VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM

• K Number: K070296
• Device Name: VISIOLITE OPHTHALMIC ER: YAG LASER SYSTEM
• Manufacturer: ACE VISION GROUP
• Date Cleared: 2007-10-03 ( 245 days)
• Product Code: GEX
• Regulation Number: 878.4810
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: K052354 , K971843
• Predicate For: N/A

Intended Use

The VisioLite® is indicated for the ophthalmic soft tissue surrounding the eye and orbit.

Device Description

The VisioLite® Ophthalmic Er: Y AG Laser System creates a laser beam with a wavelength of 2940nm, which is highly absorbed by water, collagen and hydroxy apatite and therefore causes rapid vaporization, or ablation, in both hard and soft biological tissues. Because the absorption is highly efficient, tissue removal is very precise with virtually no collateral thermal damage.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.

Instead, the document is a 510(k) summary for the VisioLite® Ophthalmic Er:YAG Laser System, focusing on its substantial equivalence to predicate devices and outlining technical characteristics.

Here's a breakdown of what is mentioned regarding safety and effectiveness, which are the closest equivalents to "acceptance criteria" in this context:

• Acceptance Criteria (implicit for GEX product code and Class II device): The device is substantially equivalent to legally marketed predicate devices. This implies that the device must meet the safety and effectiveness standards of its predicates.

  • Predicate Devices: Oculase MD from Biolase Technology Inc (K052354) and Laserscope Vela Erbium: YAG laser system (K971843).
  • Specific Criteria Met:
    • Electrical safety testing
    • Laser safety testing
    • Electromagnetic compatibility testing
    • Compliance with applicable requirements of CFR 1040 (likely related to laser product performance standards).
    • Compliance with general controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).

• Study Proving Acceptance Criteria: The document states:

  • "There are no substantial differences between the VisioLite® Ophthalmic Er: Y AG Laser System defined in this 510(k) submission and the predicate devices."
  • "The VisioLite® Ophthalmic Er:YAG Laser System included electrical safety testing, laser safety testing and electromagnetic compatibility testing."
  • "The VisioLite® Ophthalmic Er:YAG Laser System meets the applicable requirements of CFR 1040."

Therefore, I cannot provide the detailed information requested in your bullet points because the provided text describes a regulatory submission for substantial equivalence rather than a performance study with detailed acceptance criteria for metrics like sensitivity or specificity.

The document does not include:

1. A table of acceptance criteria and reported device performance beyond general safety and regulatory compliance.
2. Sample size for a test set or data provenance regarding clinical performance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method for a test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of human readers with/without AI assistance.
6. Standalone performance details (as it's a laser system, not an AI diagnostic tool).
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a clinical performance study.
8. Sample size for a training set (as this is not an AI/ML device that requires a training set in the typical sense).
9. How ground truth for a training set was established.

Regulation Number and Section

§ 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.