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510(k) Data Aggregation
(108 days)
The Arrow UltraQuik® Peripheral Nerve Block Needle is indicated for the delivery of single-shot peripheral nerve block anesthesia or analgesia using medical imaging devices.
The Arrow UltraQuik Peripheral Nerve Block (PNB) Needle is a single shot needle which is comprised of a cannula, hub, and fluid extension tube with female luer fitting. The single shot needles are available in various gauges, lengths, and point styles. These include:
- Gauge
- 20 Ga (Touhy only)
- 21 to 24 Ga
- Lengths
- 35 mm to 150 mm
- Point style
- Bevel tip
- Pencil point
- Touhy tip
- Cannula echogenicity
- The cannula is naturally echogenic but the addition of grooves on the cannula enhance the echogenicity
The UltraQuik may be used with medical imaging, i.e., ultrasound to assist in needle tip location.
Here's an analysis of the acceptance criteria and study information for the ARROW UltraQuik Peripheral Nerve Block Needle, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance:
| Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength (Non-Inserted Regions) | > 15 N force to break | Injection Tubing to Needle Hub: mean 27 N |
| Injection Tubing to Luer Lock: mean 27 N | ||
| Tensile Strength (Needle Cannula to Hub joint) | > 40 N force to break | All have a mean > 99 N |
| Needle Sharpness (Penetration Force) | None (Pass/fail criteria not explicitly stated) | All have a mean > 3.17 N |
| Injection Leakage | No leak at 50 psi for 30 sec | No leakage observed |
| Resistance to Leakage (Aspiration/Vacuum) | No internal leakage at -25 mmHg for 120 sec | No leakage observed |
| Corrosion Resistance | No visible sign of corrosion | No observed corrosion |
| Needle Stiffness (Deflection) | < 0.5 mm deflection | All have a mean < 0.5 mm |
| Needle Markings | Permanent markings at 10 mm | Cannula are so marked |
| Component Capability (Usability Testing) | Usability testing favorable | Results were favorable |
| Imaging & Echogenic Properties | Deemed "easier to recognize" by clinicians (qualitative acceptance) | Comparative ultrasound images performed; clinical preference survey found echogenic design "easier to recognize." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated for each test beyond "all" or generic descriptions. For the usability/clinical preference survey, the number of clinicians involved is not specified.
- Data Provenance: The study appears to be retrospective bench testing and a prospective (though informal) clinical preference survey. The geographic origin of the data (country) is not specified, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: For the Imaging and Echogenic property evaluation, a "clinical preference survey was done with clinicians." The specific number of clinicians is not stated.
- Qualifications of Experts: The term "clinicians" is used, implying medical professionals who use such devices. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.
4. Adjudication Method for the Test Set:
- Adjudication Method: The document does not describe an adjudication method for the quantitative bench tests. For the clinical preference survey, it simply states "all found the echogenic design to be easier to recognize," suggesting a consensus or unanimous opinion among the surveyed clinicians, but no formal adjudication process (like 2+1 or 3+1) is mentioned.
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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This device is a medical instrument (needle) and involves bench testing and a clinical preference survey, not an AI-powered diagnostic or assistive tool for human readers. Therefore, there's no mention of AI assistance or improvement in human reader performance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No, a standalone performance test for an algorithm was not done. This device is a physical medical instrument, not an algorithm.
7. The Type of Ground Truth Used:
- Ground Truth Type:
- For the majority of the tests (tensile strength, sharpness, leakage, corrosion, stiffness, markings), the "ground truth" is defined by engineering specifications and measurable physical properties (e.g., force in Newtons, pressure in psi, deflection in mm).
- For "Component Capability (Usability Testing)" and "Imaging and Echogenic property evaluation," the ground truth involves subjective feedback and preference from clinicians based on their experience and visual assessment.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: This concept is not applicable here as this is a medical device approval that involved bench testing and a clinical preference survey, not an AI/machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Ground Truth for Training Set Establishment: This is not applicable as there is no training set mentioned or implied for this device's approval process.
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