(296 days)
The Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
The Syringe with permanently attached needle is intended for single use only. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 20G-34G gauge needle. The product is for single use and provided sterile (EtO). The shelf-life of the product is five-years. The proposed syringes are available in different combination of syringe volumes and/or needle sizes.
The provided document is a 510(k) summary for a "Syringe with permanently attached needle" and does not contain information about acceptance criteria for an AI/ML powered device, nor a study proving such a device meets those criteria.
The document describes a traditional medical device (a syringe) and its substantial equivalence to a predicate device based on non-clinical performance testing against established ISO and ASTM standards. Therefore, most of the requested information regarding AI/ML device performance and testing is not applicable to this submission.
Here's an analysis based on the information provided, noting where the requested AI/ML specific information is absent:
1. A table of acceptance criteria and the reported device performance
The document does not present acceptance criteria in a formal table with reported performance in the way typically expected for an AI/ML diagnostic or prognostic device. Instead, it states that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."
The non-clinical tests performed are listed as compliance with various ISO and ASTM standards. The acceptance criteria for these standards are implicit within the standards themselves, and the document explicitly states the device "complies" with them and that "The test results demonstrated that the proposed device is as safe and as effective as the predicate device."
- Example from document:
- Acceptance Criteria (implicit in standard): Sterile hypodermic syringes for single use must meet requirements of ISO 7886-1:2017.
- Reported Device Performance: "Syringe performance: ISO 7886-1 [Compliant]" (from Table 2) and "Test results demonstrated that the proposed device complies with... ISO 7886-1:2017".
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 applicable/not provided as this is not an AI/ML device and no diagnostic test set or data provenance is mentioned beyond general non-clinical device testing.
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/not provided as this is not an AI/ML device and no expert-adjudicated ground truth is established. The "ground truth" for a syringe is its physical and functional properties meeting specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/not provided as this is not an AI/ML device and no adjudication method is relevant.
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
There was no MRMC comparative effectiveness study done. This is not an AI/ML device designed to assist human readers. "No clinical study is included in this submission" (Section VIII).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided as this is not an AI/ML device and therefore no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is established by compliance with recognized international and national standards (e.g., ISO, ASTM) for the physical and biological properties of the syringe and needle, along with material specifications for biocompatibility. For instance, sterility is confirmed by SAL (Sterility Assurance Level) compliance, and material safety by ISO 10993 series standards.
8. The sample size for the training set
This information is not applicable/not provided as this is not an AI/ML device and therefore no training set was used.
9. How the ground truth for the training set was established
This information is not applicable/not provided as this is not an AI/ML device and therefore no training set ground truth was established.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).