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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 the breast in three dimensions. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

The Affirm Breast Biopsy Guidance System is used with Selenia Dimensions 2D or with Selenia Dimensions 3D tomosynthesis. Lesion location can be obtained from either 2D stereotactic or 3D tomosynthesis image acquisition. Both stereotactic and 3D localization calculate a three dimensional location for percutaneous placement for biopsy, pre-surgical localization or treatment devices. Safety Features include: Automatic detection of mounting, latching, and connection of biopsy guidance module; C-arm motion disabled if biopsy guidance module is not locked in place; Automatic compression release disabled when biopsy guidance module installed; Motorized movement of biopsy device only under user control; Audible alert if biopsy device motion could result in mechanical interference.

The provided text describes a Special 510(k) Premarket Notification for the "Modified Affirm Breast Biopsy Guidance System." However, it does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria in the format requested.

The document states that the device "meets IEC 60601-2-45 Medical Electrical Equipment - Safety of Mammographic X-ray Equipment and Mammographic Stereotactic Devices" and that "Hologic successfully performed design control verification and validation tests in accordance with 21 CFR Part 820." It also mentions that "Accuracy can be verified during the biopsy process."

The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device (K103512), specifically regarding a software change that enables the use of 3D tomosynthesis calculations for lesion localization, in addition to the existing 2D stereotactic capabilities. The manufacturer asserts that the "3D tomosynthesis lesion location is substantially equivalent to and as safe and effective as the cleared Affirm Breast Biopsy Guidance System and poses no additional risks or hazards."

Without explicit reported device performance metrics or a detailed study description in the provided text, I cannot populate most of the requested table.

Here's a breakdown of what can and cannot be answered based on the input:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not specified in the provided text. The document refers to "design control verification and validation tests," but does not detail the specific test set size or data provenance (e.g., country of origin, retrospective/prospective nature).

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

• Not specified in the provided text.

4. Adjudication method for the test set:

• Not specified in the provided text.

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 study is mentioned. The device is a guidance system for biopsy, not an AI-assisted diagnostic tool for human readers in the classical sense of an MRMC study. The "AI" component would be the 3D tomosynthesis calculations for localization, but the text focuses on its equivalence rather than reader improvement.

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

• The document implies that the "3D tomosynthesis lesion location" calculation itself was evaluated for "accuracy" and "substantial equivalence." This suggests an evaluation of the algorithm's output (lesion coordinates) as a standalone function, separate from a human interpreting images. However, specific details of such a standalone study (e.g., methodology, metrics, and number of cases) are not provided.

7. The type of ground truth used:

• The document states "Accuracy can be verified during the biopsy process." This strongly suggests that the ground truth for localization accuracy would be based on biopsy results or confirmation during the interventional procedure. However, it is not explicitly stated how this ground truth was used in specific verification or validation tests mentioned.

8. The sample size for the training set:

• Not specified in the provided text. This document is for a modified version of an already cleared device, primarily focusing on a software change. Details of the original device's training are not provided, nor are details of any specific training done for the 3D tomosynthesis algorithm.

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

• Not specified in the provided text.

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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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The MultiCare Platinum device combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system to produce a device that has specific application in first localizing, and then giving a physician the capacity of performing Fine Needle Aspiration or core biopsy of lesions determined to be suspicious through prior mammographic examination.

The MultiCare Platinum device combines the function of a standard x-ray mammography unit with that of a stereotactic lesion localization system.

The provided text is a 510(k) summary for the MultiCare Platinum mammographic x-ray system. This document focuses on demonstrating substantial equivalence to predicate devices based on regulatory compliance and design specifications, rather than clinical performance studies using AI algorithms or human reader studies. Therefore, many of the requested elements are not present in the provided text.

Here is an analysis based on the available information:

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

2. Sample size 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. The 510(k) summary focuses on engineering and regulatory compliance, not on clinical performance testing with a specific test set of images or patient data.

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. Ground truth establishment with experts is typical for clinical performance studies, which are not detailed here.

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

There is no indication that an MRMC comparative effectiveness study was done. The device described is a mammographic x-ray system, not an AI-powered diagnostic tool. The submission is a traditional 510(k) for a medical imaging device.

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

This is not applicable as the device is an imaging system, not an algorithm.

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

This information is not provided as there are no clinical performance studies detailed that would require a ground truth. The "ground truth" for this submission revolves around meeting technical and safety standards.

8. The sample size for the training set

This information is not provided. This concept is relevant for AI algorithms, which are not the subject of this 510(k) summary.

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

This information is not provided. This concept is relevant for AI algorithms, which are not the subject of this 510(k) summary.

