(290 days)
The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle is intended for use in injecting a single dose of local anesthetic or analgesic into a patient for regional anesthesia or pain therapy with the echogenic reflective pattern providing visualization of the needle tip using Ultrasound Imaging. The needles are intended to mate with the male connector of a Luer Lock or Luer Slip Syringe or an extension set.
The SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle consists of a stainless steel needle and a clear or colored (translucent) standard female Luer lock square or round Hub locking connector for rapid (flashback) visualization. The stainless steel needles are available with and without an echogenic feature (i.e. mechanical dimpling treatment to the needle point surface), and with or without lubrication. The needles are available in a range of wall thicknesses, gauges and lengths to match the end-user need (16 to 30 gauges).
The provided document is a 510(k) summary for a medical device (SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance in the context of AI/ML or diagnostic accuracy.
Therefore, many of the requested categories for AI/ML study details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific performance metrics (like sensitivity, specificity, AUC), are not applicable or available in this document. This document describes a traditional medical device, not an AI/ML system.
However, I can extract information related to the performance data presented to support the substantial equivalence claim.
Here's the information derived from the document:
1. Table of Acceptance Criteria and the Reported Device Performance
The document doesn't explicitly state "acceptance criteria" with numerical thresholds for performance, but rather lists the mechanical and biocompatibility tests performed and concludes that the device "exhibited comparable mechanical and functional characteristics to the predicate device in addition to being biocompatible acceptable."
| Test Category | Specific Tests Performed | Reported Device Performance |
|---|---|---|
| Mechanical Testing | - Bond strength of hub and cannula |
- ISO 594-1 (Luer Fittings)
- ISO 7864:11 (Sterile hypodermic needles)
- Luer compatibility
- Hub and Needle Strength
- Penetration Force | "Exhibited comparable mechanical and functional characteristics to the predicate device." The device's performance in these tests was deemed acceptable and comparable to the predicate device, supporting substantial equivalence. |
| Biocompatibility Testing | - ISO 10993-5: Cytotoxicity Study Using the ISO Elution Method - ISO 10993-4: In Vitro Hemolysis Study (Modified ASTM-Extraction Method)
- ISO 10993-11: USP and ISO Systemic Toxicity Study - Extracted
- ISO 10993-10: ISO Intracutaneous Study - Extract
- ISO 10993-10: ISO Maximization Sensitization Study - Extract | "Biocompatible acceptable." The product contact materials were "well characterized chemically and physically," and test results confirmed "compliance with ISO 10993 requirements." |
| Sterility | "Supplied Packaged Sterile" | The device is supplied as sterile. (Sterilization method: EO (Ethylene Oxide)) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated for each test. The document refers to "the following performance data was provided" without specifying the number of units tested for each mechanical or biocompatibility assessment.
- Data Provenance: Not specified. This is a submission to the FDA for a new device, so the testing would have been conducted by the manufacturer or their contracted labs. No information about country of origin of data (e.g., patient data) is relevant here as this is a physical device. The studies are prospective in the sense that they were conducted for this specific submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable for this type of medical device submission. Ground truth in the context of diagnostic accuracy or AI/ML is not relevant here. The "truth" for mechanical and biocompatibility tests is based on the results of validated laboratory methods and adherence to international standards (ISO, ASTM).
4. Adjudication method for the test set
- This is not applicable. No human interpretation or adjudication common in AI/ML validation studies is mentioned. The assessment is based on objective laboratory measurements against established standards.
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 is not applicable. The device is a physical anesthesia needle, not an AI system. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not applicable. The device is a physical anesthesia needle, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the performance data in this context refers to established international standards and validated laboratory test methods (e.g., ISO 594-1, ISO 7864:11, ISO 10993 series). The device's characteristics were measured against these standards to demonstrate compliance and comparability to the predicate.
8. The sample size for the training set
- This is not applicable. There is no "training set" as this is a physical medical device, not an AI/ML model.
9. How the ground truth for the training set was established
- This is not applicable. There is no "training set" or corresponding ground truth.
§ 868.5150 Anesthesia conduction needle.
(a)
Identification. An anesthesia conduction needle is a device used to inject local anesthetics into a patient to provide regional anesthesia.(b)
Classification. Class II (performance standards).