(265 days)
The LightLance™ Laser Skin Perforator is intended to be used for ablation of skin tissue to establish capillary blood access. The LightLance™ Laser Skin Perforator general indication for use is for the perforation of skin to draw capillary blood for screening purposes. The device is specifically indicated for obtaining capillary blood samples for subsequent analysis of blood glucose concentration in both institutional and home settings.
The LightLance™ Laser Skin Perforator is a pulsed erbium doped yittrium-aluminumgamet (Er: YAG) laser. It outputs a single pulse of laser light with a wavelength of 2940 nm, which ablates a small hole in the skin to a depth sufficient to access capillary blood.
The LightLance™ Laser Skin Perforator is a device designed for ablating skin tissue to access capillary blood, specifically for obtaining blood samples for glucose concentration analysis.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Safety | The device must be safe for its intended use, comparable to legally marketed predicate devices. | "Thoroughly tested according to international standards equivalent to the standard IEC 601. Results from the testing indicate that the device is as safe... as the predicate device." |
| Effectiveness | The device must be effective for its intended use (establishing capillary blood access), comparable to legally marketed predicate devices. | "Thoroughly tested according to international standards equivalent to the standard IEC 601. Results from the testing indicate that the device is as ... effective as the predicate device." "The LightLance™ Laser Skin Perforator has the same intended use and general and specific indications as both of predicated Lasette devices." |
| Substantial Equivalence | The device must be substantially equivalent to legally marketed predicate devices (LASETTE™ K983673 and K981746). | "The LightLance™ Laser Skin Perforator substantially equivalent to the current, legally marketed LASETTE™ (K983673) and (K981746)." "The minor technological differences do not raise any new questions of safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The document mentions "Performance data demonstrates that LightLance™ is as safe and effective as the Lasette" and "Results from the testing indicate that the device is as safe and effective as the predicate device." However, the specific number of subjects or tests involved in this performance data is not provided.
- Data Provenance: Not explicitly stated. The document refers to "international standards equivalent to the standard IEC 601," implying a standardized testing methodology, but does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the given text. The document refers to "testing" and "results" related to safety and effectiveness but does not detail how ground truth was established for these tests, nor the involvement or qualifications of experts.
4. Adjudication Method for the Test Set
- This information is not provided in the given text.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No, an MRMC comparative effectiveness study was not done (or at least not described in the provided text). The study focused on demonstrating substantial equivalence to a predicate device through performance testing against international standards, not on comparing human reader performance with and without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
- The device is a physical medical device (laser skin perforator), not an AI algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not apply to this product. The device is used by a human to perform its function.
7. The Type of Ground Truth Used
- Since the device is a physical instrument for producing a physical effect (skin perforation for blood access), the ground truth would likely be established by direct observation and measurement of the device's physical performance characteristics. This would include parameters such as:
- Depth of perforation.
- Consistency of perforation.
- Ability to access capillary blood successfully.
- Safety parameters (e.g., thermal damage to surrounding tissue, sterility, electrical safety).
- The document indicates "thoroughly tested according to international standards equivalent to the standard IEC 601," which suggests a technical, objective ground truth based on measurable physical properties and compliance with safety and performance specifications.
8. The Sample Size for the Training Set
- The device is a physical medical device, not an AI/machine learning algorithm. Therefore, the concept of a "training set" in the context of machine learning does not apply to this product.
9. How the Ground Truth for the Training Set was Established
- As the device is not an AI/machine learning algorithm, there is no "training set" or "ground truth for the training set" in that context.
§ 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.