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The Smart Finder is intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

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This document, K203509, is a 510(k) clearance letter for a mammographic x-ray system called "SMART FINDER." It primarily covers the administrative aspects of the device's clearance for marketing. It does not contain information regarding detailed acceptance criteria, study methodologies, performance metrics (such as sensitivity, specificity, AUC), sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/CAD device.

The "SMART FINDER" device, as described, is intended for "mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement." This suggests it's a hardware device used for image-guided procedures, not an AI or CAD software that analyzes images for diagnostic aid.

Therefore,Based on the provided text, I cannot provide the requested information about device acceptance criteria and the study proving it meets them. The document is a 510(k) clearance letter for a medical device called "SMART FINDER," which is described as a "mammographic x-ray system" used for stereotactic guidance in procedures like fine needle aspiration and biopsy.

This document does NOT contain the following information:

• A table of acceptance criteria and reported device performance: This letter is an administrative clearance, not a technical report on performance.
• Sample sizes used for the test set and data provenance: No study details are provided.
• Number of experts used to establish ground truth and their qualifications: No study details are provided.
• Adjudication method for the test set: No study details are provided.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size: No study details are provided.
• If a standalone (algorithm only) performance study was done: No study details are provided.
• The type of ground truth used: No study details are provided.
• The sample size for the training set: No study details are provided.
• How the ground truth for the training set was established: No study details are provided.

The document indicates that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for 510(k) clearance. However, the details of the studies and data used to demonstrate this substantial equivalence are not included in this administrative letter.

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Affirm® Contrast Biopsy is indicated as an optional accessory for the Selenia Dimensions 2D Full Field Digital Mammography System and 3Dimensions system. It is designed to allow the accurate location of lesions in the breast in three dimensions, using information extracted from stereotactic pairs of two-dimensional images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices). Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm® Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.

The proposed Affirm® Contrast Biopsy is a licensable software for the Selenia Dimensions and 3Dimensions system platforms (P010025 and P08003, respectively). The proposed software option will be used with the Affirm® Breast Biopsy Guidance System (K103512). The proposed software is a stereotactic lesion localization system option for the Dimensions systems. It allows clinicians to perform biopsy targeting on captured contrast enhanced images. Affirm® Contrast Biopsy uses the same workflow as stereotactic biopsy, substituting standard scout and stereo pair views with contrast enhanced views captured at the associated angles. The proposed device is compatible with the standard vertical biopsy approach as well as the right or left lateral approach.

Affirm® Contrast Biopsy introduces new software and labeling. There are no changes to the Dimensions platform and Affirm® Breast Biopsy Guidance System hardware, platform software architecture, or stereotactic function as a result of the proposed software.

The provided text is a 510(k) Summary for the Hologic Affirm® Contrast Biopsy system. It primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, rather than presenting a performance study against specific acceptance criteria for AI/ML device performance.

Therefore, the document does not contain the detailed information required to answer the specific questions about acceptance criteria and a study proving the device meets them, especially in the context of an AI/ML system's performance. The device described appears to be a hardware/software system for guiding biopsies using contrast-enhanced imaging, not an AI/ML algorithm that requires performance metrics like sensitivity, specificity, or reader studies.

Specifically, the document states: "Non-clinical bench testing demonstrates the Affirm® Contrast Biopsy is substantially equivalent to the predicate and reference device with regards to the indication for use, software, technology, and performance. Design verification testing demonstrates the proposed device complies with design specifications. The software, and performance showed that the overall system demonstrated equivalent performance and equivalent safety and effectiveness as the predicate..." This indicates that bench testing and design verification were conducted to show equivalence, typical for traditional medical devices, not a study focused on AI/ML performance.

