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The Radius Snare is intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.

The Radius Snare is composed of two primary parts: a stainless steel outer sheath tube and a stainless steel core wire with a loop snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. The Radius Snare has loop sizes which range from 5 - 35 millimeters. The over-all length of the device is 150 centimeters. The Radius Snare is packaged in a mylat/Tyvek pouch and ETO sterilized to SAL 10°.

The provided text describes a medical device, the Radius Snare, and its 510(k) submission to the FDA. However, the document does NOT contain information about acceptance criteria for performance metrics or a study detailing specific device performance against such criteria. The "Performance Testing" section states that modifications were assessed based on an FDA guidance document, but it does not present any quantitative performance data, sample sizes, or details about ground truth establishment.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an analysis of what information can be extracted:

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

   • Not Available. The document states that "Performance testing to assess the impact of the modifications was from the FDA guidance document 'Coronary and Cerebrovascular Guidewire Guidance' dated January 1995." It concludes that the device "meets the minimum requirements that are considered adequate for its intended use." However, it does not specify what those minimum requirements (acceptance criteria) were, nor does it present any specific performance metrics (e.g., retrieval success rate, deployment accuracy, force required, etc.) or a table comparing them to 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)

   • Not Available. The document does not mention any sample sizes for testing, nor does it specify data provenance. It only refers to "Performance 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)

   • Not Applicable/Not Available. There is no mention of expert-established ground truth or any clinical study involving experts. The performance testing appears to be primarily bench or in-vitro testing based on device characteristics.

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

   • Not Applicable/Not Available. The concept of "adjudication" typically applies to clinical studies or assessments where human judgment is involved in determining outcomes or ground truth, which is not described here.

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 physical medical snare, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant.

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

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

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

   • Not Available. Given the nature of the device (a snare for retrieving objects), the "performance testing" likely involved evaluating physical characteristics, retrieval forces, deployment, and material integrity against predetermined engineering specifications, rather than clinical ground truth like pathology or expert consensus. The specific metrics and how they constituted "ground truth" for the device's function are not detailed.

8. The sample size for the training set

   • Not Applicable/Not Available. This is a physical medical device, not a machine learning model, so there is no concept of a "training set" in the context of the provided document.

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

   • Not Applicable/Not Available. As above, no training set is relevant.

In summary, the provided document focuses on the regulatory submission and essential equivalence of a physical medical device based on design and general performance testing against a guidance document, rather than detailing a specific study with quantitative acceptance criteria and performance data for a diagnostic or AI-driven device.

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The Modified Radius Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Modified Radius Cougar Wires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an 014 guidewire.

The Modified Radius Cougar Wire is constructed from a composite stainless steel and Nitinol core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is hydrophilic coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.

The provided text describes a 510(k) premarket notification for a medical device, the Modified Radius Cougar Wire. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a performance study with acceptance criteria in the typical sense of AI/software performance.

Therefore, many of the requested points regarding AI device performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this submission. This is a submission for a physical medical device (guidewire) and its performance is evaluated through in vitro (bench) testing, not through analysis of images or other data by an AI algorithm.

Here's an interpretation of the requested information based on the provided text, acknowledging the differences in context:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide explicit numerical "acceptance criteria" in the format of a typical acceptance test specification (e.g., "Accuracy > 90%"). Instead, it lists performance tests that were conducted to demonstrate that the modified device "meets the minimum requirements that are considered adequate for its intended use" and is "substantially equivalent" to predicate devices. The "reported device performance" is essentially that the device passed these tests.

Note: The specific quantitative results or detailed pass/fail criteria for these in vitro tests are not provided in this summary. The 510(k) process relies on demonstrating that these tests were "performed" and the device was found to be "substantially equivalent" rather than publishing raw results in the summary.

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

• Sample Size for the Test Set: Not specified in the provided summary. This would typically involve a certain number of guidewire samples for each in vitro test.
• Data Provenance: Not applicable in the context of data used for AI. For a physical device, the "provenance" of test results comes from the manufacturer's internal testing facilities.
• Retrospective or Prospective: Not applicable as these tests are laboratory (in vitro) evaluations.

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

• Not applicable. The "ground truth" for these physical performance tests is determined by specific laboratory measurement techniques and engineering standards, not by expert interpretation of data.

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

• Not applicable. This concept pertains to resolving discrepancies in expert labeling or review for AI datasets.

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. This is a submission for a physical guidewire, not an AI software device. An MRMC study is completely irrelevant here.

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.):

• The "ground truth" for these performance tests is defined by established engineering and material science standards (e.g., ISO standards for tensile strength, biocompatibility standards). For example, a guidewire's tensile strength must meet a certain threshold as measured by a calibrated tensile testing machine.

