(70 days)
The Thompson Surgical Instruments, Inc. Retractor Lite intended as a task light for surgical procedures. It is designed to be used in conjunction with a retractor blade which it can attach to through the use of TECASONTM P XRO clips. The Retractor Lite is designed to provide visible illumination of the surgical field or the patient through a Xenon light source only. The Retractor Lite is designed to be used by surgeons and other medical care practitioners in a surgical setting.
Thompson Surgical Instruments. Inc. Retractor Lite is a fiber optic surgical light designed to provide visible illumination of the surgical field or the patient. The Retractor Lite consists of a flexible "gooseneck" supported lighthead for easy positioning, a fiber optic bundle, and two molded clips made of TECASONTM P XRO used to attach the gooseneck portion of the light to a retractor blade. The Thompson surgical Retractor Lite is designed as a task light for surgical use.
This is a 510(k) summary for a surgical light, not a medical AI device, and therefore does not contain the detailed study information typically found in submissions for AI/ML-driven devices. As such, I cannot provide a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.
Here's why the requested information is not available in the provided text:
- Device Type: The "Retractor Lite" is a fiber optic surgical light, a traditional medical device, not an AI/ML-driven device. 510(k) submissions for such devices typically focus on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and intended use, rather than complex performance studies with acceptance criteria, ground truth, and expert evaluation as would be required for AI.
- 510(k) Summary Nature: A 510(k) summary is a brief overview, primarily concerned with establishing substantial equivalence to a legally marketed predicate device. It doesn't contain detailed study protocols, acceptance criteria, or performance metrics in the way an AI device submission (which might include clinical validation studies) would.
Information provided in the 510(k) summary:
- Acceptance criteria and reported device performance: Not explicitly stated as detailed performance criteria (e.g., sensitivity, specificity, AUC) for an AI device. The submission relies on demonstrating substantial equivalence to predicate surgical lamps, implying that if it functions similarly, it meets the required performance for its intended use.
- Sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information: These are all concepts relevant to the evaluation of AI/ML models. Since this is a traditional medical device (a surgical light), these types of studies and associated data are not part of its 510(k) submission. The FDA clearance is based on the device's design, materials, and intended use being substantially equivalent to existing, legally marketed surgical lamps.
§ 878.4580 Surgical lamp.
(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.