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510(k) Data Aggregation
(132 days)
Guardian 1000 with its delivery accessories 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.
Guardian 1000 with its delivery accessories is indicated for use in surgical applications requiring the ablation. vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry.
Guardian 1000 delivers an invisible laser beam in the infrared spectrum at 980 nm using a gallium aluminum arsenide (GaAlAs) source. The laser light beam is carried to the focusing lens on the handpiece probe by quartz optical fibers.
Guardian 1000 consists of two main sub-systems: a laser console and its delivery accessories, as follows: The laser console includes:
- i an external enclosure
- । power electronics
- touch screen display with control electronics which controls:
- o power electronics
- O user interface
- o laser source temperature
- laser source emission o
- . a laser system including:
- O laser source
- cooling system (Peltier cells, dissipator and fans) o
- fiber launching system o
- aiming beam o
Laser radiation is delivered to the patient trough an optical fiber and several handpieces depending on the treatment.
The optical fiber is connected to the laser unit trough a SMA905 connector
The provided document is a 510(k) summary for the Guardian 1000 laser device, seeking substantial equivalence to predicate devices. It describes the device's technical specifications, intended use, and provides a summary of performance data.
However, the document does NOT contain information about acceptance criteria and a study proving the device meets those criteria, as typically understood for AI/ML-based medical devices with performance metrics like sensitivity, specificity, or accuracy. This document pertains to a laser surgical instrument, and its "performance data" focuses on electrical safety, EMC, software verification/validation, and its ability to achieve certain therapeutic temperature ranges.
Therefore, I cannot directly answer your prompt using the provided text in the way you've framed it (e.g., ground truth, MRMC study, expert consensus, training/test set sample sizes, AI-human improvement, etc.), as these concepts are not applicable to the type of device and study described in this 510(k) summary.
The "performance data" section of this document is largely related to engineering and physical performance metrics, not clinical diagnostic or AI-driven performance metrics.
I can, however, extract the closest available information related to "acceptance criteria" and "study" from the provided text, interpreting them within the context of a laser device rather than an AI/ML diagnostic.
Here's the closest interpretation of the requested information based on the provided document:
Acceptance Criteria and Device Performance for Guardian 1000 (Laser Surgical Instrument)
The "acceptance criteria" for a laser surgical instrument are primarily defined by safety standards, electromagnetic compatibility, and the device's ability to perform its stated therapeutic function. The "study" in this context refers to the testing conducted to demonstrate compliance with these standards and functional claims.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with relevant electrical safety standards for medical devices. | "The system complies with the IEC 60601-1, IEC 60601-2-22 standards for safety." |
| Electromagnetic Compatibility (EMC) | Compliance with relevant EMC standards for medical devices. | "The system complies with the...IEC 60601-1-2 standard for EMC." |
| Software Functionality | Software verification and validation testing conducted according to FDA guidance. | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'." |
| Therapeutic Temperature Range (Topical Heating) | Ability to achieve and maintain a therapeutic temperature range for topical heating (for temporary relief of minor muscle/joint pain). Explicitly accepted range: 40-45 degrees Celsius. | "The Guardian 1000 device is capable of achieving therapeutic temperature range of 40 - 45 degrees centigrade as accepted by the FDA." |
| "An increase in topical heating of the tissue level by at least 5 degrees centigrade was reached within one (1) minute as demonstrated in the bench testing." | ||
| "The therapeutic temperature range was maintained for over 10 minutes testing time." | ||
| Minimum Temperature Increase (Topical Heating) | An increase in topical heating of the tissue level by at least 5 degrees Celsius within one minute. | "An increase in topical heating of the tissue level by at least 5 degrees centigrade was reached within one (1) minute as demonstrated in the bench testing." |
| Observed range: pre-exposure 31.8-34.3°C to during exposure 40.8-43.9°C. | ||
| Maintenance Duration (Topical Heating) | Ability to maintain the therapeutic temperature range for the recommended treatment time (10 minutes). | "The therapeutic temperature range was maintained for over 10 minutes testing time." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (for Topical Heating): 3 subjects.
- Data Provenance: The document does not specify country of origin for the subjects, but the manufacturer is based in Italy. The tests were "bench testing" and "measurements were conducted on 3 subjects," implying a prospective, controlled testing environment, not retrospective patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the type of testing described. Ground truth in this context is defined by physical measurements (e.g., temperature adherence to a specified range) against established scientific principles and FDA-accepted therapeutic ranges, not expert consensus on diagnostic imaging.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for expert consensus on subjective evaluations (e.g., image interpretation). The "ground truth" for the laser device's performance is objectively measured physical parameters (temperature, time).
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 would be relevant for devices that assist human readers in tasks like interpreting medical images (e.g., AI in radiology). The Guardian 1000 is a laser surgical instrument, not an interpretive diagnostic aid. Therefore, no effect size for human reader improvement with AI assistance is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This concept is not applicable as the device is a physical laser instrument, not an algorithm, and its performance is not "algorithm-only" or "human-in-the-loop" in the artificial intelligence sense. Its performance is the direct output of its physical operation.
7. The Type of Ground Truth Used
The "ground truth" for the performance of the Guardian 1000 laser device is based on objective physical measurements (e.g., temperature readings) compared against established medical and engineering standards (IEC standards for safety/EMC, and FDA-accepted therapeutic temperature ranges for topical heating) and bench testing demonstrations. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be.
8. The Sample Size for the Training Set
This information is not applicable. The Guardian 1000 is not described as an AI/Machine Learning device that undergoes a training phase with a "training set." Its functionality is based on known physical principles of laser operation and engineering design.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as there is no "training set" for this device in the context of AI/ML.
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