Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

Under supervision of a healthcare professional

· The SchurSign Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

SchurSign Tissue Marker consists of a radiographic soft tissue marker and a delivery system. SchurSign is a sterile, single patient use, discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI).

The proposed SchurSign Tissue Marker is placed into soft tissue during open, percutaneous, or endoscopic procedures to mark a surgical location.

The proposed SchurSign Tissue Marker is comprised of chitosan filled with Barium Sulfate.

The proposed SchurSign Tissue Marker delivery system is a distal delivery needle tip, rigid shaft, sterile, and single patient use preloaded delivery system incorporating the SchurSign Tissue Marker.

The delivery system consists of a cannula with a handle, a push rod with a plunger, and an end cap. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle. The SchurSign Tissue Marker delivery system is used to place the SchurSign Tissue Marker into soft tissue during open, percutaneous, or endoscopic procedures to radiographically mark a surgical location. The delivery system device has a bevelled 12 cm / 14 to 10 gauge needle with 1 cm depth marks and a plunger.

SchurSign is available in seven different sizes:

The provided text describes the SchurSign Tissue Marker and its comparison to a predicate device, Beacon Tissue Marker, to demonstrate substantial equivalence for FDA clearance. However, the document focuses on biocompatibility testing, imaging visibility (in vitro and in vivo), and overall device equivalence rather than the performance of an AI/algorithm-based diagnostic device.

Therefore, many of the requested points regarding AI/algorithm performance (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance, types of ground truth for AI) are not applicable or not present in this document because the SchurSign Tissue Marker is a physical medical device, not an AI software.

Below is a summary of the information that is available in the document, framed as closely as possible to your request.

Acceptance Criteria and Study for SchurSign Tissue Marker

The document describes the acceptance criteria and studies conducted to demonstrate the substantial equivalence of the SchurSign Tissue Marker to its predicate device, the Beacon Tissue Marker (K130763). This is primarily focused on physical and biocompatibility performance, not an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the successful completion of the biocompatibility tests according to ISO standards and a demonstration of equivalent imaging visibility to the predicate. The "reported device performance" section focuses on the results of these tests and the conclusion of substantial equivalence.

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

• Test Set Sample Size: Not explicitly stated for each biocompatibility test or imaging study. The studies refer to "mice," "guinea pig," "rat," and "swine" without specific numbers for each group. For the in vitro imaging, it mentions "chicken breast."
• Data Provenance: The studies were conducted as part of the regulatory submission, implying they were performed by or for the manufacturer. The location (country of origin) of these tests is not specified, but the manufacturer is based in Germany. The studies are prospective in nature, designed specifically for this regulatory submission.

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

• Not Applicable. This device is a physical tissue marker, not an AI/algorithmic diagnostic device requiring expert interpretation for ground truth establishment. Biocompatibility results are typically determined by laboratory assays and pathologist evaluation of tissue samples, not a consensus of clinical experts in the manner described for AI. The swine study involved histopathology, which would be interpreted by pathologists, but details on the number or qualifications are not provided.

4. Adjudication Method for the Test Set

• Not Applicable. No expert adjudication method (like 2+1, 3+1) is mentioned as it's not relevant for the type of device and studies conducted.

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

• No. This type of study is specifically for evaluating the effectiveness of AI or diagnostic systems with human readers. The SchurSign Tissue Marker is a passive marker device.

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

• Not Applicable. The device is not an algorithm.

7. The Type of Ground Truth Used

• Biocompatibility: Ground truth is based on established biological and chemical assay readouts (e.g., cell viability in cytotoxicity, observed reactions in sensitization tests, macroscopic/microscopic findings in implantation) as per ISO and USP standards.
• Imaging Visibility: Ground truth is the physical presence and visibility of the marker in anatomical models (ex vivo chicken breast) and living tissue (in vivo swine), confirmed by direct observation on imaging modalities (X-ray, ultrasound) and potentially post-mortem examination or histopathology.
• Histopathology: Ground truth is established by pathological examination of tissue samples from the swine study.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device; hence, there is no "training set."

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

• Not Applicable. No training set exists for this device.

