(190 days)
The Sol-M TB Syringe is intended to be used for medical purposes to inject fluids into or withdraw fluids from the body.
The Sol-M Insulin Syringe with needle, with the calibration unit of insulin for U-100, is a device intended for medical purposes for the manual aspiration of insulin, and for the injection of insulin into parts of the body below the surface skin.
The Sol-M Syringe is a sterile, single use, standard 3 piece piston syringe with a fixed needle. The Sol-M 0.3, 0.5 and 1 ml Insulin Syringe will be labeled with a Units Scale calibrated for U-100 Insulin. The 0.5 and 1 ml TB Syringe will be labeled with a mL Scale. The piston type syringe is a plastic disposable syringe made of the following components: 1. Barrel – The barrel has a scale showing the capacity of the syringe as well as the company brand name with the Do Not Reuse symbol. 2. Plunger - The plunger is used to aspirate fluid into the barrel or push fluid out of the barrel. 3. Stopper - The Stopper maintains the fluid in the barrel between the base of the barrel and Plunger. 4. Cap The Cap is used to cover and protect the tip of the barrel from being damaged.
This is a 510(k) premarket notification for a medical device (syringes), not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, MRMC studies, and standalone performance is generally not applicable in the context of AI/ML device evaluations. Traditional medical device clearances like this one focus on demonstrating substantial equivalence to a legally marketed predicate device through non-clinical bench testing.
Based on the provided document, here's what can be extracted related to performance and testing, framed in the closest possible way to your request, but acknowledging the difference in context:
1. A table of acceptance criteria and the reported device performance
For the Sol-M Insulin Syringes:
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance (Compliance) |
|---|---|---|
| Delivery Accuracy | ISO 8537:2007 Sterile single use syringes, with and without needles, for insulin | Complies with ISO 8537:2007 |
| Stainless Steel Needle Tubing | ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical devices/Amendment:2001 | Complies with ISO 9626:1991 |
For the Sol-M TB Syringes:
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance (Compliance) |
|---|---|---|
| Manual Use Syringes | ISO 7886-1:1993 Sterile Hypodermic syringes for single use Part 1: Syringes for manual use | Complies with ISO 7886-1:1993 |
| Hub/Needle Bond Strength | Per ISO 7886 (likely referring to the relevant section within 7886-1 or similar) | Complies with ISO 7886 |
| Stainless Steel Needle Tubing | ISO 9626:1991 Stainless steel needle tubing for the manufacture of medical devices/Amendment:2001 | Complies with ISO 9626:1991 |
For both devices (general characteristics):
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance (Compliance) |
|---|---|---|
| Lubricant amount/cm2 | Predicate: 1 ml – 0.078 Mg/cm2 | Subject device: 1ml-0.078mg/cm2 (Matches predicate) |
| Biocompatibility | Per ISO 10993-1 | Complies with ISO 10993-1 |
| Labeling | Per 21 CFR 801 | Complies with 21 CFR 801 |
| Materials | Barrel, Plunger, Cap: Polypropylene; Gasket: Santoprene | Matches predicate |
| Gradations Legibility | Bold markings | Bold markings (Matches predicate) |
| Barrel Transparency | Clear | Clear (Matches predicate) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Bench tests were conducted to verify that the proposed devices met all design specifications." However, it does not specify the sample sizes for these bench tests. The data provenance is not explicitly mentioned as country of origin, but these are non-clinical tests performed to regulatory standards. The testing is prospective in the sense that new samples of the device were tested against established standards.
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)
This is not applicable as this is a traditional medical device (syringes) and not an AI/ML device relying on expert-annotated ground truth for performance evaluation in the way an AI would. Performance is measured against engineering and material standards (e.g., ISO standards).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable in the context of traditional device bench testing against ISO standards. Test results are typically objective measurements.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by international and national standards for medical syringes (e.g., ISO 8537, ISO 7886-1, ISO 9626, ISO 10993-1, 21 CFR 801). The device's physical and functional characteristics are objectively measured against these established parameters.
8. The sample size for the training set
Not applicable, as this is not an AI/ML device and does not involve training data.
9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device and does not involve a training set or its ground truth.
§ 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).