(77 days)
The KSEA Endoscopes for Dental Procedures are designed to be used for examination of the operative site during endodontic procedures.
The Endoscopes for Dental procedures are indicated for use whenever magnification is desirable and/or access is restricted during dental, endodontic, and periodontic procedures.
The KSEA Endoscopes for Dental Procedures are manually operated surgical devices. The KSEA Endoscopes for Dental Procedures are rigid rod lens endoscopes. The body contact portions of the KSEA Endoscopes for Dental Procedures are composed of medical grade stainless steel.
The provided document is a 510(k) summary for Karl Storz Endoscopy - America, Inc.'s "Endoscopes for Dental Procedures," seeking clearance for a medical device. This type of document, particularly from 1998, focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies with detailed acceptance criteria and statistical analysis as would be expected for novel or higher-risk devices today.
Therefore, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is provided:
Explanation:
- Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This typically involves comparing technological characteristics, intended use, and performance data (often bench testing or limited clinical data if necessary to address specific performance differences). It does not usually require the kind of detailed, prospective clinical trials with predefined acceptance criteria and statistical power analysis that would be needed for a PMA (Premarket Approval) or for a novel device where no substantial equivalence can be claimed.
- Device Type: This device is an endoscope for dental procedures, described as "manually operated surgical devices" and "rigid rod lens endoscopes." These are well-established technologies, and significant new performance claims beyond those of predicate devices would be unusual.
- Date: The document is from 1998, an era when 510(k) submissions generally had less stringent requirements for detailed clinical performance data compared to current FDA guidelines, particularly for devices like endoscopes with established safety and effectiveness profiles.
Information from the document that does relate to the request (albeit indirectly, by absence):
- Table of acceptance criteria and reported device performance: This information is not present in the document. The document states: "The KSEA Endoscopes for Dental Procedures are substantially equivalent to the predicate devices since the basic features, design and intended uses are the same. The minor differences between the KSEA Endoscopes for Dental Procedures and the predicate devices raise no new issues of safety and effectiveness, as these design differences have no affect on the performance, function or intended use of the devices." This implies that the performance is considered equivalent to the predicate, and no new performance thresholds were established or tested.
- Sample size used for the test set and the data provenance: This information is not present. No specific test set or clinical study data is referenced. The submission relies on substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present. No test set or ground truth establishment is described.
- Adjudication method for the test set: This information is not present. No test set or adjudication process is described.
- 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: This information is not present. The device is a manually operated endoscope, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. The device is a manually operated endoscope, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present. No specific ground truth data is mentioned for performance evaluation.
- The sample size for the training set: This information is not present. The device is not an AI/ML algorithm that requires a training set.
- How the ground truth for the training set was established: This information is not present. The device is not an AI/ML algorithm that requires a training set.
In summary, the provided 510(k) summary demonstrates substantial equivalence by comparing the device's design, materials, and intended use to a predicate device, rather than by presenting a detailed performance study against specific acceptance criteria.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.