Ask a specific question about this device

The EasyMark Tissue Marker is intended for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.

The EasyMark 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 17 ga. cannula with 1 cm depth marks and a push rod. The tissue marker is preloaded in the distal end of the cannula. This device offers the user the choice of two unique tissue markers (i) 316 LVM Stainless Steel Anchor shaped Marker (ii) Titanium 6AI-4V ELI Ribbon shaped Marker.

The provided text describes the 510(k) premarket notification for the EasyMark Tissue Marker. It details the device, its indications for use, and a comparison to predicate and reference devices. However, it does not contain specific acceptance criteria or the study results proving the device meets those criteria, nor does it include information about a standalone study, MRMC study, sample sizes, ground truth establishment, or expert details for such studies.

Based on the information provided, here's what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The document lists the types of non-clinical tests performed but does not state the specific acceptance criteria for each test or the quantitative results from those tests.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided as the document only states "non-clinical testing and evaluation was conducted." It doesn't detail specific sample sizes for any of the performance tests.

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 provided as the document does not describe any studies involving human experts or ground truth establishment in this manner.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no studies involving human interpretation or adjudication are 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
This information is not provided. The EasyMark Tissue Marker is a physical implantable device, not an AI software. Therefore, an MRMC study with human readers improving with AI assistance would not be relevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. The device is a physical tissue marker, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided. The document describes performance testing, but not the specific methods used to establish ground truth for metrics like "Accuracy of Marker Deployment." It likely refers to objective measurements against predefined specifications.

8. The sample size for the training set
Not applicable. The EasyMark Tissue Marker is a physical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established
Not applicable. The EasyMark Tissue Marker is a physical device, not an AI model that requires a training set.

Summary of Provided Information (within the scope of the document):

Device Name: EasyMark Tissue Marker
Intended Use: To attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the biopsy procedure.

Non-clinical Testing and Evaluation Performed to demonstrate substantial equivalence to the predicate device:

• Performance Testing Bench:
  • Accuracy of Marker Deployment
  • Marker Deployment Force
  • Usability of the Device
  • Imaging Assessment (X-ray and MRI)
  • Safety and Compatibility in Magnetic Resonance (MR) Environment
  • Tissue Marker Migration Potential
  • Delivery Device Cannula Tensile Test
  • Delivery Device Push Rod Tensile Test
• Biocompatibility
• Sterilization
• Packaging
• Shelf Life

Predicate Device: UltraClip® Tissue Marker, K993785
Reference Device (for biocompatibility of delivery device): SelectCore, K093256

Conclusion: The non-clinical testing and evaluation demonstrated that the EasyMark Tissue Marker "does not raise new concerns of safety or effectiveness and is substantially equivalent to the predicate device."

Disclaimer: The provided document is a 510(k) summary for a medical device. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not typically include detailed acceptance criteria or study results in the format requested, especially since the device is a physical marker and not an AI or diagnostic software tool.

Ask a specific question about this device

The FibermarX™ Radiopaque Tissue Marker is intended to be implanted into the body to accurately visualize and constitute the reference frame for stereotactic radiosurgery and radiotherapy target localization. In addition, the markers are indicated in situations where tissue needs to be marked for future medical procedures such as IMRT/IGRT.

The device is a sterile, single-patient-use, barium sulfate infused non-absorbable polymer monofilament that is visible on standard radiographs (x-ray, CT, mammography). FibermarX™ is passed through soft tissue and tied into place during open, percutaneous, or arthroscopic/laparoscopic/endoscopic procedures and standard surgeon's knots or a continuous running outline are used to quickly mark the soft tissue for subsequent imaging or for radiotherapy target localization.

The provided document is a 510(k) premarket notification for a medical device called the FibermarX™ Radiopaque Tissue Marker. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data that would typically include detailed acceptance criteria and performance metrics of the new device in a standalone clinical trial.

Therefore, the document does not contain the requested information regarding acceptance criteria and a study that proves the device meets those criteria in the context of a comparative effectiveness study, standalone AI algorithm performance, or using experts to establish ground truth. The submission focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device.

