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510(k) Data Aggregation
(298 days)
The NATROX™ System is a low-dose tissue oxygenation system intended to provide topical oxygen to aid in the healing of chronic wounds such as:
- Skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions,
- Decubitis ulcers (bedsores), .
- Amputations/infected stumps, .
- Skin grafts,
- Burns, and
- Frostbite
The NATROX™ Topical Oxygen Delivery System is a small battery-powered electronic device approximately the size of a cell phone, containing an oxygen generator that produces 99% oxygen from room air at a rate of approximately 13 mL/hour. A small diameter tube transmits the oxygen to the wound bed, where the wound is exposed to the oxygen atmosphere inside the Oxygen Delivery System (ODS), Island Oxygen Delivery Pad (IODP) wound dressing or into the patient's own wound dressing, The NATROX™ System provides oxygen to diffuse evenly over the wound bed under an occlusive dressing, constantly refreshing the oxygen supply to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue.
The provided text describes the NATROX™ Topical Oxygen Delivery System and its safety and effectiveness. However, it does not contain specific acceptance criteria in a quantifiable format (e.g., "wound size reduction of X% with p-value < Y"). Instead, it broadly states that the device "meets all requirements" and "meets the specified criteria." The clinical study details are also very high-level.
Based on the provided text, here's an attempt to structure the information, acknowledging the missing acceptance criteria and detailed performance metrics:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is safe for use and does not result in adverse effects. | A 6-week clinical study on 10 patients using the VELOX device (an earlier version of NATROX™ producing the same oxygen concentration and flow) "did not result in adverse effects." The NATROX™ system has also been tested according to IEC 60601-1 and IEC 60601-1-2 and "was found to meet all requirements." |
| Efficacy: Aids in the healing of chronic wounds, specifically by reducing wound size and pain. | The 6-week clinical study on 10 patients using the VELOX device "demonstrated that use of the VELOX device significantly reduced wound size and wound pain." The system provides topical oxygen to enhance the normal process of wound healing for chronic and hard-to-heal wounds with compromised oxygen delivery to healing tissue. Performance data also supports that the NATROX™ device and accessories "meet the specified criteria." |
| Usability: The device is usable in a clinical setting. | The 6-week clinical study implicitly supported the usability of the device, as it was successfully used in 10 patients. Specific metrics or user feedback details are not provided. |
| Technical Conformance: Meets relevant electrical safety and electromagnetic compatibility standards. | The NATROX™ Topical Oxygen Delivery System has been tested according to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance) and IEC 60601-1-2 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests), and "was found to meet all requirements." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 10 patients.
- Data Provenance: The text does not explicitly state the country of origin for the clinical study data or whether it was retrospective or prospective. Given the manufacturer is based in Cambridge, UK, it's plausible the study was conducted in the UK. The description of it as "A clinical study was conducted" suggests it was a prospective study, but this is not explicitly stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention using experts to establish ground truth for the clinical study's outcomes (wound size reduction, pain, adverse effects). The evaluation appears to be based on direct clinical observation and measurement.
4. Adjudication Method for the Test Set
The document does not provide any information on an adjudication method for the clinical study results.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with AI vs. without AI assistance. The device is a topical oxygen delivery system, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance
This question is not applicable as the NATROX™ System is a medical device for delivering oxygen, not an algorithm for diagnosis or analysis. Therefore, there is no "standalone algorithm performance" to report.
7. Type of Ground Truth Used (Clinical Study)
The ground truth for the clinical evaluation was based on direct clinical measurements and observations of "wound size" reduction, "wound pain" reduction, and the occurrence of "adverse effects" in patients.
8. Sample Size for the Training Set
- The document does not mention a 'training set' as the device is a physical medical device, not a machine learning algorithm.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable as there is no mention of a training set for an algorithm.
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