(86 days)
The modified and the currently marketed Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAC/Nd:YAG) Surgical Lasers are intended for use in endoscopic holmium laser resection of the prostate (HoLRP) for tr ign prostatic hypertrophy (BPH).
The modified Coherent VersaPulse Select Single Wavelength (Ho:YAG) and Dual Wavelength (Ho:YAG/Nd:YAG) Surgical Lasers are comprised of the following main components:
- · a laser console
- · a fiber port (for delivery systems)
- · control and display panels
- · footswitch and handswitch delivery controls
- · a remote control unit
- · a variety of delivery device systems and accessories
Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on the use of the Coherent VersaPulse Select Surgical Lasers for endoscopic holmium laser resection of the prostate (HoLRP) for benign prostatic hypertrophy (BPH):
1. Table of Acceptance Criteria and Reported Device Performance
The provided document is a 510(k) summary for a modified medical device seeking substantial equivalence to predicate devices. As such, it doesn't explicitly state quantitative "acceptance criteria" in the way one might see for a completely novel device with performance targets. Instead, the primary acceptance criterion is substantial equivalence to previously cleared devices regarding safety and effectiveness for the specified indication.
Therefore, the table below reflects this by comparing the modified device's characteristics to those of its predicate devices, as discussed in the rationale for substantial equivalence and the conclusions. The "Reported Device Performance" here refers to the demonstrated similarity to the predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Modified Device vs. Predicate) |
|---|---|
| Indications for Use | Shares the same indications for use, specifically including endoscopic HoLRP for BPH. |
| Design Features | Shares same design features: control system, wavelengths (Ho:YAG, Ho:YAG/Nd:YAG), beam quality, laser configuration, active medium, cooling system, and controls and displays. |
| Functional Features | Shares similar functional features: power, repetition rate, energy, spot sizes, and treatment areas. |
| Safety and Effectiveness | Demonstrated safe and effective in clinical data for the HoLRP for BPH indication, similar to the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Clinical data was provided," but does not specify the number of patients or cases included in this clinical data for the modified device or for demonstrating equivalence.
- Data Provenance: Not explicitly stated regarding country of origin. The study appears to be clinical data provided for regulatory submission within the US, implying it likely originates from or is relevant to the US regulatory context. The study is retrospective, as it refers to "Clinical data was provided" for previously cleared devices being used to support the safety and effectiveness of the modified device. It doesn't describe a new prospective trial for the modified device itself to establish de novo safety/effectiveness.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the document. The study described focuses on demonstrating the safety and effectiveness of a surgical laser system, which typically involves clinical outcomes tracked by treating physicians rather than ground truth established by independent experts for diagnostic tasks.
4. Adjudication Method for the Test Set
This information is not applicable/provided. The clinical data likely details patient outcomes and procedural success, which would be assessed by the treating clinicians and researchers, not through an adjudication process with multiple readers as would be typical for image-based diagnostic AI.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. This type of study is relevant for diagnostic devices, particularly AI-powered ones, where the performance of human readers with and without AI assistance is compared. The device in question is a surgical laser, and the "study" referred to is clinical data supporting its safety and effectiveness for a surgical procedure.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone performance study was not done. This device is a surgical laser, an active medical device that requires a human operator for its function. It is not an algorithm that can operate independently.
7. The Type of Ground Truth Used
The "ground truth" for this type of device and study would be based on clinical outcomes data related to the safety and effectiveness of the HoLRP procedure using the laser. This would include, but not be limited to:
- Resolution of BPH symptoms
- Reduction in prostate size (if measured)
- Adverse events (e.g., bleeding, complications)
- Procedure success rates
These outcomes are observed and documented by treating clinicians.
8. The Sample Size for the Training Set
This information is not provided and is not applicable to this type of device. The device is a surgical laser, not an AI/ML algorithm that requires a "training set" in the computational sense. The "clinical data" described supports the safety and effectiveness, similar to how traditional medical devices are cleared.
9. How the Ground Truth for the Training Set was Established
This information is not provided and is not applicable for the same reasons as point 8.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.