(65 days)
Shifa Syringes are intended for injection of
Shifa Syringes are sterile disposable medical piston syringes consisting of barrel with luer-lock or slip-lock nozzle, gasket, and a needle. They are sold with or without needles. The barrel, and plunger are polypropylene, the gasket is natural rubber, and the needle is stainless steel.
This document describes a medical device, a sterile disposable syringe, and its testing for substantial equivalence to predicate devices. It is not a study proving the device meets acceptance criteria in the context of AI/ML performance. Therefore, I cannot extract the information required by your prompts, as they are specific to AI/ML studies.
Here's a breakdown of why and what information is present:
Context: The provided text is a "Summary of Safety and Effectiveness" for the SHIFA SYRINGES-STERILE DISPOSABLE, under a K962614 submission (likely a 510(k) premarket notification to the FDA). This document demonstrates the equivalence of a new medical device to existing predicate devices, primarily through physical characteristics, material composition, intended use, and a battery of standard safety and performance tests for syringes.
Why your specific questions cannot be answered: Your questions (#1-9) are designed to elicit information about the performance evaluation of an Artificial Intelligence (AI) or Machine Learning (ML) enabled medical device. This document describes a traditional medical device (a syringe) and its compliance with established standards, not an AI/ML algorithm.
Information I can provide based on the text (reformatting some of your questions to fit the content):
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (Implied/Direct) | Reported Device Performance |
|---|---|---|
| Water Extract Appearance | Transparent, colorless, and no foreign matter | Transparent, colorless, and no foreign matter |
| Transmittance | Above 93% | Above 93% |
| Difference in level of pH | Lower than 2.0 | Lower than 2.0 |
| Heavy metals | Less than 2 PPM | Less than 2 PPM |
| Incompatibility between syringe and injection fluid | No change in appearance, opacity, or color of syringe or fluid | No change in appearance, opacity, or color of syringe or fluid |
| Quantity of silicone lubricant | 3cc-Below 8 mg/pc; 5cc-Below 8 mg/pc; 10cc-Below 15 mg/pc | 3cc-Below 8 mg/pc; 5cc-Below 8 mg/pc; 10cc-Below 15 mg/pc |
| Intravenous injection test | Complies with USP XXII | Complies with USP XXII |
| Intracutaneous | Complies with USP XXII | Complies with USP XXII |
| Pyrogen Test | Complies with USP XXII | Complies with USP XXII |
| Sterility Test | No microbial growth in fluid thioglycolate medium after 7 days @ 22-25°C and soybean casein digest medium after 7 days @ 30-32°C. | No microbial growth in fluid thioglycolate medium after 7 days @ 22-25°C and soybean casein digest medium after 7 days @ 30-32°C. |
| Air leakage during aspiration | No leakage past piston or seal, no fall in manometer reading. Piston not detached from plunger. | No leakage past piston or seal, no fall in manometer reading. Piston not detached from plunger. |
| Air leakage under compression | No leakage past piston or seal. | No leakage past piston or seal. |
| Dead space of syringe | Less than 0.075 ml. in 3cc & 5 cc. Less than 0.1 ml. in 10cc. | Less than 0.075 ml. in 3cc & 5 cc. Less than 0.1 ml. in 10cc. |
| Air leak test of package Wrapper / Blister Package (combined) | No bubbles within 10 seconds after pressurized @ 0.07 KGF/CM2. | No bubbles within 10 seconds after pressurized @ 0.07 KGF/CM2. (Reported separately for "package Wrapper" and "Blister Package" but with identical results and implied criteria). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. This type of regulatory submission typically tests a representative sample of units (e.g., a batch) to demonstrate compliance, but specific numbers are not usually detailed in the public summary.
- Data provenance: The manufacturer is Alshifa Medical Supplies Industry, Dubai, United Arab Emirates. The tests would have been conducted by or for this manufacturer. The nature of these tests (e.g., chemical analysis, physical properties) means they are generally performed prospectively on manufactured units.
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)
- N/A. This is a physical device; "ground truth" in the AI/ML sense (e.g., an expert label on an image) is not applicable. The "truth" is determined by established scientific and engineering measurement methods (e.g., chemical assays, physical property tests).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This is not an AI/ML study involving human interpretation.
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
- N/A. This is not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/ML study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Scientific and Engineering Standards: The "ground truth" for the tests performed (e.g., sterility, heavy metals, pH, physical dimensions) is implicitly derived from established scientific and engineering principles, analytical chemistry techniques, and recognized pharmacopeial standards (like USP XXII).
8. The sample size for the training set
- N/A. There is no AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
- N/A. There is no AI/ML algorithm requiring a training set.
§ 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).