(45 days)
The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use: Ear, Nose and Throat and Oral Surgery, Arthroscopy, Gastroenterology, Orthopedics, General Surgery, Dermatology & Plastic Surgery, and Podiatry, GI/GU, Gynecology, Neurosurgery, Ophthalmology, Pulmonary Surgery, Cardiac Surgery, Thoracic Surgery, Urology, Dermatology/Aesthetics, Vascular Surgery.
The EPIC 10S system uses an Indium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC 10S laser is comprised of a base console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The Epic 10S delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.
The provided document is a 510(k) summary for the Biolase Epic 10S laser device. It explicitly states that no non-clinical or clinical test data was performed on this device for the purpose of this 510(k) submission.
Instead, the submission claims substantial equivalence to a legally marketed predicate device, the Diolase 10S (K121327), based on a comparison of technological characteristics and expanded Indications for Use. Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document.
The document indicates that the Epic 10S is substantially equivalent to the Diolase 10S for the stated indications.
Here's a breakdown of why the requested information cannot be provided based on the input:
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A table of acceptance criteria and the reported device performance, Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective), Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience), Adjudication method (e.g. 2+1, 3+1, none) for the test set, 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, If a standalone (i.e. algorithm only without human-in-the-loop performance) was done, The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The document states: "Non-clinical testing was not performed on this device since the purpose of this 510(k) is to only expand the Indications for Use from the original 510(k) clearance under 510(k) No.: K121286. All indications included in this 510(k) have already been cleared by the FDA for an equivalent medical device manufactured by Biolase Technology, Inc." (Page 8).
- It also states: "Clinical testing was not conducted on this device." (Page 8).
- Therefore, there is no performance data, test set, ground truth, or details on reader studies for this submission. The device is being cleared based on its similarity to a previously cleared device.
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The sample size for the training set, How the ground truth for the training set was established:
- Since no new clinical or non-clinical studies were conducted for this submission (as stated above), there is no training set mentioned or described within this document. The submission relies on the prior clearance of a predicate device.
In summary, the provided submission (K130465) relies on a claim of substantial equivalence to a predicate device (Diolase 10S, K121327) and did not involve new testing, clinical or non-clinical, to establish acceptance criteria or device performance.
§ 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.