8. The sample size for the training set:

• Not applicable. There is no concept of a "training set" for physical device performance testing in this context. The "training" in manufacturing comes from process validation and quality control, not machine learning.

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

• Not applicable.

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The Radius .018 Cougar Wire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. The Radius .018 Cougar Wires are compatible with all currently approved and marketed PTCA/PTA balloon catheters which are labeled for use with an .018 guidewire.

The Radius .018 Cougar Wire is constructed from a composite stainless steel and Nitinol core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is hydrophilic coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.

Here's the analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

Device: Radius .018 Cougar Wire (PTCA Guidewire)

1. Table of acceptance criteria and the reported device performance:

Note: The document states, "the proposed Radius .018 Cougar Wire meets the minimum requirements that are considered adequate for its intended use." This indicates that the device's performance in these in vitro tests met the pre-defined acceptance criteria, even though the specific numerical results or thresholds are not provided in this summary.

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

• Sample Size: Not specified. The document only mentions that "the following in vitro performance tests were performed." It does not provide the number of devices or iterations tested for each performance criterion.
• Data Provenance: The tests are described as "in vitro performance tests," meaning they were conducted in a laboratory setting. There is no mention of country of origin for the data or whether it was retrospective or prospective, as these terms are typically relevant for clinical studies, not in vitro device performance testing.

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

This information is not applicable as this document describes in vitro performance testing of a medical device, not a study involving human interpretation or subjective assessment where expert-established ground truth would be necessary. The ground truth for these tests would be determined by objective physical measurements against established engineering specifications.

4. Adjudication method for the test set:

This information is not applicable for the same reasons as point 3. Adjudication methods like 2+1 or 3+1 are used in studies where there is subjective interpretation and a need to resolve discrepancies between human readers. The tests performed here (Tensile Strength, Torque Strength, etc.) are objective physical measurements.

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 applicable. The document describes the premarket notification for a PTCA guidewire, which is a physical medical device. It does not involve AI or human readers, so an MRMC comparative effectiveness study for AI assistance would not be relevant.

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

This information is not applicable. As mentioned in point 5, the device is a physical guidewire and does not involve an algorithm.

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

The ground truth for the performance tests (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrity) would be based on engineering specifications and established industry standards for guidewire performance. These are objective, measurable characteristics, not subjective interpretations requiring expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This information is not applicable. The document describes the performance testing of a physical medical device, not a machine learning model that would require a training set.

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

This information is not applicable for the same reason as point 8.

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The Radius Micro Snare is intended for use to retrieve and/or manipulate objects in the distal peripheral vessels of the cardiovascular system and hollow viscus. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the peripheral and cardiovascular system.

The Radius Micro Snare is composed of two primary parts: an outer sheath tube and a core wire with a snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. The outer sheath is a stainless steel tube joined to a polyimide tube. The stainless steel and polyimide tubes are covered with PTFE. The stainless steel core is a solid .008" diameter stainless steel core that is a smaller version of the solid core wire in the FDA cleared Radius PTCA Guidewire and the FDA cleared Radius Snare. A stainless steel loop is soldered to the distal end of the core. The Radius Micro Snare has loop sizes, which range from 2 - 7 millimeters. The over-all length of the device is 190 centimeters. A molded ABS operating handle is included on the proximal end of the Micro Snare to aid in advancing and retracting the outer sheath over the snare loop. The Radius Micro Snare will be packaged in a Mylar/Tyvek pouch and ETO sterilized to SAL 10-6.

The provided text describes the Radius Micro Snare and its clearance through the FDA 510(k) process. However, it does not contain the specific details required to fully address your request regarding acceptance criteria and the study proving the device meets those criteria.

Here's an analysis based on the information provided, highlighting what's present and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. The general acceptance criteria for a 510(k) device is "substantial equivalence" to a predicate device. This is determined by comparing technological characteristics and intended use.
• Reported Device Performance: The document only lists the types of in vitro performance tests conducted, but does not provide specific numerical results or acceptance thresholds for these tests. The tests listed are:
  • Tensile Strength
  • Torque Strength
  • Tip Flexibility
  • Biocompatibility

What is missing: Actual quantitative acceptance criteria (e.g., "Tensile strength must exceed X Newtons") and the corresponding measured performance data for the Radius Micro Snare.

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

• Sample Size: Not specified. The document mentions "in vitro performance tests" but does not give the number of devices tested for each performance characteristic.
• Data Provenance: The tests are stated to be "in vitro," meaning they were conducted in a lab environment. The country of origin of the data is not specified, but given the submission is to the FDA in the USA, it's likely the testing was conducted or overseen in the USA. The study design is implied to be a series of physical and mechanical bench tests, not a clinical study involving human or animal data, so "retrospective or prospective" is not directly applicable in the typical sense.

