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The OneMark Breast Localization Marker is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or soft tissue intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or detection imaging (OneMark Detection Imaging System), the OneMark Breast Localization Marker is located and may be surgically removed with the target tissue. The OneMark Detection Imaging System is intended only for the detection of the OneMark Breast Localization Marker.

OneMark is an integrated localization system consisting of the OneMark Detection Imaging System and the OneMark Breast Localization Marker preloaded in an injector device. The OneMark Detection Imaging System is an ultrasound-based intraoperative inspection tool used by clinicians to localize the OneMark Breast Localization Marker, a hydrogel pellet implanted in tissue to mark the site of a lesion. The primary goal of the system is to aid a surgeon in resection of a marked cancer lesion. The system may be used to inspect the marked tissue in all typical workflow situations from initial implant post-biopsy through resection and ex-vivo specimen review.

This FDA 510(k) summary for the OneMark Breast Localization Marker and OneMark Detection Imaging System does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding test sets, ground truth establishment, or clinical studies (MRMC or standalone algorithm performance).

The document primarily focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices. It lists various non-clinical tests performed but does not provide specific performance metrics, acceptance criteria, or results from these tests beyond stating that they indicate substantial equivalence.

Therefore, the requested information cannot be extracted from the provided text. The document does not describe:

1. A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance criteria are mentioned for the device's function (e.g., accuracy of localization, sensitivity/specificity).
2. Sample size used for the test set and the data provenance: No information about a test set, its size, or origin (country, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications: No details on expert involvement or ground truth establishment.
4. Adjudication method for the test set: Not applicable as no test set data is presented.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance: No MRMC or clinical effectiveness study is described. The device is a localization marker and detection system, not an AI diagnostic tool that assists human readers in interpreting medical images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable as the "OneMark Detection Imaging System" is an ultrasound-based intraoperative inspection tool designed for clinical use, implying human operation and interpretation. The "algorithm" mentioned (processing phase shift into a vibrant color image) is part of a system used by clinicians, not a standalone diagnostic AI.
7. The type of ground truth used: No ground truth for an efficacy study is described.
8. The sample size for the training set: No information on a training set.
9. How the ground truth for the training set was established: Not applicable.

The "Non-clinical performance bench testing" is listed, but no details about its methodology, specific acceptance criteria, or results are provided. The "GLP animal testing" is also mentioned, but again, without specific performance data relevant to the device's localization accuracy or 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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