Here's a breakdown of why the requested information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document discusses "design specifications" and "equivalent performance" but no specific quantitative acceptance criteria or results are listed.
2. Sample size used for the test set and the data provenance: Not mentioned. There is no description of a clinical test set or data origins.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable based on the provided text, as no clinical test set for performance evaluation (e.g., sensitivity/specificity) is described using expert ground truth.
4. Adjudication method: Not applicable.
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 not an AI-assisted interpretation device in the traditional sense, but rather a biopsy guidance system. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is described as a system for guidance, not a standalone diagnostic algorithm.
7. The type of ground truth used: Not applicable. No ground truth for performance evaluation (e.g., pathology, expert consensus) is described.
8. The sample size for the training set: Not applicable. This document does not describe an AI/ML model that would have a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided FDA 510(k) clearance letter and summary are for a biopsy guidance system that uses contrast-enhanced images, which is cleared based on substantial equivalence to existing predicate devices through bench testing and design verification, rather than a clinical performance study with specific AI/ML acceptance criteria and human-in-the-loop evaluations.

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The FUJIFILM Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Aspire Cristalle (FDR MS-3500) digital mammography system. It is designed to allow for accurate determination of three dimensional lesion locations in the breast using information extracted from stereotactic pairs of two-dimensional images and/or Digital Breast Tomosynthesis (DBT) images. It is intended to provide guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices).

The Biopsy Positioner (FDR-2000BPY) is an optional accessory for the Digital Mammography system. It is designed for positioning the needle when performing Stereotactic and/or Tomosynthesis Biopsies, fine needle aspirations, core needle, and vacuum assisted biopsies in an upright position. The Biopsy Positioner uses a Stereo pair of images and/or Tomosynthesis images. The position of the three coordinates (X, Y, and Z) is computed using the position of the object on each of the images, as indicated by the operator, and the known geometry of the system.

FDR-2000BPY is mainly composed of the following elements:

• The Positioner that supports and positions the needle .
• The Positioner Control Cabinet which supplies power to the positioned .
• The Operation panel which displays the distance between the compression plate and . target pathology, the distance between the target pathology and the needle, and also electrically drives the positioner in the X, Y and Z directions.

The subject of this Special 510(k) premarket notification is addinq use of Digital Breast Tomosynthesis (DBT) images for extracting information to determine three dimensional lesion locations in the breast.

This document describes the Biopsy Positioner (FDR-2000BPY) for determining 3D lesion locations in the breast for interventional purposes using stereotactic and/or Digital Breast Tomosynthesis (DBT) images.

There is no information in the provided text regarding a study on "AI" performance or human reader improvement with AI assistance. The device described is a biopsy positioner and not an AI algorithm for image interpretation.

Here's the information that can be extracted based on the provided text, focusing on the device itself and its performance:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Bench testing was performed... to evaluate the stereotactic and tomosynthesis biopsy needle positioning accuracy." It does not specify a numerical sample size for this bench testing.

• Data Provenance: Bench testing, so it is synthetic/physical testing, not patient data. No country of origin is specified for the bench testing.

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

• This device is a biopsy positioner, not an image interpretation or diagnostic AI device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of diagnostic performance is not directly applicable.
• The accuracy of the device (e.g., needle positioning) would be verified against physical measurements or established calibration standards during bench testing. No human experts are mentioned for establishing ground truth in this context.

4. Adjudication Method for the Test Set

• Not applicable as the testing involves physical performance metrics (e.g., positioning accuracy) rather than subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done. The device is a biopsy positioner accessory, not an image reader or an AI diagnostic tool. There is no mention of human readers or AI assistance in the document.

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

• This question is built on the premise that the device is an "algorithm." The FDR-2000BPY is a physical "Biopsy Positioner," an accessory to a mammography system. While it has software and computes 3D coordinates, it is not described as a standalone diagnostic algorithm. Its performance is integrated with the mammography system and involves human operation for marking targets.
• The "performance data" section focuses on hardware-related compliance (EMC, radiation safety) and "needle positioning accuracy" via bench testing, not autonomous algorithmic performance.

