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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 Scion Balloon Elevator is designed for endoscoopic surgery involved in extraperitoneal or subcutaneous spaces in such common procedures as Saphenous Vein Harvest. The Balloon elevator is designed to fit on the end of our Endoscope Retractor (510K #93006) and atraumatically provide support for the distal end of the retractor. The other function of the balloon is to gently spread tissue by the inflation of the balloon.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Scion Balloon Elevator." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, ground truth establishment, or any other details related to the evaluation of the device's technical capabilities or clinical effectiveness.

The letter focuses solely on the regulatory approval process, stating that the device is substantially equivalent to legally marketed predicate devices and therefore can be marketed.

Therefore, I cannot provide the requested information based on the input text.

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The indications for the use of the DuoClip Titanium Clips are the same as those for a Hemostatic Clips (Product Code 79MCH, Class1, Regulation# 878.4300). The indications is for ligating blood vessels.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA regarding the "DuoClipper Titanium Clips" (later referred to as DuoClip Titanium Clips). It is a regulatory approval document and does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter states that the device is "substantially equivalent" to legally marketed predicate devices for the indication of "ligating blood vessels." Substantial equivalence means that the device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Therefore, I cannot provide the requested information based on the provided text. The document does not describe:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set or data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. A multi-reader multi-case (MRMC) comparative effectiveness study, its effect size, or human reader improvement with AI. (This device is a physical clip, not an AI or imaging device).
6. A standalone (algorithm only) performance study.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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Ask a specific question about this device