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The Coramate system is a core soft tissue biopsy medical devices to be used in humans to take out adequate samples from superficial soft tissues as breast, lymph nodes, thyroid, muscles, abdominal wall, thoracic wall and parotis. The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Coramate system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

The Spirotome system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from subdermal structures as breast, abdominal wall, thoracic wall, lymph nodes, thyroid, parotis, muscles and liver. The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Spirotome system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

The Cervicore system is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the human cervix. The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities by inspection or colposcopy. The Cervicore system is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

The Easy Punch is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of tissue from the skin. The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. The Easy Punch is intended to provide soft tissue for histological and biomolecular detection and confirmation of palpable abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

The Spirotome Bone is a family of core soft tissue biopsy medical devices to be used in humans to take out adequate samples of soft tissue from bony structures. The Spirotome Bone is intended to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities. An early detection and correct diagnosis is a prerequisite for a successful multimodality treatment of malignant disease. Therefore, an adequate sampling of human tissue is necessary to make a reliable diagnosis of benignancy or malignancy and to characterize as complete as possible the nature of the lesion without unnecessary discomfort to the patient. In case of malignancy, a proper multimodality treatment is necessary i.e. surgery and/or chemotherapy and/or hormone therapy and/or biological therapy. In case of benignancy, adequate follow-up of the patient can be provided.

The Coramate/Spirotome system is a mechanical biopsy device to harvest soft tissues from the human body. 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 provided text describes a 510(k) premarket notification for the Coramate/Spirotome system, a mechanical biopsy device. However, it does not include specific acceptance criteria or a detailed study proving the device meets those criteria in a quantitative manner as typically expected for AI/ML device performance.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices and states that "Thorough preclinical testing was performed to ensure the device performs as intended" and "Clinical testing indicates that all performance and safety aims are reached." It's a qualitative assertion rather than a presentation of specific metrics.

Therefore, for many of the requested items, the information is either not present or cannot be inferred from the provided document.

Here's a breakdown based on the request and the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The document does not explicitly state quantitative acceptance criteria for the device's performance (e.g., a specific percentage of adequate samples, or a particular diagnostic accuracy). The overarching "acceptance criteria" appear to be that the device performs "as intended" with "aimed performance and maximal safety," similar to predicate devices, and without complications.

Reported Device Performance:

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

• Sample Size for Test Set: Not explicitly stated in terms of a specific number of cases or patients from a defined clinical study. The document mentions "clinical tests" and "clinical international + LLN relating to the performance in various other soft tissues than the breast," but no numbers are provided.
• Data Provenance: The document states that "Most of the clinical work has been done in human breast tissues as has been published in international PEER reviewed Journals and Meetings. In addition, recent clinical international + LLN relating to the performance in various other soft tissues than the breast." This implies prospective and/or retrospective clinical data from multiple international sources, but no specific countries or study designs are elaborated.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. It can be inferred that experts in pathology or relevant medical specialties would be involved in assessing the biopsy samples, but no details are given.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified.

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

• MRMC Study: No, this type of study is not mentioned as this device is a physical biopsy instrument, not an AI or imaging diagnostic tool that would typically involve human readers interpreting results with or without AI assistance.

6. Standalone Performance Study

• Standalone Performance: Not applicable in the context of an AI algorithm. The performance described relates to the device's ability to extract adequate tissue samples, which is inherent to the device's mechanical function, not an algorithm running independently. The "clinical testing" mentioned is the closest equivalent, demonstrating the device's performance in a real-world setting.

7. Type of Ground Truth Used

• Ground Truth: The primary ground truth for the performance of a biopsy device is the histological and biomolecular analysis of the tissue samples obtained. The text repeatedly mentions the device's intention "to provide soft tissue for histological and biomolecular detection and confirmation of imaged abnormalities" and "to make a reliable diagnosis of benignancy or malignancy." This implies the ground truth is established through laboratory analysis of the collected tissue.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a mechanical biopsy tool, not an AI/ML algorithm that requires a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no AI/ML training set.

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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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