7. The Type of Ground Truth Used

• For the needle positioning accuracy, the ground truth would likely be physical measurements against known target coordinates or established calibration standards in a bench test environment. It is not expert consensus, pathology, or outcomes data, as these relate to diagnostic accuracy, not the accuracy of a physical positioning system itself.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical accessory with integrated software for coordinate calculation, not a machine learning model that requires a "training set" in the conventional sense. The "training" for such a system would involve engineering and calibration, not data-driven model training.

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

• Not applicable, as there is no "training set" for an AI model. For the device's development and calibration, ground truth would be established through engineering specifications, precise physical measurements, and system calibration procedures.

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The MAMMOMAT Revelation is intended to be used for mammography exams, screening, diagnostics, biopsies and dual energy procedures under the supervision of medical professionals. The Mammography images can be inter hard copy film or soft copy workstation.

With Biopsy Option:

The InSpect feature for MAMMOMAT Revelation with HD Biopsy options is intended to provide digital X-ray images of core biopsy specimens in order to allow rapid verification that the correct tissue has been excised with the biopsy procedure.

MAMMOMAT Revelation is a floor-mounted full field digital mammography system for screening, diagnostic and biopsy procedures on standing, seated or recumbent patients.

The system consists of an examination stand with X-ray generator, a gantry with tube housing assembly and mammography support table including detector, and an acquisition workstation with a radiation shield. The MAMMOMAT Revelation comes with a variety of compression plates and a biopsy attachment for diagnostic adjunct procedures.

The MAMMOMAT Revelation features an updated detector (LMAM 2v2), an upgrade to the MS Windows 10 operating system, the capability to do contrast enhanced mammography and tomosynthesis guided biopsy.

The Siemens MAMMOMAT Revelation device was evaluated in non-clinical bench tests. Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance for Test Set:

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the bench tests. These tests are non-clinical and conducted in a laboratory setting.

3. Number of Experts and Qualifications for Ground Truth of Test Set:

Not applicable. The tests described are bench tests focused on technical performance metrics (detector characteristics, image quality, targeting accuracy) and do not involve human readers or expert-established ground truth in the traditional sense of a clinical study. The "ground truth" for these tests would be the established physical and technical specifications or reference measurements.

4. Adjudication Method for Test Set:

Not applicable. As these are bench tests, an adjudication method for human interpretation is not relevant. The results are based on direct measurement and comparison against defined technical criteria.

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

No. The document describes non-clinical bench tests. There is no mention of an MRMC comparative effectiveness study involving human readers.

6. Standalone (Algorithm Only) Performance:

The document describes tests of the physical device's characteristics and its features. It does not specifically detail a "standalone" algorithm performance study without a human-in-the-loop, as the device is a medical imaging system. The "algorithm" here would refer to the internal image processing and AEC calculations, which are components of the system test.

7. Type of Ground Truth Used:

The ground truth for these non-clinical tests is based on:

• Established specifications and performance of the predicate device (for detector characteristics).
• Defined technical standards and internal system test records (for dual energy image quality).
• Physical measurements against a known target in a phantom (for targeting accuracy).

8. Sample Size for Training Set:

Not applicable. The document describes tests for a medical imaging device, not an AI or machine learning algorithm that typically requires a separate training set. The "MAMMOMAT Revelation" is a physical mammography system.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no mention of a separate training set for an AI algorithm.

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The Xpress BCD is a reusable device indicated for use with stereotactic biopsy platforms to apply temporary focal mechanical compression to a stereotactic breast biopsy site to achieve hemostasis. Rx Only. Federal (USA) law restricts this device to sale by or on the order of a physician.

