(309 days)
Anesthesia conduction needles are intended for the transient delivery of anesthetics to provide regional anesthesia or to facilitate placement of an epidural catheter.
needles, including Epidural Needle for Single Use(AN-E), Spinal Needle for Single Use(AN-S), AN-SII), consist of needle tube, hub, stylet and jacket The product is mainly used for epidural and/or spinal block (also called as epidural and/or spinal anesthesia) in human bodies.
The needles have been categorized as following in detail:
- AN-SI Spinal Needles (same to IMD's Quincke needle)
- AN-SII Spinal Needle (same to IMD's Pencil point needle)
- AN-E Epidural Needles (same to IMD's Tuchy needle)
These needles are provided as sterile, single use devices. They may be packaged individually or included in regional anesthesia trays (kits). Anesthesia conduction needle. This is a simple hypodernic regional allestilesia trays (Mis). Anoonball concession of the aresthesia onduction needle. The later needie to hake the intral punction and election of local and the end anesthelics into the epidural space for longer pain relief.
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The provided document is a 510(k) summary for Anesthesia Conduction Needles (K120475). It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include information about a study proving the device meets specific acceptance criteria in the way typically expected for a medical device performance study, especially one involving AI or detailed clinical outcomes.
Instead, the document focuses on demonstrating substantial equivalence to an existing predicate device (IMD's Tuohy needle, Quincke needle, Pencil Point needle K070354) through non-clinical performance and biocompatibility testing against recognized international standards.
Therefore, many of the requested fields regarding acceptance criteria, study design, expert involvement, and AI performance cannot be directly extracted from this document. I will fill in what is available and indicate when information is not present.
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable table format for device performance in a clinical setting with associated outcomes. Instead, it refers to conformity with international standards for device components and materials as the basis for performance.
Acceptance Criteria (Implicit from Standards Conformity) and Reported Device Performance:
| Acceptance Criteria (Reference Standard) | Reported Device Performance |
|---|---|
| Stainless Steel components: ISO 9626 | Met applicable sections of ISO 9626 |
| Hub: ISO 594-1 and ISO 594-2 | Met applicable sections of ISO 594-1 and ISO 594-2 |
| Hub to Needle Bond Strength: ISO 7864 | Met applicable sections of ISO 7864 |
| Sterile hypodermic needles for single use: ISO 7864:1993(E) | Met applicable sections of ISO 7864 |
| Biological evaluation of medical devices: ISO 10993-1:2009 | Materials are safe for intended use (biocompatibility testing) |
| Sterilization effectiveness | Equivalent to predicate device (materials, packaging, processes are the same) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "Performance testing was conducted to verify that the proposed device met all design specifications," but does not detail the sample sizes, origin, or retrospective/prospective nature of this testing. This implies bench testing or material conformance rather than a clinical human subject study.
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 information is not applicable/provided. The device is an anesthesia conduction needle, and the testing described is non-clinical (material and structural compliance with standards, biocompatibility). There is no "ground truth" established by human experts in the context of diagnostic or interpretive performance for such a device in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. As above, there is no diagnostic or interpretive test set that would require an adjudication method.
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 information is not applicable. The device is an anesthesia conduction needle (a physical medical instrument), not an AI-powered diagnostic or decision-support system. Therefore, an MRMC study or AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable. The device is a physical medical instrument, and the testing focuses on its physical and material properties, and sterility, against engineering standards.
8. The sample size for the training set
This information is not applicable/provided. There is no "training set" in the context of an AI algorithm described for this device. For the non-clinical testing, sample sizes are not explicitly stated in this summary.
9. How the ground truth for the training set was established
This information is not applicable/provided. As there is no training set for an AI algorithm, this question is not relevant. For the non-clinical tests, the "ground truth" is adherence to the specified international standards.
§ 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).