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The Coramate/Spirotome system is intended for diagnostic sampling of breast tissue during breast biopsy procedures. It is to be used for diagnostic purposes only and is not intended for therapeutic uses.

The Coramate/Spirotome system 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 surqical procedures.

The Coramate/Spirotome system is a mechanical biopsy device to harvest soft tissues from the human body, in particular from the female breast to detect and confirm malignant cells in the earliest phase of progression.

The Coramate/Spirotome system consists of 2 major components: the set of needles (Spirotome) and a powered device that operates the needles (Coramate). The set of needles can be operated manually as well (single-use and reusable Spirotome). The needle set contains 3 needles that work in conjunction. The trocar needle brings the cutting cannula up to the diseased site. The receiving needle, with a helix at the top, penetrates the diseased area, and the cutting cannula frees the sample from the surrounding tissues.

The following accessories are optionally provided with the system e.g. releasing element, needle spacer and needle protecting tube.

The Coramate contains a combination of interfaces, motors and software in addition to a battery with loader. The interfaces fix the needle set into the device. The 4 small motors perform the necessary movements of the needles. The software guides the motors into smooth and ordered movements of the needles. The batteries power the device.

The provided text describes a medical device called the Coramate/Spirotome system, a mechanical biopsy device intended for diagnostic sampling of breast tissue. However, it does not contain a detailed study with specific acceptance criteria and performance data in the format requested.

The document is a Premarket Notification 510(k) Summary for regulatory purposes. It focuses on demonstrating substantial equivalence to a predicate device (Mammotome Biopsy System, K033700) rather than providing a detailed clinical study with quantitative performance metrics against pre-defined acceptance criteria.

Here's a breakdown of the information that can be extracted and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

• Missing from the text. The document states, "Clinical testing indicates that all performance and safety aims are reached" and that the device performs "with aimed performance and maximal safety and similar to the predicate device." However, no specific numerical acceptance criteria (e.g., minimum diagnostic accuracy, sample yield, complication rates) or quantitative performance results are provided to populate such a table.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not explicitly stated. The text mentions "Most of the clinical work has been done in human breast tissues." No specific number of patients or samples is given for a test set.
• Data Provenance: The document mentions "European Medical Device Directive 92/42/EEC" and the manufacturer's location in Belgium, implying European data. The "international PEER reviewed Journals and Meetings" suggest a broader geographic scope, but specific countries are not detailed.
• Retrospective or Prospective: Not explicitly stated for either the Spirotome or Coramate clinical work.

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)

• Missing from the text. There is no information about the number or qualifications of experts used for establishing ground truth. The text mentions "histologic examination" as the method for confirming the nature of the samples, implying pathologists were involved, but specifics are absent.

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

• Missing from the text. There is no description of any adjudication method for ground truth establishment.

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. The Coramate/Spirotome system is a mechanical biopsy device, not an AI-powered diagnostic imaging tool that would typically involve human readers interpreting images with or without AI assistance. Therefore, an MRMC study as described is not relevant to this device.

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

• Not applicable. As a mechanical biopsy device, the concept of "algorithm only" or "standalone" performance without human intervention (for taking the biopsy) doesn't apply directly in the way it would for an AI diagnostic algorithm. The device's performance is inherently linked to its use by a human operator.

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

• The ground truth mentioned is histologic examination of the tissue samples. This implies a pathology-based ground truth.

8. The sample size for the training set

• Missing from the text. There is no mention of a "training set" in the context of device development or evaluation described here. The clinical work is referenced, but not in terms of training a distinct model. The preclinical testing on animal breast tissues could be considered an early phase of "training" or optimization, but no sample size is given.

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

• Missing from the text. As no specific training set is identified, there is no description of how its ground truth was established.

In summary, the provided 510(k) summary focuses on regulatory approval through substantial equivalence, and therefore lacks the detailed clinical study information and quantitative performance metrics that would be found in a research paper directly describing acceptance criteria and their fulfillment.

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