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The HydroMARK Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The HydroMARK Breast Biopsy Site Marker [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component, and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices.

The HydroMARK Breast Biopsy Site Marker has a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium or Stainless Steel. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray, and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI.

The provided text describes the regulatory clearance of the HydroMARK Breast Biopsy Site Marker, primarily focusing on demonstrating substantial equivalence to a predicate device, especially with an expanded Indication for Use to include axillary lymph nodes. It does not contain information about a study proving the device meets specific acceptance criteria related to a machine learning or AI algorithm.

The document mainly covers:

• Acceptance Criteria for Device vs. AI Algorithm: The "acceptance criteria" here refer to regulatory requirements for demonstrating "substantial equivalence" of a medical device to a previously cleared predicate device, rather than criteria for an AI algorithm's performance. The performance criteria for the device itself are related to visibility under imaging and biocompatibility.
• Device Performance: The document states that the device meets "all system requirements" and is "substantially equivalent" to the predicate. The performance is assessed through non-clinical bench testing for biocompatibility and design verification, as well as a literature search and clinician survey for the expanded indication.

Based on the provided text, the device itself (HydroMARK Breast Biopsy Site Marker) is a physical marker, not an AI algorithm. Therefore, the questions related to AI algorithm performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment) are not applicable to the information contained in this FDA 510(k) summary.

Therefore, I cannot provide the requested information regarding an AI algorithm's acceptance criteria and study data because the provided document describes a physical medical device (a biopsy site marker), not an AI-powered diagnostic or assistive tool.

The acceptance criteria discussed in the document are primarily related to:

• Safety and Effectiveness: Demonstrated through biocompatibility testing (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Subchronic Toxicity, Implantation, Genotoxicity, Carcinogenicity).
• Functional Performance: Visibility under ultrasound for at least 6 weeks, permanent visibility by x-ray and MRI.
• Substantial Equivalence: Comparison to a predicate device (Devicor Medical Products Inc. HydroMARK Breast Biopsy Site Marker K210752) in terms of Indications for Use, design, functionality, materials, packaging, and sterilization.
• Expanded Indication for Use (Axillary Lymph Nodes): Supported by a literature search and clinician survey to show that this expanded use does not raise new safety or effectiveness concerns.

To directly answer the prompt's implied request for AI algorithm-specific details based only on the provided text, the relevant sections are empty as this is not an AI device submission.

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The HydroMARK Breast 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 HydroMARK Breast Biopsy Site Marker [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component, and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices.

The HydroMARK Breast Biopsy Site Marker is a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium or Stainless Steel. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray, and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI.

This document describes a 510(k) premarket notification for the HydroMARK Breast Biopsy Site Marker. The notification is for modifications to the labeling of an already cleared device, not for a new device or significant changes to its fundamental scientific technology, materials, manufacturing, or intended use.

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are focused on demonstrating that the labeling changes do not raise new or different issues of safety and effectiveness compared to the previously cleared devices.

Acceptance Criteria and Reported Device Performance (Table):

Detailed Breakdown of the Study and Related Information:

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

   • Sample Size: Not applicable in the traditional sense of a clinical or performance study involving patient data. The "test set" here refers to the revised labeling documents.
   • Data Provenance: The study involved document analysis of labeling changes to the existing HydroMARK Breast Biopsy Site Marker and its predicate/reference devices (K121113, K130537, K161021). No patient-specific data or data from a specific country of origin is mentioned for this particular submission, as it focuses on regulatory labeling compliance.

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

   • Not explicitly stated. The "ground truth" for labeling changes would likely be established by the manufacturer's regulatory affairs and quality assurance teams, in consultation with relevant internal subject matter experts (e.g., medical, engineering) to ensure accuracy, clarity, and compliance with regulations. External regulatory consultants might also be involved. Specific numbers or qualifications of individual experts are not provided in this summary.

3. Adjudication method for the test set:

   • Not applicable as this was a document analysis assessing compliance with regulatory and safety information, not a comparative review of clinical outcomes by multiple experts. The "adjudication" would be internal review and approval processes within the submitting company to ensure the labeling changes are justified and complete.

4. 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 breast biopsy site marker (a physical device), not an AI-powered diagnostic tool. The concept of "human readers improve with AI" is not relevant to this device.

5. 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 implantable marker, not a software algorithm.

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

   • The "ground truth" for this submission is regulatory compliance and demonstration that the modified labeling does not introduce new safety or effectiveness concerns, based on the established safety and performance of the physical device (which was previously cleared). This is primarily based on:
     • Comparison to the predicate device's cleared labeling and performance.
     • Internal design verification and risk assessment processes (implied by ISO 14971:2007 mention).
     • Applicable regulatory standards and guidelines for medical device labeling.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI-based device, so there is no "training set" in the context of data used to train an algorithm.

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

   • Not applicable for the same reason as above.