The XPress BCD device is an accessory used in conjunction stereotactic breast biopsy devices. The XPress BCD is comprised of Delrin® DuPont (acetal homopolymer resin, Delrin 150NC010), or similar material. There are three (3) independent XPress BCD device configurations that are provided as a set: configuration 1 (large flat), configuration 2 (modified pyramidal), and configuration 3 (modified spherical). These different configurations are used based on the biopsy site being treated. The Xpress design includes a mechanical slot for attaching to compression paddles of mammographic x-ray systems. The XPress BCD is used in conjunction with the XPress BCD Cover (K863853; classification JAA; manufactured by Preferred Medical Products, Ducktown, TN). It is used to enclose the XPress BCD for use as intended. The XPress BCD Cover, is a sterile, single-use covering. The XPress BCD Cover is a 4 X 5 inches covering of a 0.002 mm thick polyethylene blend material, and its closure system is a round or oblong synthetic rubber band made of a polyisoprene polymer, measuring 2 X 1/8 X 1/16 inches. The XPress BCD Cover is packaged with the XPress BCD or may be purchased separately.

1. Acceptance Criteria and Reported Device Performance

The document describes a clinical study to evaluate the performance of the XPress BCD Breast Compression Device for achieving hemostasis after stereotactic-guided breast biopsy. The primary clinical performance measure/adverse effect was hematoma formation, defined as a new three-dimensional mass (> 0.52 cm³) detected on standard post-biopsy full-field mammography.

The document does not explicitly state pre-defined acceptance criteria with specific numerical thresholds for hematoma formation rate. However, the study results are presented, demonstrating the device's performance in this aspect.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

Note: The document focuses on demonstrating that the device is "as safe and effective as the predicate device" through a clinical study, rather than specific acceptance thresholds.

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

• Sample Size for Test Set: The study included 120 biopsies performed on 118 female subjects.
• Data Provenance: The study was a "prospective historical control single arm clinical study (NCT02327598)" conducted at "one investigational site". The country of origin is not explicitly stated, but the FDA submission suggests it is likely the USA. The study design is prospective.

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

• Number of Experts: The study involved primary investigators and two "independent mammographers" for review.
  • Five investigators and six assistants participated in the study for immediate post-compression hematoma detection.
  • Two independent mammographers reviewed the imaging for hematoma and fat necrosis.
• Qualifications of Experts: The qualifications of the "primary investigators" are not specified beyond their role in the study. The "independent mammographers" are referred to as such, suggesting they are qualified radiologists specializing in mammography, but their specific years of experience or board certifications are not provided.

4. Adjudication Method for the Test Set

• The document implies that immediate post-compression hematoma detection was performed by primary investigators.
• For delayed hematomas and fat necrosis, the "primary study" and "independent mammographers" assessed the mammographic evidence.
• There is no explicit mention of an adjudication method (like 2+1 or 3+1 consensus) if there were disagreements between the independent mammographers or between the primary study findings and the independent reviewers. Both reviewers' findings for hematoma and fat necrosis are reported separately, suggesting independent assessments without a formal reconciliation process mentioned.

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

No, an MRMC comparative effectiveness study was not explicitly stated or described. The study was a "single arm clinical study" focusing on the XPress BCD device's performance after biopsy. There is no comparison of human readers with vs. without AI assistance. The study evaluates a physical device, not an AI algorithm.

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

This question is not applicable. The XPress BCD is a physical breast compression device, not an AI algorithm. Therefore, no standalone algorithm performance study would be conducted.

7. The type of ground truth used

The ground truth for hematoma formation was based on:

• Clinical observation: Primary investigators detected immediate post-compression hematoma.
• Imaging review: Mammograms were used to detect hematomas and fat necrosis, reviewed by primary study staff and two independent mammographers.
• Patient follow-up/outcomes data: Phone contact after 24 hours and 7 days, and clinical/ultrasound evaluation for returning patients, were part of the follow-up for adverse events. Hematoma was defined as a "new three dimensional mass (> 0.52 cm') detected on standard post-biopsy full-field mammography." This suggests an imaging-based "ground truth" for the primary outcome.

8. The Sample Size for the Training Set

This question is not applicable. The XPress BCD is a physical device, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI.

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

This question is not applicable as there is no training set for a physical device.

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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 indications for use of the product is to remove the cold from the bucky by placing this sheet between patient's breast and the image receptor plate allowing the patient to feel more comfortable and less cold without interfering with image quality.

