(281 days)
The Kogent™ Spetzler Lighted Suction Tubes are intended to provide surgical site illumination from a high intensity light source.
This device is a disposable Kogent™ Spetzler Lighted Suction Tubes, designed for single use in surgical procedures. Lighted Suction Tubes require connection with a suitable operating room suction system to deliver suction as well as with a suitable illumination machine. Lighted Suction Tubes are designed to provide illumination while having the ability to aspirate the surgical site. The devices are provided sterile by Ethylene Oxide and in sterile packaging.
The provided document is a 510(k) Pre-market Notification for a medical device called "The Kogent™ Spetzler Lighted Suction Tubes." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials.
Therefore, much of the information requested in your prompt regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, and training set details for AI/software devices cannot be found in this document, as it describes a physical surgical instrument, not an AI or software-based medical device.
However, I can extract the relevant information about the "acceptance criteria" as described in this 510(k) submission, which primarily revolves around demonstrating substantial equivalence through bench testing and comparison to a predicate device.
Here's the information that can be extracted, interpreted within the context of a 510(k) submission for a non-AI surgical device:
1. A table of acceptance criteria and the reported device performance
For a 510(k) submission for a physical device, "acceptance criteria" are generally evaluated by demonstrating that the new device is as safe and effective as a legally marketed predicate device. The performance is reported in terms of equivalence or similarity in key characteristics.
| Acceptance Criteria (Comparison to Predicate) | Reported Device Performance (Kogent™ Spetzler Lighted Suction Tubes) |
|---|---|
| Technological Characteristics: | |
| Indications for Use | Equivalent |
| Target Population | Equivalent |
| Design | Similar (Differences in tip configuration and handle design were evaluated and deemed not to affect safety or effectiveness.) |
| Materials | Equivalent |
| Performance | Equivalent |
| Sterility | Equivalent |
| Biocompatibility | Equivalent |
| Maximum Power Input | Equivalent |
| Energy Used and/or Delivered | Equivalent |
| Compatibility with Environment and Other Devices | Similar (Difference in connector type, but deemed not to affect safety or effectiveness.) |
| Where Used | Equivalent |
| Illumination Pattern | Equivalent |
| Illumination Intensity | Similar (Slightly higher for subject device, deemed not to impact safety or effectiveness.) |
| Max. Tip Temperature | Similar (Slightly lower for subject device, deemed not to impact safety or effectiveness, results in cooler tip and less risk of overheating.) |
| Compliance with Standards: | |
| IEC 60601-1 (Electrical Safety) | Satisfies testing requirements |
| ISO 10993 (Biocompatibility) | All biocompatibility testing results satisfied corresponding requirements |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions "Bench testing was performed on the Kogent™ Spetzler Lighted Suction Tubes to verify the design inputs." However, it does not specify the sample size (e.g., number of units tested). This is typical for engineering bench tests for this type of device, where specific product units are tested to confirm design specifications.
- Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Katalyst Surgical, LLC, which is based in Chesterfield, MO, USA. This is prospective testing conducted specifically for this submission.
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)
This question is not applicable to a 510(k) submission for a non-AI surgical instrument. The "ground truth" for a physical device's performance is established through objective engineering measurements and adherence to recognized standards, not by expert consensus on interpretations as would be the case for an AI diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in studies involving human interpretation or clinical outcomes, typically for AI or diagnostic devices. For this physical surgical device, performance is evaluated against engineering specifications and relevant standards.
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
Not applicable. An MRMC study is relevant for diagnostic or AI-assisted interpretation tasks. This document is for a basic surgical illumination and suction device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" (or basis for verification) in this context involves:
- Engineering specifications and measurements: Verifying design dimensions and characteristics.
- Industry Standards: Compliance with IEC 60601-1 (electrical safety) and ISO 10993 (biocompatibility).
- Direct comparison to a legally marketed predicate device: Demonstrating equivalence in performance and characteristics.
8. The sample size for the training set
Not applicable, as there is no "training set" for a physical surgical device in the way there is for an AI algorithm.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for this type of device.
§ 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.