(49 days)
The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, ablation, and coagulation of soft tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing.
The Dornier Scanner is for use as an accessory for the Dornier Medilas E Laser (K981438). It is indicated for use in medicine and surgery in the medical specialties as listed in the Indication for Use Statement for the Dornier Medilas E Laser System.
No new indications are being requested.
The Dornier Scanner handpiece is intended to be used in general and surgical procedures for incision / excision, vaporization, ablation, and coagulation of soft tissue and cartilage. The Dornier Scanner may also be used for skin resurfacing. The Dornier Scanner is for use as an accessory for the Dornier Medilas E Laser (K981438).
This looks like a 510(k) summary for a medical device submitted to the FDA, rather than a study report detailing acceptance criteria and performance data.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth, expert qualifications, and multi-reader multi-case studies cannot be extracted from the provided text.
The document states that the safety and effectiveness of the Dornier Scanner is based on "substantial equivalence" to predicate devices (Dornier VarioSpot 90 handpiece and Coherent's Computerized Pattern Generator). It does not describe a new study with explicit acceptance criteria and performance metrics for the Dornier Scanner itself.
Here's a breakdown of why the requested information is not present based on the provided text:
- Acceptance Criteria and Device Performance Table: Not provided. The document makes a claim of "substantial equivalence" rather than presenting specific performance metrics against pre-defined acceptance criteria.
- Sample Size and Data Provenance: Not applicable, as no new study is described where data was collected. The comparison is based on the characteristics of existing predicate devices.
- Number and Qualifications of Experts for Ground Truth: Not applicable. Ground truth typically refers to validated outcomes in a clinical study; since no such study for the Dornier Scanner is described, no experts were needed to establish ground truth.
- Adjudication Method: Not applicable for the same reasons as above.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned and not applicable. This type of study involves human readers interpreting data, often with AI assistance, which is not relevant to a laser handpiece accessory.
- Standalone Performance Study: Not mentioned and not applicable. "Standalone" performance usually refers to an algorithm's performance without human intervention, which again, is not relevant to a laser handpiece.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided text is a regulatory submission for premarket notification (510(k)) that focuses on demonstrating "substantial equivalence" of a new device (Dornier Scanner) to existing predicate devices, rather than presenting a detailed study report of the new device's performance against specific acceptance criteria.
§ 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.