(10 days)
Insulin syringes are intended only for the injection of U-100 insulin.
The sureone disposable insulin syringe is used for subcutaneous injection of U-100 insulin. This device is a sterile, single-use, disposable piston syringe with permanently affixed hypodermic single lumen needle. The sureone disposable insulin syringe consists of a syringe barrel, a plunger rod, and a hypodermic single lumen needle permanently bonded to the tip of the syringe with epoxy. The sureone disposable insulin syringes are available in 1.0cc (100 units), 0.5cc (50 units), and 0.3cc (30 units) syringe capacities with the following sizes of hypodermic single lumen needle: 28 GA x ½", 29 GA x ½", and 30 GA x 3/10". In addition, the 1.0cc and 0.5cc syringe capacities are available with a 31 GA x 5/16" needle.
The provided text is a 510(k) summary for the sureone Insulin Syringe and focuses on substantial equivalence to predicate devices, particularly regarding the addition of a new needle size. It does not contain the detailed information required to answer all parts of your request about acceptance criteria, specific study results, sample sizes, ground truth establishment, or expert involvement for a performance study.
Medical device submissions often refer to compliance with recognized standards rather than presenting new study data for every claim, especially for devices undergoing minor modifications. This appears to be the case here, as the device is stated to meet ISO standards.
However, based only on the provided text, I can infer and extract the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states the device "meets the following standards," implying these standards serve as the acceptance criteria. No specific performance metrics or their values are reported in a comparative table format within this document, only that the device meets the standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 8537, Sterile, Single-Use Syringes, with or without Needle, for Insulin | Device meets this standard. |
| ISO 9626, Stainless Steel Needle Tubing for Manufacture of Medical Devices | Device meets this standard. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text, but given the nature of standards compliance, it would likely involve in-house testing by the manufacturer.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable/not specified. The "ground truth" here is compliance with established international standards, not expert consensus on medical images or diagnoses.
- Qualifications of Experts: Not applicable/not specified.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods are typically used in studies involving expert interpretation of data (e.g., medical imaging), which is not described here. Device performance is assessed against engineering and material standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:
- No, a MRMC comparative effectiveness study was not done or described in this document. This type of study is relevant to diagnostic or interpretative AI-powered devices, not typically for an insulin syringe.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:
- Not applicable. This is a physical medical device (insulin syringe), not an algorithm or AI product.
7. The Type of Ground Truth Used:
- The "ground truth" for this submission is compliance with the requirements specified in ISO 8537 (Sterile, Single-Use Syringes, with or without Needle, for Insulin) and ISO 9626 (Stainless Steel Needle Tubing for Manufacture of Medical Devices). These standards define performance characteristics such as volume accuracy, sterility, needle dimensions, material properties, etc.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This device does not involve a "training set." The performance is validated against established international engineering and manufacturing standards.
§ 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).