Summary of Device and Acceptance Criteria Pertaining to the Provided Text:

The K030666 510(k) submission for the MultiCare Platinum System and Accessories primarily establishes safety and effectiveness by demonstrating compliance with international and national electrical safety standards (UL 2601-1, CSA C22.2 No. 601.1-M9, IEC 601-1), federal radiation performance standards (21 CFR 1020), and design adherence to American College of Radiology (ACR) accreditation requirements for image quality and dose. The "study" proving these criteria are met consists of the design and testing processes undertaken by the manufacturer to ensure the device meets these established engineering and regulatory benchmarks, as well as the provision of a comprehensive operator's manual. No clinical performance studies with patient data, AI algorithms, or human reader evaluations are described in this summary. The FDA's substantial equivalence determination is based on this regulatory and design compliance against predicate devices.

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The Modified 650 Mammography System is intended to produce radiographic images of the breast. Its specific intended use is for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for breast cancer diagnosis. Diagnosis mammography involves the production of magnified breast images, crease spot compression views, and the thorough examination of breast determined suspicious through screening mammography by a physician in preparation for biopsy.

Not Found

This submission describes a mammography system (Modified 650 Mammography System, also referred to as Affinity System), which is a device for producing radiographic images of the breast for screening and diagnostic mammography. It is not an AI/ML device. The provided text details regulatory compliance and clearances, rather than performance studies of an AI algorithm.

Therefore, the requested information elements related to AI/ML device performance and studies cannot be extracted from the provided text.

Here's a breakdown of what can be extracted, and why other elements cannot:

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

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

• Cannot be extracted. This information is relevant for AI/ML device studies, not for the regulatory compliance and design specifications of a mammography imaging system as described.

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)

• Cannot be extracted. This refers to AI/ML ground truth establishment, which is not applicable here.

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

• Cannot be extracted. This refers to AI/ML study methodologies, not applicable here.

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

• Cannot be extracted. This refers to AI/ML comparative studies, not applicable here.

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

• Cannot be extracted. This refers to AI/ML performance, not applicable here.

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

• Cannot be extracted. This refers to AI/ML ground truth, not applicable here.

8. The sample size for the training set

• Cannot be extracted. This refers to AI/ML training data, not applicable here.

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

• Cannot be extracted. This refers to AI/ML training data ground truth, not applicable here.

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The Modified M-IV Mammography System is intended to produce radiographic images of the breast. It is suitable for reasons of images for initial examination for screening and diagnostic mammography. Screening mammography involves the production of images for initial examination for reasons of images for initial examination for Screening mainmography inverves the production of magnified images for more thorough examination of areas of the breast determined suspicious mages for more morough oxamilasses in the sampression views, and the unrough sereening manilies are . . . . . . . production of images used by a physician in preparation for biopsy.

Modified M-IV Mammography System

This document (K011987) is a 510(k) summary for a Modified M-IV Mammography System. It primarily focuses on regulatory compliance and the intended use of the device, rather than detailed performance studies and acceptance criteria typically associated with algorithm-driven devices.

Based on the provided text, the device is a mammography system, which is a hardware device for producing radiographic images, not an AI-enabled diagnostic algorithm. Therefore, many of the requested categories for AI device studies (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The "acceptance criteria" discussed are primarily regulatory and operational standards for the mammography system itself, not performance metrics of an AI algorithm.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information (which are largely not applicable to this type of device submission):

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

• Not Applicable. This submission is for a physical mammography system, not an AI algorithm. There is no "test set" of images or patient data in the context of an algorithm's performance.

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

• Not Applicable. Ground truth, in the context of AI, refers to expert consensus on disease presence/absence. This is not relevant for a hardware device submission.

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

• Not Applicable. No adjudication method for a test set is discussed as this is not an AI algorithm submission.

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 is a hardware device. No AI component is mentioned, and therefore, no MRMC study or assessment of human reader improvement with AI assistance would be performed or reported in this type of 510(k).

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

• Not Applicable. This is a hardware device. "Standalone performance" in the context of an algorithm is not relevant here.

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

• Not Applicable. Ground truth in the context of disease diagnosis is not relevant for the regulatory acceptance of a mammography image acquisition system. The "ground truth" for this device is its adherence to technical standards and its ability to produce images, not the diagnostic accuracy of those images themselves.

8. The sample size for the training set:

• Not Applicable. This submission is for a physical mammography system. There is no AI training set involved.

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

• Not Applicable. As there is no AI training set, there's no ground truth establishment for it.

Summary Explanation:

This 510(k) submission (K011987) for the "Modified M-IV Mammography System" focuses on demonstrating the safety and effectiveness of the physical device itself, not on the performance of a diagnostic algorithm or AI. The "acceptance criteria" are therefore centered on compliance with established engineering, electrical safety, radiation emission, and imaging quality standards for mammography equipment (e.g., UL, CSA, IEC, 21CFR 1000, ACR guidelines). The document indicates that the device has been "designed for" these classifications/certifications and "tested and conforms" to the federal standards, suggesting internal testing and design verification were performed to meet these criteria.

The absence of information regarding test sets, training sets, expert review, or AI performance studies is entirely consistent with a 510(k) submission for a non-AI-enabled hardware device like a mammography machine.

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