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510(k) Data Aggregation
(82 days)
LDE4 Lancing Device
LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood.
LDE4 Lancing device is used with a disposable blood lancet to obtain a capillary blood sample from the fingertip for testing utilizing small amounts of blood. It has nine levels of penetration depths. LDE4 lancing device is compatible with CareSens lancets, Soft series disposable blood lancet from SteriLance and most other blood lancets.
The provided text is a 510(k) summary for the LDE4 Lancing Device. It details the device's technical characteristics and the performance data submitted to support its substantial equivalence to a predicate device. However, it does not contain a typical acceptance criteria table with reported device performance in distinct metrics like sensitivity, specificity, accuracy, or F1 score, which are common for AI/ML-based diagnostic devices. This document focuses on demonstrating that the lancing device performs its intended mechanical function, is biocompatible, and can be properly cleaned and disinfected.
Based on the information provided, here's a breakdown of the requested elements:
1. A table of acceptance criteria and the reported device performance
The document doesn't provide specific numerical acceptance criteria in the format of a typical diagnostic device performance table (e.g., sensitivity, specificity). Instead, the performance evaluations verify that the device functions as intended and meets safety standards. The "acceptance criteria" are implied by the successful completion and positive results of the various tests.
| Performance Characteristic | Acceptance Criteria (Implied by successful test) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meet ISO 10993-1 standards for medical devices | Cytotoxicity testing: Passed |
| Skin sensitization: Passed | ||
| Intracutaneous reactivity: Passed | ||
| Cleaning and Disinfection | Complete inactivation of HBV and no performance/physical change after 520 cycles | Virus elimination efficacy tests performed: Demonstrated complete inactivation of Hepatitis B Virus (HBV) on ABS and POM. |
| Robustness test: No change in performance or physical appearance of surface materials after 260 cleaning and 260 disinfection cycles (520 total), simulating 5 years of single-patient use. | ||
| Puncture Depth | (Various levels with ±0.3mm tolerance) | 1: 0.5 ± 0.3mm |
| 1.5: 0.7 ± 0.3mm | ||
| 2: 0.9 ± 0.3mm | ||
| 2.5: 1.1 ± 0.3mm | ||
| 3: 1.3 ± 0.3mm | ||
| 3.5: 1.5 ± 0.3mm | ||
| 4: 1.7 ± 0.3mm | ||
| 4.5: 1.9 ± 0.3mm | ||
| 5: 2.1 ± 0.3mm | ||
| Mechanical Performance | Functional performance as described | Appearance: Verified |
| Basic dimensions: Verified | ||
| Compatible performance: Verified | ||
| Bounce performance: Verified | ||
| Puncture Test: Verified | ||
| Adjustable performance: Verified | ||
| Lancet unloading performance: Verified |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state sample sizes for each particular test type. For instance, the number of devices or material samples used for biocompatibility or cleaning/disinfection validation is not specified. The studies appear to be prospective bench tests and laboratory evaluations, not clinical trials with human subjects as a "test set" in the context of diagnostic AI. The provenance is implied to be laboratory testing conducted by the manufacturer or its contract labs.
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 information is not applicable to the provided document. The LDE4 Lancing Device is a mechanical device, and its performance evaluation does not involve establishing ground truth through expert consensus as would be typical for image-based diagnostic AI. The "ground truth" here is objective physical measurements and established biological/chemical testing standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretation, which is not relevant for the type of bench testing described for a lancing device.
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
This information is not applicable. The LDE4 Lancing Device is a standalone mechanical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies or human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The LDE4 Lancing Device is a mechanical lancing device, not an algorithm, and therefore does not have "standalone" AI performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance described in this document is based on:
- Established physical and chemical standards: For puncture depth measurements, material properties, and mechanical functionality.
- Standardized biological testing methods: For biocompatibility (ISO 10993-1) and virus inactivation efficacy.
8. The sample size for the training set
This information is not applicable. The LDE4 Lancing Device is a mechanical device and does not utilize a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not applicable, as there is no training set for a mechanical lancing device.
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