(74 days)
The Air Controlled Sterile Irrigation System is used intra-orally by trained dental professionals for delivery of sterile water for oral surgical procedures as a replacement irrigating solution to the dental operative unit's water supply, specifically for cooling a dental rotary instrument.
The StarDental® Air Controlled Sterile Irrigation System is used intra-orally by trained dental professionals for delivery of sterile water for oral surgical procedures as a replacement irrigating solution to the dental operative unit's water supply, specifically for cooling a dental rotary instrument. The Air Controlled Sterile Irrigation System consists of a connector assembly and pinch valve assembly which can be autoclaved.
This looks like a 510(k) summary for a medical device called the "StarDental® aXcs Sterile Water System," also referred to as the "StarDental® Air Controlled Sterile Irrigation System." This document is a regulatory submission to the FDA, not a study report. It focuses on demonstrating substantial equivalence to existing devices, not on providing performance data or clinical study results in the way you've described for AI/algorithm performance.
Therefore, most of the information you've requested regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this type of regulatory submission. These elements are typically found in clinical trial reports or validation studies for new technologies, especially those involving AI or complex performance claims.
Here's a breakdown of why the information isn't available and what is available:
This document:
- Is a 510(k) Summary: This is a premarket notification to the FDA to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This process often relies on comparisons of design, materials, intended use, and operational principles, rather than extensive clinical performance studies.
- Focuses on "Substantial Equivalence": The core argument is that the new device is as safe and effective as predicate devices that are already on the market.
- Describes Device Purpose: It clearly states the device's intended use: "delivery of sterile water for oral surgical procedures, specifically for cooling a dental rotary instrument."
Why your requested information is largely absent:
- No Acceptance Criteria Table or Reported Device Performance: This document doesn't typically include specific performance metrics or thresholds the device must meet, nor does it report on a study directly measuring those metrics. Substantial equivalence is often argued based on design similarity and known performance of predicate devices.
- No Sample Sizes, Data Provenance, Expert Ground Truth, Adjudication, MRMC, Standalone Performance: These are all hallmarks of a clinical study or a performance validation for an AI/algorithm-driven device. This irrigation system is a mechanical device, not an AI system. Therefore, these types of studies were not conducted or reported here.
- No Information on Training Set Size or Ground Truth Establishment (for training): Again, this is not an AI/algorithm device, so there is no "training set."
What can be inferred or extracted from the document related to "performance" in a broad sense:
While not formal acceptance criteria as you'd find for AI, the document implies that the device must:
- Deliver sterile water: This is fundamental to its intended use in oral surgical procedures. The design aims to maintain sterility.
- Be air-controlled: This describes its mechanism of operation.
- Be safe and effective for cooling dental rotary instruments: This is the ultimate goal of the sterile water delivery.
- Meet general controls provisions: These are FDA requirements for medical devices (registration, listing, GMP, labeling, etc.) which implicitly ensure a baseline of safety and effectiveness.
In summary, based solely on the provided text, I cannot provide most of the requested information because it describes a regulatory filing for a mechanical device demonstrating substantial equivalence, not a performance study for an AI or complex diagnostic system.
If this were an AI device, the 510(k) summary would typically refer to a separate validation report where these details would be found.
§ 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.