The "Clinical data" would likely involve patient imaging but the method for confirming findings (e.g., pathology, other imaging modalities, clinical follow-up) is not detailed.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable/not specified. This device is a passive component (collimator), not a machine learning algorithm that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of what is known about the study:

• The submission refers to "Bench data and Clinical data" as evidence that the device achieves its intended use.
• The device (VPC-94 collimator) is stated to have "better" resolution at comparable sensitivity compared to its predicate device (Dyna Camera 2C - 615-211 high-energy collimator), partly because the VPC-94 uses two detector heads instead of one.
• The overall conclusion is that the VPC-94 is "substantially equivalent" to the predicate device, has the "same intended use," and raises "no new safety or effectiveness concerns." This suggests the studies were primarily designed to demonstrate this equivalence rather than to establish new performance benchmarks against specified acceptance criteria.

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