(170 days)
The LMT-3000 is a portable, battery-operated laser lancing device indicated for obtaining capillary blood samples in both institutional and at-home settings.
The LMT-3000 lancing device uses a battery-powered laser beam (Er:YAG laser technology), which makes a tiny hole in the skin to obtain a capillary blood sample. The LMT-3000 ablates the epidermis and a thin layer of papillary dermis with minimal photothermal and photomechanical damage to the surrounding tissue.
The LMT-3000 is a laser lancing device indicated for obtaining capillary blood samples. The device uses Er:YAG laser technology to ablate the epidermis and a thin layer of papillary dermis to create a small hole for blood collection.
Here's the breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria in a table format for performance metrics like "blood sample volume sufficient for analysis" or "pain reduction percentage." Instead, the "acceptance criteria" are implied by the comprehensive non-clinical performance tests and the conclusion drawn from the clinical study that there was "no significant difference in the glucose value between the needle lancet and laser lancet" and that "Some patients in the study reported less pain using the LMT-3000 compared to using the steel lancet."
Therefore, the reported device performance, in relation to implied acceptance, is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Passed testing per ISO 10993-1 |
| Electrical Safety | Passed testing per IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Passed testing per IEC 60601-1-2 |
| Laser Safety | Passed testing per IEC 60825-1 |
| Usability | Passed testing per IEC 60601-1-6 and IEC 62366 |
| Performance in Home Health Care | Passed testing per IEC 60601-1-11 |
| Performance for surgical, cosmetic, therapeutic, diagnostic | Passed testing per IEC 60601-2-22 |
| Software Verification and Validation | Passed testing per IEC 62304/FDA Guidance |
| Cleaning and Sterilization | Passed |
| Storage and Transport | Passed |
| Clinical Equivalence in Glucose Value Acquisition | No significant difference in glucose value detected compared to standard steel lancets. |
| Clinical Advantage in Pain Perception (not quantitative) | Some patients reported less pain compared to steel lancets. |
2. Sample Size and Data Provenance
- Sample Size for the Test Set: 50 patients.
- Data Provenance: The document does not specify the country of origin of the data. The study was "randomized" and appears to be prospective as it involved two visits one week apart and a specific sampling protocol for the LMT-3000 and steel lancets.
3. Number of Experts and Qualifications for Ground Truth
- The document does not mention the number of experts used to establish ground truth or their specific qualifications for the clinical study. The "ground truth" for glucose values would typically be provided by a calibrated lab instrument, not expert consensus in this context.
4. Adjudication Method
- The document does not describe any adjudication method for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This device is a lancing device for blood collection, not an imaging or diagnostic algorithm that typically involves human readers. The study compares the device's technical performance (glucose value acquisition) and patient experience (pain) directly against a predicate method.
6. Standalone (Algorithm Only) Performance
- Yes, a standalone study was done in the sense that the LMT-3000's primary function (obtaining a blood sample and its impact on glucose measurement) was evaluated directly. There isn't an "algorithm" in the typical AI sense; rather, the device itself is the technology being evaluated for its performance characteristics. The clinical performance study directly assessed the device's ability to facilitate blood collection for glucose analysis.
7. Type of Ground Truth Used
- For the clinical study, the ground truth for performance was primarily glucose values obtained from the collected blood samples. These values would typically be from laboratory analysis using a standard glucose meter or lab equipment. The patient's reported pain also served as a subjective outcome measure.
8. Sample Size for the Training Set
- The document does not mention a training set in the context of machine learning, as the LMT-3000 is a physical medical device, not an AI/ML algorithm requiring a training dataset. The non-clinical tests would have involved various samples of the device itself for validation.
9. How Ground Truth for Training Set was Established
- As there's no mention of a traditional training set for an AI/ML algorithm, the concept of establishing ground truth for a training set does not apply directly here. The "ground truth" for the non-clinical tests (e.g., biocompatibility, electrical safety) is defined by the respective international standards (e.g., ISO 10993-1, IEC 60601-1) and their established pass/fail criteria.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.