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The 14G CORMARK™ Biopsy Site Identifier is intended for use during an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.

The 14G CORMARK™ Biopsy Site Identifier is composed of a bioresorbable collagen plug embedded with a titanium non-resorbable radiopaque marker or clip.

At the completion of a breast biopsy procedure, the marker is deployed into the biopsy cavity, using a stainless steel syringe-like applicator with 1 cm markings to aid in needle placement. The marker is intended to help relocate the biopsy site for any subsequent intervention or diagnosis. The collagen slowly absorbs and the titanium radiopaque marker is left behind as the permanent identifier of the biopsy site.

The provided document is a 510(k) summary for the 14G CORMARK™ Biopsy Site Identifier, which seeks to establish substantial equivalence to a predicate device, the Caris™ Site Marker.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that the 14G CORMARK™ Biopsy Site Identifier is substantially equivalent to the predicate device, Artemis Caris™ Site Marker. This means the acceptance criteria are implicitly that the new device performs at least as well as the predicate device and that any modifications do not raise new issues of safety or effectiveness.

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

The document does not explicitly describe a separate test set size or data provenance (e.g., country of origin, retrospective/prospective) for proving acceptance criteria in a clinical study. The submission relies on demonstrating substantial equivalence through design verification and validation tests, and by comparing the characteristics of the new device to the predicate device.

The study referenced is not a clinical trial with a "test set" in the typical sense of patient data. It is a series of "design verification and validation tests" related to the design modifications.

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

This information is not provided in the document. As the submission relies on design verification and validation tests related to manufacturing and material properties rather than clinical outcomes on patients, the concept of "ground truth established by experts" in the context of clinical evaluation of performance is not applicable here.

4. Adjudication Method for the Test Set:

This information is not provided in the document. As noted above, the submission does not detail a clinical study with an adjudicated "test set" in the context of human interpretation or diagnostic accuracy. The "tests conducted" are likely engineering and bench-top tests.

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

An MRMC comparative effectiveness study was not performed or reported in this document. The submission focuses on demonstrating substantial equivalence through design and material comparisons, and engineering tests. It does not evaluate human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study was not performed or reported. This device is a physical medical device (tissue marker and applicator), not an algorithm or software. Therefore, the concept of "algorithm only performance" does not apply.

7. Type of Ground Truth Used:

The "ground truth" for this submission would be defined by engineering specifications, material properties, and functional requirements established during the design process and verified through testing. For example, testing for proper deployment, bioresorption rates, radiopacity, and mechanical integrity would be compared against predefined specifications. The document states: "The device passed all design verification and validation tests conducted." This implies that the device met its pre-defined engineering and performance criteria, which serve as the "ground truth" for this type of submission.

8. Sample Size for the Training Set:

This information is not provided and is not applicable. The device is a physical medical implant, not an AI or machine learning model that requires a "training set" of data.

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

This information is not provided and is not applicable for the same reasons as point 8.

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The Caris™ MiniTome Biopsy Instrument is indicated to provide breast tissue samples for histologic examination with partial or complete removal of an imaged abnormality.

The extent of an histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of an imaged abnormality does not predict the extent of removal of its 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 Caris™ MiniTome Biopsy Instrument is percutaneous device that removes a single intact biopsy sample. The Caris MiniTome is hand-held and may be used with common imaging modalities such as ultrasound and upright mammography. The system consists of imaging modulities outchation needle, which also acts as a guidewire, the Caris™ MiniTome Biopsy Instrument, and a control module with flexible drive cable.

The Caris™ MiniTome Biopsy Instrument consists of a hand piece that has a stainless steel rno outlo - mirih a tungsten cutting wire loop. A guidewire extension runs through the central lumen of the device and attaches to a localization needle. The Caris™ MiniTome is placed over a localization needle, which is placed through or adjacent to the targeted tissue site. The localization needle has a braided mesh at the distal tip that is deployed to anchor the needle in place.

Once the MiniTome has been guided over the localization needle and is in position, the start button on the controller is pressed. This activates a controller sequence which first allows RF energy from a standard electrosurgical generator to pass through the cutting wire, deploys the cutting wire into a loop, rotates the distal tip and cutting wire a predefined number of rotations, then shuts off the RF current from the electrosurgical generator. Thus, the cutting loop automatically rotates through the desired excision zone to resect the tissue sample. An integral "Python" sleeve, which is a component of the Caris™ MiniTome, is manually advanced to encapsulate the excised specimen. Then the device and specimen is removed through the percutaneous incision.

