(189 days)
The Lucia is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
The Lucia has a hand-held treatment probe, is non-invasive, low level visible lamp that provides continuous heat therapy at fixed frequency, The System consists of a Drive Unit, Power Supply, controls and optional treatment probes that contain the visible radiating elements. The Lucia generator automatically calculates energy output in relation to set treatment parameters. The parameters (treatment time, output power delivered) can be adjusted by using key, treatment specifications and menus. The progress of the treatment is displayed on the LCD display in real time. The Lucia generator operates simultaneous and independent management of outputs for connecting probes with laser sources from the Red wavelength. The Lucia generator is supplied with 2 completely independent outputs for using two freatment probes. The LCD displays operating parameters from both channels. This allows two operators to carry out laser therapy independently: just like having two separate instruments.
Here's a breakdown of the acceptance criteria and study information for the Lucia device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Primary Goal: Elevate skin temperature for therapeutic purposes. | "Performance data was presented which showed that skin temperature was elevated as required for this type of device." |
| Intended Use Safety: Provide topical heating for temporary relief of minor muscle/joint pain, stiffness, minor arthritis pain, muscle spasm; temporary increase in local blood circulation; and/or temporary muscle relaxation. | The device met regulatory requirements and was deemed substantially equivalent to a predicate device (LAPEX BCS) with the same intended use. This implies the device safely and effectively achieves the stated therapeutic effects through topical heating. |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Performance data was presented which showed that skin temperature was elevated as required for this type of device." This suggests a test was conducted, but details are not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The study appears to be a technical performance evaluation (skin temperature elevation) rather than one requiring clinical interpretation needing expert consensus.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method. Given the nature of the stated performance data ("skin temperature was elevated as required"), it's likely a direct measurement rather than an expert-adjudicated outcome.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
The document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. This type of study is more common for diagnostic devices where human interpretation is a key component. The Lucia is a therapeutic heating device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The concept of "standalone" performance typically applies to AI algorithms. The Lucia is a physical infrared lamp device, so this question is not applicable in the traditional sense. The performance data would directly reflect the device's physical output.
7. The Type of Ground Truth Used
The ground truth for the "Performance data" was likely direct measurement of skin temperature elevation. The statement "skin temperature was elevated as required for this type of device" implies a quantitative measurement against predefined physiological or regulatory targets.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This is expected as the Lucia is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set (as the device is not an AI algorithm), this question is not applicable.
§ 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.