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The Mammotome AutoCore™ Single Insertion Core Biopsy System is indicated to obtain tissue samples from the breast or lymph nodes for diagnostic analysis of breast abnormalities. This instrument is for diagnostic use only and is not indicated for therapeutic use.

The extent of a histologic abnormality cannot always be reliably determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benian, it is essential that the tissue marqins be examined for completeness of removal using standard surgical procedures.

The Mammotome AutoCore™ Single Insertion Core Biopsy System is an automated core needle biopsy system. It is a single insertion, multiple sample device that includes automated arming and automated sample collection. It is available in two gauge sizes (12G and 14G) and acquires soft tissue samples using a spring-loaded inner piercing stylet and outer cutting cannula in the probe needle.

The provided text does not contain detailed acceptance criteria or extensive study results that prove the device meets specific performance metrics. It primarily discusses the regulatory submission for the Mammotome AutoCore™ Single Insertion Core Biopsy System.

However, based on the limited information regarding performance testing, here's what can be extracted and inferred:

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

The document mentions several performance tests were conducted. While specific acceptance criteria values are not provided, the table below lists the characteristics tested, which implies that the device met the internal acceptance criteria for each test to achieve substantial equivalence.

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

• Bench Testing: The document does not specify sample sizes for the bench tests (static force, lesion displacement, overmold bond strength, bend load). It also does not specify data provenance or if it was retrospective or prospective.
• Animal Testing: The document does not specify sample sizes for the animal testing. It also does not specify data provenance or if it was retrospective or prospective.

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):

The document does not describe any human expert involvement in establishing ground truth for the performance tests mentioned. The tests appear to be primarily engineering and animal model assessments.

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

No information is provided about adjudication methods for the test sets, as the studies described are not clinical or interpretative in nature where adjudication would typically be relevant.

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 Mammotome AutoCore™ is a physical biopsy system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance would not be conducted for this device.

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

Not applicable, as this is a physical medical device and not an algorithm.

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

• Bench Performance: For bench tests, the ground truth would be based on engineering specifications and physical measurements, rather than clinical or pathological ground truth as defined in diagnostic studies.
• Animal Performance: For animal testing, the ground truth for "appropriate sample weight, acquisition, and quality" would likely be determined by veterinary pathologists or other trained personnel assessing the biopsy samples obtained from the animal models, comparing them against established criteria for diagnostic-quality tissue samples.

8. The sample size for the training set:

Not applicable. This document describes the regulatory submission for a physical medical device, not an AI or machine learning 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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The HydroMARK™ Plus Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least six (6) weeks, and be permanently visible by x-ray and MRI.

The HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird, subject device) is a two-component marker that provides permanent marking of a breast biopsy or axillary lymph node biopsy site following a breast biopsy procedure. The implantable marker is made of a highly expandable solid cylinder of polymerized and desiccated hydrogel that has the permanent titanium marker embedded. Upon fluid contact (e.g., water, blood, etc.), the hydrogel material expands to an equilibrium point. Once the material hydrates, it is visible under ultrasound. Over time, the hydrogel is resorbed by the patient's body. The titanium wire is permanently visible under x-ray and MRI even after the hydrogel is resorbed. The HydroMARK™ Plus Breast Biopsy Site Marker is a permanent implant and is not intended to be removed unless the marked tissue requires surgical removal. The marker is supplied pre-loaded in a sterile, disposable applicator that is designed to fit into specified commercially available breast biopsy devices. During a breast biopsy procedure, the marker is deployed through a compatible introducer or by direct puncture into the biopsy cavity created by the breast biopsy device.

The HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird shape) does not involve AI. The provided text describes a medical device, a breast biopsy site marker, and its substantial equivalence to a predicate device. None of the listed points (acceptance criteria, device performance, sample size, ground truth, experts, adjudication, MRMC study, standalone performance, training set, or ground truth for training) are relevant to this type of device submission, especially concerning AI/ML aspects.

The submission focuses on establishing substantial equivalence to a legally marketed predicate device (HydroMARK™ Plus Breast Biopsy Site Marker with a Dragonfly shape, K221961) based on similar design, functionality, performance, and materials.

The key acceptance criteria and performance data for this device are related to its physical characteristics and biological compatibility, rather than AI model performance metrics.

