Search Results

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.

• 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):

1. 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.

2. 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.

3. 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.

4. 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.

5. 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."

6. 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.

7. 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.

8. 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.

Ask a specific question about this device

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:

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.

Ask a specific question about this device

The Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for: Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.

The Quantum Light Therapy System is a hand-held, non-invasive, pain therapy system which utilizes non-heating lamps consisting of both laser and light emitting diodes(LED) in three optional applicator heads. It combines the clinically accepted therapentic treatment of numerous predicate light therapy callor itsacs: It commercial distribution and 510(k) approved into one complete, compact, and costeffective system. The system consists of a basic hand-held, battery operated control unit and three optional (one-LED; two-laser) and interchangeable applicator heads which can only be used with the Quantum Light Therapy System control unit. The three distinct applicator heads produce wavelengths that range between 609-645mm which falls within the spectrum as defined by 21 CFR §890.5500. The two laser applicator heads produce an output power of

Here's an analysis of the provided text regarding the Quantum Light Therapy System, focusing on acceptance criteria and the study (or lack thereof) proving its performance.

It's important to note that this document is a 510(k) summary for a medical device. 510(k) clearances typically establish substantial equivalence to a predicate device, rather than requiring extensive clinical trials to prove efficacy against specific acceptance criteria. Therefore, the information provided focuses more on demonstrating equivalence and compliance with standards than on a detailed clinical study demonstrating specific performance metrics.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in the typical sense of numerical thresholds for clinical performance (e.g., minimum sensitivity, specificity, accuracy, or reduction in a pain score). Instead, the "acceptance criteria" for a 510(k) device like this are primarily related to substantial equivalence to predicate devices, safety, and compliance with relevant technical standards.

The "reported device performance" is framed in terms of its intended use, similarity to predicate devices, and adherence to various electromagnetic and safety standards.

Here's a table summarizing what can be inferred as "acceptance criteria" from the document and the corresponding "performance" as stated:

"Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin..." (same as predicate indications). |
| Technological Characteristics Equivalence: Similar technological characteristics (wavelengths, power output) to predicate devices. | "The technological equivalence to the predicate devices is substantiated by the wavelengths and power outputs generated by the individual Quantum System applicator heads."

The two laser applicator heads produce an output power of "

Ask a specific question about this device