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MammoSTAR Biopsy Site Identifier is indicated for use to radiographically mark soft tissue at the surgical site during a surgical procedure or for future surgical procedures.

MammoSTAR Biopsy Site Identifier is a sterile, single use tissue marker consisting of pyrolytic carbon coated zirconium oxide discrete marker e that is visible on standard radiographs (x-ray, mammography, fluoroscopy, kV, and CT) as well as ultrasound and Magnetic Resonance Imaging (MRI) incorporated into lyophilized BiomarC Delivery Gel. MammoSTAR is placed into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location.

Based on the provided FDA 510(k) clearance letter, the "MammoSTAR Biopsy Site Identifier" is cleared without new device performance data. The clearance is based on the device being identical to its predicate device (K100994) with only one difference being an added contraindication and an extended shelf life, which was verified through testing. Therefore, there is no specific performance data from a new study presented in this document to describe or prove the device meets acceptance criteria.

The document indicates that no new performance data was required because the device is deemed identical to the predicate device, and thus, already meets the established criteria for safety and effectiveness based on the predicate's clearance.

Here's an attempt to answer your request based on the information provided and inferred within the document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is a "Change Being Effected (CBE) determination" where the device is considered identical to its predicate except for an added contraindication and an extended shelf-life, explicit "acceptance criteria" and "reported device performance" from a new study are not provided for the claims of equivalency in the typical sense. Instead, the acceptance criteria are implicitly met by being identical to the predicate device, which was previously deemed safe and effective.

The only "performance" mentioned that might resemble a test is the shelf-life verification.

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The UltraCor™ Twirl™ Breast Tissue Marker is intended for use to attach to soft breast tissue, including axillary lymph nodes, to radiographically mark the location of the biopsy procedure.

The UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover) consists of a disposable beveled needle applicator containing a Nitinol radiographic marker is intended for long-term radiographic marking of the tissue site. The applicator has a beveled 17g x 10cm needle with 1 cm depth marks and a locking plunger. Each marker shape is deployed from the beveled needle tip into the tissue site.

Here's an analysis of the provided text regarding acceptance criteria and performance studies, based on the requested categories.

Important Note: The provided document is an FDA 510(k) summary for a breast tissue marker. This type of device is a physical implant, not a software-driven AI solution. Therefore, many of the typical questions related to AI/ML device performance (like MRMC studies, training/test set ground truth establishment for an algorithm, expert adjudication for image interpretation, etc.) are not applicable to this document. The "tests" performed here are physical and chemical property tests, not clinical performance studies involving patient images and expert readers.

I will populate the table and address the questions as best as possible given the nature of the device and the provided document.

Acceptance Criteria and Device Performance Study for UltraCor™ Twirl™ Breast Tissue Marker (Curls and Clover)

As per the FDA 510(k) Summary (K243642), the device is a physical breast tissue marker. The "performance testing" summarized here pertains to the physical and chemical properties of the marker and its applicator, assessing its safety and effectiveness for its intended use as an implantable marker. It is designed to be substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" with numerical thresholds for these tests, but rather reports "Pass" or lists the type of analysis performed. This is common for biocompatibility and material safety testing where the goal is to demonstrate compliance with standards rather than specific performance metrics against a clinical endpoint.

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

Due to the nature of the device (implantable clip, not an AI diagnostic algorithm), the concept of a "test set" in the context of clinical data/images doesn't apply directly.

• Sample Size: The document does not specify the sample sizes (number of markers or material samples) for each individual non-clinical test (e.g., how many markers were tested for deployment force, or how many rats were used for the subchronic toxicity study). However, the tests performed (biocompatibility, mechanical, radiographic visibility) inherently involve testing a sufficient sample size of the device or its components to ensure statistical reliability and demonstrate compliance with relevant standards.
• Data Provenance: Not applicable in the sense of patient data. The tests are laboratory-based, performed on the device itself or its materials. The document does not state the country of origin for the testing.
• Retrospective or Prospective: Not applicable; these are laboratory and animal studies, not human clinical studies involving observational data.