Here's a summary of the relevant information provided, structured to respond to the prompt as closely as possible, even though AI/ML specific information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for performance testing. It states that "Performance Testing was conducted" and "The results of all performance testing met acceptance criteria." The provenance is not explicitly mentioned but is implied to be from the manufacturer's internal testing as part of their ISO 13485:2016 compliant Quality Management System. This type of device does not typically involve clinical data from patients or diverse populations for basic substantial equivalence claims like this.

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

Not applicable. This device is a physical marker and its performance evaluation involves objective physical, chemical, and biological tests rather than interpretation by human experts to establish ground truth for a test set in the context of AI/ML.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically relevant for human interpretation or multi-reader studies, which are not described for this device.

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 device is not an AI-powered diagnostic tool, and therefore, no MRMC study was conducted in relation to AI assistance.

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

Not applicable. This device is not an algorithm or software requiring standalone performance evaluation in the context of AI/ML.

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

The "ground truth" for this device's performance would be derived from objective engineering, material, and biocompatibility testing standards. For instance:

• Visibility: Confirmed through imaging techniques (ultrasound, X-ray, MRI) in a controlled setting or phantom, comparing against known visual properties.
• Biocompatibility: Determined by adherence to ISO 10993 standards through laboratory assays and in-vivo animal studies.
• Deployment Force, Marker Size: Measured quantitatively using calibrated instruments.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a training set for an AI/ML model.

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

Not applicable. This device does not involve a training set for an AI/ML model.

Conclusion stated in the document: The applicant concluded that the HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird shape) is substantially equivalent to the predicate device (HydroMARK™ Plus Breast Biopsy Site Marker, K221961, Dragonfly shape) based on "similar functional and performance characteristics" and "substantially equivalent design, functionality, and performance characteristics." The "minor differences between the subject device and predicate device regarding marker shape do not raise concerns of safety and effectiveness."

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The LumiMARK™ Biopsy Site Marker is indicated to mark tissue associated with a percutaneous breast biopsy procedure, including axillary lymph nodes, and be permanently visible under ultrasound, x-ray, and MRI.

The LumiMARK™ Biopsy Site Marker implant component [subject device] is composed of a nitinol (nickel/titanium alloy) material versus HydroMARK™ Breast Biopsy Site Marker [predicate device] which is composed of titanium or stainless steel encapsulated in resorbable hydrogel. The marker 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 allows the marker to be inserted with direct puncture under ultrasound. The applicator system is of similar design and materials as the currently marketed Devicor Medical Products Inc. HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device].

LumiMARK™ Biopsy Site Markers will be available in three different shapes. These permanently visible, implantable markers will allow the physician to identify different biopsied sites under ultrasound, x-ray, and MRI. A similar marker device commercialized by Devicor Medical Products, Inc. is already available (under K212158), and this HydroMARK™ Breast Biopsy Marker [predicate].

The deployment system used for the LumiMARK™ Biopsy Site Marker device [subject] will be similar to the HydroMARK™ Breast Biopsy Site Marker [predicate] delivery system with minor design changes to the plunger assembly and cannula. The nitinol markers will be intended for direct puncture or insertion through another introducer needle that is already in the breast or axillary lymph node.

The provided text describes the regulatory clearance of a medical device, the LumiMARK™ Biopsy Site Marker, and asserts its substantial equivalence (SE) to a predicate device, the HydroMARK™ Breast Biopsy Site Marker (K212158).

However, the text does not contain information about acceptance criteria, reported device performance in those criteria, sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established for training sets.

The document focuses on "Performance Testing" and "Biocompatibility Testing" as part of verification data to support substantial equivalence. For both categories, the reported result is "PASSED" and a general statement that "The results of all performance testing met acceptance criteria." However, the specific acceptance criteria themselves, and the quantitative performance metrics attained, are not detailed.

It also explicitly states that the "fundamental scientific technology when compared to the HydroMARK™ Breast Biopsy Site Marker (K212158) [predicate device] has not changed," and that the "minor differences between the subject device and predicate device do not raise concerns of safety and effectiveness." This suggests that the demonstration of substantial equivalence relies heavily on the similarity to the already cleared predicate device, rather than extensive de novo clinical studies with detailed performance metrics.

Therefore, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not provided. The document states "Performance Testing was conducted," but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective).

