(76 days)
The STERIPACK Sterile Disposable Syringe is intended to be used for injecting fluids into, or withdraw fluids from, the body. The STERIPACK Sterile Disposable Insulin Syringe is intended to be used for the subcutaneous injection of insulin.
The STERIPACK Sterile Disposable Syringe, with or without a hypodermic needle, is a sterile, single use, piston syringe, designed for manual use. The STERIPACK Sterile Disposable Syringe is available in 3, 5, 10 and 50 ml volume sizes with luer lock, slip tip, and eccentric configurations.
The STERIPACK Sterile Disposable Insulin Syringe with permanently affixed hypodermic needle, is a sterile, single use, insulin syringe, designed for manual use. The STERIPACK Sterile Disposable Insulin Syringe is available in 0.5 and 1.0 ml volume sizes, color coded with markings for delivery of 100 units of insulin/ml (U-100).
The provided text describes the STERIPACK™ Sterile Disposable Syringes and STERIPACK™ Sterile Disposable Insulin Syringes. This device is a medical device, and the information given is part of a 510(k) summary for premarket notification to the FDA. Such submissions typically focus on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed clinical study results with specific acceptance criteria and performance metrics in the way a diagnostic AI device study would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable to this type of device and submission.
Here's the information that can be extracted or inferred based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Claimed Compliance) |
|---|---|
| ISO 7886-1 (1993) for Hypodermic Syringes | Complies |
| ISO 8537-1991 for Insulin Syringes | Complies |
| ISO 594-1 (1986) for Conical Fittings | Complies |
| ISO 7864 for Sterile Hypodermic Needles for Single Use | Complies |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document summarizes a 510(k) application for sterile disposable syringes. The "test set" and "data provenance" as applied to a diagnostic AI algorithm's performance are not relevant here. The "performance characteristics" describe compliance with international standards, which would typically involve laboratory testing of manufactured samples to these standards, not a clinical "test set" with patient data.
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)
- Not Applicable. Ground truth, in the context of diagnostic performance evaluation, is not relevant for this device. The standards themselves define the test methodologies and acceptance criteria for physical properties and sterility.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often in diagnostic imaging. This is not relevant to the compliance testing of a sterile disposable syringe.
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. An MRMC study is relevant for evaluating the impact of AI on human readers (e.g., radiologists). This device is a mechanical medical instrument, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a sterile disposable syringe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of device, the "ground truth" would be defined by the specifications and test methodologies outlined in the referenced ISO standards. For example, dimensions, fluid leakage, sterility, and material compatibility are verified against the requirements of these standards. The standards themselves set the benchmarks for "truth" regarding the device's physical and functional properties.
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. As there is no training set for an AI algorithm, this question is not relevant.
§ 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).