(337 days)
The Monteris Medical AutoLITT System is indicated for use to necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy in medicine and surgery in the discipline of neurosurgery with 1064 nm lasers.
The Monteris Medical AutoLITT System is intended for planning and monitoring thermal therapies under MRI visualization. It provides MRI-based trajectory planning assistance for the stereotaxic placement of MRI compatible (conditional) AutoLITT Laser Delivery Probe. It also provides real-time thermographic analysis of selected MRI images.
When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the AutoLITT analysis.
The Monteris AutoLITT™ System is a combination of three major components: Monteris AutoLITT™ Laser Probe, Monteris AutoLITT™ Probe Driver, Monteris AutoLITT™ VizApp Software
The provided text describes a 510(k) premarket notification for the Monteris Medical AutoLITT™ System. However, it does not contain specific information regarding acceptance criteria, a detailed study proving the device meets said criteria, or most of the requested fields such as sample sizes, ground truth establishment, or expert qualifications for a test set.
The document primarily focuses on establishing substantial equivalence to predicate devices, providing a device description, intended use, and general summary of supporting data.
Here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
Note: The provided document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the format of a table. It only generally states: "Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling."
| Acceptance Criteria (Explicitly Stated) | Reported Device Performance (Explicitly Stated) |
|---|---|
| Not explicitly stated in quantitative terms. | "Bench testing has demonstrated that the System is in compliance with the medical community's expectations and the product labeling." |
| Compliance with ISO 10993 (Biocompatibility) | "Biocompatibility data demonstrates that the Laser Probe is in compliance with ISO 10993." |
| Ability to coagulate brain tissue under MRI guidance | "Animal testing demonstrated that the System, can be used to coagulate brain tissue under MRI guidance." |
Study Details
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not provided. The document mentions "Bench testing" and "Animal testing" but does not specify sample sizes or data provenance for a test set in the context of performance metrics for the software components (e.g., thermographic analysis).
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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 provided. The document states, "When interpreted by a trained physician, this System provides information that may be useful in the determination or assessment of thermal therapy. Patient management decisions should not be made solely on the basis of the AutoLITT analysis." This suggests human interpretation is critical, but details about ground truth establishment are missing.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not provided.
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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:
- Not provided. The document does not mention an MRMC study. The device provides "planning assistance" and "real-time thermographic analysis," implying human-in-the-loop use, but no comparative effectiveness study details are given.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not explicitly stated in terms of specific performance metrics. The device provides "thermographic analysis" and "planning assistance," but its intended use is "when interpreted by a trained physician," suggesting it's not designed for standalone diagnostic or therapeutic decisions.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly provided. For biocompatibility, lab testing based on ISO standards is the ground truth. For animal testing, the observation of "coagulated brain tissue" under MRI guidance serves as the ground truth. For the software components (planning assistance, thermographic analysis), the method for establishing ground truth for performance evaluation is not detailed.
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The sample size for the training set:
- Not provided. The document does not discuss a training set, which is typical for AI/ML device submissions, but this document predates widespread AI/ML regulatory guidance.
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How the ground truth for the training set was established:
- Not provided.
In summary, the provided 510(k) submission is for a device involving image guidance and thermal therapy, but it precedes the era of detailed performance studies for AI/ML components as requested in your prompt. The "Summary of Supporting Data" mainly covers biocompatibility, general bench testing, and animal testing to broadly assure safety and effectiveness, rather than specific performance metrics for the software-driven analysis components.
§ 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.