Here's a breakdown of what can be extracted or inferred from the document based on the standard 510(k) submission process:

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

The document does not provide a formal table of acceptance criteria and reported device performance in the manner one would see for a clinical trial or AI algorithm validation. Instead, it describes non-clinical tests conducted to support substantial equivalence. The "performance" is generally demonstrated by showing that the device is comparable to the predicate device in specific aspects.

Inferred "Acceptance Criteria" (based on non-clinical tests) and "Reported Device Performance":

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 applicable in the context of human data. The "test set" here refers to physical samples of the device used for non-clinical testing (e.g., individual markers for biocompatibility, imaging, and radiation impact). The specific number of physical units tested is not detailed, but it would have been sufficient for the conducted non-clinical tests.
• Data Provenance: Not applicable as this is non-clinical testing of the device itself, not human data. The tests were performed by the manufacturer or a contracted lab.

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)

• Number of Experts: Not applicable. Ground truth, in the context of clinical or AI studies, is not established for non-clinical device testing. The results of the physical tests are the "ground truth" for the device's characteristics.

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

• Adjudication Method: Not applicable. This concept applies to expert review of clinical data, which is not part of this 510(k) non-clinical submission.

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

• MRMC Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not conducted and is not mentioned. This type of study would be relevant for evaluating diagnostic imaging devices or AI-assisted systems reading images from human patients, which is not the nature of this device or its submission.

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

• Standalone Performance: No, a standalone algorithm performance study was not done. This device is a physical tissue marker, not an algorithm.

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

• Type of Ground Truth: For the non-clinical tests, the "ground truth" is derived from objective, quantitative measurements and laboratory analyses (e.g., chemical analysis results for extractables, physical measurements for mechanical properties after radiation, optical/imaging assessments of visibility).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device is not an AI algorithm, so there is no training set in the conventional sense.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this device.

Ask a specific question about this device

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 wide. The marker is placed into the barrel of the introducer and maintained in place 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 breast) and subsequently be detected by means of radiography (including mammographic imaging), ultrasound and MRI.

Delivery System:
The Delivery System consists of a stylet, a stylet-lock to prevent and 15ga introducer needle. The stainless steel needle is approximately 10.8 cm long with 1cm depth reference marks. The marker is preloaded inside the needle and retained by a bone wax plug. When the stylet is completely depressed the marker and bone wax plug, are deployed from the end of the needle.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Unfortunately, the provided text does not include specific acceptance criteria with quantifiable metrics for the SmartClip™ Soft Tissue Marker alongside reported device performance data, nor does it detail a specific study with the characteristics you requested.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria. While it mentions "Performance Testing," it lists the types of tests conducted (e.g., Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility, Biocompatibility, Packaging, Sterilization) but does not provide the concrete results, statistical analyses, or the detailed parameters of these tests.

Based on the provided text, I can extract the following information, but cannot fully populate the requested table or answer all questions due to the lack of specific performance study details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size for any of the performance tests (e.g., simulated use, mechanical integrity, imaging assessment). The data provenance is also not detailed (e.g., country of origin, retrospective/prospective). The emphasis is on types of tests performed rather than the experimental design or results.

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

This information is not provided in the document. The tests described (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility) are primarily bench-top or in vitro tests and physical characterizations, which generally do not require expert adjudication in the way clinical diagnostic studies might. For "Imaging Assessment," while expert interpretation would be involved, the text doesn't detail a specific study with expert readers.

4. Adjudication Method for the Test Set

As the document primarily discusses engineering and material tests, a formal "adjudication method" (like 2+1 or 3+1 for clinical image interpretation) is not applicable or mentioned.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not mentioned or indicated in this submission. This device is a passive tissue marker, not an AI-powered diagnostic tool.

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

No, this is not applicable as the SmartClip™ is a physical medical device (a tissue marker) and not an algorithm or AI system.

7. The Type of Ground Truth Used

For the performance tests mentioned:

• Mechanical Integrity/Simulated Use: Ground truth would be based on engineering specifications and acceptable performance parameters.
• Imaging Assessment: Ground truth would be the presence of the marker and its visibility under various imaging modalities, likely assessed visually by imaging professionals or engineers against expected image characteristics.
• MR Compatibility: Ground truth established through adherence to recognized MR safety standards and testing protocols (e.g., heating, artifact assessment).
• Biocompatibility: Ground truth established through in vitro and/or in vivo studies following ISO 10993 standards. The document states it "Passed."

