Search Results

The Rhapsody H-30 Holmium Laser System is intended for incision, resection, ablation, vaporization, coagulation, hemostasis of soft tissue, or stone fragmentation during open surgical, laparoscopic, percutaneous or endoscopic procedures in urologic, gynecologic, gastroenterological, or pulmonary applications.

The Rhapsody H-30 Holmium Laser System is an enclosed, transportable solid-state (i.e., Ho:YAG) laser source unit. The laser system unit produces a beam of coherent nearinfrared light (2100 nm wavelength) upon activation by depressing a footswitch pedal. The beam is directed to the treatment zone by means of a compatible optical delivery system, such as a holmium laser fiber. Components of the unit include a footswitch pedal and rotatable control panel. The system is a reusable, non-sterile device and is supplied in a wooden shipping crate.

Here's an analysis of the provided text regarding the Rhapsody H-30 Holmium Laser System's acceptance criteria and studies:

Based on the provided FDA 510(k) summary, the Rhapsody H-30 Holmium Laser System is a medical device, not an AI/ML-driven device. Therefore, many of the requested categories related to AI/ML software performance (e.g., sample sizes for test/training sets, expert consensus, MRMC studies, standalone algorithm performance) are not applicable or explicitly mentioned in this type of submission.

The acceptance criteria and study information provided primarily relate to the safety and essential performance of the physical laser system and its firmware, demonstrating substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated for each test. These are likely engineering and performance tests on the physical device, not statistical tests on patient data.
• Data Provenance: Not applicable in the context of patient data for a physical device. The tests were likely conducted by the manufacturer (Cook Incorporated) as part of their design verification and validation process.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable as this is a physical medical device, not an AI/ML diagnostic system requiring expert consensus on image interpretation or other data. The "ground truth" for these tests is defined by engineering standards and specifications (e.g., a specific power output, adherence to IEC 60601-1).

4. Adjudication method for the test set

• Not applicable. The tests involve objective measurements against predefined engineering specifications and regulatory standards.

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

• No. This is not an AI/ML device, so MRMC studies are not relevant. This device is a surgical laser system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is a physical medical device. The "firmware" mentioned (LCK 1.6) is embedded control software for the laser, not a standalone diagnostic or assistive algorithm. Its performance is integrated with the device's function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The "ground truth" for these performance tests is based on engineering specifications, manufacturing tolerances, and compliance with recognized international standards (e.g., IEC 60601-1 for electrical safety). For example, the laser's output energy is compared against its design specification (±10% of factory setting).

8. The sample size for the training set

• Not applicable. This is a physical device, and the "firmware" mentioned does not involve machine learning requiring training data.

9. How the ground truth for the training set was established

• Not applicable. (See #8).

Summary of the Study:

The studies performed for the Rhapsody H-30 Holmium Laser System were primarily engineering verification and validation tests. These tests were designed to ensure that the device met its design specifications and complied with relevant safety standards, demonstrating its reliability and performance. Key tests included:

• Firmware Verification and Validation: To confirm that the internal LCK 1.6 firmware operates as intended.
• Electrical Safety and Essential Performance Testing: To ensure compliance with IEC 60601-1, a critical standard for medical electrical equipment.
• Laser Output Performance and Endurance Testing: To verify the laser's output energy accuracy (within ±10% of factory settings) and its ability to operate for extended periods at maximum output (30 minutes at 2.5 J @ 12 Hz).

The conclusion was that all predetermined acceptance criteria were met, supporting that the device meets its design requirements and is substantially equivalent to its predicate device (H-30 Holmium Laser System, K130444) without raising new safety or effectiveness concerns.

Ask a specific question about this device