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To mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The HydroMark Breast Biopsy Site Marker contains a resorbable hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking. The HydroMark Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMark is deployed by the delivery system and is left in the tract created during the biopsy procedure. This Special 510(k) addresses the addition of a smaller size HydroMark Breast Biopsy Site Marker which will be provided in a smaller, rigid, sharp delivery system for use under ultrasound deployment either directly or though a commercially available 16 gauge x 9 cm coaxial needle. This Special 510(k) also describes minor modifications to the delivery system used for the ATEC 9 Ga Biopsy System and the EnCore 10 Ga Directional Vacuum-Assisted Biopsy Devices, and includes compatibility testing to allow the existing Mammotome MR Targeting Set to be labeled for use with other commercial MRI biopsy devices. Associated changes to the IFU and labels are also provided.

The acceptance criteria regarding device performance and the study details for the HydroMark Biopsy Site Marker are outlined below.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The submission does not explicitly state the sample size for the test set for any of the non-clinical performance tests.
• The data provenance is non-clinical bench testing and simulated use testing. No human subject data (country of origin, retrospective/prospective) is reported for this 510(k). This is a Special 510(k) for minor device modifications and a new size.

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 in the document. Given that the testing was non-clinical bench and simulated use, it's unlikely that "experts" in the clinical sense (e.g., radiologists) were explicitly used to establish ground truth in the way they would for reading images. The ground truth for performance metrics (tensile strength, penetration force, hydration, visibility) would have been established by engineering specifications and objective measurements.

4. Adjudication method for the test set:

• This information is not applicable as the described studies are non-clinical bench and simulated use testing, not clinical studies requiring adjudicators for subjective outcomes.

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, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (biopsy site marker), not an AI/software device.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant, not an AI algorithm.

7. The type of ground truth used:

• The ground truth for the non-clinical performance data was based on engineering specifications, objective measurements, and established industry standards (e.g., ISO 10993-1 for biocompatibility). For visibility, the ground truth was the objective observation of the marker under the specified imaging modalities (ultrasound, x-ray, MRI) as per the intended use.

8. The sample size for the training set:

• This information is not applicable. There is no "training set" in the context of an AI/algorithm for this physical medical device submission.

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

• This information is not applicable as there is no training set for an AI/algorithm in this submission.

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To mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The HydroMark Breast Biopsy Site Marker contains a resorbable hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking.

The HydroMark Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMark is deployed by the delivery system and is left in the tract created during the biopsy procedure.

The Biopsy Sciences HydroMark Breast Biopsy Site Markers will have a change in vendor for the supplier of the hydrogel material. The change in the supplier of the hydrogel has no effect on the finished product specifications.

The provided document is a 510(k) summary for the HYDROMARK BIOPSY SITE MARKER. It describes a device that marks breast tissue during a percutaneous biopsy procedure. It does not contain information about an AI/ML device or its performance criteria. Instead, it focuses on the substantial equivalence of an updated version of an existing medical device.

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods for an AI/ML device, as these details are not present in the provided text.

The document indicates that "Non-clinical testing included physical, functional and biocompatibility of the finished products manufactured in a newly qualified facility, using hydrogel material from a new supplier. The devices performed as intended according to the original specifications established for the finished device." However, specific acceptance criteria values or detailed performance metrics are not provided in this summary.

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The Biopsy Sciences LLC., HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The Biopsy Sciences HydroMark Breast Biopsy Site Markers are made of desiccated hydrogel embedded with either a stainless steel or titanium coil. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark Site Marker is currently provided pre-loaded in a sterile, disposable, flexible plastic syringe-like applicator that is compatible with the J&J Ethicon Endo-Surgery Mammotome probe. Two modified applicators have been developed which are both 15 gauge stainless steel syringe-like applicators. One has cm markings and a beveled tip to aid in needle placement by direct puncture, or to fit inside a 13 gauge or larger coaxial needle. The distal tip of the applicator is etched to enhance its visibility under ultrasound guidance. An additional stainless steel applicator has been developed to be compatible with the Suros 12 gauge biopsy system. The hydrogel portion of the HydroMark Breast Biopsy Site Marker has a dimensional change to accommodate the 15 gauge applicators, which by design create smaller cavities. The titanium and stainless steel coils embedded in the hydrogel are identical to the original device.