8. The Sample Size for the Training Set

This is not applicable as the SmartClip™ is not a machine learning or AI device that requires a training set.

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

This is not applicable as the SmartClip™ is not a machine learning or AI device.

In summary: The provided 510(k) summary for the SmartClip™ Soft Tissue Marker focuses on demonstrating substantial equivalence through a comparison of "Indications for Use," "Technological and Performance Characteristics," and listing the types of performance tests conducted (Simulated Use, Mechanical Integrity, Imaging Assessment, MR Compatibility, Biocompatibility, Packaging, Sterilization). It explicitly states that "The SmartClip™ met all specified criteria and did not raise new safety or performance questions." However, it does not provide detailed quantitative acceptance criteria or the specific results and statistical data from these performance tests.

Ask a specific question about this device

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 consists of a disposable beveled needle applicator containing a nitinol radiographic ring wireform. The wireform is intended for longterm radiographic marking of the tissue site. The applicator has a beveled 17G x 10cm needle with 1cm depth marks and a locking plunger. The ring is deployed from the beveled needle tip into the tissue site.

The provided text describes a 510(k) premarket notification for the UltraCor Twirl Breast Tissue Marker. However, it explicitly states that no performance data (bench testing or clinical analysis) was warranted due to the nature of the change.

The key information regarding acceptance criteria and study details is as follows:

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

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

• Sample Size: Not applicable. No test set was used for a performance study.
• Data Provenance: Not applicable.

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

• Number of Experts: Not applicable.
• Qualifications of Experts: Not applicable.

4. Adjudication method for the test set:

• Adjudication Method: Not applicable.

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:

• MRMC Study: No. This device is not an AI-assisted diagnostic tool, but rather an implanted marker.

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

• Standalone Performance: No. This device is an implanted marker, not a diagnostic algorithm.

7. The type of ground truth used:

• Ground Truth Type: Not applicable. The submission is based on an update to the Indications for Use, supported by a literature review and physician statements on existing clinical practice, rather than a direct performance study to establish a ground truth.

8. The sample size for the training set:

• Sample Size: Not applicable. No training set was used.

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

• Ground Truth Establishment: Not applicable.

Explanation from the document:

The 510(k) submission (K180061) for the UltraCor Twirl Breast Tissue Marker focused on an update to its Indications for Use to include axillary lymph nodes. The manufacturer explicitly states:

• "The change to the Indications for Use described in this submission does not affect the design of the device and no new or increased risks have been identified, therefore additional bench performance testing was not warranted." (Page 5, Section 8. Performance Data)
• "The change to the Indications for Use is clinically supported by both a comprehensive literature review and physician statements." (Page 5, Section 9. Clinical Analysis)

Therefore, this submission did not involve a study to prove performance against specific acceptance criteria in the traditional sense of a diagnostic or therapeutic device. Instead, it leveraged existing knowledge and clinical practice to justify the expanded indication of an already cleared device.

Ask a specific question about this device

The Radiopaque Tissue Marker is indicated for use to radiographically mark soft tissue during a surgical procedure or for future surgical procedures.

The device is a sterile, single-patient-use, barium sulfate infused polypropylene suture that is radiopaque using standard radiographs (x-ray, mammography). The device is placed into soft tissue sites during open, percutaneous, or endoscopic procedures and standard surgeon's knots are tied to quickly and inexpensively mark the soft tissue so that the integrity and location of the marked soft tissue can be evaluated.

This document is a 510(k) summary for a medical device called a "Radiopaque Tissue Marker." It outlines the device's characteristics, its intended use, and the non-clinical testing performed to establish substantial equivalence to a predicate device.

Here's an analysis based on the provided text, addressing your questions:

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

The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance metrics for the device. Instead, it describes non-clinical tests performed to demonstrate substantial equivalence to a predicate device. The performance is assessed against the predicate device, not against specific, pre-defined numerical thresholds for accuracy, sensitivity, or specificity.

