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510(k) Data Aggregation
(342 days)
JSM insulin pen needle is intended for use with pen injector devices for the subcutaneous injection of insulin in the treatment of diabetes.
JSM insulin pen needle consists of a cap, needle, hub and paper. The cap and paper function to maintain the sterility of the needle. This device is single use and sterilized by EO gas. The hub can be connected with pen injector. After removing the paper, the needle can be screwed on to the pen. The needle cap protects the needle. This device has various gauge sizes (29G, 30G, 31G, 32G) and length (4mm, 5mm, 6mm, 10mm, 12mm) The color of needle cap per needle gauge is distinguished according to the standard given by our company.
The provided text describes a 510(k) premarket notification for a medical device, the JSM Insulin Pen Needle. It details the device's characteristics, comparison to a predicate device, and performance testing results against various ISO standards.
However, the questions posed (regarding acceptance criteria and a study proving a device meets these criteria, especially concerning AI/human reader performance, ground truth, and training data) are not applicable to this document.
This document describes the regulatory approval process for a physical medical device (an insulin pen needle) and focuses on engineering and biocompatibility performance data, not artificial intelligence or diagnostic algorithms. There is no mention of "AI" or "human readers" or "ground truth" in the context of an algorithmic assessment.
Therefore, I cannot provide a table of acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text. These concepts are relevant to the evaluation of AI/ML-driven diagnostic devices, which is not what this document describes.
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(291 days)
Jeesung safety syringe and single use needles is a sterile, single-use, disposable and non-reusable, manual retractable safety syringe intended for injection of fluids into the body, while reducing the risk of sharps injuries and the potential for syringe reuse.
Jeesung Safety Syringe and Single Use Needles is an integrated needle and piston syringe with an anti-needle-stick mechanism. There is a swell on the top of inside barrel, which can be used to fix the hub of needle to the top of inside barrel. Four legs on the bottom of hub are caught on the swell part on the top of inside barrel when the hub is pulled. After using this syringe (such as injecting medicine into body etc.), the hub of needle is pulled back to the inside of the barrel. Because the four legs of hub is bound to the top of the plunger which has a smaller swell part than the top of inside barrel for being caught. Therefore, by pushing plunger until it makes a binding sound, the hub can follow with the plunger is broken off and the needle cannot be come out of the barrel. This renders the needle unusable and safe from accidental needle sticks. Jeesung Safety Syringe and Single Use Needles has syringe capacity of 3cc attached with 18-30 gauge and the length of the needle (8mm, 10mm, 13mm, 19mm, 25mm, 32mm, 38mm).
The provided text describes a medical device, the "Jeesung Safety Syringe and Single Use Needles," and its acceptance criteria, particularly focusing on biocompatibility and general performance standards.
Here's an analysis of the acceptance criteria and supporting studies, formatted as requested:
1. A table of acceptance criteria and the reported device performance
| Test Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Tests | ||
| Cytotoxicity test | Non-cytotoxicity (ISO10993-5:2009) | Non-cytotoxicity (Pass) |
| Hemolysis test | Non-hemolytic (ISO10993-4:2002(E), ISO10993-4:2002/Amd.1:2006) | Non-hemolytic (Pass) |
| Acute systemic toxicity test | No dead animals, No strange reaction animals (ISO10993-11:2006(E)) | Non-acute systemic toxicity (Pass) |
| Skin sensitization test | Non-skin hypersensitivity reaction (ISO10993-10:2010(E)) | There was non-skin hypersensitivity reaction. (Pass) |
| Pyrogen Test | Non-pyrogenicity (ISO 10993-11:2006, USP 38 NF 33 ) | Non-pyrogenicity (Pass), Endotoxin concentration ) |
| Syringe Performance (ISO7886-1:1993) | ||
| Inner/outside and structure | Surface is smooth / no particle and foreign substance | Surface is smooth / no particle and foreign substance |
| Graduated scale | Dead space (0.06ml), capacity (2.19ml), Graduation lines were evenly spaces, overall length of scale (32.0mm) | Dead space (0.06ml), capacity (2.19ml), Graduation lines were evenly spaces, overall length of scale (32.0mm) (These appear to be reported values rather than strict criteria, but imply meeting a standard) |
