(71 days)
The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures. Refer to the laser system Directions for Use manual for specific indications for Use.
The Diamond LaserKnife ™ is an accessory hand piece for CO2 laser systems, that consists of a diamond cutting blade and handle coupled to a flexible fiber guide cable that conducts CO2 laser energy to the blade tip. The laser energy is emitted from the facets at the blade tip to the tissue when the laser is energized.
The provided document is a 510(k) summary for the Diamond LaserKnife™, a laser scalpel, and does not contain a study that proves the device meets specific acceptance criteria in the manner of a clinical trial or performance study with detailed statistical outcomes.
Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Sapphire Laser Scalpel, K863086). The "Conclusions Drawn from Tests and Analysis" section indicates that the device's performance was evaluated through non-clinical tests.
Therefore, the following information is extracted from the provided text, and where specific details are not available, it is explicitly stated.
Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | The device must be indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures. | The Diamond LaserKnife™ is indicated for incision and/or excision, with or without cauterization/coagulation, of soft tissue in open dental, dermatology, general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, and urological procedures. Specific procedures are further detailed in Attachment 2 (e.g., incisional/excisional biopsies, removal of warts, hemorrhoidectomy, incision/excision of tumors/lesions/cysts, vascular lesions, etc.). |
| Technological Characteristics (Cutting Mechanism) | The device should cut tissue during surgical procedures and conduct laser energy to the tissue for cauterization and coagulation, similar to the predicate. | A crystal with sharpened edges is used as a scalpel to cut tissue during surgical procedures and also conducts laser energy to the tissue to cauterize and coagulate. |
| Laser Energy Emission and Tissue Reaction (Fluence) | The predicted energy levels at the point of application must meet criteria derived from the performance of similar devices, based upon fluence (energy per unit area) and reaction of tissue to discrete values of fluence. This implies the device must deliver laser energy effectively for incision/excision and cauterization/coagulation, comparable to existing cleared devices. | The predicted energy levels at the point of application meet criteria derived from performance of similar devices, based upon fluence (energy per unit area) and reaction of tissue to the discrete values of fluence. The "Non-Clinical Tests" description indicates that "laser energy fields emitted from the tip when the laser is energized compared to similar devices cleared for marketing in the past" were evaluated. |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This was a non-clinical evaluation comparing laser energy fields, not a study involving patient data or typical "test sets" for diagnostic or clinical performance.
- Data Provenance: Not applicable. The "study" involved analysis of laser energy fields from the device itself and comparison to characteristics of similar, previously cleared devices. It was not a retrospective or prospective study from a specific country of origin in terms of patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth, in a clinical or diagnostic sense, was not established since this was a non-clinical device characteristic comparison. The "ground truth" here would be the established performance characteristics (fluence, tissue reaction) of existing, cleared laser scalpels.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. This type of adjudication is not relevant for the non-clinical tests described.
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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. This is a laser scalpel, a surgical instrument; MRMC studies apply to diagnostic imaging, especially with AI assistance to human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a manual surgical instrument, not an AI algorithm. Its performance is inherent in its physical and energy delivery characteristics, used by a human surgeon.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for this substantial equivalence determination was the established and accepted performance characteristics of legally marketed predicate laser scalpels, specifically regarding laser energy emission (fluence) and its anticipated effects on tissue.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 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.