What is missing: Specific sample sizes for each in vitro test.

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

• Not Applicable. For this type of mechanical and material performance testing (tensile strength, torque strength, tip flexibility, biocompatibility), ground truth is established through standardized engineering and laboratory testing protocols, not typically through human expert consensus in the way an imaging AI algorithm's performance might be evaluated. Biocompatibility testing involves specific biological assays.

4. Adjudication Method for the Test Set:

• Not Applicable. See point 3. Mechanical and biocompatibility tests have objective pass/fail criteria based on measured values, not subjective adjudication.

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

• No. The document does not describe any MRMC study. This type of study is relevant for diagnostic imaging devices where human readers interpret results, often with and without AI assistance. The Radius Micro Snare is a physical interventional device, not a diagnostic imaging tool.

6. Standalone (Algorithm Only) Performance Study:

• No. The Radius Micro Snare is a physical medical device, not a software algorithm. Therefore, "standalone algorithm performance" is not applicable.

7. Type of Ground Truth Used:

• Objective Laboratory Measurements and Standardized Biocompatibility Assays. For tensile strength, torque strength, and tip flexibility, the ground truth would be the measured physical properties of the device as per engineering standards. For biocompatibility, the ground truth would be the results from standardized biological tests (e.g., cytotoxicity, sensitization, irritation) confirming the material's safety in biological environments.

8. Sample Size for the Training Set:

• Not Applicable. The Radius Micro Snare is a physical device, not an AI/ML algorithm that requires a "training set" in the context of data science. Its design and manufacturing are based on established engineering principles and materials science.

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

• Not Applicable. See point 8.

Summary of what the document implies about meeting acceptance criteria:

The FDA's 510(k) clearance letter (K022201) indicates that the device was found "substantially equivalent" to legally marketed predicate devices. This means the FDA determined that the Radius Micro Snare shared similar intended use and technological characteristics with the predicate devices, and that any differences did not raise new questions of safety or effectiveness. The performance testing mentioned (tensile strength, torque strength, tip flexibility, biocompatibility) would have been conducted to demonstrate that the device meets appropriate engineering and safety standards, thereby supporting the claim of substantial equivalence. The "acceptance criteria" here are inherently tied to ensuring the device performs comparably and safely to its predicates in these specific technical areas.

In essence, the document serves as a regulatory submission and approval, not a detailed scientific paper describing the specifics of each test and its numerical outcomes against predefined acceptance criteria.

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The Radius Snare is intended for use in the cardiovascular system and hollow viscous to retrieve and/or manipulate objects using minimally invasive surgical procedures. Manipulation procedures include retrieval and/or repositioning of intravascular foreign objects such as coils, balloons, catheters and/or guidewires within the cardiovascular system.

The Radius Snare is composed of two primary parts: an outer sheath tube and a core wire with a snare attached to the distal end. The outer sheath acts as a catheter through which the core wire, with snare, slides. The outer sheath is a stainless steel coil with a PTFE overjacket. The stainless steel core is the same solid .0135" diameter stainless steel core wire in the FDA cleared Radius PTCA Guidewire. A stainless steel loop is soldered to the distal end of the core wire. The Radius Snare has loop sizes which range from 5 - 35 millimeters. The over-all length of the device is 150 centimeters. The Radius Snare will be packaged in a mylar/Tyvek pouch and ETO sterilized to SAL 10-2.

The provided text describes specific performance tests conducted on the Radius Snare device. However, it does not explicitly state numerical acceptance criteria for these tests, nor does it provide detailed results demonstrating the device meets specific criteria. Instead, the document focuses on demonstrating substantial equivalence to predicate devices through design, materials, and function, and then lists the types of performance tests performed.

Therefore, for aspects like "Table of acceptance criteria and reported device performance," "sample sizes used for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone study," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," the information is not available within the provided text.

Here's a breakdown of what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on Available Text):

• Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
  • Not available. The document only mentions that "in vitro performance tests were performed," but does not specify the number of units tested or any details about data provenance.
• 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/Not available. The study described involves in vitro performance testing of the device's physical and mechanical properties, not an assessment of diagnostic performance that would require expert ground truth.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set:
  • Not applicable/Not available. As above, this is not a clinical study involving human assessment.
• 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. This is not an AI-powered device, nor is an MRMC study described. The device is a medical snare used in interventional procedures.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
  • Not applicable. This question pertains to AI/algorithm performance. The Radius Snare is a physical medical device. The "performance testing" referenced is for the device's mechanical and material properties.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc):
  • Not applicable/Not available in the context of clinical outcomes. For the in vitro performance tests, the "ground truth" would be established engineering or material science standards and specifications, but these are not detailed in the document.
• The sample size for the training set:
  • Not applicable. This refers to a machine learning context.
• How the ground truth for the training set was established:
  • Not applicable. This refers to a machine learning context.

