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The Discovery NM 750b Gamma Camera is intended to measure and image the distribution of selected single photon emission radioisotopes in the human body to aid in the evaluation of lesions. The resultant images are intended to be reviewed by qualified medical professionals. The Discovery NM 750b Gamma Camera is intended for diagnostic imaging of the breast and other small body parts. The Discovery NM 750b Gamma Camera when used for breast imaging is intended as an adjunct to mammography or other breast imaging modalities (it is not intended for primary screening of the population). The Discovery NM 750b Gamma Camera is indicated for planar and dynamic planar scintigraphy in the energy range 80-200ke V for the detection and display of radioisotope tracer uptake in patients of all ages.

When used with the optional Discovery NM 750b Biopsy system, the Discovery NM 750b is designed to accurately locate, in three dimensions, lesions in the breast using information derived from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes such as biopsy and pre-surgical localization.

The Discovery NM 750b Biopsy system is an optional accessory for the Discovery NM 750b gamma camera (K102231) that utilizes stereotactic imaging to help guide invasive procedures. It is intended for 3D lesion localization to provide the physician image guidance for vacuum assisted needle biopsy of breast lesions determined to be suspicious through molecular breast imagine or other imaging.

The Biopsy system uses a pair of CZT "biopsy" detectors with fixed stereotactic positions. These two detectors acquire pair of anqulated two-dimensional images that are used in determining the 3D localization of the pre-identified suspicious lesion.

The Discovery NM750b Biopsy system includes hardware and software components, which auides the user throughout the biopsv work-flow. The hardware components enable the use of a variety of off-the-shelf biopsy vacuum needles.

In addition to the hardware components, the biopsy system accessory includes software components which, in part, through the user interface help quide the user stepwise through the biopsy workflow. The Discovery NM 750b Biopsy system is designed to support a variety of commercially available vacuum assisted biopsy devices and needles.

The provided text lacks specific acceptance criteria and detailed study results for the Discovery NM 750b Biopsy system. While it mentions various tests performed, it does not present quantifiable metrics or a clear study that "proves" the device meets specific acceptance criteria in a structured manner.

However, based on the information provided, here's an attempt to answer your request by extracting what is available and noting what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it describes general successful completion of various tests.

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

The document mentions "additional engineering bench performance testing using phantoms" and "simulated clinical use testing performed by physicians using a commercially available breast biopsy phantom and a supporting phantom." It specifies "This phantom setup had radiotracer-injected simulated lesions against a uniform radioactive background. The activities of the lesions and background were set to be representative of actual clinical use."

• Sample Size for Test Set: Not explicitly stated as a number of cases or lesions. It refers to "cases that represent a broad range of clinically relevant scenarios."
• Data Provenance: The data appears to be prospective from simulated clinical scenarios using phantoms. There is no mention of human subject data or country of origin for such data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Experts used: "physicians" performed the simulated clinical use testing.
• Qualifications of experts: Not specified beyond "physicians."

4. Adjudication Method for the Test Set

Not mentioned. The testing was described as "physician-performed clinical simulation testing." It's unclear if multiple physicians reviewed the same cases or if there was any adjudication process if different outcomes were observed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study is not mentioned. The study described focused on the device's performance in simulated clinical scenarios, not on comparing human reader performance with and without AI assistance from this specific device.

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

The document describes the "Discovery NM750b Biopsy system" as including both hardware and software components that "guides the user throughout the biopsv work-flow." The testing involved "simulated clinical use testing performed by physicians." This suggests the evaluation was for the system as a whole, with human involvement, rather than a standalone algorithm performance without human interaction.

7. The Type of Ground Truth Used

The ground truth for the "simulated clinical use testing" was based on a phantom setup with "radiotracer-injected simulated lesions" where their "activities of the lesions and background were set to be representative of actual clinical use." This is an artificial, controlled ground truth rather than expert consensus, pathology, or outcomes data from human patients.

8. The Sample Size for the Training Set

The document describes the device as an optional accessory using "stereotactic imaging and optics principles" that are "well established." It states the "technological characteristics and corresponding fundamental principles of operation of the Biopsy System are identical or equivalent to that of the GammaLoc system and Senoegraphe Stereo." This suggests the device leverages existing, established technology rather than a machine learning model that would require a distinct training set. Therefore, a training set size is not applicable as described in the context of typical AI/ML-based devices.

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

As no training set (in the AI/ML sense) is mentioned or implied for this device's core functionality, this question is not applicable. The device relies on physical principles and established imaging techniques.

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