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

• Not provided. The testing described is primarily bench performance and biocompatibility, not clinical studies requiring expert ground truth establishment in the traditional sense for diagnostic AI tools.

4. Adjudication method for the test set:

• Not applicable/Not provided. No clinical test set requiring adjudication by experts 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:

• No such study was done or mentioned. This device is an implantable biopsy site marker, not an AI-powered diagnostic tool, so MRMC studies for AI assistance are not relevant to its clearance.

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

• Not applicable/Not provided. This device is a physical implantable marker and does not involve an algorithm for standalone performance.

7. The type of ground truth used:

• For "Performance Testing" and "Biocompatibility Testing," the "ground truth" would be established by objective measurements and adherence to specified scientific and engineering standards (e.g., mechanical properties, chemical composition, biological response) rather than expert consensus on medical images or pathology. The text indicates use of standards like ISO 13485, ISO 14971, and ISO 10993 series for these tests.

8. The sample size for the training set:

• Not applicable/Not provided. This device is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

• Not applicable/Not provided. (As it's not an AI model, there's no training set or ground truth in this context.)

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HydroMARK™ Plus 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™ Plus Breast Biopsy Site Marker contains a two-component implantable marker that provides permanent marking of a breast biopsy or axillary lymph node biopsy site following a breast biopsy procedure. The implantable marker is made of a highly expandable solid cylinder of polymerized and desiccated hydrogel that has the permanent titanium marker embedded. Upon fluid contact (e.g., water, blood, etc.), the hydrogel material expands to an equilibrium point. Once the material hydrates, it is visible under ultrasound. Over time, the hydrogel is resorbed by the patient's body. The titanium wire is permanently visible under x-ray and MRI even after the hydrogel is resorbed. The implantable component of the HydroMARK™ Plus Biopsy Site Marker is supplied preloaded in a sterile, disposable applicator that is designed to fit into specified commercially available breast biopsy devices. During a breast biopsy procedure, the marker is deployed through a compatible introducer or by direct puncture into the biopsy cavity created by the breast biopsy device.

The provided text is a 510(k) Summary for the HydroMARK™ Plus Breast Biopsy Site Marker, seeking to establish substantial equivalence to a predicate device (HydroMARK™ Breast Biopsy Site Marker). It details various performance and biocompatibility tests conducted to demonstrate this equivalence, rather than providing the kind of robust clinical study data typically associated with an AI/ML device approval that would include information on expert reader performance, ground truth establishment, and training/test set details as requested in the prompt.

Therefore, much of the requested information regarding AI/ML-specific study design (such as number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, and training/test set details for AI models) is not applicable to this submission, as it describes a physical medical device (a biopsy site marker) and its performance, not an AI/ML diagnostic or assistive tool.

However, I can extract the relevant acceptance criteria and reported device performance from the provided document, relating to the physical device itself.

Here's the breakdown based on the provided text, focusing on the device's performance characteristics as a physical marker:

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

Since this is a physical device and not an AI/ML algorithm, the "acceptance criteria" are derived from the "Indications for Use" and various performance tests aiming to demonstrate substantial equivalence to the predicate device. The performance is reported as meeting these criteria, often by demonstrating equivalence or acceptable results compared to the predicate or relevant standards.

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

• Sample Size for Test Set: Not directly specified in terms of "cases" like in an AI/ML study, but performance and biocompatibility tests were conducted. For instance:
  • Implantation Data: Refers to "All animals survived" and "no abnormalities or adverse reactions were observed at necroscopy" for the HydroMARK Plus Implantation Data. The specific number of animals is not provided in this summary. It mentions "standard muscle implantation and lymph node sites" for HydroMARK device data and "additional implantation study" for HydroMARK Plus.
  • Residual Moisture, Time to Equilibrium, Toxicity, Pyrogenicity, Irritation, Sensitization: These are laboratory bench tests and animal studies. Specific sample sizes (e.g., number of test articles or animals per test) are not detailed in this summary document, but results are reported as "PASSED."
• Data Provenance: Not explicitly stated regarding country of origin. The studies are described as "Non-Clinical Bench Performance Data" and "Biological Evaluation Testing," which are typically laboratory or animal studies, not human clinical trials. They would be prospective in the sense of being planned tests on the device.