Comfort Cover is a single-use disposable cover placed between the patient's breast and the image receptor plate during mammography. The purpose of this product is to allow the patient to feel more comfortable and less cold during the mammographic examination without interfering with image quality. Comfort Cover will allow for artifact-free images in both Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT), patient radiation dose is equivalent to that when using no Comfort Cover and the Image quality is equivalent to images exposed without Comfort Cover.

Comfort Cover is designed to fit small and large image receptor plates of all leading mammographic equipments. The product is constructed of a fabric material with a purple printed design and has adhesive backing with a paper liner. Both the material and adhesive backing of the product do not affect imaging.

The product is directly applied wrinkle free to the image receptor plate of the mammographic machine by the adhesive backing exposed by peeling off the liner. After the patient's mammogram, the product is peeled off the image receptor plate and disposed. As the product removes cleanly without leaving behind any residue, the image receptor plate does not need to be cleaned between Comfort Covers nor between patients.

The provided document, a 510(k) Premarket Notification for the "Comfort Cover," describes the device, its intended use, and comparative testing against a predicate device. However, it does not contain the level of detail typically found in a clinical study report or a regulatory submission for a device involving AI or complex performance metrics. The Comfort Cover is a disposable cover for mammography plates to enhance patient comfort without affecting image quality.

Below is an attempt to extract and synthesize the requested information based on the document, noting where specific details are not provided or are not applicable to this type of device.

1. Table of Acceptance Criteria and Reported Device Performance

• Irritation and Skin Sensitization: Pass ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization). | - The subject device passed all tests (ISO 10993-5 and ISO 10993-10). |
  | Mechanical/Physical Performance | - Visual and Dimensional: No visible defects, correct dimensions.
• Thermal Conductivity: Performance in line with material properties (implied comparison to predicate).
• Ink Smear: No ink smearing as per ASTM D5264-98.
• Peel Adhesion: Adequate peel adhesion as per ASTM D6252-98 (90° Angle).
• Removes Cleanly: Product removes cleanly without leaving residue (in-house method). | - The subject device passed all visual and dimensional examinations.
• Thermal Conductivity Test was performed.
• Ink Smear Test was performed and passed.
• Peel Adhesion Test was performed and passed.
• Removes Cleanly Test was performed and passed (removes cleanly from mammographic equipment without leaving residue). |
  | Radiological Performance | - Artifact-free images: Allow for artifact-free images in both Full Field Digital Mammography (FFDM) and Digital Breast Tomosynthesis (DBT) when using Comfort Cover.
• Patient Radiation Dose: Equivalent to that when using no Comfort Cover.
• Image Quality: Equivalent to images exposed when using no Comfort Cover.
• Radiolucent: Does not image, no artifacts, quality of images not affected. | - Comfort Cover allows for artifact-free images in both FFDM and DBT.
• Patient radiation dose is equivalent to that when using no Comfort Cover.
• Image quality is equivalent to images exposed when using no Comfort Cover.
• The device is radiolucent. |
  | Usability | - Fulfill design requirements of making mammography examination more comfortable.
• Not negatively impact patient positioning. | - The Comfort Cover fulfilled its design requirements of making the mammography examination more comfortable.
• The Comfort Cover did not negatively impact patient positioning. |
  | Comparison to Predicate (Overall) | - Similar Indications for Use, Target Population, Where Used, Product Size, Packaging and Labeling, Biocompatibility, Sterility, Dispensing Method, and Environment Compatibility.
• Minor material differences (fabric type, ink color) do not affect safety and effectiveness.
• Provides comfort and removes cold without affecting image quality.
• Allows for artifact-free images and image quality equivalent to images exposed without Comfort Cover.
• Removes cleanly without residue.
• Printed ink does not smear.
• Remains where placed.
• Radiolucent. | - All "None" in the "Significant Differences" column of Table 5-1 indicate similarity.
• Stated: "Safety and performance testing results have shown that the slight differences in material composition do not affect safety and effectiveness."
• Stated: "Provides comfort and removes cold during a mammographic examination without affecting quality of the images."
• Stated: "Allows for artifact-free images and image quality equivalent to Comfort Cover."
• Stated: "Removes cleanly from the mammographic equipment without leaving behind any residue."
• Stated: "Printed ink does not smear."
• Stated: "Remains where placed."
• Stated: "Does not image, no artifacts, quality of images not affected, radiolucent." |