Here's a summary of the acceptance criteria and the study information based on the provided text, with a focus on what's available and an indication of what's not explicitly stated:

The provided document is a 510(k) summary for a medical device called the Caris™ MiniTome Biopsy Instrument, seeking clearance from the FDA. It does not describe an AI/ML powered device or a diagnostic algorithm that requires a comparative effectiveness study or extensive standalone performance metric reporting. Instead, it describes a physical biopsy instrument. Therefore, many of the requested points related to AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable to this type of device and are not present in the document.

The document focuses on demonstrating substantial equivalence to predicate devices and proving the physical device's safety and functionality through various engineering and biological tests relevant to a physical medical instrument.

Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly present a table of "acceptance criteria" for a diagnostic algorithm's performance (e.g., sensitivity, specificity thresholds). Instead, "acceptance criteria" here implicitly refer to meeting established standards and demonstrating functional performance suitable for its intended use as a physical biopsy device.

• Operates at a power level and operation speed suitable for breast biopsy samples.
• Is effective at cutting and retrieving intact, un-fragmented biopsy specimens suitable for post-biopsy histopathologic evaluation. |
  | Biocompatibility: Device materials must not be harmful to the body. | Biocompatibility testing performed on the final product, demonstrating compliance with ISO 10993 standard. Tests passed:
• Cytotoxicity (ISO Elution Method)
• In Vitro Hemolysis Study (Modified ASTM-Extraction Method)
• ISO Acute Intracutaneous Reactivity Study in the Rabbit
• ISO Sensitization Study in the Guinea Pig (Maximization Method)
• ISO Acute Systemic Toxicity Study in the Mouse
• Pyrogen Test (Rabbit) |
  | Electrical Safety: Device must be safe for electrical operation. | Electrical safety testing conducted, including compliance to relevant sections of EN 60601-1-2, EN60601-2-2, and EN60601-2-18. Testing demonstrated that the Caris™ MiniTome is safe for its intended use. |
  | Functional Equivalence: Similar principles of operation, technological characteristics to predicate devices. | The Caris™ MiniTome Biopsy Instrument has the same general intended use, similar principles of operation (electrosurgical cutting, entrapment mechanism), and similar technological characteristics to predicate breast biopsy devices (Auto Suture ABBI System, Site Select Breast Biopsy Device, BMI Mammotome, Mammotome Hand Held Probe, En Bloc Biopsy System, Core Tissue Biopsy System). It does not introduce new technological issues. |

Study Details (as applicable to a physical medical device)

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

   • Test Set Sample Size: The document mentions "a variety of animal and human tissues, including freshly excised human breast tissue" were used for performance testing. Specific numbers of tissue samples or study participants are not provided.
   • Data Provenance: The studies were conducted by the manufacturer, Artemis Medical, Inc. The country of origin for the studies or tissues is not specified (though the company is based in Hayward, California, USA). The studies appear to be for device verification, not clinical trials in the sense of prospective patient outcomes. They are likely laboratory-based and may include retrospective use of excised tissue.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This concept (experts establishing ground truth for a diagnostic algorithm's test set) is not applicable to this type of physical device clearance. The "ground truth" for the device's function is the direct observation of its ability to cut and retrieve tissue, which is then assessed (presumably by pathologists) for its suitability for "histopathologic evaluation." The document doesn't specify how many pathologists or their qualifications were involved in verifying the "suitability" of the retrieved samples.

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

   • This is not applicable as it pertains to expert consensus for a diagnostic ground truth, which is not described for this physical instrument.

4. 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, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for AI-powered diagnostic aids, not for a physical biopsy instrument.

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

   • Not applicable. This device is a physical instrument, not a standalone diagnostic algorithm. It requires a human operator for its use.

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

   • For the performance claim regarding sample quality, the "ground truth" is based on histopathologic evaluation of the retrieved tissue samples. The text states the samples were "suitable for post-biopsy histopathologic evaluation."
   • For biocompatibility and electrical safety, the "ground truth" is compliance with established international standards (ISO 10993, EN 60601 series) based on the results of specific standardized tests.

7. The sample size for the training set:

   • Not applicable. This device is hardware; there is no "training set" in the context of machine learning.

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

   • Not applicable. This device is hardware; there is no "training set" or "ground truth" establishment in the context of machine learning.

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