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The cannulas/needles for anesthesia and analgesia enhanced for ultrasound visibility - Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba and Spectra Sonic Block Crawford Needles - are intended for the transient delivery of anesthetics to provide regional analgesia or to facilitate placement of a catheter.

The Spectra Sonic Block Needles consist of a stainless steel needle and a clear standard female Luer locking hub. The needles are available in a range of needle tip configuration, gauges and lengths to match the end-user need. These needles have an echogenic treatment to help ensure strong reflection during ultrasound procedures. Spectra Sonic Block Needles will be marketed as sterile, non-pyrogenic, and single use devices.

The needles / cannulas for anesthesia and analgesia enhanced for ultrasound visibility are single use sterile and non-pyrogenic devices used to gain entry or puncture the tissue and inject anesthetics to induce single shot anesthesia and analgesia. The needles / cannulas may be used during all anesthesia and analgesia procedures according to the physician's indication.

Needles / cannulas for anesthesia and analgesia enhanced for ultrasound visibility are standard needles /cannulas equipped with dimpled echogenic tip in order to significantly enhance ultrasound visibility. This surface technology allows for a variety of sizes. The inner diameter is not effect by the echogenic treatment. This feature completely encircles the tip of the needles / cannulas so all sides appear bright under ultrasound. In order to enhance ultrasound visibility, the needles / cannulas are equipped with a special dimpled pattern named Sonic Block dimples to the needles / cannulas surface. These reflectors are designed to optimally reflect ultrasound waves.

This document is a 510(k) premarket notification for a medical device, specifically anesthesia conduction needles (Spectra Sonic Block Tuohy, Quincke, Chiba, and Crawford needles). It aims to demonstrate substantial equivalence to a predicate device (Pajunk Medical Systems, K113207).

The information provided does not describe an AI medical device or a study involving AI assistance for human readers. Instead, it focuses on the physical and performance characteristics of a traditional medical device (needles) to prove its substantial equivalence to an already marketed device. Therefore, many of the requested items related to AI system acceptance criteria, MRMC studies, standalone algorithm performance, and ground truth establishment for AI training/test sets are not applicable to this document.

However, I can extract the information relevant to the device's acceptance criteria and the studies performed to prove it meets those criteria, within the context of a traditional medical device submission.

Here's the breakdown of the available information:

Device: Spectra Sonic Block Tuohy, Spectra Sonic Block Quincke, Spectra Sonic Block Chiba, and Spectra Sonic Block Crawford Needles

Type of Device: Anesthesia Conduction Needles (Class II, Product Code: BSP)

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

The document doesn't present a formalized "acceptance criteria" table in the way one might typically see for an AI device (e.g., minimum sensitivity, PPV). Instead, it demonstrates performance by meeting established medical device standards and showing equivalence to a predicate device. The performance data effectively serve as proof of meeting implicit acceptance criteria related to safety and efficacy for this type of device.

• Standard ISO Luer hubs (in accordance with ISO 594)
• Needle bond strength (in accordance with ISO 7864)
• Stiffness and breakage (in accordance with ISO 9626) |
  | Material Compatibility & Safety | Cannula: 304 Stainless Steel (Same as predicate)
  Square Hub: Polycarbonate (Same as predicate)
  Protector: LDPE (Same as predicate)
  Adhesive: Epoxy (Same as predicate)
  Claims: Does not pose a chemical hazard, device does not contain a thermal source, device does not admit any form of radiation, device does not contain an electrical source. |
  | Dimensional Specifications | Tip Configurations: Tuohy, Beveled (Chiba & Facetted), Crawford, Quincke (Identical to predicate)
  Lengths: 20mm-180mm for all types (Identical to predicate)
  Diameters (Gauges): 16G-26G for all types (Identical to predicate)
  Needle Bevels: Tuohy (8°), Crawford (45°), Quincke (16°), Chiba (30°) (Identical to predicate) |
  | Intended Use | "Intended for the transient delivery of anesthetics to provide regional analgesia or to facilitate placement of a catheter." (Substantially similar to predicate). |
  | Echogenicity (Ultrasound Visibility) | Enhanced for ultrasound visibility using a "dimpled echogenic tip" named "Sonic Block dimples" designed to optimally reflect ultrasonic waves. (Different method from predicate's "CornerStone" but functionally similar/improved). |

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 performance testing for a physical medical device (needles), not a machine learning model's test set. Therefore, "sample size" refers to the number of needles or materials tested according to various ISO and AAMI standards. The exact number of samples for each specific test (e.g., how many needles for bond strength, how many material samples for biocompatibility) is not detailed in this summary. It states that "The Spectra Medical Devices, Inc. Sonic Block Needles passed all tests."

• Data Provenance: Not applicable in the context of clinical data for an AI model. The tests are laboratory-based performance validations.

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 the document describes a physical medical device (needles) and its performance against engineering and biocompatibility standards, not an AI model requiring expert ground truth for interpretation.

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

Not applicable. This is for assessing clinical performance in AI, not for physical device testing.

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 needle, not an AI system. There is no human reader assistance component.

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.

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

Not applicable to this type of device submission. The "ground truth" for this device's performance is established by compliance with recognized international standards (ISO, AAMI) for mechanical, biological, and sterility properties. For example, the "ground truth" for bond strength is the force required to meet the ISO 7864 standard.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device. There is no "training set."

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

Not applicable. Since there is no training set for an AI model, there's no ground truth for it.

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