(76 days)
The Epic Pro 940 with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indication, incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingival; examples include: frenectomy, frenotomy, 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 940 with surgical laser operation, used in contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue.
The Epic Pro 940 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 940 diode laser system is a surgical device designated for a wide variety of surgical and oral soft-tissue procedures and dental whitening. Epic Pro 940 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 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 a medical device called "Epic Pro 940 Diode Laser System." It details the device's characteristics, indications for use, and a comparison to a predicate device ("Epic Pro"). The document focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving a new device meets acceptance criteria through a traditional clinical study with a test set, ground truth, and expert evaluation as would be done for an AI/ML-driven device.
Therefore, the following information regarding acceptance criteria, study design, and performance metrics for AI/ML devices is not available in this document:
- A table of acceptance criteria and reported device performance for an algorithm.
- Sample size used for a test set or data provenance for an algorithm.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- MRMC comparative effectiveness study results or effect sizes.
- Standalone (algorithm-only) performance results.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
Explanation Based on the Provided Document:
This 510(k) submission for the Epic Pro 940 Diode Laser System relies on demonstrating substantial equivalence to a predicate device (Epic Pro, K163128). The key change in the new device is the replacement of a 980nm diode laser module with a 940nm diode.
The document states:
"Epic Pro 940 is a modified version of Epic Pro (K163128). The change involved is limited to the replacement of the existing 980nm diode laser module, used in Epic Pro, with a 940nm diode in Epic Pro 940. Epic Pro 940 operates the same as the predicate device and the modification does not impact the intended use and indications for use."
Acceptance Criteria and Device Performance (in the context of substantial equivalence):
Instead of traditional "acceptance criteria" for a novel AI/ML algorithm's performance, the acceptance here is based on the new device performing as well as the legally marketed predicate device, and demonstrating that the change (wavelength) does not introduce new safety or efficacy concerns.
The "performance data" provided to support this claim focuses on:
- Biocompatibility Testing: Conducted according to ISO 10993-1. (Results "demonstrate biocompatibility").
- Electrical Safety and Electromagnetic Compatibility (EMC): Tested according to recognized standards (IEC 60601-1-2, IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60, IEC 62366-1, IEC 60601-1-6). The device "passed the required testing and is in full compliance with the standards."
- Software Verification and Validation: Performed according to IEC 62304 and FDA guidance.
- Bench Testing: "Ex-vivo animal tissue testing was performed to evaluate performance between the subject device and its predicate. The results demonstrate that Epic Pro 940 performs as well as the predicate device, Epic Pro."
- Clinical Testing: "Clinical testing was not performed for the subject device since the indications for use are the same as for the predicate device and the performance characteristics are equivalent."
Summary Table (Applying the prompt's structure to the available information):
| Criterion Type (AI/ML context) | Directly Addressed in Document (for substantial equivalence) | Reported Device Performance/Method |
|---|---|---|
| Acceptance Criteria | Functional Equivalence/Safety | Not explicitly defined as pass/fail thresholds for an algorithm, but rather compliance with safety standards and equivalent performance to predicate. |
| Device Performance | Safety, EMC, Usability, Bench Performance | Biocompatibility: Met ISO 10993-1. Electrical Safety/EMC: Passed all required IEC tests. Software: V&V done per IEC 62304 & FDA guidance. Bench Testing: Performed ex-vivo animal tissue comparison; "performs as well as the predicate device." |
| Test Set Sample Size | N/A (No traditional clinical test set for AI/ML performance) | Not applicable. Bench testing involved ex-vivo animal tissue, but sample size is not stated. |
| Data Provenance | N/A | Not applicable. Bench testing was ex-vivo. |
| Number of Experts | N/A | Not applicable. No ground truth experts for algorithm evaluation. |
| Experts Qualifications | N/A | Not applicable. |
| Adjudication Method | N/A | Not applicable. |
| MRMC Study | No | Not performed, as this is a physical device modification, not an AI assistance system. |
| Standalone Performance | N/A | Not applicable. This is not an algorithm-only device. |
| Type of Ground Truth | N/A | Not applicable. The "ground truth" here is the established safety and efficacy of the predicate device and compliance with engineering standards. |
| Training Set Sample Size | N/A | Not applicable. No AI model to train. |
| Training Set GT Establishment | N/A | Not applicable. |
In conclusion, this document is a 510(k) submission focused on demonstrating substantial equivalence of a modified laser device, not an AI/ML device that requires performance criteria based on a clinical test set with human expert consensus ground truth.
§ 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.