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The MicroMark clip is intended to staple soft breast tissue at the surgical site during an open or percutaneous biopsy procedure and radiographically mark the location.

It is indicated for use to radiographically mark breast tissue following an open surgical breast biopsy or percutaneous breast biopsy.

The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers.

This document is a 510(k) premarket notification for a medical device called the "MicroMark Clip." It seeks to establish substantial equivalence to a legally marketed predicate device, the "BMI Surgical Staple Marker." This type of submission generally focuses on comparisons to existing devices rather than extensive clinical studies with acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.

Based on the provided text, a formal study with acceptance criteria and reported device performance, as well as details about sample sizes, expert ground truth, adjudication methods, or MRMC comparative effectiveness studies, was not performed or is not described in this document.

Instead, the submission primarily relies on:

1. Technological Characteristics Comparison: The core argument for substantial equivalence is that the MicroMark Clip has technological characteristics "substantially equivalent" to the predicate device.
2. Identical Design, Construction, and Materials: The document explicitly states: "The design, construction, materials, nominal specifications are identical to the marketed predicate device." Both devices are described as consisting of a non-absorbable, X-ray compatible material.
3. Identical Intended Use: The intended use of both devices is to "be applied to soft breast tissue during open or percutaneous procedures and radiographically mark the surgical location."

Therefore, I cannot provide the requested table or detailed study information because it is not present in this 510(k) submission. The FDA's letter confirms substantial equivalence based on the provided information, which emphasizes the similarity to the predicate device rather than independent performance testing against defined acceptance criteria.

To elaborate on why this information is missing:

• 510(k) Process: A 510(k) premarket notification is a regulatory pathway for medical devices that are substantially equivalent to a legally marketed predicate device. The core of a 510(k) is to demonstrate this equivalence, often by comparing design, materials, technological characteristics, and intended use. It typically does not require new clinical studies demonstrating safety and effectiveness against specific performance criteria if equivalence can be established through other means (e.g., bench testing, material comparisons, and comparison to the predicate's known performance).
• "Acceptance Criteria" in 510(k): While a 510(k) doesn't typically define "acceptance criteria" for clinical performance in the same way a clinical trial would, the "acceptance criteria" here implicitly refer to meeting the requirements for demonstrating substantial equivalence to the predicate device, which the FDA concluded was met.

In summary, the document you provided does not contain the information requested in points 1-9 because this type of 510(k) submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with explicit acceptance criteria and corresponding performance data.

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The BMI Mammotome is intended for diagnostic sampling of breast tissue during a biopsy procedure.

The Mammotome is comprised of a disposable needle instrument housing. The Mammotome probe may be used with imaging guidance (such as ultrasound, X-ray, and CT), and it may be either stereotactically mounted or hand held depending on physician preference and the type of tissue sampled. The disposable Mammotome probes are available in various sizes and lengths. The probe components include an outer trocar cannula and a sliding inner hollow coaxial cutter. The trocar cannula incorporates a distal sampling notch and a proximal notch which forms the tissue retrieval chamber. The sampling notch thumbwheel is used to manually turn and orientate the sampling notch as desired.

This document, K920565, describes the Summary of Safety and Effectiveness for the BMI Mammotome, intended for diagnostic sampling of breast tissue during a biopsy procedure. However, it does not contain the kind of performance data usually associated with AI/ML-driven medical devices that would require acceptance criteria and studies proving the device meets those criteria in terms of diagnostic accuracy (e.g., sensitivity, specificity).

The document is a 510(k) premarket notification for a medical device (a biopsy needle), and its focus is on demonstrating substantial equivalence to a predicate device. This involves comparing intended use and technological characteristics, not quantitative performance metrics like those for an AI diagnostic algorithm.

Therefore, most of the requested information cannot be extracted from this document based on the device type and the content provided.

Here's a breakdown of why and what little can be inferred:

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

• Not applicable. This document does not define quantitative performance criteria (e.g., accuracy, sensitivity, specificity) because it's a physical device for tissue sampling, not a diagnostic algorithm. The "performance" being evaluated is substantial equivalence to a predicate device in terms of function and safety, not diagnostic accuracy.

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

• Not applicable. There is no "test set" in the context of evaluating diagnostic performance from data. The evaluation is based on device design and comparison to a predicate.

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. Ground truth in the sense of diagnostic accuracy is not established for this type of device in this document.

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

• Not applicable. No test set for diagnostic performance.

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 is a mechanical biopsy device, not an AI system. MRMC studies are for evaluating AI's impact on human diagnostic accuracy.

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

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

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

• Not applicable. Ground truth for diagnostic performance is not relevant to this substantial equivalence claim for a biopsy device. The "ground truth" for the device's function is its ability to retrieve tissue, which is inherent in its design and comparison to the predicate.

8. The sample size for the training set

• Not applicable. There is no training set mentioned or implied, as this is not an AI/ML device.

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

• Not applicable. No training set.

Summary of available information from the provided text:

• Device Name: BMI Mammotome
• Intended Use: Diagnostic sampling of breast tissue during a biopsy procedure.
• Predicate Device: Biopsys Medical Needle (intended for removal of soft body tissue for biopsy, definitive diagnosis, or confirmation of a clinical diagnosis).
• Technological Characteristics: Substantially equivalent to the predicate. Made of stainless steel, manually and mechanically pierce tissue, cut tissue with a hollow cutter, collect or eject tissue.
• Mechanism: Disposable probes with an outer trocar cannula and a sliding inner hollow coaxial cutter. Incorporates a distal sampling notch and a proximal notch for tissue retrieval. Sampling notch can be manually oriented.
• Guidance Method: Can be used with imaging guidance (ultrasound, X-ray, CT), stereotactically mounted or hand-held.

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The Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location.

The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers or surgical instruments.

The provided text is a summary of safety and effectiveness from a 510(k) submission for a Surgical Staple Marker. It focuses on establishing substantial equivalence to predicate devices rather than describing a study that proves the device meets specific acceptance criteria in terms of performance.

Therefore, many of the requested details cannot be extracted from this document, as it does not contain the specifics of a performance study with acceptance criteria.

Here's an attempt to answer based on the available information:

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

The document does not explicitly state acceptance criteria or report specific performance metrics for the device. Instead, it argues for substantial equivalence based on intended use and technological characteristics.

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

Not applicable. The document does not describe a performance study with a test set.

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. The document does not describe a performance study with ground truth established by experts.

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

Not applicable. The document does not describe a performance study.

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 device is a surgical staple marker, not an AI-powered diagnostic tool, and the document does not describe an MRMC study.

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

Not applicable. The device is a physical surgical staple marker, not an algorithm.

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

Not applicable. The document does not describe a performance study requiring ground truth. The basis of the submission is substantial equivalence to predicate devices.

8. The sample size for the training set

Not applicable. The device is a physical surgical staple marker, not a machine learning model, and the document does not describe a training set.

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

Not applicable. The device is a physical surgical staple marker, not a machine learning model, and the document does not describe a training set or ground truth establishment for it.

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