The provided text describes modifications to an existing device (HydroMark Breast Biopsy Site Marker) and its substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for a new device.

Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not explicitly detailed in the provided document. The document focuses on regulatory approval (510(k)) based on modifications to an already approved device and its substantial equivalence to predicate devices.

However, I can extract the stated Intended Use which can be interpreted as the functional performance expected from the device, and the general conclusion regarding meeting design criteria.

Here's a breakdown of what can be inferred or is missing, based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state "acceptance criteria" for performance metrics like sensitivity or specificity. Instead, it defines the intended use which implies the performance expectations. The "reported device performance" is essentially the claim that the device, with modifications, still meets these intended uses.

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

Not applicable/Not provided. The document describes a 510(k) submission for device modifications based on non-clinical performance data (bench testing related to compatibility) and substantial equivalence to predicate devices. It does not mention a clinical test set with human subjects to evaluate imaging visibility in a patient population. The data provenance is internal testing by Biopsy Sciences, Inc. for design verification and validation.

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

Not applicable/Not provided. No clinical test set with a need for expert-established ground truth is described in this document.

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

Not applicable/Not provided. No clinical test set requiring adjudication is described.

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 document pertains to a physical medical device (biopsy marker), not an AI algorithm. Therefore, no MRMC study or AI assistance evaluation was conducted.

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

Not applicable. This document pertains to a physical medical device (biopsy marker), not an AI algorithm. Therefore, no standalone algorithm performance was evaluated.

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

Not applicable/Not provided for clinical performance. For the non-clinical performance data (compatibility), the ground truth would be established by engineering specifications and successful function during testing.

8. The sample size for the training set

Not applicable/Not provided. This document does not describe the development or training of an AI algorithm.

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

Not applicable/Not provided. This document does not describe the development or training of an AI algorithm.

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The Biopsy Sciences, LLC. HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The Biopsy Sciences HydroMark Breast Biospy Site Markers are made of resorbable FocalSeal-L Surgical Sealant, the same material used in the Biopsy Sciences Lung Biopsy Site Marker and in the currently cleared HydroMark Breast Biopsy Site Marker. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark is available with either stainless steel or titanium coils, depending on physician preference. Both coils provide permanent visibility under x-ray and MRI. The HydroMark Site Marker is provided pre-loaded in a sterile. disposable applicator that is compatible with the J&J Ethicon Endo-Surgery Mammotome probe. The HydroMark is deployed by the delivery system through the Mammotome probe and is left in the void created during the biopsy procedure.

The provided text describes a 510(k) submission for the HydroMark Breast Biopsy Site Marker. This submission is for modifications to an existing device (K060769) to include an option for a stainless steel coil in addition to the previously available titanium coil. The primary purpose of the submission is to demonstrate substantial equivalence to the predicate device, not to establish new performance criteria for the marker's primary function (marking tissue, visibility under imaging modalities).

Therefore, the study focuses on comparing the new stainless steel coil to the existing titanium coil for visibility under MRI, rather than establishing specific quantitative acceptance criteria for the overall device performance like accuracy or sensitivity.

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated. The text mentions "comparative studies" and "comparing the MRI images of the stainless steel coil to the predicate titanium coil," but does not provide details on the number of samples (coils or imaging sequences) used.
• Data Provenance: Not explicitly stated. The study appears to be non-clinical, meaning it likely involved controlled laboratory testing of the coils rather than human subject data.

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

• This information is not provided. The study appears to be a technical comparison of imaging characteristics rather than a clinical interpretation task requiring expert consensus on diagnosis or efficacy. The "ground truth" here would be the physical properties and visual characteristics of the coils themselves and their MRI artifacts.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. As it's a technical comparison of MRI visibility and artifacts, expert adjudication in the sense of clinical decision-making is not described.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (biopsy site marker) and its imaging properties, not an AI or software device evaluating images.

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

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

7. The Type of Ground Truth Used

• The ground truth for this non-clinical study appears to be a direct comparison of the physical appearance and MRI characteristics of the stainless steel coil versus the predicate titanium coil. This would involve objective assessment of artifact size and visibility by engineers or imaging specialists, rather than expert consensus on a pathology or clinical outcome.

8. The Sample Size for the Training Set

• Not applicable. This is a non-clinical comparison for device modification, not a machine learning model requiring a training set.

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

• Not applicable for the same reason as point 8.

