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The Rabbit is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. It is designed to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Candidate Device is a coaxial breast biopsy system, which is intended to retrieve tissue samples from the breast for histological analysis .The device is provided sterile for single use only. The system includes a disposable biopsy device, Localization needle, stylet, and hook wire. The biopsy device includes a circular scalpel and a Garrote wire to transect the specimen.

This document focuses on the Rabbit breast biopsy instrument, a conventional medical device, rather than an AI-powered system. Therefore, most of the requested information regarding AI-specific criteria (like acceptance criteria for AI performance, MRMC studies, standalone AI performance, or training set details) is not applicable.

Here's an analysis based on the provided text, addressing the applicable points:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a non-AI device relying on substantial equivalence, there are no explicit quantitative "acceptance criteria" for diagnostic performance in the way one would define them for an AI algorithm (e.g., specific sensitivity/specificity thresholds). Instead, the acceptance is based on demonstrating equivalence to predicate devices and meeting general device safety and performance standards.

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

• Not applicable for this type of device. The provided text does not describe a clinical study with a "test set" for diagnostic performance in the context of an AI algorithm. Substantial equivalence for this device relies on demonstrating that its design, materials, and intended use are comparable to legally marketed predicate devices, implying similar safety and effectiveness.

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):

• Not applicable. As above, there's no diagnostic test set in the AI sense for which ground truth would need to be established by experts for this 510(k) submission.

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

• Not applicable. No adjudication method is described for a test set.

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 biopsy instrument, not an AI diagnostic tool. No MRMC study is mentioned.

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

• Not applicable. This is a physical biopsy device, not an algorithm.

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

• Pathology/Histology: The primary "ground truth" related to the device's function is the histological examination of the tissue samples it retrieves. The device's purpose is to provide these samples, which are then analyzed by pathologists. The K-number does not detail specific studies proving the accuracy of the biopsy in comparison to a gold standard, but rather establishes equivalence to predicate devices that are accepted for providing such samples.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

Summary of Device and 510(k) Process:

The provided documents detail a 510(k) premarket notification for the "Rabbit" breast biopsy instrument. The FDA reviewed this submission and determined the device to be substantially equivalent to three predicate biopsy devices already on the market (Auto Suture ABBI System, SiteSelect Breast Biopsy Device, Mammotome).

For conventional medical devices under a 510(k) pathway, "acceptance criteria" largely revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This typically involves comparing:

• Indications for Use: The "Rabbit" is indicated for providing breast tissue samples for diagnostic sampling of breast abnormalities for histologic examination, identical or very similar to predicate devices.
• Technological Characteristics: The device description details its coaxial design, components (scalpel, Garrote wire), and single-use sterile nature. This is compared to the predicate devices.
• Performance Data: While not explicitly detailed as specific diagnostic performance metrics in this summary, the submission would have included verification and validation testing (e.g., mechanical strength, cutting performance, material biocompatibility per ISO 10993-1, sterility) to demonstrate that the device performs as intended and is safe. The FDA's finding of substantial equivalence implies these tests were sufficient.

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The Rabbit Mobile Standing Frame is a mobile transport device for a child who needs to The itabolt Moone Banding, Frances anding, and requires anterior support from feet to sternum during incremental weight bearing from prone to upright standing. The Rabbit is storiall daring meremental whigh cood head, neck, and upper body control, and is atmized by a chird the dasping of their own volition, but requires support and alignment in weight bearing.

Rabbit Mobile Standing Frame

The provided text is a U.S. FDA 510(k) clearance letter for a medical device. This type of document declares a device to be substantially equivalent to a predicate device already on the market, thereby allowing it to be marketed.

However, a 510(k) clearance does not typically include detailed acceptance criteria or a study proving device performance in the way requested for software or AI medical devices. The FDA's substantial equivalence determination for this physical medical device (a mobile standing frame) is based on demonstrations of similarity in intended use, technology, and safety/effectiveness principles to existing devices, rather than a clinical trial demonstrating specific performance metrics against an acceptance criterion.

Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in this document because it is not a requirement for this type of 510(k) clearance for this device.

To directly address your request, based solely on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. This document is a 510(k) clearance letter, confirming substantial equivalence, not a performance study report. Specific quantitative acceptance criteria or performance metrics for this physical device (Rabbit Mobile Standing Frame) are not detailed within this letter. The FDA's review for this device would have focused on its design, materials, and intended use being substantially equivalent to a predicate device, rather than statistical performance metrics like sensitivity/specificity often seen with diagnostic AI/software.

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

• Not applicable. No test set or associated data provenance is described in this regulatory clearance letter.

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

• Not applicable. This document does not describe a test set or ground truth establishment process involving experts.

4. Adjudication Method for the Test Set:

• Not applicable. No test set or adjudication method is described.

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

• No. An MRMC study is typically for evaluating the impact of AI on human reader performance in diagnostic tasks. This device is a "Mobile Standing Frame," a physical assistive device. This document does not mention any such study.

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

• Not applicable. This device is a physical mobile standing frame, not an algorithm. This document does not mention any such study.

7. Type of Ground Truth Used:

• Not applicable. No ground truth (expert consensus, pathology, outcomes data, etc.) is mentioned as being used for performance evaluation in this clearance letter.

8. Sample Size for the Training Set:

• Not applicable. This document does not describe a training set for an algorithm.

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

• Not applicable. This document does not describe a training set or how its ground truth was established.

In summary: The provided document is a regulatory clearance letter for a physical medical device, not a technical report detailing performance studies or acceptance criteria typically associated with software or AI medical devices. Therefore, the requested information regarding acceptance criteria, study methodologies, and data specifics is not present.

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