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510(k) Data Aggregation
(87 days)
The product is used to obtain capillary blood samples from fingertip in a home. The device contains a sharp injury protection feature.
The Disposable Safety Lancets consists 7 parts, include a trigger, plastic handle, out shell, back cover, spring, protective cap and needle. The models of the Disposable Safety Lancets are 21G; 23G; 26G; 28G; 30G. The product is used to obtain capillary blood samples from fingertip in a hospital or at home. The device contains a sharp injury feature. The lancet is hit by pressure, and once the device strikes, the lancet needle can puncture the skin. And once activated, the needle retracts into the body of the device which reduces the risk of injury as the result if an exposed needle. Used Gamma sterilization, and are products for single use.
The provided text describes the 510(k) summary for a medical device (Disposable Safety Lancets) and focuses on demonstrating substantial equivalence to a predicate device, rather than the acceptance criteria and study data for an AI/algorithm-driven device.
Therefore, most of the requested information regarding AI/algorithm performance (e.g., sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, etc.) cannot be extracted from this document, as it pertains to a physical medical device (blood lancet) and not an AI-powered diagnostic or assistive tool.
However, I can extract the acceptance criteria and performance results for the physical device's non-clinical testing.
Here's the information that can be extracted from the document:
1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Testing for a Physical Device)
| No | Testing Item | Acceptance Criteria (Specification) | Reported Device Performance (Result) |
|---|---|---|---|
| 01 | Appearance | Disposable Safety Lancets the surface should be smooth without edge, no dirt and damage, deformation and other poor appearance. | Pass |
| 02 | Launch Length | The length of the needles in the Disposable Safety Lancet is different in different gauges. The launch length of the needle is determined according to the length of the purchase, and the general emission length is 1.8mm-2.2mm. | Pass |
| 03 | Sharpness/Penetration testing | Penetration force ≤1.00N. | Pass |
| 04 | Feature | The tip of the needle can shrink quickly after firing, and the tip of the needle is not exposed. | Pass |
| 05 | Feature | Disposable Safety Lancets Only one launch, not another. | Pass |
| 06 | Initial bioburden | Initial bioburden of the device shall be less than 100CFU/g | Pass |
| 07 | Sterile | The sterile blood lancet shall be sterile | Pass |
| 08 | Cap removal force | The moment for breaking the safe mode should range from 30 Ncm to 35 Ncm. | Pass |
| 09 | Needle removal force | The bond between the lancet body and needle should be greater than or equal to 10N/15s. | Pass |
| 10 | Drop testing | The carton box should have no puncture after the drop test. | Pass |
Information that cannot be extracted from the provided text (as it's not relevant to this type of device submission):
- Sample sizes used for the test set and data provenance (e.g., country of origin, retrospective/prospective).
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs. without AI assistance.
- If a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI models.
- The sample size for the training set (for AI models).
- How the ground truth for the training set was established (for AI models).
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