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The Biopsy Sciences LLC HydroMark Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible uneler ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The Biopsy Sciences HydroMark Biospy Site Markers are made of The Bropsy Deleal-L Surgical Sealant, the same material used in the Biopsy Sciences Lung Biopsy Site Marker. The HydroMark is visible under mammography, ultrasound and magnetic resonance imaging. It expands in the void created during biopsy and does not migrate. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The HydroMark also contains a titanium coil that provides permanent visibility under xray and MRI. The HydroMark Site Marker is provided pre-loaded in a sterile, The Hydroman's Stor that is compatible with the J&J Ethicon disposaore applicator tome probe. The HydroMark is deployed by the delivery system through the Mammotome probe and is left in the void created during the biopsy procedure.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the HydroMark Biopsy Site Marker:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing specific quantitative acceptance criteria with reported performance metrics. However, based on the "Intended Use" and "Technological Characteristics" sections, we can infer the implied acceptance criteria and the claims made about the device's performance.

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

The document does not explicitly state a specific "test set" sample size in the context of human clinical trials for establishing performance metrics against acceptance criteria. The testing described is primarily non-clinical and animal testing.

• Test Set Sample Size: Not specified for human clinical data. The studies mentioned are non-clinical and animal studies.
• Data Provenance: The document does not specify the country of origin for the animal studies or any human clinical data that might have been used in a "test set." It can be inferred that these studies were likely conducted in the US, given the submission to the FDA. The studies are prospective in nature, as they involve testing the device.

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

Since the primary evidence cited is non-clinical and animal testing, there is no mention of experts establishing a ground truth for a human test set. The evaluation of visibility, migration, and accurate marking in animal studies would have likely been performed by researchers and veterinarians, but their specific qualifications are not detailed.

4. Adjudication Method for the Test Set

As there is no mention of a human clinical test set requiring expert ground truth, no adjudication method (like 2+1 or 3+1) is described. The evaluation in non-clinical and animal studies would follow experimental protocols.

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

No, an MRMC comparative effectiveness study is not mentioned. This document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical and animal performance data, rather than comparative effectiveness studies with human readers or AI assistance.

6. Standalone (Algorithm Only) Performance Study

No, a standalone study (algorithm only) was not performed. The HydroMark Biopsy Site Marker is a physical medical device, not an AI algorithm. Therefore, the concept of "algorithm only" performance does not apply. The performance is intrinsically linked to the physical properties of the marker and its interaction with biological tissue and imaging modalities.

7. Type of Ground Truth Used

The ground truth for the claims made is established through:

• Direct Observation/Measurement in Non-Clinical Testing: For biocompatibility, delivery system compatibility, and migration.
• Imaging Observations in Animal Studies: For accurate marking, visibility under ultrasound, X-ray, and MRI, and assessment of migration.
• Material Science/Chemical Properties: For the degradation of the hydrogel via hydrolysis and the permanent visibility of the titanium coil.

8. Sample Size for the Training Set

This product is a physical medical device, not an AI/machine learning algorithm. Therefore, the concept of a "training set" in the context of AI does not apply.

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

As explained above, there is no "training set" for this device. The development and verification of the device's properties would involve standard engineering, material science, and biological testing methodologies rather than AI-specific training paradigms.

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The Biopsy Sciences, LLC., Lung Biopsy Site Marker is intended to provide accuracy in marking a biopsy location for visualization during surgical resection.

Biopsy Sciences Lung Biopsy Site Markers are made of resorbable FocalSeal-L Surgical Sealant, an FDA approved hydrogel used on the surgical site during lung surgery. The FocalSeal-L hydrogel material degrades in a manner similar to absorbable sutures, via hydrolysis. The Site Markers mark the site of the biopsy tissue sample, which provides accurate visualization during surgical resection of the tumor. Lung biopsy procedures are performed by fine needle aspiration through a coaxial needle. When the fine needle aspiration device is removed, the delivery system is mated to the coaxial needle. The plunger of the delivery system is depressed, which accurately places the Site Marker in the biopsy tract.

The provided text is a 510(k) premarket notification for a medical device and does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is primarily focused on seeking FDA clearance by demonstrating substantial equivalence to predicate devices, rather than presenting detailed performance study results.

Therefore, I cannot extract the requested information.

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The Biopsy Sciences, LLC., Bio-MARK Resorbable Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, and be visible under MRI, ultrasound and x-ray for at least 6 weeks.