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

This is not applicable as the device is a physical marker and its performance evaluation involves laboratory testing and animal studies (e.g., biocompatibility) rather than human expert interpretation of images for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. There is no human interpretation of data requiring adjudication for this type of device and performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a MRMC study was not done. This type of study is specifically designed for evaluating diagnostic algorithms or imaging techniques where human readers interpret medical images. The UltraCor™ Twirl™ Breast Tissue Marker is a physical implantable device, and its safety and performance are assessed through physical, chemical, and, in some cases, animal biocompatibility testing. It is not an AI-based diagnostic tool.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance tests outlined here is established through:

• Standardized Physical and Chemical Measurements: For tests like marker differentiation, visibility, retention, deployment accuracy, force, and corrosion, the ground truth is determined by objective, measurable physical and chemical properties and engineering specifications.
• Biocompatibility Standards: For the extensive biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, implantation), the "ground truth" is compliance with international standards (e.g., ISO 10993 series) and observed biological responses in in vitro and in vivo models. "Pass" indicates that the material did not induce unacceptable biological reactions.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The implanted SmartClip® is indicated for radiographic marking of sites in soft tissue. In addition, the Marker is indicated in situations where the soft tissue site needs to be marked for future medical procedures.

The SmartClip® is an ethylene oxide sterile, single use device composed of a soft tissue marker preloaded in a delivery system. The marker is intended to be placed within soft tissue. The marker is visible using radiography (including mammographic imaging), ultrasound and MRI.

Marker:
A sterile, single use device permanently implanted marker is approximately 8 mm long and 1.25mm wide. The marker is placed into the barrel of the introducer and maintained prior to insertion by a biocompatible bone wax plug. The marker can be implanted into various types of soft tissue (e.g., lung, gastrointestinal system, and subsequently be detected by means of radiography (including mammographic imaging, ultrasound and MRI.

Delivery System:
The Delivery System consists of a stylet-lock to prevent accidental deployment and 17ga introducer needle with male luer lock nut. The stainless steel needle is approximately 2.2 cm. The marker is preloaded inside the needle and retained by a bone wax plug. The male luer lock nut provides secure attachment to the proximal end of a biopsy needle. When the stylet is completely depressed the marker and bone wax plug are deployed from the end of the proximal end of the biopsy needle.

The provided text is a K233639 510(k) Summary for the Elucent Medical, Inc. SmartClip Secure Soft Tissue Marker. It details the device, its intended use, and a summary of testing performed to demonstrate substantial equivalence to a predicate device. However, it does not include specific acceptance criteria or a detailed study description with performance metrics for how the device meets those criteria.

Here's a breakdown of what is and is not available in the provided text regarding your request:

Information NOT available in the provided text:

• A table of acceptance criteria and the reported device performance: The document states that "Tested units met the acceptance criteria as defined in formal verification protocols," but it does not list these criteria or the specific performance results against them.
• Sample sizes used for the test set and the data provenance: Only general types of tests are listed (e.g., Simulated Use, Mechanical Integrity). The specific sample sizes for these tests are not provided, nor is the data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and their qualifications: This information is not present, as clinical testing was deemed "not applicable" for this submission.
• Adjudication method for the test set: Not applicable, as no human reader studies are described.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: This device is a physical tissue marker, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study with AI assistance is not applicable and not mentioned.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): As clinical testing was not applicable, ground truth in the context of diagnostic accuracy is not discussed. The "ground truth" for the non-clinical tests would be the established engineering and safety standards.
• The sample size for the training set: Not applicable, as this is a physical device, not a machine learning model.
• How the ground truth for the training set was established: Not applicable.

Information available in the provided text (related but not directly answering the core request about AI performance):

The document focuses on non-clinical testing to demonstrate the safety and effectiveness of the device. It lists the categories of tests performed:

• Simulated Use
• Mechanical Integrity
• Imaging Assessment
• MR Compatibility
• Biocompatibility (ISO 10993-1)
• Packaging (ISO 11607-1)
• Shelf Life
• Sterilization (ISO 11135)

The conclusion states: "SmartClip® Secure Soft Tissue Marker was verified to meet the all the product requirements and specifications. Tested units met the acceptance criteria as defined in formal verification protocols, meeting all requirements."