In summary: The provided document is a 510(k) summary for a medical device (Radius Snare). It focuses on demonstrating substantial equivalence to predicate devices and lists types of in vitro performance tests conducted (Tensile Strength, Torque Strength, Torqueability, Tip Flexibility, Coating Adherence/Integrity, Biocompatibility). It explicitly states the sterilization method. However, it does not provide detailed acceptance criteria, specific test results, or any information related to clinical studies, human reader performance, or artificial intelligence algorithms.

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The Next Generation Guidewire is designed to be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile duct, cystic, pancreatic, and right and left hepatic ducts.

Radius Medical Technologies, Inc. has developed a line of Endoscopic guidewires ranging in sizes of 0.025" to 0.035" diameter and lengths of 260 cm to 450 cm (in standard and stiff body types). The wires will be offered with a 5 cm radiopaque distal tip (angled and straight). The wires are constructed of a solid nitinol core wire, which tapers at its distal end. A shrink jacket surrounds the core over the entire length except the distal most 5 cm. A radiopaque tube covers the distal 5 cm. Single striped bands of ink are placed circumferentially onto the jacket and spaced in 1 cm intervals beginning at the 6 cm location and continuing to the 40 cm location from the distal tip. Multiple ink bands are used to delineate the 10, 15, and 20 cm locations. A coating is applied over the tip portion of the guidewire.

This document is a 510(k) premarket notification for the Radius Medical Technologies Next Generation Guidewire and does not contain information regarding an acceptance criteria table, device performance metrics, detailed study designs, or AI/ML components. Therefore, I cannot provide the requested information.

The document primarily focuses on:

• Regulatory information: Device classification, regulation numbers, product codes, and substantial equivalence determination.
• Device description: Physical characteristics, materials, and sizing of the guidewire.
• Intended use: To guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures.
• Predicate devices: Comparison to existing legally marketed guidewires.
• Performance testing (general statement): Mentions various tests performed (distal tip tensile, torqueability, tip flexibility, coating adherence/integrity, and electrical resistance) but does not provide specific acceptance criteria or detailed results.

There is no mention of an AI/ML component, expert ground truth, sample sizes for AI model training/testing, or MRMC studies in this document.

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The Radius PTCA Guidewire is intended to facilitate the placement of balloon dilitation catheters during PTCA and/or PTA. Radius PTCA Guidewires are compatible with all currently approved and marketed PTCA balloon catheters which are labeled for use with an .014 guidewire.

The Radius PTCA Guidewire is constructed from a solid stainless steel core to which a coil is attached to the tapered distal section. The proximal section of the wire is coated with PTFE, and the distal coil portion of the wire is silicone coated. The device is packaged in a protective hoop sealed into a Tyvek/mylar pouch, and is sterilized using ETO gas.

The provided document (K970466) is a 510(k) Premarket Notification for a medical device, specifically a PTCA Guidewire. This type of submission is for demonstrating substantial equivalence to a predicate device, not typically for a comparative effectiveness study with human readers or AI.

Therefore, many of the requested categories are not applicable to the information contained in this 510(k) summary. I will fill in the applicable information and indicate where information is not present or not relevant to this type of regulatory document.

Here's the breakdown based on the provided text:

Acceptance Criteria and Study Details for K970466:

1. A table of acceptance criteria and the 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 specified in the provided document. The performance tests ("in vitro performance tests") and biocompatibility tests were conducted, but the number of units tested is not disclosed.
• Data Provenance: The tests were conducted by Radius Medical Technologies, Inc. (Maynard, MA, USA), suggesting the data originated in the USA. The tests are "in vitro," so the data is laboratory-generated, not from human subjects. It would be considered prospective for the device's development but conducted prior to market entry.

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

• Not applicable. This device is a guidewire, and its performance is evaluated through objective physical and chemical tests, not through expert interpretation of images or clinical data. Therefore, "ground truth" in the clinical imaging sense is not relevant here.

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

• Not applicable. See point 3. The testing involves measurable parameters (e.g., tensile strength, flexibility, chemical reactions for biocompatibility), not subjective interpretations 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

• No. An MRMC study is not relevant for this type of medical device (PTCA Guidewire) as it is not an imaging analysis or diagnostic AI device. This document focuses on the physical and biocompatibility properties of the guidewire itself.

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

• Not applicable. This device is a physical medical instrument, not an algorithm or AI system.

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

• Not applicable. The "ground truth" for this device's performance is objective measurement against specified engineering requirements and established biocompatibility standards. For substantial equivalence, the performance is compared to the predicate device's established performance, implying the predicate itself served as a benchmark for what constitutes acceptable performance for such a device.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no concept of a "training set."

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

• Not applicable. See point 8.

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