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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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