(30 days)
For the injection of U100 insulin. The Easy.Touch disposable sterile insulin syringes are intended for injection of U100 insulin only.
The Easy Touch insulin syringe consists of a calibrated hollow barrel which can contain the medication and the distal end of barrel is fixed with needle. The needle cannot be exchanged after assembling because needle is fixed in the barrel nozzle lumen. The plunger and gasket are the same shape as the conventional insulin syringes. The needle cap cover is intended to provide physical protection to the needle tube. The cap is color coded orange, same as equivalent insulin syringes. The syringes are available in 0.3 ml/cc, 0.5 ml/cc and 1 ml/cc sizes. They are supplied with a sterile fluid path, (EO), non-toxic, and non pyrogenic, for single use only, disposable. The devices operate on the principles of common piston svringes. This premarket notification is for additional needle gauges and lengths as compared to our previous submission, K091472.
The provided text describes the 510(k) summary for the Easy-Touch Insulin Syringe (K102178). This document is a premarket notification to the FDA for a medical device and is not a study proving device performance against specific acceptance criteria in the context of AI/ML or diagnostic imaging.
Therefore, many of the requested categories in your prompt are not applicable to the provided text. The device in question is a simple medical tool (insulin syringe), and the "study" referred to in the document is a series of bench tests to demonstrate substantial equivalence to predicate devices, not a clinical trial with human subjects or complex performance metrics.
Here's an attempt to answer the applicable parts of your request based on the provided information, with notes where information is not available or not relevant:
Acceptance Criteria and Device Performance for Easy-Touch Insulin Syringe (K102178)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (from K102178) |
|---|---|
| Biocompatibility | Bench tests demonstrated that the device is "as safe" as the predicate device. |
| Mechanical Testing | Bench tests demonstrated that the device "performs in a substantially equivalent manner" to the predicate device. |
| Sterility Testing | Bench tests demonstrated that the device is "as safe" as the predicate device (including EO residues). |
| Performance | Bench tests demonstrated that the device is "as effective" as the predicate device. |
| Intended Use | For the injection of U100 insulin. The device and predicate have "identical technological characteristics and perform the same way as common piston syringes." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document only mentions "Bench tests were performed."
- Data Provenance: Not specified, but given it's a bench test (laboratory testing), it's not applicable in the same way as clinical data (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. For a simple physical device like an insulin syringe, "ground truth" established by human experts in the context of diagnostics or AI is not relevant. The "truth" of its performance (e.g., sterility, mechanical function) is determined by standardized laboratory tests and measurements.
4. Adjudication method for the test set
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic evaluations. This device relies on objective physical and chemical 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 is not an AI/ML device or a diagnostic device where human readers would be involved.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device.
7. The type of ground truth used
- Objective lab measurements and adherence to standards. The "ground truth" for a mechanical device like this is based on whether it meets predefined physical, chemical, and biological specifications (e.g., proper dimensions, lack of particulate matter, absence of microbial growth, proper dose delivery, biocompatibility).
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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).