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The Biopsy Digit S and SL are intended to be used for mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.

The Biopsy Digit S and Biopsy Digit SL are modifications to the Biopsy Digit AM needle guidance system. previously cleared as #K062039. and supplied as an accessory to the Giotto Image 3D/DL mammography system. The CMOS digital camera used on the Biopsy Digit AM is not used on the Biopsy Digit S/SL. Rather a 65mm (high) X 80mm (wide) portion of the full field amorphous selenium detector of the Giotto Image 3D/DL is used to acquire the mammographic, targeting, image data. The mechanics, cleanable surfaces, on-board electronics, and user interface software are all the same as on the biopsy Digit AM. The Biopsy Digit S/SL receives power from the Giotto Image 3D/DL. The Biopsy Digit S/SL in conjunction with the Giotto Image 3D/DL, take two exposures at separate angles ± 22.6° from the perpendicular of the digital detector centerline. The x-ray tube is driven first to one side of center and then to the other by an electro-mechanical mechanism, which is an integral part of the Giotto Image 3D/3DL, so that a stereo pair of images can be acquired. The two views provide two separate 2dimensional projections of the subject anatomy. The two views are stored in the computer system, and can be retrieved and viewed on the computer monitor. The operator, using a mouse, identifies the region of interest on the monitor. The computer then calculates of the region of interest in three dimensions, using trigonometry, and then transfers the coordinates to the needle-positioning unit. The software algorithm used for the calculation is identical to that used by the Biopsy Digit AM (#K062039). The needle-positioning unit then drives the needle holder to the required location so that the operator can insert the needle or locating wire into the exact coordinates necessary.

The provided 510(k) summary for the Giotto Biopsy Digit S/SL does not contain explicit acceptance criteria or a detailed study description with specific performance metrics and statistical analyses typically associated with proving a device meets acceptance criteria.

The document describes the device as a modification of a previously cleared device (Biopsy Digit AM) and focuses on demonstrating substantial equivalence through non-clinical testing. It highlights changes in the detector technology (from CMOS to an amorphous selenium detector) and confirms that the mechanics and software algorithms remain the same.

However, based on the information provided, here's what can be inferred and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

This information is not provided in the document. There is no mention of the number of images, cases, or subjects used in any of the described tests. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not stated.

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

This information is not provided. The document mentions "end user validation testing," but does not specify how many users participated, their qualifications, or how any "ground truth" for this validation was established. For stereotactic accuracy testing, the "ground truth" would likely be derived from physical measurements against a known standard, not expert consensus.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of the testing described (comparative image parameters, stereotactic accuracy, end-user validation), an adjudication method (like 2+1 or 3+1 expert consensus) is unlikely to be directly applicable in the way it would be for diagnostic AI performance. For end-user validation, feedback mechanisms would be used, but the specific method is not detailed.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described in this 510(k) submission. The device is a needle guidance system, not a diagnostic AI intended to assist human readers in interpretation. Therefore, assessing how human readers improve with or without AI assistance is not relevant to this device's function as described.

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

Standalone performance, especially for the "software algorithm used for the calculation" of the region of interest in three dimensions, was implicitly tested. The document states:

• "Stereotactic accuracy testing for both biopsy systems in compliance with IEC Standard 60601-2-45"
  This testing would assess the accuracy of the system (including the algorithm) in guiding the needle, independent of a specific human operator's interpretation. However, specific results of this standalone accuracy are not provided. The document emphasizes that "The software algorithm used for the calculation is identical to that used by the Biopsy Digit AM (#K062039)," relying on the previous clearance for the algorithm's validation.

7. The Type of Ground Truth Used

• For Image Parameter Testing: Likely objective measures derived from test phantoms or calibrated imaging standards.
• For Stereotactic Accuracy Testing: Established through physical measurements against known targets or a gold standard measurement device, as per IEC Standard 60601-2-45.
• For End User Validation: Likely user feedback and possibly a demonstration of successful task completion based on the device's intended use.
• For Compliance with Standards: Objective verification against the requirements of the specified IEC standards.

The document does not explicitly state the exact nature of the ground truth for each test, but it can be inferred from the type of testing.

