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The Pelton & Crane P50 series Dental Operative Units and Accessories are intended to supply power to and serve as a base for other dental devices and accessories by providing air, water, vacuum and low voltage electrical power to dental instruments and dental handpieces. The Pelton & Crane P50 series Dental Operative Units and Accessories are designed for use by a trained professional in the field of dentistry.

The P50 series Dental Operative Unit and Accessories serves as a base that includes components to deliver air, water, electrical power, and vacuum to dental handpieces, instruments, and accessories. The controls are contained in a Doctor's Unit, an Assistant's Unit, and a Cuspidor. Additional parts include mount arms, patient dental chair, foot control, and a junction box that houses a power supply and air/water regulators. The unit may also include a dental operating light and a monitor. Various handpieces, instruments, and accessories can be added to the P50 series Dental Operative Unit which Pelton & Crane does not manufacture but does provide a means to connect them to the P50 series Dental Operative Units. These include, but not limited to, pneumatic handpieces, electric motors with handpieces, scalers, intra-oral cameras, curing lights, air/water syringes, SE and HVE vacuum instruments. Water quality is maintained automatically by the preprogramed cleaning functions for the water lines, cuspidor spouts, and instrument hoses including motors and syringes. Instructions are provided for waterline treatment and suction cleaning agents. Water supply is available by either the municipal water supply or a self-contained water bottle.

The retrieved document is a 510(k) Pre-Market Notification for the Pelton & Crane P50 series Dental Operative Unit and Accessories. This notification focuses on demonstrating substantial equivalence to a predicate device rather than providing a study proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not applicable or available in this type of submission.

However, I can extract the relevant information that is present:

1. A table of acceptance criteria and the reported device performance

The document does not present specific acceptance criteria in the form of a table with numerical thresholds for performance metrics. Instead, it provides a comparison table (Table 5.3) outlining technological characteristics between the proposed device (P50 series Dental Operative Unit and Accessories) and the predicate device (ESTETICA Dental Treatment Unit and Accessories, K161488). The document states that "The performance testing results provided in this submission supports that the proposed device performs as well as the predicate devices for its intended use" and that "Hence, the device is deemed to be substantially equivalent to the ESTETICA Dental Treatment Unit and Accessories (K161488)."

Here is a summary of the comparative characteristics, serving as the basis for "performance" as described in this 510(k) submission:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The submission relies on "Non-Clinical Test Data" to demonstrate substantial equivalence, which primarily involves performance bench testing against international standards and comparative performance testing of integrated accessories versus cleared stand-alone devices. There is no mention of a traditional "test set" in the context of clinical data for performance evaluation.

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 is not applicable as there was no clinical test set requiring ground truth establishment by experts for a specific performance metric.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as there was no clinical test set requiring adjudication.

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

This is not applicable. The device is a "Dental Operative Unit and Accessories" and is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers. Its primary function is to provide power, air, water, and vacuum for other dental instruments.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical dental unit, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical performance testing, the "ground truth" was adherence to established international standards (e.g., AAMI ES60601-1, IEC 60601-1-2, ISO 10993-1, etc.) and comparative performance to cleared stand-alone predicate devices for integrated accessories. Specific outcomes data or expert consensus on clinical findings are not mentioned as "ground truth" in this context.

8. The sample size for the training set

This is not applicable as this is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established

This is not applicable as this is not an AI/ML device requiring a training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-Clinical Test Data" and primarily involves:

• Performance bench testing: Conducted according to international standards for dental operative units to determine conformance in regards to basic safety and essential performance. Relevant standards cited include:
  • AAMI ES60601-1:2005 +AC1; A2
  • IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007)
  • IEC 60601-1-2 Edition 3: 2007-03 (EMC)
  • IEC 80601-2-60 Edition 1.0 2012-02 (Dental equipment specific)
  • ISO 9168 Third edition 2009-07-15 (Hose connectors)
  • ISO 14457 First edition 2012-09-15 (Handpieces and motors)
  • ISO 7494-2 Second edition 2015-04-01 (Air, water, suction)
  • ISO 7494-1 Second edition 2011-08-15 (General requirements)
• Biocompatibility testing: Completed for applicable components, referencing ISO 10993-1 and ISO 7405. Reference devices (Spirit - K143696 and ELECTROmatic - K163317) were used due to identical patient contacting parts.
• Software documentation: For moderate level of concern per FDA Guidance Document for Software Contained in Medical Devices, referencing IEC 62304.
• Comparative performance testing: The functions of the integrated accessories were compared to "cleared stand-a-lone device[s]."
• Risk Management: Compliance with ISO 14971:2007, with the Risk Management File reviewed by Intertek for 60601-1 certification.

The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product."

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