*In summary, the provided document is a 510(k) summary for a physical medical device (soft tissue marker) and does not contain the detailed information you requested regarding acceptance criteria and study data for AI performance or diagnostic accuracy studies. The submission is based on demonstrating substantial equivalence through non-clinical performance and safety testing against engineering standards.

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The Trilogy Tissue Marker is intended for use to attach to breast tissue at the surgical breast biopsy or percutaneous breast biopsy to radiographically mark the biopsy procedure, and be permanently visible under MRI, x-ray and ultrasound.

The Trilogy Tissue Marker is a sterile, single use device comprised of a disposable delivery device preloaded with a tissue marker. The disposable delivery device includes an introducer needle comprised of a plastic molded deployment handle, a thumb slide, a 14 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. Trilogy tissue markers are made of a non-resorbable polymer embedded with a nitinol shape, allowing for permanent visibility under ultrasound, x-ray, and MRI. This device offers the choice of three unique tissue marker shapes (i) Ring (ii) Cross (iii) Ribbon.

The provided document is a 510(k) summary for the Trilogy Tissue Marker. It details a comparison between the subject device and a predicate device (EasyMark™ Tissue Marker) to demonstrate substantial equivalence, rather than a study about acceptance criteria for an AI device. Therefore, much of the requested information regarding AI device acceptance criteria and study design is not available in this document.

However, I can extract the information related to the device performance and the testing conducted to support its substantial equivalence with the predicate device.

Here's a breakdown of the available information:

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

The document does not detail specific quantitative acceptance criteria or performance metrics in a readily extractable table form. Instead, it lists the types of performance tests conducted and states that the device meets "all system requirements" and is "substantially equivalent" to the predicate device.

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

The document does not provide details on the sample sizes used for the "Non-Clinical Bench Performance Testing." It also does not specify data provenance (e.g., country of origin or retrospective/prospective nature), as the testing appears to be primarily bench-based (laboratory testing).

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)

This information is not applicable and not provided. The study described is not a clinical study involving expert interpretation of medical images or data from human subjects. It focuses on the physical and functional aspects of a medical device (a tissue marker).

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

This information is not applicable and not provided, as the study is not an AI performance evaluation involving multiple readers or complex ground truth adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study relates to the performance of AI systems in assisting human readers, which is not the subject of this 510(k) submission.

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

A standalone performance study of an algorithm was not done. This submission is for a physical medical device (tissue marker), not an AI algorithm.

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

The concept of "ground truth" as typically used in AI studies (e.g., expert consensus, pathology, outcomes data) is not directly applicable here. The "ground truth" for the bench performance testing of this physical device would stem from objective measurement standards and engineering specifications. For instance, "Accuracy of Marker Deployment" would be evaluated against designed specifications for marker placement, and "Tissue Marker Migration Potential" would be assessed against defined metrics for stability.

8. The sample size for the training set

This information is not applicable and not provided, as this is not an AI device that requires a training set.

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

This information is not applicable and not provided, as this is not an AI device.

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The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue.

The MOLLI 2 System is intended only for the non-imaging detection of the MOLLI Marker that has been implanted in a site intended for surgical removal.

The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can only be implanted for less than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by nonimaging guidance (MOLLI 2 System), the MOLLI Marker is located and surgically removed with the target tissue. The MOLLI 2 System is intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

This FDA 510(k) summary focuses on design modifications to an existing device, the MOLLI 2 System, specifically introducing new MOLLI Wand configurations (MOLLI OncoPen, MOLLI OncoPen Prime, MOLLI OncoPen Elite) and corresponding software/hardware updates. As such, the submission primarily relies on non-clinical testing to demonstrate substantial equivalence, rather than a full de novo clinical study with detailed performance outcomes like sensitivity and specificity.

Therefore, many of the requested detailed points regarding acceptance criteria, study design for performance metrics like sensitivity/specificity, expert consensus, and effects on human reader performance are not explicitly available or described in this type of submission. The provided text outlines what non-clinical tests were conducted to support the changes.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that "Performance Testing including Multi Marker Localization System Accuracy, Wand Essential Performance (Accuracy and Feedback) and Multi Tissue Accuracy Testing" was performed. However, it does not provide specific acceptance criteria values (e.g., "accuracy must be > 95%") nor the reported numerical performance values. It only concludes that "The results of these reports indicate that the subject device is substantially equivalent to the predicate device."