2. Sample size used for the test set and the data provenance
The document does not provide specific sample sizes (e.g., number of covers, images, or participants) for the test sets. It states that "a number of non-clinical performance tests" were completed.

• Biocompatibility: Testing was conducted per ISO 10993-5 and ISO 10993-10 on the subject device.
• Mechanical Testing: Performed on "both the subject and the predicate devices."
• Radiological Studies: Phantom image testing was performed "as per MQSA regulations and with relevant International Electro technical Commission (IEC) standards (62220-1-2:2007 and 61223-3-2)." This implies the use of standardized phantoms, not patient data.
• Usability Studies: Included "radiologists, radiology technologists and patients." The number of each group is not specified.

Data provenance (country of origin, retrospective/prospective) is not specified, but given the nature of the tests (lab-based, phantom studies, usability feedback), it is likely all internal data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. For the usability studies, "radiologists" and "radiology technologists" were involved, but their number and specific qualifications (e.g., years of experience) are not detailed. For radiological studies, phantom images were used, implying objective measurements rather than expert human interpretation for ground truth.

4. Adjudication method for the test set
Not applicable or not described. The tests are primarily objective measurements (e.g., passing a specific ISO standard, conforming to ASTM methods, measuring radiation dose, image quality metrics from phantom images). For usability, it simply states that user needs were fulfilled, but no adjudication method for consensus is mentioned.

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 was done, nor is this device related to Artificial Intelligence (AI). The Comfort Cover is a physical accessory for patient comfort during mammography.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI.

7. The type of ground truth used

• Biocompatibility: In-vitro and in-vivo (skin irritation/sensitization) test results against ISO standards.
• Mechanical Testing: Objective measurements (e.g., ASTM standards, in-house developed test for residue).
• Radiological Studies: Objective measurements from phantom images (e.g., presence/absence of artifacts, radiation dose measurements, image quality metrics) compared to baselines (without Comfort Cover) and regulatory/IEC standards.
• Usability Studies: User feedback (radiologists, technologists, patients) on comfort and impact on positioning.

8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model and does not have a "training set."

9. How the ground truth for the training set was established
Not applicable.

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The Affirm Prone Biopsy System combines the function of a standard x-ray mammography unit with that of a lesion localization system to produce a device that has specific application in first accurately localizing lesions in the breast in two and/or three dimensions, and then providing guidance for interventional purposes (such as biopsy, pre-surgical localization or treatment devices) for lesions determined to be suspicious through prior mammographic examination.

It is intended for lesion location for biopsy while the patient is in the prone position to provide guidance for interventional purposes (such as biopsy, presurgical localization or treatment devices).

The Affirm Prone Biopsy Table is a mammographic x-ray system intended for lesion location while the patient is in the prone position. The subject device will be capable of both 2D and 3D imaging methods to calculate the target location. The system localizes suspicious lesions, as determined through prior mammographic examinations, using either stereotactic or tomosynthesis techniques. The system then affords a physician the capacity of performing vacuum assisted or needle core biopsy, or wire localization of the lesion.

Localization can be accomplished either via conventional 2D stereotactic imaging, or by use of a 3D data set. With the 3D data set, the image plane or "slice" most fully containing the suspected lesion is chosen by the physician from the data set to compute the lesion depth within the breast.

Here's an analysis of the provided text to extract information about acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, specific quantitative acceptance criteria or a direct performance table are not explicitly stated or presented. The document focuses on regulatory compliance and substantial equivalence to predicate devices.

