(248 days)
K2 mobile laser is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows:
Endodontic procedures: Pulpotomy, Root canal therapy
Periodontal procedures: Sulcular debridement
Implant procedures: Implant recovery
Surgery procedures:
Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy, Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty
Other procedures:
Gingival troughing, Hemostasis and coagulation, Leukoplakia,
Treatment of aphthous-ulcer canker sores and herpetic,
Laser Assisted whitening,
Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor muscular back pain; the temporary increase in local blood circulation; the temporary relation of muscle
The dental diode laser (Model: K2 MOBILE) is a surgical device designed for a wide variety of dental soft tissue procedures. Diode laser is used as a source of invisible infrared radiation for this device and delivered to the treatment area through optical fiber is incorporated into a tip. The dental diode laser (Model: K2 MOBILE) is handpiece type using an internal rechargeable battery. The rechargeable battery charger are provided.
The provided text describes the K2 Mobile, a dental diode laser, and establishes its substantial equivalence to predicate devices (Photon Plus and iLaseTM) based on various performance and safety criteria. However, it does not include a table of acceptance criteria and reported device performance in terms of clinical accuracy metrics (e.g., sensitivity, specificity, AUC) or human reader performance with/without AI assistance. The document focuses on showing that the K2 Mobile meets safety and electrical standards and shares similar technical specifications and intended use with the predicate devices. Therefore, much of the requested information cannot be extracted directly from this document.
Here's a breakdown of what can be inferred and what is not available:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the context of clinical performance metrics, nor does it report specific clinical performance values for the K2 Mobile. Instead, equivalence is established by demonstrating that the device meets recognized safety and performance standards (like IEC 60825-1, IEC 60601-1, IEC 60601-2-22, 21CFR1040.10, 21CFR1040.11, IEC 62133, IEC 60601-1-2), and that its specifications fall within acceptable ranges compared to the predicate devices.
Table of Technical Specifications and Comparison for Substantial Equivalence:
| Feature | Acceptance Criteria (Predicate) | K2 Mobile Reported Performance | Comparison |
|---|---|---|---|
| Product Code | GEX | GEX | Same |
| Regulatory Class | 2 | 2 | Same |
| Indications for Use | Similar indications to PD1 (Photon Plus) and PD2 (iLaseTM), covering various oral soft tissue procedures, tooth whitening, and pain relief. | Similar to predicate devices, included in PD1's indications. | Equivalent |
| Principle of Operation | Laser diode as source of invisible infrared radiation delivered via optical fiber. | Same | Same |
| Laser Medium | Diode Laser | Diode Laser | Same |
| Laser Classification | Class IV (4) Laser | Class IV (4) Laser | Same |
| Laser Wavelength | 980nm (PD1), 940nm (PD2) | 980nm | Same as PD1 |
| Laser Power Range | 0-10W (PD1), 0-5W (PD2) | 0-6W (max 3.5W CW, max 6.0W pulsed) | Equivalent (within PD1 range, similar to PD2) |
| Operation Mode | Continuous (CW), Pulse mode | Continuous (CW) mode, Pulse mode | Same |
| Pulse Width/Interval | 0.1ms to 9.9s (PD1) | On/off time: 50ms (Pulse mode 1), 5ms (Pulse mode 2) | Equivalent (within PD1 range) |
| Pulse Repetition Rate | 1Hz to 5,000Hz (PD1) | 10Hz (Pulse mode 1), 100Hz (Pulse mode 2) | Different (but deemed safe/effective after testing) |
| Aiming Beam | 650nm, 2mW (PD1); 635nm, 5mW (PD2) | 635nm, 5mW | Same as PD2 |
| Fiber Core Diameter | 400 μm | 400 μm | Same |
| Power Input | Rechargeable Li-polymer 7.4V, 5A (PD1); Rechargeable Li-ion 3.6V, 650mA (PD2) | Rechargeable Li-ion 3.7V, 1700mA | Different (but deemed safe/effective after testing) |
| Prescription/OTC | Prescription | Prescription | Same |
| Intended User | Licensed practitioner | Licensed practitioner | Same |
| Safety and Performance | Compliance with specified IEC/CFR standards | Tested per IEC 60825-1, IEC 60601-1, IEC 60601-2-22, 21CFR1040.10, 21CFR1040.11, IEC 62133, IEC 60601-1-2 | Compliant |
| Biocompatibility | Compliance with ISO 10993 series | Tested per ISO 10993-1, -5, -10, -11, -4 | Compliant |
| Reprocessing | Compliance with FDA reprocessing guidance | Validated reprocessing process found effective | Compliant |
Study Information (as extractable from the provided text):
-
Sample size used for the test set and the data provenance:
- The document describes non-clinical performance testing (laser performance, output power, electrical safety, EMC, biocompatibility, reprocessing). It does not mention a "test set" in the context of clinical data for algorithmic performance.
- Data Provenance: Not applicable as no clinical trial or algorithm evaluation data is provided. The tests appear to be laboratory-based and engineering compliance tests.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here is defined by engineering and safety standards, not clinical expert consensus on diagnostic or treatment outcomes.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept applies to clinical studies where expert consensus is needed to establish a ground truth for a diagnostic outcome.
-
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:
- No. The document describes a medical device (laser surgical instrument), not an AI/CADe (Computer-Assisted Detection) or CADx (Computer-Assisted Diagnosis) device. Therefore, MRMC studies are not relevant in this context.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/algorithm-based device.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance and safety tests, the "ground truth" is adherence to established international and national standards (e.g., IEC 60825-1, IEC 60601-1, 21CFR1040.10, ISO 10993 series) and the specifications of predicate devices.
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning product and therefore does not have a "training set."
-
How the ground truth for the training set was established:
- Not applicable.
§ 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.