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The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

The SecurMark Biopsy Site Marking System is intended for use with the manual method of deployment. It can be visualized under various imaging modalities such as ultrasound, x-ray, magnetic resonance, direct visualization, and others. This system is intended for single patient use only.

The SecurMark Biopsy Site Marker is a sterile, single patient use device comprised of a single, biocompatible titanium or stainless steel marker surrounded by a bioabsorbable suture-like material and deployment device.

The deployment device is a hand-held device that delivers the marker from the distal tip. The deployment device consists of a flexible cannula, handle, flexible push rod, and plunger. The marker is located at the deployment device.

The provided text is a 510(k) summary for the SecurMark Biopsy Site Marking System. It details the device, its indications for use, and a comparison to predicate devices. However, explicit acceptance criteria and a description of a study proving the device meets these criteria are not detailed in the provided text.

The section titled "Non-Clinical Evaluation" generally states that tests were performed and that "The devices met or exceeded the acceptance criteria for all evaluations." but it does not specify what those acceptance criteria were, what the reported device performance was against those criteria, or the methodology of the study.

Therefore, I cannot populate most of the requested table and information as it is not present in the provided text.

Here is what can be inferred or stated based on the provided text:

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

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 specified.
• Data Provenance: Not specified (likely from the manufacturer's internal testing, no country of origin is mentioned, retrospectivity/prospectivity not mentioned).

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 specified. The evaluation appears to be non-clinical (device performance tests) rather than reader studies involving human observers and ground truth from experts.

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

• Not applicable as the evaluations are non-clinical device performance tests.

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

• No MRMC or comparative effectiveness study is described. The device is a physical marker system, not an AI-assisted diagnostic tool.

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

• Not applicable as the device is a physical marker system, not an algorithm.

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

• Not applicable in the human sense. For the non-clinical tests, the "ground truth" would be engineering and material science standards/specifications.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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The SeCurMark Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

The SeCurMark family of Tissue Site Marking Systems is composed of two components:

• . an implantable component, composed of a bioabsorbable and permanent component, and
• a deployment device utilized for placement of the implantable component at the site of . interest.
  This family of devices is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, and direct visualization. The device is intended for single patient use only.

The provided text is a 510(k) summary for the SeCurMark Biopsy Site Identification System. This document focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing a specific study with acceptance criteria and performance metrics typically seen for diagnostic or AI-driven devices.

Therefore, much of the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert qualifications, and ground truth establishment cannot be found in this document. This filing is about a physical medical device (an implantable clip and its deployment system), not a software or AI-based diagnostic tool.

However, I can extract what is available:

1. Table of acceptance criteria and the reported device performance:

This document does not provide a table of acceptance criteria or specific quantitative performance metrics for the device’s efficacy (e.g., accuracy, sensitivity, specificity, or resolution of the marker). The submission focuses on substantial equivalence based on design control processes for safety and effectiveness.

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

This information is not provided in the document. The filing refers generally to "Verification and validation testing" as part of the design control process, but does not specify sample sizes or data provenance for these tests.

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

This information is not provided as there is no mention of a ground truth established by experts in the context of this device's performance given its nature as a physical marker.

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

This information is not provided.

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:

This information is not applicable as the SeCurMark Biopsy Site Identification System is a physical implantable marker and not an AI or diagnostic imaging device that would involve human readers interpreting AI output.

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

This information is not applicable as the SeCurMark Biopsy Site Identification System is a physical implantable marker and not an algorithm or AI system.

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

The document does not specify a formal "ground truth" in the context of diagnostic accuracy, as it pertains to a physical marker rather than a diagnostic interpretation. The "truth" in this context would likely be related to the physical presence, stability, and visibility of the marker through imaging, which would be assessed through standard engineering and biocompatibility testing, not expert consensus on diagnostic images.

8. The sample size for the training set:

This information is not provided as this is not an AI or machine learning device requiring a training set.

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

This information is not provided as this is not an AI or machine learning device requiring a training set with established ground truth.

Summary of the Study Mentioned (Verification and Validation Testing for Substantial Equivalence):

The document states: "Verification and validation testing has been conducted as part of the Suros divisions design control process and has proven that the SeCurMark family of devices is substantially equivalent to the predicates devices and is safe and effective for use."

