(377 days)
The Alma Diode Tabletop Laser is intended for use in dermatologic and general surgical procedures.
Indications for Use
The Alma Diode Tabletop Laser includes three possible diode laser modules depending on the customer order.
Diode Laser Modules:
The indications for use for the 810 nm Alma Diode Tabletop Laser include:
-The Alma 810 rm diode tabletop laser is indicated for endoluminal or endovenous laser surgery for saphenous incompetent veins.
The indications for use for the 980 nm Alma Diode Tabletop Laser include:
-The Alma 980 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 980 mm diode tabletop laser assisted lipolysis.
The indications for use for the 1470 nm Alma Diode Tabletop Laser include:
-The Alma 1470 nm diode tabletop laser is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Alma 1470 nm diode tabletop laser is further indicated for laser assisted lipolysis.
The Diode Tabletop System is a small, tabletop laser console that can be sold with one of three wavelengths - 1470nm, 980mm or 810mm. It is comprised of 4 major components. The main console unit contains the laser moduler, cooling and user interface. The Footswitch is used to activate the laser. The diode laser modules are contained in the main console and emit laser energy in the required wavelength. All of the accessories connect via a fiber to the SMA connection port on the laser console. A single use, radial emitting fiber will be provided sterile by an OEM manufacturer. The fiber is sterilized using ETO. It is for prescription use only.
The provided text pertains to a 510(k) premarket notification for a medical device called the "Alma Diode Tabletop Laser." It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed.
However, the document does not contain information related to acceptance criteria, device performance against those criteria, sample sizes for test or training sets, data provenance, expert involvement for ground truth, adjudication methods, multi-reader multi-case studies, or standalone algorithm performance, as would be expected for a product relying on AI/ML or complex diagnostic capabilities.
The core of this 510(k) submission is for a laser surgical instrument, and the significant change described is the addition of a temperature sensing thermistor to a cannula used during laser lipolysis. The testing for this modification focused on bench testing to verify the performance of the temperature sensor and its accuracy in an ex vivo porcine model, rather than complex AI/ML performance metrics.
Therefore, many of the requested elements of your prompt are not applicable or cannot be extracted from this specific document.
Here's what can be extracted based on the provided text, and where gaps exist:
Acceptance Criteria and Study Details for the Alma Diode Tabletop Laser (K212073)
Summary of Device and Key Change:
The Alma Diode Tabletop Laser is a laser surgical instrument used in dermatologic and general surgical procedures, specifically for saphenous incompetent veins and laser-assisted lipolysis. The K212073 submission describes a modification to a previously cleared device (K160952), primarily the addition of a temperature-sensing thermistor to a cannula used during laser lipolysis procedures. This thermistor is designed to detect tissue temperature in near real-time and alert the user if a preset temperature is exceeded.
Study Type:
The study described is non-clinical bench testing to verify the performance of the modified device, particularly the added temperature sensing functionality.
Missing Information:
- This document does not describe the testing of an AI/ML component. Therefore, acceptance criteria regarding AI diagnostic performance (e.g., sensitivity, specificity, AUC) are not present.
- No human reader studies (MRMC) were conducted as the device's function does not involve diagnostic interpretation by human readers.
- No standalone algorithm performance metrics are provided as it's not an AI-driven diagnostic algorithm.
- Ground truth establishment methods (expert consensus, pathology, outcome data) are not relevant in the context of this device's functional testing.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of quantitative acceptance criteria and corresponding reported performance values for properties like sensitivity, specificity, or similar metrics typically associated with AI/ML products. Instead, the performance testing described relates to the functionality of the new temperature sensor.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance |
|---|---|
| Demonstrate time required for temperature sensor to register tissue temperature and notify user. | Performed (details not explicitly quantified in this summary) |
| Demonstrate accuracy of temperature detection in an ex vivo porcine model. | Performed (details not explicitly quantified in this summary) |
| Demonstrate relationship between tissue temperature at thermistor and temperature at a specified distance from the thermistor (in ex vivo porcine model). | Performed (details not explicitly quantified in this summary) |
| Meet general safety and performance standards for medical electrical equipment and laser products. | Passed (compliant with IEC 60601-1, -1-2, -2-22; IEC 60825-1; ISO 17665-1; ISO 10993) |
| Software Validation & Verification Test | Passed |
| Biocompatibility evaluation | Passed |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "ex vivo porcine model" for performance testing of the temperature sensor.
- Sample Size: Not specified (e.g., number of porcine samples or measurements).
- Data Provenance: Ex vivo porcine model (experimental, not human clinical retrospective or prospective data). The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for the performance of a temperature sensor is typically established by calibrated reference instruments, not expert human readers or consensus, especially in an ex vivo setting.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers in diagnostic studies, which is not relevant here.
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. An MRMC study was not conducted. This device is a surgical laser, and the testing described is not related to human diagnostic performance or AI assistance in interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is not an AI/ML algorithm or diagnostic device tested for standalone performance. The testing involved the functional performance of a physical component (temperature sensor) within a laser system.
7. The Type of Ground Truth Used
The ground truth for the temperature sensor's performance would be derived from calibrated temperature measurement devices in the ex vivo porcine model, comparing the thermistor's readings against these reference measurements. This is a type of "bench testing" or "experimental setup" ground truth, not expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML product that undergoes a training phase with a dedicated dataset.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for this device.
§ 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.