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

Not specified in the provided text. The testing was non-clinical (laboratory/benchtop) rather than human subject testing, so "country of origin of the data" and "retrospective or prospective" do not apply in the typical sense of clinical trials.

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

Not applicable/specified. For non-clinical performance testing, the ground truth would typically be established by calibrated instruments or predefined scenarios, not human experts.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where human readers interpret data, not for non-clinical device performance testing.

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

No, a MRMC comparative effectiveness study was not done. The submission focuses on non-clinical testing for design changes.

6. Standalone (Algorithm Only) Performance

The "MOLLI 2 System" is a device that includes hardware (wands, tablet) and software. The performance testing described (Multi Marker Localization System Accuracy, Wand Essential Performance, Multi Tissue Accuracy) would be considered standalone performance of the device's ability to detect and localize markers, without a human "interpretation" component in the clinical sense. However, the exact metrics and results are not provided.

7. Type of Ground Truth Used

For the non-clinical performance testing, the ground truth would typically be established through:

• Engineering specifications / Known values: For accuracy tests, the true position or characteristics of the marker would be precisely known or set.
• Calibrated measurement tools: Instruments used to measure the output of the device would be calibrated to provide true values.
• Controlled experimental setups: Scenarios designed to simulate real-world use with known parameters.

8. Sample Size for the Training Set

Not applicable. This is a 510(k) for device modifications, not an AI/ML algorithm development submission requiring a "training set" in the machine learning sense. The software modifications are to support communication and compatibility with new hardware, implying changes to control logic rather than a learning algorithm.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. The MOLLI Marker can be implanted for greater than 30 days. Using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (MOLLI Systems (MOLLI System and MOLLI 2 System)), the MOLLI Marker is located and surgically removed with the target tissue.

The MOLLI Systems (MOLLI System and MOLLI 2 System) are intended only for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

The MOLLI Systems (MOLLI System and MOLLI 2 System) are precision surgical marking and guidance systems for locating non-palpable lesions during surgery. The systems consist of a temporary marker (MOLLI Marker), a marker delivery system (MOLLI Introducer), a detection wand (MOLLI Wand/MOLLI 2 Wands), and a visualization tablet (MOLLI Tablet/MOLLI Tablet 2). The MOLLI Wand/MOLLI 2 Wand Family and MOLLI Tablet/MOLLI 2 Tablet constitute the system. The MOLLI System is intended for the non-imaging detection and localization of the MOLLI Marker that has been implanted in a site intended for surgical removal.

The MOLLI 2 System's acceptance criteria and the study proving it meets these criteria are described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document primarily describes non-clinical testing, specifically "Biocompatibility testing." It does not provide details about a "test set" in the context of human data or clinical study for device performance evaluation. Hence, there's no information on sample size for a test set or data provenance (e.g., country of origin, retrospective or prospective) for such a study.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. The study mentioned is non-clinical biocompatibility testing, not a study requiring expert readers to establish ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication by experts is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not reported. The information provided focuses on non-clinical testing related to extending the implant duration of the MOLLI Marker.

6. If a Standalone Performance Study Was Done:

The document describes "Biocompatibility testing" as part of non-clinical testing to demonstrate safety. This can be considered a standalone assessment of certain aspects of the device (specifically, the MOLLI Marker's biocompatibility for extended use). It's not a standalone performance study in the sense of evaluating the accuracy or effectiveness of the MOLLI Systems for detection and localization of the marker, but rather the safety of the marker itself.

7. The Type of Ground Truth Used:

For the biocompatibility testing, the "ground truth" would be established by standardized scientific methods and tests for assessing biological response to materials, as defined in international standards (e.g., ISO 10993 series). This would involve laboratory analyses and observations according to established protocols, not expert consensus, pathology, or outcomes data in the traditional sense of a clinical study.

8. The Sample Size for the Training Set:

Not applicable. The document describes non-clinical biocompatibility testing and does not mention a training set, which is typically associated with machine learning or AI model development.

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

Not applicable, as no training set is mentioned in the context of the described testing.

