(62 days)
Root Canal Hard Tissue Indications (for use on adult and pediatric patients)
- Root canal preparation including enlargement
- Root canal debridement and cleaning
Root Canal Disinfection (for use on adult and pediatric patients) - Laser root canal disinfection after endodontic treatment
EdgePro is an erbium, chromium: yttrium, scandium, gallium garnet (Er,Cr: YSGG)solid-state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2780 nm. The laser system consists of a top-table console which houses the laser head, power supply, cooling system, micro-processor and a removable tablet PC as a control panel. A flexible fiber cable, connected to the laser console, delivers laser energy to the treatment site through a laser tip attached to a Handpiece. A visible light emitted from the Handpiece head illuminates the area. The laser is activated by means of a wireless footswitch. Various laser tips are available for different clinical applications. EdgePro utilizes advanced laser and water atomization technologies to cut, shave, contour, roughen, etch and resect oral hard tissues, and direct laser energy, with or without water for cooling and hydration, to perform oral soft tissue removal, incision, excision, ablation and coagulation as well as specific endodontic and periodontal applications.
This 510(k) summary for the Biolase EdgePro laser system does not include a detailed study proving the device meets specific acceptance criteria for its intended clinical use. Instead, it relies on substantial equivalence to a predicate device (Waterlase Express) and non-clinical performance data.
Here's a breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., specific success rates for root canal preparation or disinfection) nor does it report specific clinical performance metrics for the EdgePro. The "performance" described is largely comparative to the predicate device in terms of technical characteristics and safety standards.
However, based on the "Comparison of EdgePro to Waterlase Express" table (Table 1) and the performance data section, we can infer some qualitative "acceptance criteria" through equivalence:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility | Meets ISO 10993-1 via predicate device; materials are the same. |
| Electrical Safety | Meets IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60. |
| EMC | Meets IEC 60601-1-2. |
| Software Functionality | Performs according to specifications and intended functions; V&V conducted per FDA guidance. |
| Bench Performance (Technical Characteristics) | Performs "as well as" the predicate device (Waterlase Express) across parameters like wavelength, output mode, fluence per spot, and repetition rate. Deviations in max power output, max pulse energy, spot size, and pulse duration are deemed sufficient for effective root canal indications or for convenience only, thus maintaining substantial equivalence. |
| Clinical Effectiveness | Assumed to be equivalent to the predicate device because the indications for use are a subset and performance characteristics are considered equivalent. No new clinical data presented. |
2. Sample Size Used for the Test Set and Data Provenance
- Clinical Test Set: Not applicable. No clinical testing was performed for the EdgePro subject device. The device relies on equivalence to the predicate.
- Bench Testing: The document states "Testing was conducted to evaluate performance between the subject device and predicate device." However, it does not provide any details on the sample size (e.g., how many devices were tested, how many times each parameter was measured) or data provenance for this bench testing.
- Biocompatibility (for Predicate Device): Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No clinical test set with human subject data requiring expert ground truth establishment was conducted for the EdgePro in this submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test data was collected from human subjects for the EdgePro subject device.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states, "Clinical testing was not performed for the subject device since the indications for use are a subset of the predicate device and the performance characteristics are equivalent."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This device is not an AI/algorithm-only device. It is a laser surgical instrument. The software verification and validation would be considered a form of standalone performance assessment, but it's for the device's operational software, not an AI algorithm performing a diagnostic or prognostic task.
7. The Type of Ground Truth Used
- Biocompatibility: The ground truth would be accepted biological safety standards (e.g., ISO 10993-1) as demonstrated by laboratory tests for cytotoxicity, sensitization, intracutaneous reactivity, and systemic toxicity.
- Electrical Safety & EMC: Ground truth is defined by compliance with recognized international standards (IEC 60601 series).
- Software Verification & Validation: Ground truth is the device's functional specifications and FDA guidance for software in medical devices.
- Bench Testing: Ground truth is defined by the technical specifications of the device and comparative performance to the predicate device.
8. The Sample Size for the Training Set
Not applicable. This device is a medical laser, not a machine learning model, so there is no "training set" in the context of AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML model.
§ 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.