(181 days)
The PS System is intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures.
The PS System presents a clinically effective way to irrigate the entire canal space during root canal treatments. The PS System is a closed system negative pressure irrigation apparatus that draws fluid through the individually placed cannula toward the coronal chamber by way of evacuation that is controlled independently through the dental chair vacuum system, eliminating the risk of apical irrigant extrusion during root canal procedures. The PS System creates a closed system by establishing an air tight seal between the tooth and stage via a lightcurable barrier. The PS System is designed to accommodate the full range of tooth and root canal anatomy and is offered in three specific procedural kits based on the type of tooth to be treated: anterior, premolar, and molar.
The provided document is a 510(k) summary for the PS System, a dental device used for endodontic irrigation. It describes the device's function, comparison to a predicate device, and non-clinical and clinical performance data.
Based on the document, here's an analysis of the acceptance criteria and study information, addressing your points:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance metrics. Instead, it lists the types of performance tests conducted and then concludes based on the results. The key "acceptance criteria" appear to be:
- Ability to deliver and evacuate endodontic irrigation solutions.
- Performance akin to the predicate device (EndoVac System K140685).
- Reduction of apical extrusion risk compared to conventional positive pressure syringe irrigation.
- Safety and effectiveness equivalent to the predicate.
Reported Device Performance (based on the "Non-Clinical Performance Testing and Compliance" section):
The document states that the following performance tests were conducted as part of design verification:
- Suction Flow Rate Performance
- Critical Dimensions for Clinical Performance Analysis
- Corrosion Testing
- Simulated Canal Performance Testing
- Shelf Life Verification
- Biocompatibility Analysis
- Transit Testing
- Additive Manufacturing Summary Document
The conclusion states that based on "extensive comparative analysis and testing," the PS System is substantially equivalent to the predicate, and that differences "do not raise any new questions of safety and effectiveness." This implies the tests successfully demonstrated comparable performance and met the underlying safety and effectiveness expectations for such a device. However, specific quantitative performance metrics or pass/fail thresholds for these tests are NOT provided in this summary document.
2. Sample sizes used for the test set and the data provenance
The document is a 510(k) summary, which typically provides an overview rather than detailed study protocols. As such, the sample sizes for the non-clinical tests are not specified.
Data Provenance: The studies are described as "Non-Clinical Performance Testing." The document is submitted by Inter-Med, Inc. from Racine, WI, USA, suggesting the testing was likely conducted in the US or by a US-affiliated entity. The document doesn't specify if the data is retrospective or prospective, but as it's for design verification, it would inherently be prospective testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests performed are primarily engineering and material performance tests (e.g., suction flow rate, corrosion, biocompatibility, dimensions). These types of tests typically rely on established standards and laboratory measurements rather than expert human interpretation for "ground truth." Therefore, experts in establishing "ground truth" would not be relevant in the same way they would be for, say, an AI-based diagnostic device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used in clinical studies or studies involving human readers/interpreters, especially for AI or diagnostic devices where subjective interpretation is involved. Since this document focuses on non-clinical performance testing of a physical medical device, adjudication methods are not applicable and thus not mentioned.
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
No. The PS System is a dental handpiece/irrigation system, not an AI or diagnostic imaging device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an algorithm or AI device. It is a physical medical device for irrigation. Therefore, a standalone algorithm performance study is not applicable and was not performed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance tests mentioned (Suction Flow Rate, Critical Dimensions, Corrosion, Simulated Canal Performance, Shelf Life, Biocompatibility, Transit), the "ground truth" would be established by:
- Reference standards and measurements: For dimensions, flow rates, and physical properties.
- Standardized testing protocols: For corrosion, shelf life stability, and transit resilience.
- ISO standards and established biological assays: For biocompatibility (e.g., ISO 7405, ISO 10993-1).
There is no mention of expert consensus, pathology, or outcomes data being used for ground truth in this context, as they are not relevant to the types of tests described.
8. The sample size for the training set
The device is a physical medical device, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
As there is no "training set" (see point 8), this question is not applicable.
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.