However, the "Performance Testing" section (Page 4, Section 7) indirectly points to an acceptance criterion:

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

The document does not specify a sample size for a test set in the context of clinical performance or diagnostic accuracy. The testing mentioned appears to be primarily engineering verification and validation against safety and quality standards.

The data provenance (e.g., country of origin, retrospective/prospective) related to any clinical test set is not mentioned.

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

This information is not provided in the document. The type of testing described (compliance with IEC standards, design control) does not typically involve expert-established ground truth in the same way a clinical performance study would.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1) for a clinical test set is not mentioned because a clinical test set for diagnostic performance is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance is not mentioned in this document. The device is a "Biopsy System" for guidance, not a diagnostic AI interpretation tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The document describes the "Affirm Prone Biopsy System" as a physical mammographic x-ray system that provides guidance for interventional procedures. While it utilizes "2D and 3D imaging methods to calculate the target location" (Page 4, Section 4), it is fundamentally a system that aids a physician. Therefore, a standalone (algorithm only) performance, separate from human operation or decision-making, is not described or implied. The device's function is to guide a human operator.

7. The Type of Ground Truth Used:

The document focuses on engineering and regulatory ground truth:

• Compliance with IEC 60601-2-45 standards: This implies meeting established technical specifications and safety requirements.
• Compliance with 21 CFR Part 820 (Design Controls): This refers to documented evidence that the device design meets user needs and intended uses.
• Equivalence to Predicate Devices: The "ground truth" for its performance is its demonstrated similarity in technology, operation, and functional performance to previously cleared devices.

There is no mention of clinical ground truth such as pathology, expert consensus on lesions, or outcomes data for a diagnostic or interventional accuracy claim. The device's purpose is localization and guidance, not diagnostic interpretation.

8. The Sample Size for the Training Set:

The document does not mention a training set size. This is consistent with the nature of the device being an imaging and guidance system, rather than a machine learning or AI algorithm requiring a training set for feature learning. The image processing for 2D/3D localization would be based on established algorithms, not necessarily a trained machine learning model.

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

Since a training set is not mentioned, the method for establishing its ground truth is also not applicable/provided.

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MammoGRIP aids in positioning during radiologic visualization of the breast.

MammoGRIP™ is a non-medicated, 0.1% benzalkonium chloride foam solution intended to be used during mammography to facilitate breast positioning. When MammoGRIP is applied to the technician's hands, it imparts a slightly tacky or sticky surface while it is still damp, thereby allowing the technician to have a better grip of the dry breast tissue for optimal positioning in the field of view of the mammography machine. MammoGRIP is intended to be used with standard mammogram positioning techniques.

The provided text is a 510(k) summary for the MammoGRIP device. It does not describe a study involving an AI algorithm or its performance. Instead, it describes a device that aids in breast positioning during mammography by making a technician's hands slightly tacky. The acceptance criteria and "study" mentioned refer to biocompatibility tests and verification of physical characteristics for this accessory, not an AI performance study.

Therefore, most of the requested information regarding AI device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not applicable to this document.

Here's what can be extracted based on the provided text, interpreted in the context of the device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The text describes biocompatibility tests (assays) and quality control verifications for the physical characteristics of the device. These are not "test sets" in the context of clinical performance data for an AI system. The sample size for these tests is not specified in the document, nor is the data provenance in terms of country of origin or retrospective/prospective nature, as these are typically laboratory tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" here would relate to the outcome of biological responses to the material (biocompatibility) or the physical/chemical properties of the product. These are assessed by laboratory procedures, not by expert interpretation of clinical data in the way an AI would be evaluated.

4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" are used for expert consensus on clinical findings. For biocompatibility tests, results are typically determined by standardized laboratory protocols.

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. This is not an AI device, and no MRMC study was conducted or is relevant for this type of accessory.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
No. This is not an AI algorithm.

7. The type of ground truth used
For biocompatibility, the ground truth is established by the biological response observed in standardized assays. For physical characteristics, the ground truth is the measured physicochemical properties of the formulation.