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The HydroMARK® Breast Biopsy Site Marker is indicated 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 [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in applicator devices designed to fit into the following:

• 8G Flexible Applicator System fits into:
  • O Mammotome revolve® 8G Probe (9cm with and without Specimen Management System and 12cm without Specimen Management System)
  • EnCor 7G Directional Vacuum-Assisted Biopsy Devices o
• . 10G Flexible Applicator System fits into:
  • Mammotome revolve® 10G Probe (9cm with and without Specimen Management O System and 12cm without Specimen Management System)
  • EnCor 10G Directional Vacuum-Assisted Biopsy Devices o
  • ATEC 9G Biopsy Handpiece Introducers O

The HydroMARK® Breast Biopsy Site Marker is a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI. The wire coil is available in (3) three shapes:

• Barrel Shape
• Open Coil Shape
• Butterfly Shape

The provided document is a 510(k) summary for the HydroMARK® Breast Biopsy Site Marker. It details the device's substantial equivalence to predicate devices and the non-clinical performance data supporting this claim.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test in a table format. Instead, it describes general "In-House Testing Standards" and states that all tests "PASSED," concluding that the device is "as safe, as effective, and performs as well as, the legally marketed predicate device."

However, based on the descriptions of the tests, we can infer the performance criteria. The device aims to demonstrate substantial equivalence to its predicate for various aspects, including safety, effectiveness, and performance characteristics.

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

The document provides a summary of non-clinical bench testing. It does not specify sample sizes for individual tests. The data provenance is "In-House Testing Standards as established by Devicor Medical Products, Inc." which indicates retrospective testing performed by the manufacturer, relying on internal procedures and industry best practices. There is no mention of country of origin for the data beyond the manufacturer being in Cincinnati, OH, U.S.A.

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

The document focuses on non-clinical (bench, human factors, biocompatibility, sterilization) tests, not clinical studies. Therefore, there is no mention of experts establishing ground truth for a test set in the context of clinical outcomes or imaging interpretation. The "ground truth" for these engineering and safety tests is defined by the established testing standards and internal design requirements.

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

This document describes non-clinical testing for substantial equivalence, not a clinical study involving human readers or interpretation of medical images. Hence, there is no adjudication method described for the test set. The results are reported as "PASSED" against established testing standards.

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 comparative effectiveness study was done or mentioned. This document is for a medical device (breast biopsy site marker), not an AI-powered diagnostic tool. Therefore, there's no discussion of human readers improving with or without AI assistance.

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

This point is not applicable as the device is a physical breast biopsy site marker, not an algorithm or AI.

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

For the non-clinical tests described:

• Design Verification, FEA, Hydrogel, Mechanical, Compatibility Testing: The "ground truth" is defined by the device's design requirements and the manufacturer's internal testing standards, often based on industry best practices for physical properties, functionality, and performance.
• Human Factors/Usability Testing: The "ground truth" relates to compliance with recognized standards (IEC 62366-1, IEC 60601-1-6, FDA Guidance) for user safety and effectiveness through simulated use and formative studies.
• Biocompatibility, Chemical Characterization, Bioburden, Sterilization, Endotoxin, Residual Analysis, Shelf-Life Testing: The "ground truth" is adherence to recognized international and national standards (e.g., ISO 10993 series, ANSI/AAMI, ASTM, USP) which define acceptable biological response, chemical safety, sterility, and material stability.

8. The sample size for the training set

This document describes the testing for a physical medical device (breast biopsy site marker), not an AI algorithm. Therefore, there is no concept of a "training set" in this context.

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

As there is no training set mentioned, this question is not applicable.

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The HydroMARK® Breast Biopsy Site Marker is indicated 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® Breast Biopsy Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The marker is deployed by the delivery system and is left in the tract created during the biopsy procedure. This Traditional 510(k) addresses the qualification and validation of a new source of raw material polymer of the same original formulation, produced in a new facility and in smaller batch sizes, to be used by the manufacturer of the hydrogel component of the HydroMARK® Breast Biopsy Site Marker. The hydrogel component is manufactured by Coldstream Laboratories, Inc. The new source of polymer for the hydrogel is Corden Pharma, replacing Genzyme polymer.

The provided text describes a 510(k) premarket notification for a medical device called the HydroMARK® Breast Biopsy Site Marker. The notification aims to demonstrate substantial equivalence to previously cleared predicate devices, primarily due to a change in the raw material polymer supplier for the hydrogel component.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner for specific benchmarks (e.g., "Visibility under ultrasound: >95% detected"). Instead, it lists various tests performed and states that the device "met all original finished product specifications" or "performed as intended according to the specifications established for the original device."

However, we can infer the acceptance criteria from the tests conducted and the statements of equivalence:

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

• Test Set Sample Size: For the polymer equivalence testing, "Three samples each of the predicate polymer and the new polymer" were tested by GPC. The same number seems implied for NMR and degradation profiles. For finished product testing, "The three manufacturing batches [of the new polymer] were combined and used to prepare HydroMARK® Breast Biopsy Site Markers which met all original finished product specifications". The exact number of finished devices tested is not specified, but it was enough to represent these combined batches.
• Data Provenance:
  • Polymer Raw Material: The new polymer batches were from the Corden Pharma Liestal, Switzerland facility. The predicate polymer was from Genzyme (original supplier/process).
  • Finished Product: The finished devices were manufactured using the new Corden Pharma polymer. The testing protocols were "identical to the tests used in the original 510(k)". The study is retrospective in the sense that it aims to demonstrate equivalence to previously established specifications and predicate devices.

