Search Results
Found 1 results
510(k) Data Aggregation
(154 days)
Collagentex RX-1 model is intended to emit light energy in the near infrared spectrum to provide non heating adjunctive use for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Collagentex RX-1 model is a stand alone device of a single quartz lamp, emitting polychromatic visible to near infrared light from 580nm to 1500nm, non-collimating, non pulsing in order to offer exposure to the user where directed at a distance of 8" and farther from the body, non topical light therapy in order to relieve minor pain temporarily. The unit can be mounted on a table top or rolled on a base with casters. Narrow band filter and acrylic shield are designed to eliminate any emission of ultraviolet or wavelength shorter than 480nm wavelengths. The lamp replacement life is 500hrs. The exposure dosage is controlled by a user set timer. Exposure area is set to receive 44.2miliWatt/sqcm or 2.6 Joule/minute of exposure at the minimum distance. The device runs on AC power of 120 Volt 60 Hz or 220 Volt 50 Hz by plugging to main power.
The provided text is a 510(k) summary for the Collagentex RX-1 device, which is an infrared lamp intended for temporary relief of minor chronic neck and shoulder pain. The document focuses on demonstrating substantial equivalence to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics in the way one might expect for an AI/ML device.
Therefore, many of the requested elements for describing acceptance criteria and a study demonstrating device performance cannot be found in this document, as the submission is not based on a clinical efficacy study with quantitative performance measures against a ground truth.
Here's an attempt to answer the questions based only on the provided text, indicating where information is unavailable.
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" and "reported device performance" in the context of this 510(k) is heavily focused on demonstrating substantial equivalence to a predicate device (Bioptron Pro Light Therapy System and Bioptron Compact III Light Therapy System, K032216). There are no specific quantitative clinical performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device) with defined acceptance thresholds. Instead, the acceptance criteria are implicitly that the device's technical characteristics and intended use are similar to the predicate device, and that it meets relevant safety and electromagnetic compatibility standards.
| Characteristic / "Acceptance Criterion" Implicit in Substantial Equivalence | Collagentex RX-1 (Reported Performance) |
|---|---|
| Indications for Use | Temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin (same as predicate) |
| Light Source | Quartz Lamp (same as predicate) |
| Light Source Power | 500 W (predicate: 90 W) - note: different, but acceptable in context of safety & efficacy |
| Emitted light wavelength (effective) | 580nm to 1500nm (predicate: 590nm to 1550nm) |
| Emitted light intensity | 44.2 miliWatt/sqcm (2.6 Joule/minute) (predicate: 40 miliWatt/sqcm, 2.4 Joule/minute) |
| Skin Surface Temperature | Under 42 C (same as predicate) |
| Treatment Time | 20 minutes (same as predicate) |
| Patient Contact | No contact to human body (same as predicate) |
| Electrical Safety | Complied with NRTL, CSA, ANSI (predicate: CE) |
| Electromagnetic Compatibility | Complied with IEC60601-1-2 3rd edition (predicate: CE) |
| Photobiological safety of device | Complied with IESNA/ANSI RP-27.1-05 (predicate: CE) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission relies on technical characteristics comparison and compliance with standards rather than a clinical human subject test set for efficacy.
3. 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)
This information is not applicable/provided. No clinical test set requiring expert-established ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. No clinical test set is described.
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
This information is not applicable/provided. The device is an infrared lamp, not an AI/ML diagnostic or assistive tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is an infrared lamp, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided in the context of a clinical performance study. The "ground truth" for this submission is the established safety and efficacy of the predicate device and compliance with recognized standards.
8. The sample size for the training set
This information is not applicable/provided. The device is an infrared lamp, not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
This information is not applicable/provided. The device is an infrared lamp, not an AI/ML algorithm requiring a training set.
Ask a specific question about this device
Page 1 of 1