8. The sample size for the training set
Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established
Not applicable. This is not an AI device.

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SPECBOARD JR is intended to be used as an accessory to a mammographic x-ray system. The SPECBOARD JR is used to contain the mammographic specimen from the patient when transported to the x-ray device and then accompany the x-ray image to the pathology laboratory.

The SPECBOARD is a medical device that allows for accurate localization of suspect lesions in breast tissue. The SPECBOARD JR is comprised of a foam core base coupled with a tape hinge along one edge to a thick cardboard cover. On the base foam core piece there is a centrally located piece of absorbent blotter paper. Along two joining edges of the blotter are two radio-opaque nickel stencils, one marked with alpha characters and the other with numerical characters. The SPECBOARD JR is used in the operating room where the surgeon will remove a suspect portion of the breast tissue and place it on the blotter portion of the SPECBOARD JR. The cover is then closed, sandwiching the breast specimen between the cover and the base. The cover is then secured with the Velcro latch and an x-ray is taken of the specimen inside the SPECBOARD JR. The resulting x-ray image will show the perpendicular stencils along the border of the blotter paper and the specimen on the blotter paper. Any lesions will show up within the specimen and the pathologist then has a reference of where to cut into the specimen to withdrawal a piece for analysis.

The provided text is a 510(k) summary for the SPECBOARD JR, which is a specimen transport and identification device used as an accessory to a mammographic x-ray system. The filing asserts substantial equivalence to a predicate device, the SPECBOARD (K891090).

Based on the provided information, there is no detailed study described that establishes acceptance criteria for device performance or provides data from such a study. The 510(k) summary focuses entirely on demonstrating substantial equivalence to the predicate device, not on proving clinical performance or meeting specific acceptance criteria through a performance study.

Here's an analysis based on the structure of your request and the information available:

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

• Acceptance Criteria: Not explicitly stated or provided in the document.
• Reported Device Performance: Not explicitly stated or provided in the document in terms of quantitative performance metrics. The filing claims the device "is expected to have the same safety record as the predicate SPECBOARD product, no failures reports." This is a statement of expectation rather than reported performance from a specific study.

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

• Sample Size: Not applicable. No test set or performance study data is described.
• Data Provenance: Not applicable.

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)

• Number of Experts: Not applicable. No performance study requiring expert adjudication is described.
• Qualifications of Experts: Not applicable.

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

• Adjudication Method: Not applicable. No performance study requiring adjudication is described.

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: No. This device is a passive accessory and does not involve AI or human readers for diagnostic interpretation in the way an AI-driven imaging CAD system would. Its function is to hold a specimen for X-ray and provide reference markers.

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

• Standalone Performance: Not applicable. This is a physical device, not an algorithm.

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

• Ground Truth: Not applicable. No performance study is described that would require a ground truth for evaluation. The device's primary function is to aid in localization for pathology, not to diagnose.

8. The sample size for the training set

• Training Set Sample Size: Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

• Ground Truth for Training Set: Not applicable.

Summary of the 510(k) Approach for SPECBOARD JR:

The 510(k) for SPECBOARD JR is a design modification submission, leveraging the substantial equivalence pathway based on predicate device K891090 (SPECBOARD). The core argument for safety and effectiveness is that:

• The SPECBOARD JR is smaller than the predicate SPECBOARD.
• It uses the same materials as the predicate.
• It has the same design elements and packages them into a smaller form factor.
• It performs the same function (containing specimens for X-ray and providing reference markers for pathology).
• The predicate device has a long history of safe use ("in worldwide use since 1989" with "no failures reports").

Because the changes are minimal and do not alter the fundamental technological characteristics or intended use, a dedicated performance study with acceptance criteria was not deemed necessary by the FDA. The FDA's decision summary explicitly states, "The information in the 510(k) is complete and supports a substantial equivalence (SE) determination." This indicates that the comparison to the predicate, demonstrating that the device is "the difference being in size," was sufficient for clearance.

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