(146 days)
810 nm and 980 nm wavelength:
The LTS-1000/1500/2500/4000 devices emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscle.
980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use in surgical applications requiring hemostasis, ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), gastroenterology, general surgery, genitourinary surgery (urology), gynecology (GYN), neurosurgery, otolaryngology (ENT), ophthalmology, arthroscopy, podiatry, pulmonology, thoracic surgery; and Laser Assisted Lipolysis.
980 nm wavelength:
The LTS-2500/4000 devices are also indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophyton rubrum and Trichophyton mentagrophytes, and/or yeasts Candida albicans, etc.)
The LTS Product Family of devices are highly reliable, compact and easy to operate medical lasers. The Console Assembly incorporates a touch-screen display panel and a Main Processor PCA. A Software Application, executed in the Main Processor PCA, generates an intuitive, easy to use, Graphical User Interface (GUI) and responds to operator input, via the touch panel, allowing the operator to select from build-in treatment protocols, or adjust and set the system's optical output power and treatment times with minimal effort.
Laser light generated by the Laser Module Sub-Assembly in the Console Assembly is delivered to a subject via a custom designed Beam Delivery Assembly that can be fitted with different Hand Piece Attachments. The various hand piece attachments are designed to allow the operator to deliver, indication specific optimized dose parameters (for example, onychomycosis).
This FDA document (K173067) is a 510(k) premarket notification for the LiteCure LightForce LTS laser systems. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific clinical performance acceptance criteria through a standalone study with a defined ground truth and statistical analysis of performance metrics like sensitivity and specificity.
Therefore, the document does not contain the detailed information requested in your prompt regarding acceptance criteria, specific device performance metrics, sample sizes, expert qualifications, or ground truth methodologies for clinical efficacy beyond a general statement of "no new safety and efficacy issues are raised" and "analyses demonstrate that system accuracy and performance are adequate for the established intended use."
The document focuses on comparing technological characteristics and indications for use of the new device to those of predicate devices to establish substantial equivalence.
Here's what can be extracted and what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance:
This document does not provide a table of numerical acceptance criteria (e.g., minimum sensitivity, specificity, or accuracy targets) for clinical performance, nor does it report specific clinical performance metrics of the device against such criteria. The "performance" discussed is primarily in the context of technological characteristics being comparable to predicate devices.
The document states: "Analyses demonstrate that system accuracy and performance are adequate for the established intended use." and "no new safety and efficacy issues are raised with this new device." This is a general statement rather than specific, quantifiable performance data against acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document does not describe a clinical test set with a specific sample size used to evaluate the device's clinical performance.
- Data Provenance: Not specified. There is no mention of country of origin or whether any data reviewed was retrospective or prospective in the context of a clinical performance study for the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/Not specified. As no specific clinical test set and ground truth establishment process for performance evaluation are described, this information is not present.
- Qualifications of Experts: Not applicable/Not specified.
4. Adjudication method for the test set:
- Adjudication method: Not applicable/Not specified. No clinical test set or adjudication process is described.
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:
- MRMC Study: No. This device is a laser system, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: No. This is a physical laser device, not an algorithm. Its "performance" would relate to its physical outputs (power, wavelength, etc.) and safety, which were assessed through verification and validation testing, not typically through a standalone algorithm performance study.
7. The type of ground truth used:
- Type of Ground Truth: Not applicable/Not specified for clinical performance. For the purpose of a 510(k), the "ground truth" for substantial equivalence often involves comparing the specifications and intended use of the new device to existing predicate devices already cleared by the FDA. When it comes to device safety and functionality, engineering verification and validation testing would use established standards and measurement techniques as their "ground truth". The document mentions "verification and validation performance testing" but does not detail the "ground truth" for clinical efficacy.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/Not specified. This is a hardware laser device, not an AI model that requires a training set.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable/Not specified. As this is not an AI model, a training set and its ground truth are not relevant to this submission.
Summary of what the document does describe regarding "acceptance criteria" and "study":
The "study" in this context refers to verification and validation testing of the device's technical specifications and safety according to recognized standards, rather than a clinical trial measuring efficacy or diagnostic performance against a ground truth.
- Acceptance Criteria: Implicitly, the acceptance criteria are that the device's technological characteristics (wavelength, output power, etc.), safety features, and intended uses are substantially equivalent to those of the predicate devices. The document does not list explicit numerical acceptance criteria for clinical efficacy.
- Reported Device Performance (Technological Characteristics - comparison to predicates):
| General Characteristic | LightForce LTS Models | Predicate Device (Power Medic K070516) | Predicate Device (GBOX-15A/B, VELAS II K151890) | Predicate Device (LTS-1500 K123014) |
|---|---|---|---|---|
| Laser Type | Diode Laser | Diode Laser | Diode Laser | Diode Laser |
| Wavelength | 810 nm ± 20 nm AND/OR 980 nm ± 20 nm | 808 nm | GBOX-15A: 810nm±10nm; GBOX-15B: 980nm±10nm; VELAS II-30A/60A: 810nm±10nm; VELAS II-30B/60B: 980nm±10nm; VELAS II-60C: 940nm±10nm | 810 nm ± 20 nm AND/OR 980 nm ± 20 nm |
| Output Power | ≤10W, ≤15W, ≤25W, ≤40W | 300-1500 mW | 1-15 W, 30 W, 60 W | ≤25W |
| Aiming Beam | Red Diode Laser, 650 nm ± 20 nm, 3.5 mW ± 0.5 mW | N/A (not listed for Power Medic) | Red Diode Laser of 635 nm, Power |
§ 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.