| Barrel | The length of the barrel is such that the syringe has a maximum usable capacity of at least 10% more than the nominal capacity | The length of the barrel is such that the syringe has a maximum usable capacity of at least 10% more than the nominal capacity (This appears to be reported value rather than strict criteria, but implies meeting a standard) |
| Piston(gasket)/plunger assembly | Design, fit of piston in barrel, fiducial line are suitable | Design, fit of piston in barrel, fiducial line are suitable |
| Liquid leakage | Pressure test – no leaked water / aspirate test – no leaked air | Pressure test – no leaked water / aspirate test – no leaked air |
| Lubricant | The quantity of lubricant: 0.18mg/cm³ | The quantity of lubricant: 0.18mg/cm³ (This appears to be reported value rather than strict criteria, but implies meeting a standard) |
| Needle Performance (ISO7864:1993) | ||
| Inner/outside and structure | No scratch, no crack, smooth, no foreign materials, sharped needle edge | No scratch, no crack, smooth, no foreign materials, sharped needle edge |
| Measurement | Outside diameter of needle (e.g., 0.6000-0.673mm for 0.645mm), length of needle (e.g., 25(+1.5/-2.5)mm for 24.7mm) | Outside diameter of needle: 0.645mm for 0.6000-0.673 criteria, length of needle: 24.7mm for 25(+1.5/-2.5) criteria (These appear to be reported values rather than strict criteria, but imply meeting a standard) |
| Elasticity test | Needle returned after remove weight. | Needle returned after remove weight. |
| Flexural rigidity | Needle was not broken. | Needle was not broken. |
| Draw test | The union of the hub and needle tube was not broken. | The union of the hub and needle tube was not broken. |
| Stimulated Clinical Use Testing | Zero failure of the protective feature | Zero failure of the protective feature |
2. Sample size used for the test set and the data provenance
- Stimulated Clinical Use Testing: The sample size for this test was 500 subject devices.
- Data Provenance: The document does not specify the country of origin for the data or whether it was retrospective or prospective. It implies the tests were conducted by the manufacturer as part of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described (biocompatibility, physical performance, simulated clinical use) are objective engineering and laboratory tests, not typically requiring expert ground truth establishment in the same way an AI diagnostic device would.
4. Adjudication method for the test set
This information is not applicable for the reported tests. The tests are based on objective measurements and predefined pass/fail criteria from international standards (ISO, USP).
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
No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices involving human interpretation, which is not the case for this mechanical safety syringe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not Applicable. This device is a mechanical safety syringe, not an algorithm. The "Stimulated Clinical Use Testing" can be considered a standalone performance test for the device's safety mechanism without human-in-the-loop assessment in the context of an AI algorithm. Its purpose was to verify the function of the safety feature itself.
7. The type of ground truth used
The "ground truth" for the various tests relies on established and internationally recognized standards and specifications for medical devices.
- Biocompatibility: Standards like ISO10993 (Cytotoxicity, Hemolysis, Systemic Toxicity, Skin Sensitization, Intracutaneous Reactivity) and USP (Pyrogen Test) and USP (Particulate Matters). The "ground truth" is that the device must meet the defined biological safety limits and particulate levels set by these standards.
- Syringe and Needle Performance: Standards like ISO7886-1 and ISO7864 define the performance characteristics, dimensional tolerances, and structural integrity required for syringes and needles. The "ground truth" is adherence to these engineering specifications.
- Stimulated Clinical Use Testing: The ground truth for this specific test was zero failure of the protective feature, meaning the safety mechanism must activate correctly every time as observed in the simulation.
8. The sample size for the training set
Not Applicable. This is a mechanical device, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not Applicable. As there is no AI model, there is no training set or ground truth for a training set.
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