(64 days)
The Epic Pro with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indications incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva); examples include: frenectomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectorny, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
The Epic Pro with surgical laser operation, used in contact or non-contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue.
The Epic Pro with dental laser operation is intended for incision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal gingiva and epithelial lining of free gingiva); examples include: frenectomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.
Epic Pro diode laser system is a surgical device designed for a wide variety of surgical and oral soft tissue procedures and dental whitening.
Epic Pro utilizes a solid state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via a flexible fiber connected at one end to the laser source and at the other end to the handpiece. Various types of single use disposable tips are designed and optimized for different applications. The device is activated by means of a wireless footswitch.
The provided text is a 510(k) Summary for the Biolase Epic Pro diode laser system. It outlines the device's technical specifications, its comparison to a predicate device (stLase, K111689), and the performance data submitted to support its substantial equivalence.
Here's an analysis to extract the requested information, noting that some details related to a "study proving acceptance criteria" (especially for AI/ML devices) are not applicable as this document describes a laser surgical instrument, not an AI/ML diagnostic tool.
1. Table of Acceptance Criteria and Reported Device Performance
For this device (a laser surgical instrument), "acceptance criteria" and "device performance" are typically related to meeting established safety and performance standards for medical devices, rather than accuracy metrics for an AI algorithm.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-1 (Biological Evaluation of Medical Devices) | The battery of testing (cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity) demonstrated biocompatibility of the device and its accessories. |
| Electrical Safety & Electromagnetic Compatibility (EMC): | |
| IEC 60601-1-2 (Medical electrical equipment - EMC) | Device passed all required testing and is in compliance with the listed standards. |
| IEC 60601-1 (Medical electrical equipment - General requirements) | |
| IEC 60601-2-22 (Laser equipment - Particular requirements) | |
| IEC 60825-1 (Safety of Laser Products) | |
| IEC 80601-2-60 (Dental equipment - Particular requirements) | |
| IEC 62366-1 (Usability Engineering) | |
| IEC 60601-1-6 (Usability - Collateral standard) | |
| Software Verification & Validation: | |
| FDA's Guidance for Software Contained in Medical Devices | The results demonstrate that Epic Pro performs according to specifications and functions as intended. |
| Bench Testing (Functional Equivalence): | |
| Functional performance equivalent to predicate device (stLase) | In-vitro testing on soft tissue demonstrated that Epic Pro performs as well as the predicate device, stLase. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Description: The "test set" in this context refers to samples used for bench testing of physical device performance, as clinical testing was not performed due to substantial equivalence claims.
- Sample Size: Not specified quantitatively. The document states "In-vitro testing was conducted on soft tissue." The number of samples of soft tissue is not provided.
- Data Provenance: Not explicitly stated, but "In-vitro testing" implies lab-based testing. It's not human patient data, so country of origin is less relevant than for clinical trials. It is retrospective in the sense that it's testing a completed device against a predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Not Applicable. As a laser surgical instrument, the assessment relies on engineering and biological testing against established standards and comparison to a predicate device, not on expert consensus for interpreting diagnostic images or clinical outcomes in the way an AI/ML diagnostic tool would.
4. Adjudication Method for the Test Set
- Not Applicable. See point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not Applicable. This is not an AI/ML diagnostic device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
- Not Applicable. This is a physical medical device, not an algorithm, so the concept of "standalone performance" in this context is not relevant. The device operates as a tool used by a human practitioner.
7. Type of Ground Truth Used
- For Biocompatibility: Standardized biological assays according to ISO 10993-1.
- For Electrical Safety/EMC: Compliance with parameters defined in the listed IEC standards.
- For Software: Verification against software specifications and intended functions.
- For Bench Testing: Comparison of functional performance on in-vitro soft tissue against the performance of a predicate device (stLase) on similar materials. This represents a "functional ground truth" based on established laser principles and predicate device performance.
8. Sample Size for the Training Set
- Not Applicable. As this is a non-AI/ML device, there is no "training set" in the context of machine learning. The device is designed and tested through traditional engineering and material science methods.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See 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.