Search Results

Ask a specific question about this device

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.

Ask a specific question about this device

The Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. The catheter should not be used in the cerebral vessels.

The Maestro Microcatheter is available in working length sizes 110cm, 130cm, 150cm, 165cm and 175cm lengths. The distal tip of the microcatheter is offered in straight or pre-shaped 45 degree and swan neck configurations. The proximal end of the catheter consists of a molded winged hub with a tapered strain relief. The outer surface of the distal 80cm of the microcatheter shaft is coated with a hydrophilic coating designed to facilitate the introduction of the catheter into the vasculature. The microcatheter incorporates a radiopaque marker at the distal tip to facilitate fluoroscopic visualization. The Maestro Microcatheter is offered with two 3ml syringes.

This document is a 510(k) premarket notification for the Maestro Microcatheter and primarily focuses on demonstrating substantial equivalence to a predicate device. It describes performance testing conducted to support this claim, but it does not detail a study involving AI or human readers, or provide specific acceptance criteria and reported device performance in the manner typically seen for AI/CADe devices.

Therefore, many of the requested sections about AI/CADe study design cannot be answered from the provided text.

Here is the information that can be extracted or inferred from the document regarding acceptance criteria and performance, as appropriate for a medical device cleared via 510(k) demonstrating equivalence:

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

The document does not explicitly present a table of acceptance criteria alongside reported performance for each specific test in numerical detail as would be expected for an AI system's metrics (e.g., sensitivity, specificity, AUC). Instead, it broadly states that the conducted tests met "predetermined acceptance criteria."

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

This document describes bench and design validation testing, not a clinical study involving a "test set" of patient data. Therefore, the concepts of sample size for a test set, data provenance, and retrospective/prospective do not apply in the context of this 510(k) submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not applicable, as this is bench and design validation testing for a physical medical device, not a diagnostic AI system requiring expert-established ground truth.

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

Not applicable for the reason stated above.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for a microcatheter, not an AI or CADe device. No MRMC study was conducted.

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

Not applicable. This is not an algorithm or AI device.

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

For the bench and design validation tests, the "ground truth" implicitly refers to physical measurements, engineering specifications, and established limits defined by relevant standards (e.g., ISO 10555-1) and internal product requirements. The tests assessed characteristics like effective length, tensile force, leakage, pushability, trackability, etc., against predefined pass/fail criteria.

8. The sample size for the training set

Not applicable. No training set is involved for this type of device submission.

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

Not applicable. No training set is involved.

Ask a specific question about this device

The Siege Vascular Plug is indicated for arterial embolization in the peripheral vasculature.

The Siege™ Vascular Plug (“Device”) is a self-expanding braided nitinol vascular occlusion implant that is supplied with components used for implantation. The Device has radiopaque marker bands attached to each end and a screw attachment for connection to a Delivery Wire. The Device is packaged collapsed within a Loader and attached to a 180cm Delivery Wire that is provided within a hoop dispenser. Touhy Borst Valves are provided for flushing and maintaining hemostasis. A Torque Device is provided for releasing the Device.

The Siege™ Vascular Plug has been designed with a material, size, configuration and shape that allows introduction through recommended 0.027" inner diameter commercial microcatheters for the occlusion of blood vessels in the peripheral vasculature. The Siege™ Vascular Plug Devices are provided in four different diameters (3mm, 4mm, 5mm, 6mm) to treat different sized blood vessels in the peripheral vasculature. The Siege™ Vascular Plug is designed to be used under fluoroscopy for delivery and implantation in the peripheral vasculature. The main users of the device are physicians trained in vascular embolization.

This document is a 510(k) summary for the Merit Siege Vascular Plug. It states that clinical testing was not required for the determination of substantial equivalence. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set information is not applicable to this submission.

The summary focuses on comparing the subject device to predicate devices (KA Medical Micro Plug Set K182944, Amplatzer® Vascular Plug K031810, Micro Vascular Plug System K123803, and Micro Vascular Plug System K133282) based on technological characteristics and performance testing.

