(150 days)
The ELARA-11" is a table-top autoclave designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories.
The automated Tuttnauer ELARA-11" is a table-top steam sterilizer (i.e., autoclave) designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, and medical clinics; in first aid rooms; and in small laboratories. This device is a pre-vacuum and post-vacuum sterilizer that has an air removal stage (i.e., pre-vacuum) before the start of the sterilization stage, as well as a post-sterilization drying stage that is based upon the combined operation of heat plus vacuum with air inlet pulses. The sterilizing agent is steam that is electrically-generated from either mineral-free or distilled water that is added to the built-in reservoir.
The ELARA-11" is a steam sterilizer composed of a pressure vessel with steam jacket, heating elements, a clean water reservoir, a waste water reservoir, a vacuum pump, and a water pump. The device has several safety features, including an automated safety door with a doublesafety locking mechanism and an automatic safety shutoff. The front panel of the device consists of a display screen, a keypad, and a printer. The ELARA-11" electronic control system is automatic, fully-configurable, and has a total of seven (7) programs: five (5) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the VacTest program). The components are made of varying grades of stainless steel.
The Elara-11" Pre-vacuum Tabletop Autoclave is a medical device designed for sterilizing medical and surgical goods. The device underwent non-clinical testing to demonstrate its performance.
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document refers to the acceptance criteria established by AAMI/ANSI ST55:2003 for tabletop steam sterilizers. The document states that the ELARA-11" meets "all aspects of the standard, including physical and microbiological performance requirements."
However, specific numerical performance metrics from the study are not provided in the summary. For example, details like the specific biological indicator kill rates, physical parameter tolerances, or dry times for various load types, which would be part of AAMI/ANSI ST55:2003, are not explicitly stated as results. The table below represents the available information:
| Acceptance Criteria (AAMI/ANSI ST55:2003) | Reported Device Performance (ELARA-11") |
|---|---|
| Physical performance requirements | Met all aspects of the standard |
| Microbiological performance requirements | Met all aspects of the standard |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set. It mentions "validation studies" and "testing shows," implying multiple trials or conditions were tested.
The data provenance is not specified in terms of country of origin or whether it was retrospective or prospective. Given that this is a 510(k) submission for a new device, it is highly likely that the "validation studies" were prospectively conducted by Tuttnauer USA Co. Ltd. to demonstrate the device's efficacy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide details on the number of experts, if any, used to establish ground truth. For sterilization validation, ground truth is typically established through established testing protocols and methodologies (e.g., biological indicators, thermocouples, chemical indicators) as defined by standards like AAMI/ANSI ST55:2003, rather than expert consensus on individual cases.
4. Adjudication Method for the Test Set:
Not applicable. As described in point 3, ground truth in sterilization validation is established through objective measurements and accepted testing methodologies, not through expert adjudication of subjective results.
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:
Not applicable. This is a sterilization device, not an AI-powered diagnostic or imaging device that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This is a sterilization device. There is no "algorithm only" performance concept in this context. The "device" itself performs the sterilization process automatically.
7. The Type of Ground Truth Used:
The ground truth for evaluating the ELARA-11" would have been established through objective measurements and validated methods as specified by AAMI/ANSI ST55:2003. This would include:
- Microbiological data: Use of Biological Indicators (BIs) to demonstrate a sufficient kill (e.g., 6-log reduction) of resistant microorganisms (e.g., Geobacillus stearothermophilus spores).
- Physical data: Monitoring of temperature, pressure, and time throughout the sterilization cycle using calibrated sensors.
- Chemical data: Use of Chemical Indicators (CIs) to provide immediate visual confirmation of exposure to sterilant conditions.
- Load testing: Verification of sterility and drying for various load types (e.g., wrapped instruments, porous loads, hollow A items) and maximum load configurations.
8. The Sample Size for the Training Set:
Not applicable. This device is not an AI/ML model that requires a training set. Its operational parameters are based on scientific principles of steam sterilization and validated through non-clinical testing.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 880.6880 Steam sterilizer.
(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).