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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 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 Endomag Magnetic Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The Endomag Magseed Pro Magnetic Marker is intended for use as a soft tissue marker. The marker is visible under ultrasound and radiographic imaging. It is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The Magseed Pro Magnetic Marker is a sterile, single use device composed of a selfexpanding four-sided tetrahedral nitinol structure, with side lengths of 6.3 mm with a magnetic core. The device is not inherently magnetic. It is capable of being magnetized and located by Endomagnetics' Sentimag Gen 2 or Gen 3 devices. The Magseed Pro Magnetic Marker comes preloaded in a 17-gauge needle delivery system.

The Magseed Pro Magnetic Marker is placed percutaneously into the tissue, using imaging guidance such as ultrasound or radiography, to mark a site intended for surgical removal. The Magseed Pro Magnetic Marker is subsequently localized by using imaging guidance (such as ultrasound or radiography) or aided by non-imaging guidance (Endomag Sentimage Systems, Sentimag Gen 3 K222832 or Sentimag Gen 2 K153044). The marker can be detected up to 45 mm from the Sentimage probe. The surgeon may use compression of the tissue with the probe to improve detection. The marker is located and surgically removed with the target tissue.

Additionally, Magseed Pro can be used in combination with Sentimag Gen 3 in Measure mode. When used in this modality, the distance between the location of Magseed Pro and the tip of the Sentimag Gen 3 probe can be measured. This distance is graphically displayed on the LCD screen of Sentimag Gen 3 in this mode.

Based on the provided text, the device in question is the "Magseed Pro Magnetic Marker System." The document describes its acceptance criteria and the study conducted to prove it meets them.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: While the document lists "Dimensional verification," "Robustness testing," "Insertion, deployment and withdrawal force testing," "MRI Compatibility," "Biocompatibility testing per ISO 10993-1," and "Corrosion testing" as performance tests, it does not explicitly state numerical acceptance criteria or detailed results for these. However, the overall conclusion of substantial equivalence implies they met their internal acceptance criteria.

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

• Sample Size: 60 patients.
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "clinical performance testing" conducted in patients, implying prospective data collection during the study.

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

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical test set. The ground truth appears to be based on direct clinical observation (successful retrieval) and pathological examination (target region excised, absence of unexpected tissue responses).

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "ground truth" seems to be derived directly from the outcomes of the surgical procedures and subsequent pathological assessments.

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 involving human readers assisting with or without AI was not conducted. This device is a physical marker and delivery system, not an AI-powered diagnostic tool. The clinical study focused on its physical performance (placement, retrieval, safety).

6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a physical marker, not an algorithm or software. Its performance is evaluated in conjunction with human use (placement, surgical removal) and detection systems (Sentimag Gen 2/3).

7. The Type of Ground Truth Used

The ground truth used was:

• Clinical Efficacy: Successful physical retrieval of the marker and excision of the target tissue during surgery.
• Pathology: Histological examination of excised tissue to confirm target region removal and assess for unexpected tissue responses.
• Outcomes Data: Observation of device-related adverse events.

8. The Sample Size for the Training Set

The document does not mention a training set, as this is a physical device and not a machine learning model. The clinical study involved 60 patients for performance and safety evaluation.

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

Not applicable, as there was no training set for a machine learning model.

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The SCOUT MD Reflector is intended to be placed percutaneously in soft tissue (>30 days) to mark a biopsy site or a soft tissue site intended for surgical removal. Using imaging guidance (such as ultrasound, MRI, or radiography) or aided by non-imaging guidance (SCOUT MD System) the SCOUT MD Reflector is located and surgically removed with the target tissue. The SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector that has been implanted in a soft tissue biopsy site or a soft tissue site intended for surgical removal.

