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The intended uses of the Biopsy Digit are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement. The intended uses are identical to those of the predicate device.

The Biopsy-Digit 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 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 does not contain specific acceptance criteria or a detailed study proving the device meets them. It describes the device's function, intended use, and substantial equivalence to a predicate device, but lacks the quantitative performance data needed to populate the requested table and answer several questions about a performance study.

Therefore, many of the requested fields will state "Not available in the provided text."

Here's a breakdown 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)

• Sample Size (Test Set): Not available in the provided text.
• Data Provenance: Not available in the provided text.

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 available in the provided text.
• Qualifications of Experts: Not available in the provided text.

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

• Adjudication Method: Not available in the provided text. The document focuses on the mechanical and functional equivalence of the device, not on diagnostic performance where adjudication would be relevant.

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: Not available in the provided text. The device is a stereotactic guidance system, not an AI-powered image analysis tool that would typically be evaluated in an MRMC study for reader improvement.
• Effect Size: Not applicable, as no MRMC study is mentioned.

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

• Standalone Performance Study: Not available in the provided text. The device is described as a system that facilitates a physician's procedure, implying human-in-the-loop operation, rather than a standalone AI algorithm.

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

• Type of Ground Truth: Not available in the provided text. The submission focuses on the mechanical accuracy of the device in determining lesion location and guiding a needle, rather than a diagnostic outcome where "ground truth" (e.g., pathology) would typically be established for diagnostic accuracy.

8. The sample size for the training set

• Sample Size (Training Set): Not applicable. The device described appears to be a mechanical device based on "human binocular vision" principles, rather than a machine learning model that requires a training set.

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

• Ground Truth Establishment (Training Set): Not applicable, as the device does not appear to be a machine learning model requiring a training set.

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The intended uses of the Biopsy M are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration. needle biopsy and guide wire placement. The intended uses are identical to those of the predicate device.

The Biopsy-M device uses two stereo images on a film to determine the location of a lesion in three dimensions. Once the coordinates of the lesion are determined by the Biopsy-M 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.

I am sorry, but the provided text does not contain information regarding the acceptance criteria, the study details (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information), or reported device performance for the Biopsy-M device. The document primarily describes the device's function, its comparison to a predicate device, and the FDA's 510(k) clearance letter.

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The Glotto RT is intended to provide film-screen X-ray imaging of the breast and other soft-tissue organs that can be imaged on a 18 x 24cm or 24 x 30cm film. With optional accessories the Giotto HT can also be used as the imaging device for sterotactic needle biopsy.

The Giotto HT is a conventional film-screen x-ray mammographic device. This device is designed to generate a high resolution image of the breast on film using an x-ray source designed specifically for mammography. It incorporates a state-of-the-art microprocessor controlled high frequency single phase x-ray generator and automatic exposure control, molybdenum rotating anode x-ray tube with 0.3 and 0.1 mm focal spots, gantry, compression device and film holder. The unique open design of the Giotto HT allows positioning of the patient with the operator facing the patient. This face-to-face positioning allows the operator to carefully center the breast and compress it quickly and efficiently. Optional accessories allow both prone and seated breast needle biopsy.

The provided document, K973d56, describes a 510(k) submission for a conventional film-screen x-ray mammographic device named Giotto HT. As a premarket notification for a medical device cleared through the 510(k) pathway, it primarily focuses on demonstrating substantial equivalence to a predicate device, not on specific clinical study results proving performance against acceptance criteria in the way a new, high-risk device might.

Therefore, the information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, as requested, is largely not present in this type of 510(k) summary. This document operates under the assumption that if the device is substantially equivalent to a legally marketed predicate device, its safety and effectiveness are established.

However, based on the provided text, I can infer some aspects related to acceptance criteria and the "study" (which in this context refers to the substantial equivalence comparison).

Here's the breakdown of the requested information, with acknowledgements of what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation:
The document doesn't list explicit "acceptance criteria" in a quantitative, measurable format as might be found in a clinical trial protocol. Instead, for a 510(k) device like this, the primary "acceptance criterion" is substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device. The "reported device performance" is essentially the claim of substantial equivalence and adherence to established standards (like ACR).

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

• Sample Size: Not applicable/Not mentioned. This document describes a comparison to a predicate device and adherence to industry standards, not a specific clinical study with a defined test set of patients or images.
• Data Provenance: Not applicable/Not mentioned.

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

• Number of Experts: Not applicable/Not mentioned. The 510(k) process for this type of device does not typically involve independent expert review of a clinical test set for ground truth establishment.
• Qualifications: Not applicable/Not mentioned.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/Not mentioned. No test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

• MRMC Study Done? No. This device is a conventional mammographic x-ray system, not an AI-powered diagnostic aid. The concept of "human readers improve with AI" is not relevant to this device.
• Effect Size: Not applicable.

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

• Standalone Performance Study Done? No. This device captures images; it is not an algorithm that performs a standalone diagnostic function.

7. The Type of Ground Truth Used

• Type of Ground Truth: Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) is effectively the established safety and effectiveness of the predicate device and the ACR accreditation program requirements. The claim is that the Giotto HT meets or exceeds these established standards.

8. The Sample Size for the Training Set

• Sample Size: Not applicable. This is a conventional imaging device, not an AI/machine learning product that requires a training set.

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

• How Ground Truth Established: Not applicable, as there is no training set for this type of device.

Summary regarding the "study that proves the device meets the acceptance criteria":

The "study" in this 510(k) submission is the comparison to the predicate device (Giotto HE, K901558) and the demonstration of compliance with ACR requirements and the MQSA program. The manufacturer asserts that:

• The Giotto HT's function, scientific concepts, physical and performance characteristics are substantially equivalent to the predicate device.
• The device is designed to meet or exceed all ACR requirements for mammography equipment (e.g., image resolution, contrast resolution, dose, kV accuracy).
• The materials in patient contact are the same as the predicate, ensuring biocompatibility.
• The intended uses are identical to the predicate.

The FDA's allowance to market the device signifies their agreement that sufficient evidence was provided to demonstrate substantial equivalence, thus inherently accepting that the device meets the necessary safety and effectiveness criteria as established by the predicate device and relevant standards in 1997.

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