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. This is a physical device submission, not an AI/ML diagnostic. "Ground truth" for this device relates to physical and biological properties (e.g., material composition, sterility, biocompatibility, physical expansion, visibility under imaging modalities) established through engineering specifications, laboratory tests, and animal studies, not human expert reader consensus on images.

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

• Not Applicable. Adjudication methods are relevant for human reader studies, typically in AI/ML performance evaluations. The presented data is from bench and animal testing.

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. No MRMC study was done, as this is not an AI/ML device for diagnostic assistance.

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

• Not Applicable. This refers to a physical medical device, not an algorithm.

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

• The "ground truth" for this medical device is established through:
  • Physical and Chemical Benchmarking: Direct measurements of material properties, expansion rates, and stability.
  • Biological/Toxicological Standards: Compliance with ISO 10993 series for biocompatibility, using laboratory assays and animal studies to assess absence of toxicity, irritation, sensitization, and pyrogenicity, and demonstration of acceptable local tissue effects upon implantation over time.
  • Imaging Visibility: Demonstration of visibility under ultrasound (acute and long-term), x-ray, and MRI, likely through phantom studies or animal imaging.
  • Engineering Specifications: Adherence to design requirements, manufacturing processes, and sterilization validation.

8. The sample size for the training set

• Not Applicable. This is a physical device, not an AI/ML system requiring a training set. The device was developed through traditional engineering and material science principles.

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

• Not Applicable. No training set for an AI model. "Ground truth" for manufacturing and design would be established through material specifications, quality control, and adherence to established engineering principles and medical device standards.

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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 Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System is indicated to provide tissue samples for diagnostic sampling of breast abnormalities.
· The Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
· The Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures. In instances when a patient presents with a palpable abnormality that has benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome revolve Dual Vacuum Assisted Biopsy (VAB) System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Mammotome revolve EX System is an electromechanical breast biopsy device indicated to provide tissue samples for diagnostic sampling of beast abnormalities for histologic examination.

The Mammotome revolve EX System is comprised of three primary subsystems:

• 1. a sterile, single-use Probe
• 2. a reusable Holster, and
• 3. a reusable control unit.

The Mammotome revolve EX System is an electromechanical breast biopsy device. The provided text describes conformity with various performance tests, but it does not contain details of a clinical study with acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, or accuracy) or a comparative effectiveness study involving human readers.

Here's an analysis of the provided information, focusing on what is available and explicitly noting the absence of details requested in some points:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical bench performance tests where the acceptance criterion was "PASSED." The specific numerical acceptance criteria for each test (e.g., maximum acceptable bacterial count for sterility) are not detailed, only the outcome.

Note: This table reflects the non-clinical tests reported. Clinical diagnostic performance acceptance criteria (e.g., sensitivity/specificity for abnormality detection) are not provided or assessed in this document.

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

The document describes non-clinical bench testing, animal lab studies, and software verification/validation. It does not refer to a "test set" in the context of human patient data for diagnostic performance.

• Test Set Sample Size: Not applicable for diagnostic performance as described in the provided text, which focuses on device functionality and safety.
• Data Provenance: The animal lab study uses an animal model, but no specific country of origin is mentioned. The other tests are bench tests or software validation. All are likely controlled laboratory or in-house tests. The studies are described as "Non-Clinical Bench Performance Testing," implying retrospective analysis of these tests was performed for this submission.

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

This information is not provided in the document. For a diagnostic device, ground truth would typically be established by expert interpretation or pathology, which is not described.

4. Adjudication Method for the Test Set

This information is not provided because a clinical test set with diagnostic adjudication is not described.

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

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study is mentioned in the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and safety testing.

6. Standalone Performance Study

No standalone diagnostic performance study (algorithm only without human-in-the-loop performance) is described. The device is a biopsy system, meaning it collects samples for diagnosis, but its own diagnostic performance (like an AI system for image interpretation) is not assessed here. The standalone performance studies relate to the device's functional integrity (e.g., sterility, electrical safety, software function, tissue sampling in an animal model).

7. Type of Ground Truth Used

For the animal lab study's tissue sample testing, the "ground truth" implicitly relates to the properties of the tissue samples collected (e.g., weight, reliability, quality). However, the specific method for establishing this ground truth (e.g., histological examination of collected animal tissue, quantitative measurements) is not explicitly detailed beyond "Tissue Sample Testing - Sample Weight - Sample Reliability - Sample Quality."

