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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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The Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions Mammography System. It is designed to allow the accurate localization of lesions in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

This submission introduces the optional Affirm Lateral Arm Upright Biopsy Accessory which attaches to the Affirm Breast Biopsy Guidance System used with the Selenia Dimensions 2D/3D Mammography System, software version 1.8.4 and higher.

The optional Affirm Lateral Arm Upright Biopsy Accessory attaches to the Affirm Biopsy Guidance Module (BGM) to enable lateral needle approach procedures. The Lateral Arm can only be used when the Selenia Dimensions C-arm is positioned at 0 degrees. When using the Lateral Arm, the X- Y- and Z-axis movement is the same as for the Affirm standard (upright) needle approach. For the lateral approach, the biopsy needle is manually advanced into the breast along its own X-axis, referred to as "Lat X".

When performing lateral approach biopsies, the biopsy device is installed onto the lateral arm in the same manner as when performing standard (upright biopsies).

New components used with the Affirm Lateral Arm Upright Biopsy Accessory include: lateral biopsy paddle, lateral arm stand, case, and QC phantom specifically to be used for Lateral approach biopsies.

The document provided describes the Affirm Lateral Arm Upright Biopsy Accessory, an optional accessory for the Selenia Dimensions Mammography System. This device is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization, or treatment devices) with a lateral needle approach.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion for this device appears to be its targeting accuracy, which is compared to existing predicate devices.

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

• Sample Size: Not explicitly stated as a number of patient cases or images. The testing focused on functional and performance characteristics using test reports.
• Data Provenance: Not applicable, as no clinical studies were performed. The testing was non-clinical.

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

• Number of Experts: Not applicable. Ground truth was established through physical measurements and engineering tests.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The testing described is primarily engineering and performance verification, not an interpretation of medical findings requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study Done? No. The document explicitly states: "No clinical studies were performed. Substantial equivalence has been demonstrated by nonclinical testing." Therefore, no MRMC study comparing human readers with and without AI assistance was conducted.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Standalone Study Done? Yes, in essence, the "Lateral Arm Targeting Accuracy Test" and "Default Needle Parameter Validation Test Report" represent standalone performance tests of the device's mechanical and software accuracy without direct human intervention in the targeting process during the test. The device provides guidance, but the testing assesses the accuracy of that guidance mechanism itself.

7. Type of Ground Truth Used:

• Type of Ground Truth: Physical measurement and engineering specifications. For target accuracy, this would involve precise measurements of the actual needle tip position relative to the intended target point within a phantom or test setup.

8. Sample Size for the Training Set:

• Sample Size: Not applicable. The device is a mechanical accessory with integrated software for guidance. It does not appear to use machine learning or AI models that require a "training set" in the conventional sense. Its function is based on pre-programmed algorithms and physical calibration.

9. How the Ground Truth for the Training Set Was Established:

• Ground Truth for Training Set: Not applicable, as there is no "training set" for an AI model. The system's accuracy and functionality were verified through engineering tests and validation against established standards.

Summary of Testing:

The document highlights that the device underwent system design control verification and validation tests, conforming to FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (moderate level of concern).

Specific tests included:

• Lateral Arm Targeting Accuracy Test: This directly addresses the core function of the device to accurately guide interventions.
• Default Needle Parameter Validation Test Report: Ensures correct operation with needle parameters.
• Updated Affirm CB test report (including Lateral Arm Accessory): Likely refers to a comprehensive test suite for the combined system.
• Third-party testing on:
  • Tensile Safety Factor (IEC 60601-1, Clause 9.8.2)
  • Strength of Compression Plates (IEC 60601-2-45, Subclause 203.8.5.4.102.5)
  • Biopsy Needle Positioning Accuracy of Mammographic Stereotactic Devices (IEC 60601-2-45, Subclause 201.9.2.1013 a,b,c)

The conclusion states that substantial equivalence was demonstrated by nonclinical testing, and no clinical studies were performed. The device's design, operation, construction, and materials were deemed substantially equivalent to the predicate and reference devices.

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The Hologic Digital StereoLoc II is an optional accessory for the Selenia full field digital mammography system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of twodimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

The Digital StereoLoc II is an optional accessory to the Selenia Full Field Digital Mammography System. It is attached to the Selenia to perform stereotactic biopsies and is composed of the following elements:

• The Biopsy Unit or Stage used for patient compression and vertical mounting of the . biopsy needle.
• The SmartWindow control module for X and Y-axis motion control and Z-axis . positioning guidance.
• DSM computer workstation and software for stereotactic targeting. .
  The breast is compressed between the compression paddle and the carbon fiber breast platform of the biopsy unit. The biopsy unit has its own manual compression mechanism that is independent of the Selenia FFDM compression device. There are two compression knobs; one at each side of the biopsy unit. The Smart Window control module gets the Cartesian coordinates (X, Y, Z) of the target from the DSM workstation.
• X and Y motion is motorized. Controlled by the operator via the SmartWindow. .
• . Z-axis motion is manual and controlled by the operator.

Although the provided text doesn't contain a detailed study with acceptance criteria and reported device performance in a tabular format, nor does it include information on sample sizes, ground truth establishment, or specific study designs (like MRMC or standalone), I can extract the relevant information regarding the device's assessment and general conclusions.

Here's a summary based on the provided 510(k) summary:

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

The document does not explicitly state quantitative acceptance criteria or a table of performance metrics. Instead, it relies on a qualitative assessment of substantial equivalence to predicate devices and compliance with relevant standards.

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

This information is not provided in the document.

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)

This information is not provided in the document.

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

This information is not provided in the document.

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

This information is not provided in the document. The filing focuses on the device's function as an accessory for guidance during interventional procedures, not on AI-assisted diagnostic improvement.

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

This information is not provided in the document. The device is described as an accessory that provides guidance for human operators during interventional procedures.

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

This information is not provided in the document.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

Summary of Device Assessment from the Provided K071542 Document:

The 510(k) summary for the Hologic Digital StereoLoc II primarily establishes substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria through a dedicated study.

Study that Proves the Device Meets the Acceptance Criteria:

The "Summary of Testing" section indicates:

• The Digital StereoLoc II System was tested by UL to IEC 60601-1 Medical Electrical Equipment Standards. This implies an assessment of electrical safety and essential performance, not clinical accuracy or diagnostic performance.
• The DSM Workstation complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0. This refers to adherence to DICOM standards for image communication.
• Hologic performs design control verification and validation tests under 21 CFR Part 820 (Quality System Regulation).

The core of the submission for demonstrating safety and effectiveness relies on:

• Comparison With Predicate Devices: The Digital StereoLoc II is stated to be "substantially equivalent" to:
  • K950220 Hologic Lorad StereoLoc II
  • K040884 Hologic Lorad DSM
  • K040125 Senographe Stereo General Electric Medical Systems
    These predicate devices are also "Mammographic X-Ray Systems which aid in the performance of breast biopsies and pre-surgical localization."
• Conclusion: "The Digital StereoLoc II principles of operation, clinical effectiveness, design, construction and materials are similar to existing marketed devices. This system poses no additional risk."

Therefore, the "proof" is based on demonstrating that the device is functionally and operationally similar to existing legally marketed devices, rather than a new clinical study with specific performance metrics against a defined ground truth. The FDA's letter confirms a "substantial equivalence" determination.

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