(37 days)
The Excalibur IV 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 pair of musculoskeletal origin.
The Excalibur IV Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of four 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) approved. 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 635nm (±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 document describes the Excalibur IV Light Therapy System, a Class II medical device, and its submission for 510(k) clearance by Stargate International, Inc. The core of the submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical efficacy through a direct comparative study with acceptance criteria.
Therefore, the requested information regarding acceptance criteria, a study proving the device meets them, sample sizes (test, training), number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be fully provided from the given text because the 510(k) summary for this device does not include such a clinical performance study. The device's clearance is based on its similarity to existing approved devices.
Here's an attempt to answer the questions based on the available information, noting the limitations:
Acceptance Criteria and Device Performance:
The document does not detail specific quantitative acceptance criteria or a dedicated study designed to prove the device meets such criteria in terms of clinical efficacy. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device in terms of intended use and technological characteristics.
| Acceptance Criteria Category (Implicit from 510(k) Process) | Reported Device Performance (as per submission) |
|---|---|
| Intended Use Equivalence | The Excalibur IV Light Therapy System has the "same intended use" as the predicate device (Quantum System, K032816). |
- Excalibur IV Indication: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
- Predicate Device Indication: Assumed to be the same, allowing for pain therapy treatment for the specified clinical presentation. |
| Technological Characteristics Equivalence | The Excalibur IV Light Therapy System has "similar technological characteristics" to the predicate device. - Wavelength: Measured at 635nm (±1%).
- Power Output: ≤4.5mW per non-convergent beam.
- Technology: Uses Gallium Aluminum Arsenide (GaAlAs) diodes with non-convergent beam output.
- Treatment Variables: Conforms to performance specifications of predicate devices in frequency, wavelength, time, and power output.
- Classification: Class IIIa laser, in compliance with 21 CFR Part 1040.
- Standards Compliance: FCC Standard 47CFR Part 15B, UL® approved electrical components, Class IIIa Laser - 21CFR Part 1040. |
| Safety & Performance Standards Compliance | Manufactured, performs, is labeled, and tested to comply with FCC Standard 47CFR Part 15B, UL® approved electrical components, and Class IIIa Laser - 21CFR Part 1040. Includes functional performance, electrical safety, and component specification testing during manufacturing. |
| No New Regulatory/Safety/Efficacy Issues | The submission concludes that the device "does not raise any new regulatory, safety, and/or clinical efficacy issues." |
Detailed Study Information (Not applicable for this 510(k) submission):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The submission does not describe a clinical performance study with a distinct test set of patient data to assess the device's efficacy. The substantial equivalence argument relies on the inherent characteristics and intended use being similar to an already approved device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. Since there's no clinical performance study with a test set requiring ground truth establishment for patient outcomes, this information is not relevant to this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical study involving expert adjudication of a test set is described.
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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:
- N/A. This device is a light therapy system, not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- N/A. The device is a physical light therapy system, not an algorithm. The submission explicitly states, "There is no software incorporated into the operation of the Excalibur IV Light Therapy System."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. For this 510(k) summary, the "ground truth" for clearance is essentially the established safety and efficacy of the predicate device (Quantum System, K032816) for its specified indications, which the Excalibur IV aims to mirror. No new clinical ground truth from patient outcomes was established or required for this submission.
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The sample size for the training set:
- N/A. This device does not use machine learning or AI that would require a "training set" in the computational sense.
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How the ground truth for the training set was established:
- N/A. As no training set for an algorithm is involved, this question does not apply.
Summary of Device Substantiation:
The Excalibur IV Light Therapy System obtained 510(k) clearance by demonstrating "substantial equivalence" to a predicate device (Quantum System, K032816) based on same intended use (adjunctive relief of minor chronic neck and shoulder pain of musculoskeletal origin) and similar technological characteristics (wavelength, power output, diode technology, conformance to clinical parameters). The submission focused on compliance with relevant electrical, laser, and manufacturing standards, as well as functional performance and component specifications, rather than new clinical efficacy trials with acceptance criteria.
§ 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.