(90 days)
The Dornier Medilas E Laser is intended to be used in small and large joint arthroscopy, laparoscopic procedures, general and all surgical procedures for incision/excision, vaporization, ablation, and coagulation of soft tissue and cartilage. All soft tissues encountered in all surgical procedures are included in this indication such as, skin, cutaneous tissue, subcutaneous tissue, straited and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Dornier Medilas E may also be used for skin resurfacing.
The Dornier Medilas E is indicated for use in medicine and surgery, in the following medical specialties:
- Dermatology
- Plastic Surgery
- General Surgery
- Urology
- Gynecology
- Pulmonary Surgery
- Gastroenterology
- ENT
- Thoracic Surgery
- Oral & Maxillofacial Surgery
- Ophthalmology
- Podiatry
Not Found
The provided document is a 510(k) Summary for the Dornier Medilas E Laser, dated July 20, 1998. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through clinical studies in the way a new medical algorithm would.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document. The 510(k) process for this device focused on technological characteristics and intended use in comparison to existing, legally marketed lasers.
Instead of a table of acceptance criteria and reported performance, the document states:
"The safety and effectiveness of the Dornier Medilas E Laser is based upon a determination of the substantial equivalence as well as the safety and effectiveness of its predicate devices which includes the following: Schwartz Electro-Optics, Inc. CRL 2940 Erbium CR Laser (K9971404 / K974039); Sharplan Model 4020 Erbium YAG Laser (K971648)."
And further:
"From a clinical perspective and comparing design specifications, the Dornier Medilas E laser and the predicate devices are substantially equivalent and have the same intended use. Based on the technological characteristics and overall performance of the devices, Dornier Surgical Products, Inc. believes that no significant differences exist between the Dornier Medilas E and the predicate devices, SEO CRL 2940 Erbium CrystaLase and the Sharplan Model 4020 Erbium YAG laser."
Summary of unavailable information from the provided text:
- A table of acceptance criteria and the reported device performance: Not applicable/not provided. The document focuses on substantial equivalence based on technological characteristics and intended use, not on specific performance metrics or acceptance criteria for a novel device.
- Sample sized used for the test set and the data provenance: Not applicable/not provided. There is no mention of a test set or data from a clinical study to assess performance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable/not provided.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not provided.
- 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: Not applicable/not provided. This device is a laser, not an AI-powered diagnostic tool, so MRMC studies are irrelevant to its evaluation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/not provided. This is a physical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/not provided.
- The sample size for the training set: Not applicable/not provided.
- How the ground truth for the training set was established: Not applicable/not provided.
The document is a regulatory submission demonstrating substantial equivalence of a physical medical device (a laser) to existing predicate devices, rather than a clinical study report for an algorithm or a device requiring specific performance metrics against 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.