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Tuttnauer electronic controlled autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments, dental handpieces and other materials that will withstand temperatures and pressure required for sterilization.

The sterilizers have 3 cycles: unwrapped instruments (134°C at 4 minutes and 29 psi); wrapped instruments (134°C at 8 minutes and 29 psi); and liquids (121℃ at 30 minutes and 16 psi). These cycles are preprogrammed and are recommended in the labeling.

Tuttnauer E Series Electronic Table-top Autoclaves are intended for use in ophthalmic, dental and medical clinics, first aid rooms, and small laboratories in conformity with 21 C.F.R. § 880.6880.

The Tuttnauer Model E series autoclave is a table-top steam sterilizer that includes as its main components an electronic control, water reservoir, heat source and sealed chamber. The E has three pre-programmed sterilization cycles. The three pre-programmed cycles are for unwrapped instruments (134°C at 4 minutes), wrapped instruments (134°C at 8 minutes) and liquids (121°C at 30 minutes). Dental handpieces can be sterilized as unwrapped or wrapped instruments without modification to cycle times or temperatures.

The Model E autoclave is produced in four sizes, the 1730 with a chamber size of 7" x 12"; the 2340 with a chamber size of 9" x 18.5"; the 2540 with a chamber size of 10" x 18.7"; and the 3870, which has a chamber size of 15" x 27."

The pressure chamber, door and locking device are constructed from stainless steel. The pressure chamber, and components are designed, tested and stamped for conformance to ASME code.

A microprocessor controls the cycle parameters. The software provides the microprocessor with the necessary information to control the device within its desired parameters. The software has been validated to ensure compliance with all applicable requirements.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Tuttnauer E Series Electronic Table-top Autoclave are implicit in its intended use and the validation studies performed. Since this is a 510(k) submission for a modification to an already cleared device, the primary acceptance criterion is substantial equivalence to the predicate device, specifically regarding the ability to sterilize dental handpieces effectively.

The reported device performance, based on the non-clinical testing, directly addresses this criterion.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: The document mentions "Representative handpieces from various manufacturers were inoculated" and "Worst-case handpiece loads were then determined for the sterilizer. Three half-cycle tests were performed for each of unwrapped and wrapped methods of sterilization." It also states, "effectively sterilize up to 5 dental handpieces contained within them during normal autoclave operation."
  • Interpretation: While a precise number isn't given for "various manufacturers," it implies a selection. For the actual testing, it specifies 3 half-cycle tests for unwrapped handpieces and 3 half-cycle tests for wrapped handpieces. The device demonstrated the ability to sterilize "up to 5 dental handpieces" in a single cycle.
• Data Provenance: This was a prospective non-clinical validation study conducted by Tuttnauer USA Co. Ltd. The country of origin of the data is implicitly the USA, where Tuttnauer USA Co. Ltd. is located and where the testing was likely performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This type of information is not provided in the given text. For sterilization validation, the "ground truth" is typically established through microbiological testing (e.g., spore strips, biological indicators) which demonstrates the killing of resilient microorganisms, rather than expert consensus on visual assessment. The text states "inoculated in their most difficult to sterilize areas," implying a microbiological challenge.

4. Adjudication method for the test set

This is not applicable and not mentioned in the provided text, as the validation of a sterilizer's effectiveness relies on objective microbiological and physical parameters (temperature, pressure, time), not on human interpretation or adjudication of images or clinical diagnoses.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

This is not applicable and not mentioned. MRMC studies are typically used for diagnostic imaging devices where human readers interpret results, and their performance with and without AI assistance is compared. This document concerns a sterilizer, where the "outcome" is sterility, measured objectively.

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

This is not applicable in the context of a sterilizer. The device itself is the "algorithm," controlling the physical process. Its performance is evaluated directly through its ability to achieve sterility without human intervention in the sterilization process itself (beyond loading and operating the machine). The validation studies described are effectively "standalone" in this regard for the device's function.

7. The type of ground truth used

The ground truth used for the validation studies was likely microbiological sterility, demonstrated by challenging the device with microorganisms ("inoculated in their most difficult to sterilize areas") and subsequently verifying their inactivation. While not explicitly stated as "microbiological testing," the context strongly implies this by using terms like "inoculated" and "effective sterilization."

8. The sample size for the training set

This is not applicable and not provided. This device is a physical sterilizer and its control system is described as a microprocessor with validated software. It is not an AI/ML device that requires a "training set" in the conventional sense. The "training" for such a system would be the design, programming, and rigorous testing of the software itself against engineering specifications.

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

This is not applicable for the reasons stated in point 8. The validation of the software (mentioned as "The software has been validated to ensure compliance with all applicable requirements") would typically involve testing against predefined engineering requirements and safety standards, not against a "ground truth" derived from data in the way an AI/ML model would be trained.

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