8. The Sample Size for the Training Set

This information is not applicable / not provided. The device is an accessory for stereotactic guidance, not a machine learning or AI algorithm that requires a training set in the conventional sense. The "software algorithm" for coordinate calculation is stated to be "identical" to the predicate device, implying it was developed and validated previously, not "trained" in this submission.

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

This information is not applicable / not provided for the same reasons as #8. If the "software algorithm" for coordinate calculation was developed using any form of historical data or training, those details are not within this 510(k) submission. The submission relies on the previous clearance (K062039) for the validation of this specific algorithm.

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The intended use of the Giotto Image 3D is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

The intended use of the Giotto Image 3D-L is to produce digital images suitable for screening and diagnostic examination of the breast for detection of breast cancer.

GIOTTO IMAGE-3DL Full field digital mammography unit with amorphous Selenium detector 24x30.

Versatile unit conceived for screening, but ideal for diagnostic. Very low x-ray dose emission, automatic and fast 3D movements of the circular arm, isocentric rotation, prearranged for stereotactic biopsy. x-ray tube with W/Re double track bi-angular anode 10°/16°, 0.1/0.3 mm focal spot, High Frequency/High Power 8 kW generator, Ag/Rh filters with automatic and manual insertion. Double digital display showing rotation and tilting angles of the circular gantry, compression force and compressed thickness.

The system includes:

• Giotto IMAGE mammography unit with motorized tube rotation ± 24° for . stereotactic biopsy.
• Amorphous Selenium detector 24 x 30 cm .
• MAW (Management & Acquisition Workstation) ) with 21" LCD 2Mpixel . monitor, dedicated computer for images acquisition/processing. DVD/CD professional burner.
• Raffaello® (AWS) software: Graphic User Interface for visualization and . processing of digital mammographic images. DICOM 3 interface.

The Giotto Image 3DL consists of gantry with a vertical column, a circular support for the x-ray tube, and compression mechanism, and an x-ray generator all of whip are very similar to the Giotto Image analog mammography system previously cleared under 510(k) K012953. It incorporates an 24 X 30 amorphous selenium detector that directly captures x-rays and converts the them into electronic signal from which the images are constructed. The images are displayed on am monitor for review by the operator.

The x-ray tube used is a Varian with tungsten anode and Ag/Rh filters. The gantry can be positioned automatically via motorized movement in 3 dimensions.

Images are produced with proprietary acquisition and processing algorithms and displayed at an operator acquisition where the operator may enter patient data (o it is received from a DICOM worklist). The images are transmitted from the acquis (ion station to a workstation for interpretation.

Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:

Acceptance Criteria and Device Performance Study for Giotto Image 3D/3D-L

Based on the provided 510(k) summary, the Giotto Image 3D and 3D-L devices were cleared based on a demonstration of substantial equivalence to predicate devices rather than meeting specific performance metrics with predefined acceptance criteria in a clinical study. The "study" described is a radiological examination of images to establish substantial equivalence in image quality, not a clinical trial with predefined performance endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not explicitly state quantitative "acceptance criteria" (e.g., sensitivity, specificity, AUC) or corresponding "reported device performance" values in the way a clinical trial typically would. Instead, the "acceptance criterion" was effectively the opinion of expert radiologists that the image quality was "sufficiently acceptable for mammographic usage to allow determination of substantial equivalence" to previously cleared devices.

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

• Sample Size: 6 patients.
• Data Provenance: Images and associated information from screening and diagnostic examinations. The images were selected by IMS and Giotto USA, LLC staff and radiologists at various mammography facilities in Europe. This indicates the data is retrospective and of European origin.

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

• Number of Experts: Unspecified, but referred to as "Expert radiologists." The plural suggests more than one.
• Qualifications: "Expert radiologists." No further specific qualifications (e.g., years of experience, subspecialty certification) are provided in the document.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated as a formal adjudication process (e.g., 2+1, 3+1). The text states, "Expert radiologists assessed the image sets and provided an opinion as to whether or not the images in each case are of 'sufficiently acceptable quality for mammographic usage to allow determination of substantial equivalence'." This suggests a consensus-based opinion or potentially independent assessments without further adjudication specified in this summary.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states, "No clinical tests were performed." The assessment focused on the quality of images rather than reader performance with and without AI assistance.