However, based on the non-clinical testing mentioned, we can infer performance aspects:

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 describes non-clinical laboratory testing. It does not mention a "test set" in the context of patient data, nor does it specify any sample sizes for patients or data provenance (country of origin, retrospective/prospective). The testing involved physical devices and materials, not patient data in the way one would analyze for an AI algorithm.

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 is not applicable to the study described. The study involves non-clinical testing of a physical device. There is no "ground truth" establishment in the context of expert consensus on medical images or diagnoses.

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

This is not applicable for the study described. There is no "test set" of patient data requiring adjudication of ground truth by multiple experts.

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 study was performed. The device is a physical radiopaque tissue marker, not an AI algorithm. Therefore, an "effect size of human readers improve with AI vs without AI assistance" is not relevant.

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

No standalone algorithm performance study was done. The device is a physical radiopaque tissue marker, not an AI algorithm.

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

This is not applicable for the study described. The "ground truth" for non-clinical device testing would be the physical and chemical properties of the materials and their behavior under controlled laboratory conditions, as measured by standard testing methods (e.g., ISO 10993 for biocompatibility, specific imaging protocols for radiopacity). It is not based on expert consensus, pathology, or outcomes data related to patient diagnosis.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI algorithm that requires a "training set."

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

This is not applicable. There is no AI algorithm or training set associated with this device.

Ask a specific question about this device

Star Tissue Marker is indicated for use to radiographically mark soft tissue at the surgical procedure or for future surgical procedures

The Star Tissue Marker consists of a radiographic soft tissue marker and the delivery system. The Star Tissue Marker includes a sterile, single patient use, PEKK discrete marker that is visible on standard radiographs (x-ray, mammography) as well as ultrasound, and Magnetic Resonance Imaging (MRI) at up to 3.0 Tesla field strength.

This submission is for a new cross sectional profile of the tissue marker. The delivery system is sterile, single patient use, and is pre-loaded incorporating the tissue marker. The delivery system has a 12 cm /14 gauge needle with 1 cm depth marks. The delivery system consists of a cannula with a handle with integral tabs to retain the tissue marker, a push rod with a plunger, and a tip cover. The tissue marker is retained within the delivery system until placement is desired, where it is delivered through the end port by fully depressing the plunger into the handle.

This document is a 510(k) premarket notification for the "Star Tissue Marker," an implantable clip used to radiographically mark soft tissue. The submission claims substantial equivalence to a predicate device, the "Beacon Tissue Marker" (K140835).

Since this is a 510(k) premarket notification for a Class II device claiming substantial equivalence to a predicate device, it does not typically include a clinical study with detailed acceptance criteria and performance data like a PMA application would. The FDA's 510(k) pathway focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often through non-clinical testing and comparison. Therefore, the requested information regarding acceptance criteria and a study proving performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, is generally not found in these types of submissions for this device.

The document states:

• The device is a "Star Tissue Marker" and the predicate device is the "Beacon Tissue Marker" cleared on May 20th, 2014 (K140835).
• The submission is for a "new cross sectional profile of the tissue marker."
• "The results of assessment of the change to the new tissue marker conducted under Design Controls, support that the new offering is substantially equivalent to the predicate tissue marker."

This implies that the "study" demonstrating equivalence would be a series of engineering and material assessments comparing the new tissue marker's design, materials (PEKK), and radiographic visibility (X-ray, mammography, ultrasound, MRI up to 3.0 Tesla) to the predicate device, rather than a clinical trial with human subjects. The acceptance criteria would likely be defined by these engineering and performance standards to match or exceed those of the predicate device.

Without more detailed information from the original submission (which is beyond this document), it's not possible to provide the specific data requested in the format of acceptance criteria and proven device performance from a clinical study. The FDA's review for a 510(k) largely relies on non-clinical data and comparisons to the predicate, as evidenced by the mention of "Compliance with Design Controls" and "Compliance with Standards" (ISO 15223-1:2012, ISO 14971:2007, EN 1041:2008).

Ask a specific question about this device