(128 days)
The Excalibur Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is clinically indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain i of musculoskeletal origin.
The Excalibur Light Therapy System is a band-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of two laser diodes in one applicator head. It combines the clinically accepted therapeutic treatment of numerous predicate light therapy systems currently in commercial distribution and 510(k) cleared. The system consists of a basic hand-held, battery operated control unit and a permanently attached applicator head. The laser operates at a measured wavelength of 635mm (±1%) and complies with all performance, labeling, and manufacturing standards set forth in 21CFR Part 1040. Stargate International, Inc. is a registered laser manufacturer with the Food and Drug Administration. The laser applicator head produces an output power of ≤4.5mw2 measured, per non-convergent beam and is classified as a Class IIIa laser.
The provided text describes the Excalibur Light Therapy System and its predicate devices, focusing on demonstrating substantial equivalence. However, it does not contain information about formal acceptance criteria or a study designed to specifically prove the device meets such criteria through clinical performance metrics (like sensitivity, specificity, accuracy, or effect sizes).
Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices (Tuco Erchonia PL3000 and Quantum System) based on:
- Identical Intended Use: "Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin."
- Similar Technological Characteristics: Wavelength (635nm), power output (≤4.5mW), and the use of Gallium Aluminum Arsenide (GaAlAs) diodes with non-convergent beams.
- Compliance with Standards: FCC, UL, and Class IIIa Laser (21CFR Part 1040).
- Functional Performance, Electrical Safety, and Component Specification Testing: This refers to engineering and manufacturing tests, not clinical performance studies.
Therefore, many of the requested fields cannot be filled as they pertain to clinical validation studies, which were not performed or reported in this 510(k) summary.
Here's a breakdown of the available information based on your request:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (e.g., "device must achieve X% pain reduction in Y% of patients"). Instead, the "acceptance criteria" for this 510(k) appear to be demonstrating substantial equivalence to predicate devices based on:
| Characteristic | Acceptance Criterion (Implied by Substantial Equivalence) | Reported Device Performance (Excalibur) |
|---|---|---|
| Intended Use | Same as predicate devices: adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin. | The Excalibur Light Therapy System has the identical intended use as the predicate devices: "Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin." |
| Technological Characteristics | Similar to predicate devices in wavelength, power output, and mechanism (LLLT). Will provide same treatment benefits/regimens as cleared predicate devices. | Uses two laser diodes in one applicator head. Operates at a measured wavelength of 635nm (±1%). Produces an output power of ≤4.5mW per non-convergent beam. Uses Gallium Aluminum Arsenide (GaAlAs) diodes with non-convergent beam output to emit visible photonic energy. Variables (frequency, wavelength, time, power output) conform to predicate device parameters. Classified as a Class IIIa laser. |
| Safety and Standards | Compliance with relevant electrical, laser, and manufacturing standards. | Manufactured, performs, is labeled, and is tested to comply with: FCC Standard - 47CFR Part 15B, All Electrical Components Utilized Are UL® Approved, Class IIIa Laser 21CFR Part 1040. System testing includes functional performance, electrical safety, and component specification, including four-staged manufacturing testing and verification. No software incorporated. |
| Clinical Efficacy | No new regulatory, safety, and/or clinical efficacy issues are raised compared to predicate devices. | "The Excalibur System will provide the same treatment benefits and regimens for clinical presentations already cleared by the Food and Drug Administration for the predicate devices." "The performance parameters and intended use of the Excalibur Light Therapy System are identical to all predicate devices." "The Excalibur Light Therapy System is manufactured and performs as intended and does not raise any new regulatory, safety, and/or clinical efficacy issues." These claims are based on equivalence to predicate substantial devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. No clinical test set data is provided or referenced for this device (Excalibur). The submission relies on the clinical data supporting the predicate devices.
- Data Provenance: Not applicable for this device's clinical performance. The 510(k) refers to "clinically accepted therapeutic uses" and "clinical parameters used by the predicate devices," implying the provenance is from studies previously submitted and reviewed for the predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth for a clinical test set for this device is established or reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set.
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
- Not applicable. This device is a light therapy system, not an AI-assisted diagnostic or therapeutic tool with human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical light therapy system. There is no algorithm or AI component. The document explicitly states: "There is no software incorporated into the operation of the Excalibur Light Therapy System."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable for this device. The efficacy of the underlying technology (Low Level Laser Therapy for pain relief) is implicitly accepted based on the prior clearance of the predicate devices. The "ground truth" for the predicate devices' efficacy would have been established through clinical studies, likely using patient-reported outcomes (e.g., pain scales, functional assessments). However, such data is not provided for Excalibur.
8. The sample size for the training set
- Not applicable. There is no AI or machine learning component requiring a training set.
9. How the ground truth for the training set was established
- Not applicable. There is no AI or machine learning component requiring a training set with ground truth.
§ 890.5500 Infrared lamp.
(a)
Identification. An infrared lamp is a device intended for medical purposes that emits energy at infrared frequencies (approximately 700 nanometers to 50,000 nanometers) to provide topical heating.(b)
Classification. Class II (special controls). The device, when it is an infrared therapeutic heating lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.