The SCOUT MD Delivery System is used to implant the preassembled SCOUT MD Reflector. The needle of the Delivery System is percutaneously advanced into tissue to the site to be marked for biopsy or surgical removal. Needle placement is confirmed under imaging technique (radiographic, ultrasound). The Reflector (tissue marker) is deployed at the target site and the Delivery Device is removed from the patient and discarded. The Reflector, a passive implant, remains in situ and, if surgical removal of the target tissue is necessary, the Reflector is located at the time of surgery (intraoperatively) by the SCOUT MD Surgical Guidance System. The SCOUT MD Guide/Handpiece connected to the SCOUT MD Console is used to detect the SCOUT MD Reflector but it does not contact tissue. SCOUT MD Guides are always used while inside the SCOUT Guide Sheath. When the SCOUT MD System detects the Reflector, the Console emits audible feedback that increases in cadence as the Guide is placed closer to the Reflector. The distance between the distal end of the Guide and the detected Reflector, in millimeters, is displayed on the Console. If necessary, the Reflector is removed from the patient during a subsequent surgical procedure along with the tissue of interest or the Reflector can be left in-situ.

The provided text is a 510(k) Premarket Notification for the SCOUT MD Surgical Guidance System. It aims to demonstrate substantial equivalence to a predicate device, the SAVI Scout Reflector and SAVI Scout System.

However, the document does not contain the detailed performance data, acceptance criteria, or study methodologies that would typically be described in a clinical study report for proving a device meets specific acceptance criteria. Instead, it lists the types of tests performed to support substantial equivalence.

Therefore, I cannot extract answers to many of your specific questions regarding acceptance criteria, sample sizes for test/training sets, ground truth establishment, expert roles, and MRMC studies, as this information is not present in the provided text.

The document implicitly "proves" the device meets acceptance criteria by stating that the results of safety and performance tests demonstrate the device is substantially equivalent to the predicate, and that any differences do not raise new questions of safety and effectiveness. This is the core argument for a 510(k) submission.

Here's an attempt to answer what can be inferred or directly stated from the provided text, with clear indications where the information is not available.

Acceptance Criteria and Device Performance (Inferred/Stated)

While explicit numerical acceptance criteria are not detailed, the summary implies that the device performance met the standards for demonstrating substantial equivalence to the predicate. The performance "tests" enumerated are implicitly the method by which acceptance was determined.

Study Details (Information from the Text):

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

   • Sample Size: Not specified. The document lists types of performance tests, but not the sample sizes used for those tests (e.g., number of devices tested, number of simulated deployments, or any human subject data).
   • Data Provenance: Not specified. The document does not mention the country of origin of any data or whether the studies were retrospective or prospective. Given the nature of the tests listed (e.g., integrity, functional, electrical safety, biocompatibility, simulated use), these are typically bench or lab-based engineering verification and validation activities, not clinical studies with human subjects in the traditional sense for AI/imaging devices.

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

   • This information is not provided. The listed tests are primarily engineering and bench testing, not clinical performance studies requiring expert ground truth establishment in the context of diagnostic accuracy. If "Simulated Use" involved expert assessment, it's not detailed.

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

   • Not applicable / Not provided. This typically refers to clinical image interpretation studies, which are not detailed here.

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 evidence of an MRMC study. This device (SCOUT MD Surgical Guidance System) is an implantable marker and a localization system. It does not appear to be an AI-powered diagnostic imaging device that would assist human readers in interpreting images. Its function is to non-imaging detect and localize an implanted reflector.

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

   • The "SCOUT MD System is intended only for the non-imaging detection and localization of the SCOUT MD Reflector." The functional and performance tests mentioned (deployment, detection, accuracy) would constitute standalone performance evaluation of the algorithm and system components. The specific details of how thoroughly this was tested are not explicitly described beyond listing the types of tests.

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

   • For the engineering and functional tests described (e.g., dimensional accuracy, detection range accuracy, material properties), the "ground truth" would be engineering specifications, physical measurements, and established scientific standards (e.g., ISO, ASTM standards for materials, sterilization, electrical safety). There is no mention of expert consensus, pathology, or outcomes data as ground truth, as these tests are not related to diagnostic accuracy.

7. The sample size for the training set:

   • Not applicable / Not provided. The document describes a "Surgical Guidance System" that non-imaging detects an implanted marker. There is no indication that this system uses machine learning or requires a 'training set' in the context of AI model development. The principle of operation is described as measuring the relative strength of RF reflective energy.

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

   • Not applicable / Not provided. As there's no mention of a traditional 'training set' for an AI model, this question is not relevant to the information provided.

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