(134 days)
The Axxion Light Guide is intended to provide surgical site illumination from a high intensity light source.
The Axxion Light Guide is a bifurcated light guide that stems from a single cable and branches twice to terminate into four cables with illumination tips at each distal end. The end existing as a single cable contains a universal light source adapter that can be attached to a multitude of high intensity external light sources (ranging from 150 Watts to 300 Watts). Light provided from the external source is propagated through fiberoptic bundles contained by a jacket made of silicone sheathe. Fiberoptic bundles terminate at four stainless steel illumination tips that deliver light to the surgical site.
The provided text describes a 510(k) premarket notification for the Axxion™ Light Guide. It focuses on establishing substantial equivalence to predicate devices rather than reporting on a study or acceptance criteria for device performance. Therefore, most of the requested information cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be extracted. The document states that the Axxion Light Guide "was shown to be substantially equivalent in design, technical requirements, materials, and intended use to the following predicate devices." This indicates a comparison to existing devices rather than a presentation of specific performance acceptance criteria and test results for the Axxion Light Guide.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be extracted. No study details (sample size, data provenance) are provided for the Axxion Light Guide's performance.
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)
- Cannot be extracted. No information on ground truth establishment or expert involvement is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be extracted. No information on adjudication methods is present.
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
- Cannot be extracted. The device is a surgical light guide, not an AI-assisted diagnostic tool, so an MRMC study related to AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be extracted. The device is a physical light guide; thus, an "algorithm only" standalone performance is not relevant or described.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Cannot be extracted. No information on ground truth is present.
8. The sample size for the training set
- Cannot be extracted. No training set for a study is mentioned.
9. How the ground truth for the training set was established
- Cannot be extracted. No training set or ground truth establishment is mentioned.
Summary of available information:
- Premarket Notification Number: K082992
- Device Name: Axxion™ Light Guide
- Manufacturer: Spinal Elements, Inc. (Carlsbad, CA, USA)
- Date Prepared: October 3, 2008
- Device Description: A bifurcated fiberoptic light guide designed to provide surgical site illumination from an external high-intensity light source. It stems from a single cable, branches twice, and terminates into four cables with illumination tips.
- Intended Use: To provide surgical site illumination from a high intensity light source.
- Regulatory Class: II (Surgical Lamp, 21 CFR 878.4580)
- Predicate Devices:
- Basis for Clearance: Substantial equivalence to the listed predicate devices in design, technical requirements, materials, and intended use. The document implies that the device meets the necessary performance characteristics by being substantially equivalent to already approved devices. No specific performance study for the Axxion Light Guide itself is detailed in this 510(k) summary.
§ 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.