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

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable to this submission. This 510(k) is not for a diagnostic algorithm or a device requiring expert interpretation for performance evaluation. It's a submission for a physical medical device (breast biopsy site marker) that primarily relies on objective chemical, physical, and imaging characteristic tests, not human interpretive performance.

4. Adjudication method for the test set

Not applicable for the same reasons as #3. There was no "ground truth" established by expert consensus or adjudication in the context of human interpretation. The "ground truth" here is adherence to objective engineering, material science, and biological specifications.

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 submission is for a physical medical device (a biopsy site marker), not an AI/CAD system or a device that directly assists human readers in interpreting images. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant to this submission.

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

Not applicable. As stated above, this is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context refers to the established specifications and performance characteristics of the predicate device and relevant industry standards (e.g., ISO, ASTM). Specifically:

• Chemical Equivalence: Established by comparing molecular weight distribution, NMR spectra, and degradation profiles to the known composition and characteristics of the original Genzyme polymer.
• Physical/Functional Performance: Established by existing specifications for visual inspection, critical dimensions, moisture content, functional deployment, hydration rate, invisibility under various imaging modalities, and biological safety (sterility, biocompatibility).
• Imaging Visibility/Safety: Established by adherence to specific ASTM standards for MRI compatibility.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context refers to the qualification and validation of the manufacturing process for the new polymer source, which involved testing "3 consecutive test batches" from the new facility.

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

Not applicable in the AI/ML sense. However, if interpreting "training set" as the batches used to qualify the new polymer manufacturing process:
The "ground truth" for qualifying these batches was established by comparison to the "original specifications" designed for the predicate device's polymer. This means the acceptable parameters (e.g., molecular weight range, chemical ratios) were already defined based on the performance of the previously approved device.

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The HydroMARK® Breast Biopsy Site Marker is indicated 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 reabsorbable 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® Breast Biopsy Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The HydroMARK® Breast Biopsy Site Marker is deployed by the delivery system and is left in the track created during the biopsy procedure.

This Special 510(k) is being submitted for modifications to two models of the cleared device, HydroMARK® Breast Biopsy Site Marker. The fundamental scientific technology of the two models of the modified HydroMARK® Breast Biopsy Site Markers has not changed. This submission contains information to support:

1. Modifications to the rigid delivery system of two models of the HydroMARK® Breast Biopsy Site Marker;
2. Compatibility for use of those two models with the Mammotome revolve® biopsy system; and
3. IFU updates related to the modifications noted for those two models.

There are no changes to the supplier of the hydrogel material, or other materials of construction. There are no changes to the finished product manufacturing site. There are no changes to the sterilization location and method, no changes to packaging, no changes to shelf-life, and no changes to indications for use or intended use.

Changes to labeling include rebranding and legal manufacturer name and address, as well as updates to the IFU to incorporate instructions for use related to the added compatibility with the Mammotome revolve® Biopsy System.

The provided document is a 510(k) summary for the HydroMARK® Breast Biopsy Site Marker, specifically for modifications to an already cleared device. As such, it does not detail a full study establishing device acceptance criteria from scratch but rather demonstrates that the modifications do not alter the existing performance and safety profile, maintaining substantial equivalence to the predicate device.

However, based on the information provided, we can extrapolate and structure the details as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the traditional sense for a new device evaluation. Instead, it describes non-clinical performance data and comparison testing for the modified device against its predicate.

• Sample Size for Non-Clinical Testing: Not explicitly stated for each test (Visual, Dimensional, Deployment, Usability).
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission by a US company, the testing is assumed to be conducted in a controlled lab/test environment, likely in the US. The tests are non-clinical (i.e., not performed on human subjects).

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

Not applicable. This submission concerns non-clinical performance and substantial equivalence based on material and design changes, not clinical outcomes requiring expert interpretation of human data.

4. Adjudication Method for the Test Set

Not applicable for this non-clinical testing. Performance was assessed against established specifications.

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

No, an MRMC comparative effectiveness study was not done. The device is a physical marker, not an AI or imaging diagnostic tool that would typically involve a MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is not an algorithm. Performance tests related to deployment, visibility, and biocompatibility are reported.

7. Type of Ground Truth Used

For the non-clinical performance data:

• Instrumental measurements/visual inspection for conformity: For visual and dimensional testing.
• Engineering specifications/functional performance criteria: For deployment and usability testing.
• ISO standards: For biocompatibility (ISO 10993-1).
• Predicate device's established performance: For visibility (ultrasound, X-ray, MRI, and duration) as the modifications did not impact these characteristics.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or an algorithm that requires a training set.

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

Not applicable as there is no training set for this device.

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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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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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