Search Results

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; and in first aid rooms.

The ELARA-11 is validated for use in sterilizing lumened device of no longer than 230 mm and no smaller than 3.4 mm for sterilization programs 2 and 4.

The ELARA-11 is validated for use in sterilizing fabric packs/textiles for sterilization programs 2 and 4.

The ELARA-11 is validated for use in sterilizing up to six dental handpieces for sterilization programs 2 and 4.

The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals.

The Model 5075 is validated for use in sterilizing lumened device of no longer than 370 mm and no smaller than 3.8 mm for sterilization programs 2 and 3.

The Model 5075 is validated for use in fabric packs/textiles for sterilization programs 2 and 4.

The ELARA-11 is a tabletop autoclave designed for sterilization of medical and surgical goods, including both wrapped and unwrapped, solid, hollow, porous products and tubes in ophthalmic, dental, and medical clinics; and in first aid rooms. The Model 5075 HSG is a horizontal autoclave designed for the sterilization of wrapped and unwrapped instruments and related items found in dental, medical and veterinary clinics, first aid rooms, and hospitals. These two devices are pre-vacuum and post-vacuum sterilizers that have 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 a single manual safety door with a double-safety 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 six (6) programs: four (4) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the Vacuum Test program). The components are made of yarying grades of stainless steel.

The 5075 HSG model is a steam sterilizer composed of a pressure vessel, heating elements, a clean water reservoir, a waste water reservoir, a vacuum pump, and a water pump. The device has several safety features, including a single manual safety door containing a double-safety locking mechanism, an automatic safety valve to protect personnel and equipment against build-up of high pressure, and a pressure gauge that indicates when there has been a failure in operation. The front panel of the device consists of a display screen, a keypad, and a printer. The 5075 HSG model electronic control system is automatic, fully-configurable, and has a total of six (6) programs: four (4) sterilization programs and two (2) test programs (Bowie & Dick test program with fixed (non-adjustable) parameters, and the Vacuum Test program). The components are made of varying grades of stainless steel and carbon steel.

This document describes the premarket notification for Tuttnauer Pre-Vacuum Tabletop Autoclave (Model ELARA-11) and Tuttnauer Pre-Vacuum Horizontal Autoclave (Model 5075 HSG). The information provided is for regulatory clearance and focuses on substantial equivalence to predicate devices, rather than a clinical study with acceptance criteria in the context of AI/ML.

Therefore, the requested information components related to acceptance criteria for AI/ML performance, sample sizes for test/training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance are not applicable to this document. This document primarily details the device's technical specifications and intended use, comparing them to existing cleared devices to establish substantial equivalence.

1. Table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria in terms of performance metrics like sensitivity or specificity. Instead, it states that the devices meet the requirements of AAMI/ANSI ST55:2003, which is a standard for table-top steam sterilizers.

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

Not applicable. This is not a study involving a test set in the context of AI/ML performance. The testing performed is related to the physical and microbiological efficacy of the sterilizers.

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

Not applicable. Ground truth in the context of expert consensus is not relevant here. The ground truth for sterilization efficacy is established through adherence to recognized standards (AAMI/ANSI ST55:2003) and biological indicator testing.

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

Not applicable. Adjudication methods are not relevant to the type of testing described for steam sterilizers.

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 document pertains to steam sterilizers, not AI/ML-driven diagnostic devices that would involve human readers.

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

Not applicable. This document describes mechanical/electrical steam sterilizers, not algorithms.

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

The ground truth for the performance testing is based on the established safety and efficacy requirements outlined in the AAMI/ANSI ST55:2003 standard, specifically through physical and microbiological performance assessments, including the biological indicator overkill method.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

Ask a specific question about this device

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:

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.

Ask a specific question about this device