• Nature of the "Study": This refers to the overall design control process, which includes various tests (e.g., biocompatibility, sterilization, mechanical testing, visibility under imaging modalities, deployment mechanism functionality). It is not a single, defined clinical study with specific performance metrics and acceptance criteria as one would expect for a diagnostic device.
• Purpose: To demonstrate substantial equivalence to the predicate devices (K062528 in-house and K042296 BiomarC) for regulatory clearance, thereby confirming the device is "safe and effective for use."
• Key Outcome: The FDA reviewed the submission and concurred that the device is substantially equivalent, allowing it to proceed to market. The letter explicitly states there are "No new safety or efficacy questions or risks are raised with the SeCurMark Biopsy System."

In essence, the "study" is the entirety of the design control, verification, and validation activities required for medical devices, geared towards proving equivalence to existing legally marketed devices, rather than establishing de novo performance against a defined clinical endpoint with specific statistical acceptance criteria.

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The Tissue Site Marking System is indicated for the permanent radiographic marking of sites in soft tissue.

The Tissue Site Marking System is supplied as a sterile device and is intended for single patient use only. The Tissue Site Marking System is composed of two elements: 1) an implantable device (marker) including a bioabsorable component and a permanent component and 2) a deployment device. The Tissue Site Marking System is intended for use with the manual method of deployment under the following imaging modalities: ultrasound, x-ray, magnetic resonance, nuclear, computed tomography, and direct visualization.

The provided text does NOT contain information about acceptance criteria, device performance, or any studies involving AI, human readers, or ground truth establishment.

The document is a 510(k) summary for a "Tissue Site Marking System," which is a medical device for marking sites in soft tissue. It primarily focuses on the regulatory aspects of the device, including:

• Classification Information: Device name, common name, proprietary name, classification, and regulation number.
• Owner/Operator Information: Company details and contact person.
• Device Description: Two components (implantable marker and deployment device) and its intended use with various imaging modalities.
• Indications for Use: Permanent radiographic marking of sites in soft tissue.
• Contraindications: None known.
• FDA Communication: A letter from the FDA confirming substantial equivalence to predicate devices and outlining regulatory responsibilities.
• Indications for Use Form: A standard FDA form reiterating the indications for use.

Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, ground truth, or MRMC studies, as this information is not present in the provided text.

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The ATEC® Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The ATEC® Breast Biopsy System is intended 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 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 procedure.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device (Vacuum Assisted Core Biopsy Device, Trade/Device Name: SUROS Surgical Systems, Inc. - ATEC® Breast Biopsy System). This type of document primarily confirms substantial equivalence to a predicate device for market clearance. It does not contain the details of a study with acceptance criteria and reported device performance in the format requested.

The document states:

• Device Name: SUROS Surgical Systems, Inc. - ATEC® Breast Biopsy System
• Indications For Use: To provide breast tissue samples for diagnostic sampling of breast abnormalities, and intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

To answer your request, a detailed study report (e.g., a clinical trial report or a performance validation study report) would be needed, which is not part of this 510(k) clearance letter. The FDA clearance confirms that SUROS demonstrated substantial equivalence to a legally marketed predicate device, implying that its performance is comparable to the predicate. However, specific acceptance criteria and performance metrics from a dedicated study are not detailed in this document.

Therefore, I cannot populate the table or provide the specific study details you requested based solely on the information provided in this 510(k) clearance letter. This document is a regulatory approval notice, not a study report.

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To obtain percutaneous core biopsy samples from soft tissue and tumors of such organs as the liver, spleen, kidney, prostate, and callors on such organs as also earlier, of breast biopsy, the product is for diagnosis only.

Vacuum Assisted Spring Loaded Core Biopsy Device

I am sorry, but the provided text from the FDA 510(k) letter dated September 8, 2004, for the "Vacuum Assisted Spring Loaded Core Biopsy Device" (K034021) does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

This letter is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device. It briefly mentions the indications for use but does not delve into the underlying studies or data that would typically be included in a scientific publication or a more detailed regulatory submission summary.

Therefore, I cannot fulfill your request for the specific details about the acceptance criteria and the study that proves the device meets them based on the provided input.

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