(118 days)
The Mini Needle is intended for use with a luer-tip syringe (e.g. luer-lock or slip-tip luer syringe) for the administration of drugs into the body.
The Mini Needle is a device intended to provide a means of fluid delivery into the human body via body surface puncture. The device is a single lumen needle available in 30G, 32G and 33G sizes with a 5.5mm exposed length. The distal end of the needle has a spring-loaded needle cap, which shields the needle prior to use.
The provided document is a 510(k) premarket notification for a medical device called "Mini Needle." It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance in the context of an AI/ML or diagnostic device.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML or diagnostic performance (e.g., sensitivity, specificity, F-measure, sample sizes for test/training sets, expert consensus, MRMC studies) is not applicable to this document.
This document describes a conventional medical device (hypodermic single lumen needle) and its premarket notification process. The "Performance Data" section details engineering and biocompatibility tests performed to ensure the device performs as intended and is safe, rather than a clinical performance study with AI/ML-specific metrics.
Here's a breakdown of the available information in the context of the device described:
1. A table of acceptance criteria and the reported device performance:
The document lists performance tests, but it does not provide quantitative acceptance criteria or numerical reported device performance in the format typically seen for AI/ML or diagnostic studies. Instead, it states that "The Mini Needle met all specified criteria and did not raise different safety or performance questions."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| ISO 594-1 & 2 (Dimensional and Physical Properties) | Met all specified criteria |
| ISO 594-1 & 2 (Bond and Material Strength) | Met all specified criteria |
| ISO 10993-1; ISO 10993-7 (Biocompatibility) | Met all specified criteria |
| ISO 11135 (Sterilization Validation) | Met all specified criteria |
| Packaging Validation (ASTM D4169-16, ASTM 2069-11, ASTM F88/F88M-15) | Met all specified criteria and performed as intended (packaging integrity) |
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 mentions "All testing was performed on test units representative of finished devices," implying a sample size appropriate for engineering validation but not specified numerically.
- Data Provenance: Not applicable in the context of AI/ML data. The tests are laboratory-based engineering and material science tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This concept is not applicable to the engineering and biocompatibility testing described. Ground truth established by medical experts is relevant for diagnostic or AI/ML performance, not for verifying physical and material properties of a needle.
4. Adjudication method for the test set:
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human readers/experts in diagnostic or AI/ML studies, which is not relevant here.
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 is not an AI/ML device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used:
- For Dimensional and Physical Properties, Bond and Material Strength, Sterilization Validation, and Packaging Validation, the "ground truth" would be established by the engineering specifications and relevant ISO/ASTM standards.
- For Biocompatibility Testing, the "ground truth" is based on the biological response observed in accordance with ISO 10993 standards, determining if the material is non-toxic or non-irritating.
8. The sample size for the training set:
Not applicable. This device does not involve a training set as it is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. This device does not involve a training set.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).