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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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