(24 days)
The Malleable Surgical Lightstic™ 180 is intended to be used as a surgical instrument for coagulation of soft tissue (including cardiac tissue) in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), in the contact or non-contact mode in both open or closed surgical procedures (with or without handpiece). Its intended use is identical to the current Surgical Lightstic™ 180 (K011988).
Coagulation of Cardiac Tissue
Malleable Surgical Lightstic™ 180
The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically associated with AI/medical device performance evaluation (e.g., sensitivity, specificity, accuracy, F1 score).
Instead, this document is a 510(k) summary for a Malleable Surgical Lightstic™ 180, a medical device that appears to be a surgical laser instrument accessory. The 510(k) process in the US FDA focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive performance studies against pre-defined acceptance criteria in the way AI algorithms are evaluated.
Therefore, most of the information requested in your prompt (sample size, experts, adjudication, MRMC study, standalone performance, training set details) is not applicable or not found in this type of regulatory submission. The summary explicitly states: "Performance Data: None required."
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Applicable | Not Applicable |
| (The 510(k) submission does not specify quantitative acceptance criteria for performance; instead, it focuses on demonstrating substantial equivalence to a predicate device.) | (The submission asserts substantial equivalence to the predicate device, implying similar safety and effectiveness without numerical performance metrics.) |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. The submission states "Performance Data: None required." The device is cleared based on substantial equivalence to a predicate device, not on a test set evaluation with specific performance metrics.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. No test set or ground truth establishment by experts is mentioned or required for this type of 510(k) submission.
4. Adjudication Method for the Test Set
- Not Applicable. No test set or adjudication process is mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study was not done, as indicated by "Performance Data: None required."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not Applicable. This is not an AI algorithm; it's a physical medical device (a surgical lightstic). Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.
7. The Type of Ground Truth Used
- Not Applicable. No "ground truth" in the context of diagnostic or interpretive performance data is mentioned or used. The basis for clearance is substantial equivalence to an already legally marketed device (K011988), which implies that its safety and effectiveness are established through that predicate.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical device, not an AI algorithm, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. There is no training set or AI algorithm involved.
Summary of Regulatory Approach:
The K013901 submission for the Malleable Surgical Lightstic™ 180 is based entirely on demonstrating substantial equivalence to an existing predicate device (Surgical Lightstic™ 180, K011988). The submitter, CardioFocus, Inc., explicitly states that the device is "identical to the current Surgical Lightstic 180 (K011988), and substantially equivalent for indications for use in cardiac tissue." They also claim "the minor differences... should not raise any concerns regarding the overall safety and effectiveness." Because of this substantial equivalence claim for a physical device, no primary performance data or clinical studies were required by the FDA for this particular clearance, as noted by "Performance Data: None required."
§ 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.