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510(k) Data Aggregation
(52 days)
BIOCARE SYSTEMS, INC.
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
The LumiWave 1X4 Infrared Therapy Device is an over-the-counter, infrared-therapy device, designed to emit energy at infrared frequencies to provide topical heating. The LumiWave 1X4 Infrared Therapy Device provides infrared therapy through the use of an efficient and easy to use set of 4 small pods that delivers infrared light for the purpose of elevating tissue temperature to treat living tissue in the body. Infrared light is delivered to the tissue through 49 Gallium Aluminum Arsenide (GaAlAs) Light Emitting Diodes (LEDs) (per pod) distributed under the each pod cover of the LumiWave 1X4 Infrared Therapy Device. The LEDs used in the LumiWave 1X4 Infrared Therapy Device have average wavelengths of between 880 nm and 893 nm depending on temperature.
The provided text is a 510(k) summary for the LumiWave 1X4 Infrared Therapy Device, which is an infrared therapy device. It does not contain information about acceptance criteria or a study proving the device meets those criteria, as one would expect for a novel device undergoing a rigorous performance study.
Instead, this 510(k) summary is focused on demonstrating substantial equivalence to a previously cleared predicate device (BioCare System's PremIR 818, K042532). The performance data cited is primarily technical specifications of the device itself, rather than clinical performance data against specific acceptance criteria.
Therefore, many of the requested fields cannot be answered from the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
The document does not specify general "acceptance criteria" for clinical performance. Instead, it details technical specifications and compares them to the predicate device to establish substantial equivalence.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (LumiWave 1X4) |
|---|---|---|
| Indications for Use | Equivalent to Predicate Device (PremIR 818) | Same as Predicate Device |
| Wavelength (Central) | Similar to Predicate Device | HIGH Mode: 900 nm; LOW Mode: 899 nm |
| Wavelength (Mean) | Similar to Predicate Device | HIGH Mode: 893 nm; LOW Mode: 890 nm |
| Wavelength (Min) | Similar to Predicate Device | HIGH Mode: 824 nm; LOW Mode: 822 nm |
| Wavelength (Max) | Similar to Predicate Device | HIGH Mode: 941 nm; LOW Mode: 934 nm |
| Delivered Energy | Similar to Predicate Device | 12 – 56 mW/cm² |
| Thermal Control | Skin temperature regulation | Between 40-43°C (HIGH Mode) and 38-41°C (LOW Mode) |
| Electromagnetic Compatibility | Compliant with EN 60601-1-2 | Complies with EN 60601-1-2 |
| General Electrical Safety | Compliant with EN 60601-1 | Complies with EN 60601-1 |
2. Sample size used for the test set and the data provenance
- Sample size: Not applicable. No clinical test set data is provided in this 510(k) summary for performance evaluation against acceptance criteria. The document focuses on technical specifications.
- Data provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No clinical test set data is provided.
4. Adjudication method for the test set
- Not applicable. No clinical test set data is provided.
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 an infrared therapy device, not an AI-based diagnostic tool. No MRMC study was conducted or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is an infrared therapy device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No clinical performance study is detailed with a "ground truth" for patient outcomes. The ground truth for this submission is substantial equivalence to the predicate device based on technical and safety specifications.
8. The sample size for the training set
- Not applicable. The device is a physical infrared therapy device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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(87 days)
BIOCARE SYSTEMS, INC.
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief / reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
The PremIR 818 is an over-the-counter, infrared-therapy device, designed to emit energy at infe i reful o to is an over the osanton and one of the PremIR 818 provides infrared therapy through infrared frequencies to provide topical houng. In and that delivers infrared light for the purposes the use of an ennoicht und odor to acat living tissue in the body. Infrared light is delivered to the of elevating tissue tomporation to to a Arsenide (GaAlAs) Light Emitting Diodes (LEDs) distributed under the face plate of the PremIR 818. The LEDs used in the PremIR have average wavelengths of between 880 nm and 884 nm.
The PremIR 818 is an infrared therapy device. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria in the manner typically seen for novel medical devices undergoing extensive clinical trials.
The document highlights the device's technical specifications and how they compare to predicate devices. The "Performance Data" section lists several measurements and compliance statements, which act as the de facto acceptance criteria and the results of the "study" (or testing) performed to meet them.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance |
|---|---|
| Delivered Energy | 35 – 56 mW/cm² |
| Central Wavelength | 884 nm |
| Mean Wavelength | 881 nm |
| Minimum Wavelength | 831 nm |
| Maximum Wavelength | 937 nm |
| Electromagnetic Compatibility | Complies with IEC 601-1-2 |
| General Electrical Safety | Complies with UL 60601-1 |
| Skin (treatment) Temperatures | Maintains between 40 and 45 degrees C for greater than 10 minutes |
Note: For a 510(k) submission, the "acceptance criteria" are largely established by demonstrating that the device operates within validated and safe parameters, similar to its predicate devices, without raising new questions of safety or effectiveness. The reported performance metrics are the results of testing conducted to show compliance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of a clinical study with human subjects or a statistical evaluation of device performance in a real-world scenario. The performance data provided (delivered energy, wavelength, temperature maintenance) appear to be results from technical bench testing of the device itself, likely on a single or a small batch of devices.
The data provenance is from technical testing of the device hardware. No human or patient data is mentioned, so no country of origin or retrospective/prospective distinction is applicable in this context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable. The "ground truth" here is based on objective physical measurements and engineering standards (e.g., wavelength measurements, power output, temperature, compliance with electrical safety standards). These do not typically require expert consensus in the same way clinical diagnostic studies do.
4. Adjudication Method for the Test Set
This section is not applicable. As the "test set" refers to physical device measurements and compliance with technical standards, there is no need for an adjudication method involving multiple observers or experts. The measurements are objective.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging or interpretation tasks where human readers make assessments. This device is an infrared therapy device, and its performance evaluation focuses on physical output and safety, not on diagnostic accuracy or human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The "Performance Data" section represents standalone testing of the device's physical output and adherence to safety standards, independent of human operators (beyond setting up the test). This is not an "algorithm" in the typical sense of AI, but rather the device's inherent functional performance.
7. The Type of Ground Truth Used
The ground truth used is based on objective physical measurements (e.g., delivered energy, wavelength) and established engineering and safety standards (IEC 601-1-2 for EMC, UL 60601-1 for electrical safety). For temperature, the ground truth is the measured temperature range and duration.
8. The Sample Size for the Training Set
This section is not applicable. The PremIR 818 is an infrared therapy device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of model development. The device's design is based on established principles of infrared therapy, not on data-driven training.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
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