(30 days)
Ablation, incision, excision, coagulation and vaporisation of soft tissues in the following open and endoscopic surgical procedures: General Surgery, Ophthalmology/Oculoplastic, Urology, Gastroenterology, Gynecology, Otorhinolaryngology, Pulmonary/Thoracic, Dermatology/Plastic Surgery, Neurosurgery (coagulation only), Orthopedic
The Diomed Delta 25 Laser consists of a Class IV InGaAs/A1GaAs laser diode with a wavelength of 1064nm ± 20 nm and a visible laser (aiming beam) of 5 milliwatt Class IIIa diode laser with a wavelength of 635 - 655 nm. The Diomed Delta 25 is a diode laser capable of delivering up to 25 W of continuous wave or pulsed radiation via an optical fiber coupled to the laser aperture.
The provided document is a 510(k) summary for the Diomed Delta 25 Laser, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed clinical study with acceptance criteria and device performance metrics. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not explicitly available in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states that "The Diomed Delta 25 laser has undergone a comprehensive series of test protocols in order to qualify and validate the performance of the device." It then concludes, "The results of the qualification/validation demonstrates equivalent performance to the predicate devices which themselves have substantial clinical and market evidence of acceptable performance."
It does not provide specific quantitative acceptance criteria or detailed reported device performance metrics. This type of 510(k) summary typically relies on demonstrating that the new device performs as well as or similarly to existing legally marketed devices, rather than establishing new performance benchmarks.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative thresholds for the Diomed Delta 25. The general criterion is "equivalent performance to the predicate devices." | Equivalent performance to the Diomed Delta 15 and Diomed Delta 30 (K051996) for technological performance, and to Adept 1064 Laser (K032218), Sciton Inc. Profile 1064 Laser System (K023881), Laserscope Lyra Surgical laser System (K020021), and Spectrum Veinlase (K981952) for laser wavelength performance. The document implies that this equivalence was demonstrated through "comprehensive series of test protocols." This suggests that the device met the performance characteristics (e.g., power output, wavelength stability, safety features) expected for this type of laser system, mirroring those of the predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify a sample size for a test set in the context of a clinical study or a dataset for AI. This is a medical device approval based on substantial equivalence, which primarily involves comparing technical specifications and safety aspects to existing cleared devices. The "test protocols" mentioned likely refer to engineering and functional testing of the laser itself, not a clinical trial with human subjects or a dataset for AI.
Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable here as no such data is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable as the document describes a physical medical device (laser instrument) and its technical equivalence, not an AI device requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set:
This information is not applicable for the same reasons as above.
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 is typically performed for diagnostic or AI-assisted devices to assess human reader performance with and without the device. The Diomed Delta 25 Laser is a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone evaluation was not done. This concept is only relevant for AI algorithms. The Diomed Delta 25 is a physical laser device.
7. The Type of Ground Truth Used:
This information is not applicable as the clearance is for a physical laser surgical instrument, not an AI device. The "ground truth" for this device would be its ability to safely and effectively produce laser energy within specified parameters, as demonstrated through engineering and safety testing.
8. The Sample Size for the Training Set:
This information is not applicable as the Diomed Delta 25 Laser is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the same reasons as above.
In summary, the provided document is a 510(k) summary for a traditional medical device (a surgical laser) seeking clearance based on substantial equivalence. It does not contain the detailed information about acceptance criteria, study design, and ground truth establishment that would be present for an AI/ML-based device. The "study" mentioned refers to the "comprehensive series of test protocols" to ensure the device's performance is equivalent to predicate devices, focusing on technical specifications and safety rather than clinical endpoints established through a patient study.
§ 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.