(287 days)
The SLT CL MD Laser Systems are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue. This device is specifically intended for use in prostate procedures which treat the clinical condition of Benign Prostatic Hyperplasia. This device is currently cleared for market for multiple surgical indications.
The specific indication for use of the SLT® Contact Laser™ Fiber Delivery System is for the Incision, Excision, Coagulation and Vaporization of soft tissue for prostatectomy in treatment of Benign Prostatic Hyperplasia (BPH).
Vaporization of Prostatic Tissue - The Contact Laser Vaporization of the Prostate (CLVP) procedure vaporizes prostate lobe tissue as well as tissue obstructing the urinary channel. This procedure is indicated for prostates up to 45 grams in size.
Coagulation and Vaporization of Prostatic Tissue - The Coagulation and Hemostatic Resection of the Prostate (CHRP)™ coagulates the prostate lobe tissue and vaporizes tissue obstructing the urinary channel. This procedure is indicated for prostates up to 75 grams.
The SLT CL MD Laser Systems are intended to be used in general surgery as well as multiple surgical specialties such as Urology, Gynecology, ENT, Head and Neck, Gastroenterology, Neurosurgery, Thorasic surgery, Pulmonology, Plastic surgery and Orthopedics. The fiber delivery systems achieve the precise tissue effects of incision, excision, vaporization and coagulation of tissue.
The provided text describes a 510(k) submission for the SLT CL MD Laser System. The submission aims to establish substantial equivalence for the use of this laser system in prostate procedures for Benign Prostatic Hyperplasia (BPH) by demonstrating its safety and effectiveness are equivalent to the traditional electrosurgical procedure (TURP).
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state quantitative acceptance criteria or device performance in the typical format of metrics like sensitivity, specificity, or accuracy. Instead, the acceptance is based on demonstrating substantial equivalence in safety and effectiveness to existing legally marketed predicate devices, specifically the "current Gold Standard Electrosurgical Procedure (TURP)" for BPH.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device compliance with relevant safety standards (UL 2601, IEC 601-1, IEC 601-2-22, etc.). Safety verified by Hazard analysis, software validation, and performance testing. | The safety of the laser system was assessed and cleared for market under prior 510(k)s (K854669, K884815, K912793, and K930490). This submission further establishes safety equivalence to TURP through clinical data. |
| Effectiveness: Achieve precise tissue effects of incision, excision, vaporization, and coagulation of tissue in general surgery and specific surgical specialties. | The device achieves the stated tissue effects. This submission specifically focuses on demonstrating effectiveness for BPH treatment (CLVP and CHRP procedures) equivalent to TURP. |
| Intended Use Equivalence: SLT CL MD Laser Systems intended use is as defined in prior clearances and is equivalent to other legally marketed predicate devices. | The device's intended use in general surgery and various specialties is already cleared. This submission focuses on demonstrating equivalence for BPH treatment. |
| Substantial Equivalence for BPH treatment: Clinical data demonstrates that the laser procedure for BPH is equivalent in safety and effectiveness to the traditional electrosurgical procedure (TURP). | CLVP Procedure: Vaporizes prostate lobe tissue and tissue obstructing the urinary channel for prostates up to 45 grams. CHRP Procedure: Coagulates prostate lobe tissue and vaporizes tissue obstructing the urinary channel for prostates up to 75 grams. These are presented as equivalent in safety and effectiveness to TURP. |
2. Sample Size Used for the Test Set and Data Provenance:
- The document states: "This submission will establish, based on clinical data, that the laser procedure for treatment of BPH is equivalent in safety and effectiveness to the traditional electrosurgical procedure."
- However, the sample size for the clinical data (test set) is not specified in this summary.
- The provenance of the data (country of origin, retrospective or prospective) is also not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- This information is not provided in the given text.
4. Adjudication Method for the Test Set:
- This information is not provided in the given text. The study describes a comparison to an established procedure (TURP), implying clinical outcomes would be the primary measure, rather than an expert consensus on individual cases in a traditional AI model evaluation.
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:
- The document describes a clinical study comparing a laser procedure to an electrosurgical procedure (TURP). This is a comparative effectiveness study, but it's not an MRMC study comparing human readers with and without AI assistance. The device is a surgical tool, not an AI diagnostic aid.
- Therefore, an MRMC study and effect size in human reader improvement with AI are not applicable in this context.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The device is a surgical laser system, intended for use by a surgeon. It is not an algorithm that performs autonomously.
- Therefore, a standalone algorithm-only performance assessment is not applicable.
7. The Type of Ground Truth Used:
- The ground truth in this context would be clinical outcomes data from patients treated with the laser procedure for BPH, compared against clinical outcomes data from patients treated with the traditional electrosurgical procedure (TURP).
- The effectiveness is assessed by the ability of the laser to achieve the intended tissue effects and clinical improvements in BPH patients, equivalent to TURP.
8. The Sample Size for the Training Set:
- This device is a surgical tool, not an AI model that relies on a "training set" in the machine learning sense. The concept of a training set is not applicable.
- The device's design, safety, and initial effectiveness were developed and tested through engineering principles, performance testing, and prior 510(k) clearances.
9. How the Ground Truth for the Training Set was Established:
- As the device is a surgical tool and not an AI model, the concept of "ground truth for the training set" is not applicable.
- The "ground truth" for the device's development and validation would stem from established medical and engineering principles, preclinical testing, and clinical experience/literature forming the basis for the predicate devices.
§ 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.