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

• Not applicable / No. The device is a full-field digital mammography unit, not an AI algorithm intended for standalone interpretation. The assessment was of the image output from the device, which is then interpreted by human radiologists.

7. The Type of Ground Truth Used

• The "ground truth" for the patients used in the image examination was their BI-RADS® Assessment Categories (1 or 2). This indicates that the patients had benign findings or were considered normal. The purpose was to assess image quality for typical examinations, not to diagnose difficult cases.

8. The Sample Size for the Training Set

• The document does not mention a training set in the context of an AI/algorithm being developed or trained. This device is a digital mammography unit, not primarily an AI diagnostic tool. Its acquisition and processing algorithms are proprietary, but the submission pertains to the hardware and its image output, evaluated by human experts.

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

• Not applicable. As no training set for an AI algorithm is mentioned, this information is not provided.

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

The BIOPSY DIGIT-AM device uses two stereo images taken by a digital solid state camera to determine the location of a lesion in three dimensions. Once the coordinates of the lesion are determined by the BIOPSY DIGIT-AM they are used to position a needle holder such that when the physician inserts the needle or guide-wire, the tip will be precisely positioned at the pre-determined coordinates.

The provided text describes a medical device called BIOPSY DIGIT-AM, which is a mammographic system intended for stereotactic guidance in breast biopsy procedures. However, the document is a 510(k) summary for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device (BIOPSY DIGIT).

It does not contain information about specific acceptance criteria, a detailed study proving performance against those criteria, or the typical elements of an AI/algorithm-focused performance study. The document primarily asserts equivalence based on "materials used, technology applied, and functional methodology" and states that "Differences of note do not affect safety and effectiveness of the device, intended use, or application methods."

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text. The document is about a mechanical/imaging system rather than an AI or algorithm-driven diagnostic tool that would typically have the kind of performance metrics you've asked for.

Here's an attempt to address your request based on the absence of information and the nature of the device described:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:
Not provided. The document describes a physical medical device, not an AI/algorithm trained on a dataset. Substantial equivalence for such devices often relies on engineering specifications and preclinical testing, rather than large clinical test sets with ground truth labels in the way AI algorithms do.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment by experts for a test set is described, as this is not an AI/algorithm performance study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No expert adjudication for a test set 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:
Not applicable. This device is a stereotactic guidance system, not an AI assistant for human readers. 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 a "System Mammographic" and "uses two stereo images... to determine the location of a lesion." While it uses a calculated determination, it's a physical system for guidance, not a standalone diagnostic algorithm. Its function is to determine coordinates for physical needle placement, which is then performed by a physician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable in the context of an AI/algorithm performance study. For a stereotactic biopsy device, the "ground truth" would implicitly be the actual pathological confirmation of the lesion's presence and type, and the device's accuracy would be measured by how closely the needle tip reaches the target. However, no such specific study or ground truth methodology for performance validation is described in this document.

8. The sample size for the training set:
Not applicable. This is not an AI/algorithm that undergoes a training phase with a dataset.

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

Summary of what the document does indicate regarding "performance":

• Principle of Operation: It works like human binocular vision to determine 3D coordinates from two stereo X-ray images.
• Intended Use: Identical to the predicate device (BIOPSY DIGIT, K990192) for mammographic stereotactic guidance (fine needle aspiration, needle biopsy, guide wire placement).
• Substantial Equivalence: The BIOPSY DIGIT-AM is described as substantially equivalent to the predicate BIOPSY DIGIT in "materials used, technology applied, and functional methodology." The submission asserts that "differences of note do not affect safety and effectiveness of the device, intended use, or application methods."
• Performance Claim: The device "performs as well as the predicate BIOPSY DIGIT." The predicate itself was implicitly deemed safe and effective for its intended use through its prior clearance.

In essence, this 510(k) submission is a declaration of equivalence to an already cleared device, arguing that the new device has no new questions of safety or effectiveness. It does not present novel performance data against specific, defined acceptance criteria in the way a new AI algorithm might.

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