(108 days)
The HILT Family Laser is intended to provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.
The HILT Family Laser provides 1,064 nm wavelength. Laser emission activation is by used selectable controller. Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
The Hilt Family Laser: HILT I, HILT III is a Nd:YAG laser, Intrared Lamp system for heat therapy. The three possible treatment configurations are initalou Eamp Hilt II, non-contact; Hilt III, both contact and non-contact. The noncontact hand piece utilizes a spacer between the output window and the skin of the patient.
The provided document is a 510(k) summary for the El En HILT Family Laser, cleared by the FDA in 2005. It does not contain information about acceptance criteria or a study proving the device meets said criteria as it is a premarket notification for a predicate device, focusing on substantial equivalence rather than performance studies with specific metrics.
Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not available in this document.
Here's a breakdown of what can be extracted and what is explicitly stated as not available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | Not Available |
| (Specific performance metrics and thresholds are not mentioned in this 510(k) summary. The basis for approval is substantial equivalence to a predicate device, not fulfillment of specific quantitative performance criteria.) | (No specific performance data, such as accuracy, sensitivity, or specificity, is reported. The device is equated to its predicate based on indications for use, principle of operation, and similar specifications.) |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable (No clinical performance data or test set mentioned for the 510(k) submission).
- Data provenance: Not applicable (No clinical performance data or test set mentioned). The submission explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
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 (No test set or ground truth established for performance evaluation).
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set:
- Adjudication method: Not applicable (No test set mentioned).
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 for topical heating, not an AI-assisted diagnostic tool for human readers.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone study: No. This is not an algorithmic device. The document explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none".
7. The type of ground truth used:
- Type of ground truth: Not applicable (No performance study with ground truth data was submitted or required for this 510(k) clearance, as it relied on substantial equivalence to a predicate device).
8. The sample size for the training set:
- Sample size for training set: Not applicable (No training set for an algorithm is relevant for this device).
9. How the ground truth for the training set was established:
- How ground truth was established: Not applicable.
Summary from the Document:
The basis for the FDA's approval of the El En HILT Family Laser (HILT I, HILT II, HILT III) was "Predicate Device" equivalence, specifically to the MLT-1000 IR Laser System. The 510(k) summary explicitly states:
- "Nonclinical Performance Data: none"
- "Clinical Performance Data: none"
The conclusion states: "The HILT Family Laser is a safe and effective device for the indications specified." This conclusion is drawn from its substantial equivalence to the predicate device, meaning it has the same indications for use, principle of operation, and similar performance specifications. No independent studies showcasing new performance data or meeting specific acceptance criteria were provided or required for this type of clearance.
§ 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.