For other tests (sterility, biocompatibility, software, electrical safety), the ground truth is defined by the technical specifications and recognized standards (e.g., ISO standards for sterility and biocompatibility).

8. Sample Size for the Training Set

Not applicable. This document describes a medical device, not an AI/ML model that requires a training set of data for diagnostic purposes. The software mentioned is for controlling the device's functions, not for diagnostic interpretation based on learned patterns from a dataset.

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

Not applicable, as there is no training set for an AI/ML model described in this document.

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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 Mammotome elite® Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities.

• The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

· The Mammotome elite® Biopsy System is intended to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

The extent of a histologic abnormality cannot always be readily determined from the palpation or imaged appearance. Therefore, the extent of removal of the palpated or imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

In instances when a patient presents with a palpable abnormality that has been classified as benign through clinical and/or radiological criteria (e.g., fibroadenoma, fibrocystic lesion), the Mammotome elite® Biopsy System may also be used to partially remove such palpable lesions. Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

The Mammotome elite® Biopsy System consists of a reusable Holster (MEH1) and a single-patient use, sterile Probe (MEP10 and MEP13) that is used with ultrasound imaging guidance to excise and collect diagnostic samples with a single insertion of the Probe. Introducer Stylets (MEI10 and MEI13) are also available as optional accessories that can be used with the Mammotome elite® Biopsy System. The components of the System are designed to operate safely when used together for diagnostic sampling of tissue during a biopsy procedure.

The Holster is a self-contained, handheld, reusable electro-mechanical vacuum-assisted biopsy device that consists of a rechargeable lithium-polymer battery and includes a charging base with AC power adapter. The Probe consists of an outer trocar shaft, a telescoping inner hollow coaxial cutter and an integrated coaxial cannula. The Probe incorporates a distal needle aperture and a proximal specimen collection cup with a tissue sample basket and specimen collection cap. The Holster contains one alignment tab that inserts into the holster notch located on the body of the Probe. The Probe body also contains two locking tabs to secure the Probe into the Holster. The Holster creates vacuum inside the device to assist in pulling tissue into the aperture while the sharpened inner cutter rotates at high speeds and extends across the aperture to acquire targeted tissue. The tissue sample is transported by vacuum to the specimen collection cup at the proximal end of the Probe. The integrated coaxial cannula may be detached either after the biopsy and remain in the breast to retain a track to the biopsy site when placing a biopsy site identifier or prior to the procedure when used in conjunction with the Introducer Stylet. The Introducer Stylet/integrated coaxial cannula combination is an option that is available for those physicians who are trained in percutaneous needle techniques for tissue collection.

The provided FDA 510(k) summary for the Mammotome elite® Biopsy System details its performance testing. However, it does not explicitly state numerical acceptance criteria for many of the tests, nor does it provide detailed quantitative results for the device performance against those criteria. Instead, it generally states that the device is "comparable to the predicate," or "complies with" certain standards.

Below is an attempt to extract the available information and structure it as requested, acknowledging the limitations of the provided document.

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

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

The document explicitly mentions "In these studies, acquisition of tissue samples from a single insertion site was evaluated..." but does not provide specific numerical sample sizes for the animal testing. It also does not provide details on the data provenance (e.g., country of origin, retrospective/prospective). It only states an "in vivo porcine animal model was used."

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth, particularly for the histological assessment of sample quality. It states, "When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures" and "Whenever breast tissue is removed, histological evaluation of the tissue is the standard of care," implying histological assessment is handled by standard professional practice, but not specifying details for this particular study.

4. Adjudication method for the test set

The document does not describe any specific adjudication method for the test set.

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, nor does the device involve AI. The device is a biopsy system and the testing involved evaluating its physical performance (e.g., tissue acquisition, transport, quality) compared to a predicate device, not diagnostic effectiveness with human readers.

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

The device is a physical biopsy system, not a software algorithm. Therefore, a standalone algorithm-only performance study is not applicable and was not conducted.

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

For the tissue sample quality evaluation in animal testing, the ground truth was histological assessment (implied by "optimal histological assessment"). For other performance aspects like sample weight and transport efficiency, the "ground truth" was direct measurement and comparison to the predicate device's measured performance.

8. The sample size for the training set

No training set is mentioned or applicable as this is a physical medical device, not an AI or machine learning algorithm.

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

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

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