(101 days)
INTENDED USE
The device Litho including a fiber optic delivery system is intended to be used in surgical procedures such as open. laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.
INDICATIONS FOR USE
The device Litho including a fiber optic delivery system is indicated for use in surgical procedures such as open, laparoscopic and endoscopic, to perform incision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones in medical specialties including, but not limited to:
- Urology
- Gastroenterology
- Arthroscopy
- Neurosurgery
- Pulmonary
- Gynecology
- ENT
- Dermatology
- Plastic Surgery
- General Surgery
The modified device Litho is a Laser surgical instrument for use in general and plastic surgery and in dermatology (GEX). Both devices are Pulsed Holmium: YAG laser with a maximum output power of 30 W @ 2.1 um. The device Litho including a fiber optic delivery system is intended to surgical procedures such as open, laparoscopic, to perform incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and in Lithotripsy of stones.
The provided text is a 510(k) summary for the Quanta Litho device, which details modifications made to an already cleared laser surgical instrument. This document does NOT contain a study that proves the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device after minor modifications and an update to regulatory standards.
Therefore, many of the requested sections about acceptance criteria, device performance studies, sample sizes, expert involvement, and ground truth establishment cannot be answered from the provided text. The document states "There are no mandatory performance standards for this device," indicating a lack of explicitly defined performance-based acceptance criteria in the context of this submission.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Explicitly stated in document) | Reported Device Performance (as stated in document) |
|---|---|
| Update to IEC 60601-1 (third edition) and collateral standards for basic safety and essential performance | "All the modifications implemented until 2013 have been reevaluated following the requirements of third edition of IEC 60601-1 and to its collateral standards." |
| No change in fundamental scientific technology | "The modified device Litho share the same architecture and the same laser source of the unmodified device Litho: both devices are Pulsed Holmium:YAG laser with a maximum output power of 30 W @ 2.1 um, with no change in the fundamental scientific technology of the device." |
| Same intended use as unmodified device | "The modified device Litho has the same intended use of the unmodified device. Moreover the the intended use of the modified device, as described in its labeling, has not changed as a result of the modifications." |
| Same overall dimensions and external appearance | "The overall dimensions and external appearance of the modified device are the same as the unmodified device." |
| (Implicit) Maintenance of safety and effectiveness after modifications | "revision of risk analysis and specific verification and validation activities to demonstrate that modified device meet the new requirements." (Specific results of these activities not provided) |
Missing/Not Applicable from the document: Specific quantitative (e.g., accuracy, sensitivity, specificity, or surgical outcome metrics) acceptance criteria typically found in performance studies for new or significantly modified devices. This submission is for incremental changes and regulatory updates, not a new performance claim.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not mentioned. The document describes device modifications and regulatory updates, not a clinical or performance study involving a "test set" of data or patients. "Verification and validation activities" are mentioned, but no details on their methodology or sample size are provided.
3. 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 mentioned. No information about experts or ground truth establishment for a test set is present. The document mentions "physicians' feedbacks" for GUI changes and laser parameter combinations, but this is not related to establishing ground truth for a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not mentioned. There is no "test set" or adjudication method described.
5. 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 device is a laser surgical instrument, not an AI or diagnostic imaging device. Therefore, an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical laser surgical instrument. The concept of "standalone algorithm performance" is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not mentioned. As no performance study with a "test set" is described, no ground truth type is specified. The modifications relate to safety, electrical standards, and usability improvements, not clinical performance metrics requiring ground truth.
8. The sample size for the training set
- Not applicable / Not mentioned. There is no "training set" as this is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable / Not mentioned. Same as above, no training set or ground truth establishment for such a set.
§ 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.