The Bio-MARK Permanent Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, be visible under MRI and ultrasound for at least 6 weeks, and be permanently visible by fluoroscopy.

The Bio-MARK biopsy site marker is made of a resorbable copolymer, a polyester derivative of lactic and glycolic acids. Polylactic/polyglycolic acid copolymers degrade and resorb in vivo by hydrolysis into lactic and glycolic acids, which are then metabolized by the body. The site markers are deployed through an applicator that fits in the J&J Ethicon Mammotome 11 gauge biopsy probe. The Bio-MARK device marks the site of biopsy tissue sample, and is visible for up to 6 weeks by x-ray, ultrasound and MRI. The body then metabolizes the marker over time. The Bio-MARK is sold in two styles: the Resorbable Bio-MARK is made of the copolymer only, the Permanent Bio-MARK is identical with the addition of a stainless steel component for permanent radiographic visibility.

Bio-MARK Site Markers are made of 75/25% poly(D,Llactide-co-glycolide) copolymer into which a USP grade contrast agent has been incorporated to provide radiopacity. The markers are deployed into the biopsy needle tract using a hand held applicator with a two finger-push control rod that delivers a single marker.

The Bio-MARK Biopsy Site Marker 510(k) submission (K023694) has limited detail regarding a formal study and acceptance criteria in the provided text. The document focuses on the device description, intended use, and substantial equivalence to predicate devices rather than a detailed performance study with explicit acceptance criteria and results.

However, based on the information provided, we can infer some "acceptance criteria" from the stated intended use and technological characteristics, and then identify what the filing states about the device meeting these:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The provided 510(k) summary does not explicitly state a sample size for a test set or provide details on data provenance (e.g., country of origin, retrospective/prospective) for a study proving the device meets acceptance criteria. The document relies on describing the device's composition and intended function, asserting that it meets its intended use based on its design and similarity to predicate devices. This type of 510(k) submission typically does not include extensive clinical trial data.

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

The provided document does not mention a test set with ground truth established by experts. No information on the number or qualifications of experts is available.

4. Adjudication Method for the Test Set:

No adjudication method is described, as no formal test set or clinical study requiring adjudication is detailed in the provided text.

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

No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. The document does not describe any studies comparing human readers with or without AI assistance. The device is a physical biopsy site marker, not an AI software.

6. Standalone (Algorithm Only) Performance Study:

Not applicable. The Bio-MARK is a physical medical device, not an algorithm or AI. Therefore, a standalone algorithm performance study was not conducted or reported.

7. Type of Ground Truth Used:

No explicit "ground truth" as typically understood in AI/imaging studies is detailed. The assessment of the device's performance appears to be based on its material properties (resorbability, radiopacity due to contrast agent/stainless steel) and its intended mechanical function (deployment, visibility over time). This would likely have been verified through bench testing, material science testing, and potentially some in-vivo animal or limited human observational studies (though not detailed here) to confirm visibility and resorption characteristics.

8. Sample Size for the Training Set:

Not applicable. The Bio-MARK is a physical medical device, not an AI or machine learning model that requires a training set.

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

Not applicable. As above, there is no training set for this device.

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The Biopsy Sciences, LLC., Maxi-Cell Biopsy Needles are intended to be used for fine needle biopsies of various soft organs and tissues, including, but not limited to, biopsies for breast, lung, thyroid, liver, pancreas, spleen, kidneys, and prostate

The biopsy needle is a single lumen needle, identical in design to the predicate, from Sherwood Medical. The shaft of the needle has been modified to provide additional sampling sites approximately 0.40inches proximal to the needle tip. Once the needle is positioned at the site of interest, the stylet is removed and the needle is manually advanced to obtain a freehand needle biopsy of tissue, or aspirate, while suction is applied with a syringe. Then as the needle is withdrawn, the side-sampling site will also remove tissue, allowing the physician to collect at least twice the amount of tissue sample typically removed by a biopsy needle. The needle is made of ASTM type 304 stainless steel, as is the stylet.

The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary for the Maxi-Cell Biopsy Needle, indicating that it was found substantially equivalent to predicate devices. It outlines the device description, intended use, and technological characteristics, but it does not include performance data, clinical study results, or specific acceptance criteria for performance metrics.

Therefore, I cannot populate the requested table or answer the specific questions related to acceptance criteria and study details.

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