Here's what can be extracted from the provided text regarding acceptance criteria and performance, although it doesn't fit the requested table format precisely due to the lack of quantitative criteria:

Acceptance Criteria and Reported Device Performance (Qualitative)

Since no specific quantitative acceptance criteria are provided in the document beyond meeting "predetermined acceptance criteria" and being "comparable to predicate devices," this table is formed qualitatively based on the tests performed and the general statement of meeting criteria.

The document explicitly states that clinical testing was not required for the determination of substantial equivalence (page 10). Therefore, the following requested information is not applicable in this context:

2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used. "A battery of testing was conducted, on the subject Merit Siege™ Vascular Plug, in accordance with protocols based on requirements outlined in guidance's and Performance industry standards." These tests were likely in vitro or in vivo (animal study).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there was no clinical test set requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as there was no clinical test set requiring 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: Not applicable. This device is a vascular plug, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a vascular plug, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" would be the engineering specifications, industry standards, and biological responses observed in biocompatibility and animal studies, rather than a clinical ground truth. For the animal study, outcomes such as acute performance, chronic performance, and tissue response were evaluated.
8. The sample size for the training set: Not applicable as no machine learning algorithm was involved.
9. How the ground truth for the training set was established: Not applicable as no training set for a machine learning algorithm was involved.

In summary, this 510(k) submission for the Merit Siege Vascular Plug demonstrates substantial equivalence through non-clinical testing (performance, biocompatibility, sterilization, and animal studies) rather than clinical studies requiring human data, expert review, or AI performance metrics.

Ask a specific question about this device

The Merit GO2WIRE™ is intended to facilitate the placement and exchange of devices during peripheral diagnostic and interventional procedures.

The Merit Go2Wire guide wire will consist of 0.035" guide wire configurations available in 145, 175, 210, 260, and 300cm. The distal tip flex configurations are Floppy, Standard and Intermediate (Modified J). The distal tip shapes are either straight or modified J.

The wire is composed of a stainless-steel core wire, a PTFE coated coil, a white PTFE sleeve, a platinum-tungsten marker coil, and an optional extension system connector. The wire's proximal end is covered by a white PTFE sleeve that terminates at 100cm from the distal tip. The distal 100 cm of the wire is covered with a green PTFE pre-coated coil. The PTFE coated coil and platinum-tungsten coil are welded to the core on the very distal tip. The distal tip is shapeable and radiopaque. A torque device is included to facilitate wire steering within the vascular anatomy.

An 0.035" extension wire consisting of PTFE coated stainless steel 155cm in length to extend the length of the wire to allow initial usage with a short wire and then extendable to allow catheter exchanges when required.

This document is a 510(k) premarket notification for a medical device called the "Go2Wire Guide Wire." It is not an AI/ML device, therefore, the information requested about acceptance criteria and study proving device meets it (including multi-reader multi-case studies, standalone algorithm performance, and training/test set details for AI/ML models) is not applicable or present in this document.

The document discusses the substantial equivalence of the Go2Wire Guide Wire to a predicate device based on various performance and biocompatibility tests.

Here's the relevant information that can be extracted, addressing the spirit of the request as much as possible for a non-AI/ML device:

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

The document does not provide a specific table with numerical acceptance criteria and reported numerical performance values. Instead, it states:

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

The document does not specify the sample sizes used for each test or the provenance of the data. The tests are described as "Performance Testing-Bench" and "Biocompatibility," indicating laboratory testing of the physical device rather than data from clinical studies.

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 as this is a physical medical device (guide wire), not an AI/ML system requiring expert interpretation for ground truth. The "ground truth" for this device would be established by validated test methods and passing results according to engineering and biocompatibility standards.

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

Not applicable. This is not an AI/ML study involving human readers or interpretation requiring 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

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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

The "ground truth" for this medical device's performance is established by:

• Reference to industry standards and FDA guidance documents for medical device testing (e.g., ISO 11070:2014, FDA Guidance for Guidewires, ISO 10993-1:2018 for biocompatibility).
• Predetermined acceptance criteria derived from these standards and comparison to a legally marketed predicate device (Wholey Guide Wire System [K120863]).
• Bench testing and biocompatibility testing results.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of AI/ML.

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

Not applicable. This device does not involve a "training set" in the context of AI/ML.

Ask a specific question about this device