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

The Models 4472 EP-1V and 5596 EP-1V autoclaves are intended to provide sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids (for non-clinical application only) in open or closed containers. It has the following automated program sterilization cycles: Program 1 (Flash - Porous), Program 2 (Flash - Nonporous), Program 3 (Wrapped - 270°F), Program 4 (Wrapped - 270°F), Program 5 (Wrapped 275°F), Program 6 (Wrapped - 250°F), Program 7 (Liquids - 250°F) For non-clinical applications only, Program 8 (Bowie-Dick Test), Program 9 (Air Leakage Test).

The Tuttnauer Model 4472 EP-1V and 5596 EP-1V Autoclaves are steam sterilizers that provide onboard steam generation capability. They are designed for sterilization of heat stable medical devices; wrapped solids, hollow and porous products, as well as liquids for non-clinical applications in open or closed (but not sealed) containers. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters. The Tuttnauer Model 4472 EP-1V and 5596 EP-1V autoclaves are steam sterilizers that include as main components: a pressure vessel with steam jacket, heating elements, a chamber water reservoir, a water pump and a vacuum pump.

The provided text is for a 510(k) summary for a steam sterilizer (autoclave), not an AI/ML medical device. Therefore, many of the requested categories for AI/ML device studies are not applicable.

Below is a summary of the acceptance criteria and study information provided for the Tuttnauer Autoclaves.

Acceptance Criteria and Reported Device Performance

(Note: The "acceptance criteria" for the specific programs are implied by successful demonstration of meeting the program parameters as part of the overall ANSI/AAMI ST-8 compliance.)

Study Details (as they pertain to an AI/ML context, if applicable):

1. Sample size used for the test set and the data provenance:

   • The document refers to "validation studies" and "all tests performed" in accordance with ANSI/AAMI ST-8. It does not specify a distinct "test set" in the context of AI/ML data, but rather the performance of the physical sterilizer under various load and cycle conditions as defined by the standard.
   • No specific sample sizes (e.g., number of sterilization cycles, number of biological indicators) are provided, nor is the country of origin of the data explicitly stated (though it's a US company seeking US clearance, implying US-based testing or compliance with US standards).
   • The studies were "validation studies," which are prospective in nature for a new device.

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

   • Not applicable. This is a physical device sterilizer, not an AI/ML diagnostic or predictive tool requiring expert ground truth for image or data interpretation. Ground truth for sterilization efficacy is typically established through established microbiological and physical testing standards (e.g., biological indicators, thermocouples).

3. Adjudication method for the test set:

   • Not applicable. This is a physical device sterilizer.

4. 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 physical device sterilizer.

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

   • Not applicable. This is a physical device sterilizer.

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

   • The ground truth for sterilizers is established by established microbiological destruction criteria (e.g., 10^-6 sterility assurance level for biological indicators) and physical parameters (temperature, pressure, time) as defined by standards like ANSI/AAMI ST-8.

7. The sample size for the training set:

   • Not applicable. This is a physical device sterilizer, not an AI/ML device trained on data. The "training" for such a device involves engineering design, manufacturing protocols, and internal testing to ensure it meets its design specifications before formal validation.

8. How the ground truth for the training set was established:

   • Not applicable. This is a physical device sterilizer.

Ask a specific question about this device

The Tuttnauer 2540 EHS Series Table-top Autoclave is intended to provide sterilization of medical and dental instruments (wrapped and unwrapped) including complex lumened devices such as dental handpieces, porous, hollow loads and to sterilize liquids for non-clinical applications. Cycle parameters are as follows:

| Cycle | Ste. Temp & Range
(°F) | Press. &
Range (Kpa) | Time
(min) | Vacuum
(kPa.) | Dry Time
(min) | Load
Configuration |
|--------------------------------------------------|---------------------------|-------------------------|---------------|------------------|-------------------|--------------------------------------------------------------------------------------------------------------------------------|
| 1. Unwrapped
273 | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | --- | Single,
unwrapped
instrument in
center of lowest
tray |
| 2. Wrapped 273
(complex/
lumened) | 273 (273-279) | 305 (305 - 330) | 8 | 25 | 20 | 4 wrapped trays
arranged so that
no instruments
touching.
Approximately
80% of area
occupied. |
| 3. Wrapped 250
(for instruments
onliquida) | 250 (250-256) | 205 (205 - 225) | 30 | 25 | 20 | Instruments
4 wrapped trays
arranged so that
no instruments
touching.
Approximately
80% of area
occupied. |
| 4. Wrapped 273
(non-lumened) | 273 (273-279) | 305 (305 - 330) | 4 | 25 | 20 | 4 wrapped trays
arranged so that
no instruments
touching.
Approximately
80% of area
occupied. |
| 5. Bowie-Dick | 273 (273-279) | 305 (305 - 330) | 3-1/2 | 20 | 2 | B-D pack in
otherwise empty
chamber |
| 6. Liquids | 250 (250-256) | 205 (205-225) | 30 | -- | -- | 6 - 250 ml.
Containers
made of heat
proof glass,
each filled up to
2/3 capacity. |

Dental and medical instruments were placed within self-sealing, disposable pouches. The pouches were placed upright in an instrument rack.

The Tuttnauer 2540 EHS Table-top Autoclave is a steam sterilizer that provides an onboard steam generation capability. It is designed for sterilization of medical and dental instruments (wrapped and unwrapped), including complex lumened devices (such as dental handpieces), porous, hollow loads and to sterilize liquids for non-clinical applications. The sterilization medium is steam, which is directly introduced into the sterilization chamber. This eliminates the need to wait for water introduced into the chamber to boil and reach sterilization parameters.

The Tuttnauer EHS Series Electronic Table-top Autoclave is a steam sterilizer that includes as its main components: a pressure vessel with steam jacket, heating elements, a dualchamber water reservoir, a water pump and a vacuum pump. The device is identical to the predicate device, with the exception of the proposed modification to the labeling that would authorize sterilization of wrapped, non-lumened devices at 273° for four (4) minutes.

The provided document describes the Tuttnauer 2540 EHS Series Table-Top Autoclave, a steam sterilizer. The acceptance criteria and the study that proves the device meets the acceptance criteria are outlined below.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criterion is successful sterilization. The device performance is reported as meeting this criterion for all tested cycles.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the specific sample size (i.e., number of sterilization cycles or instruments) used for the test set. However, it indicates that "successful sterilization was accomplished in all tests performed" (Page 3), suggesting a comprehensive testing approach for the defined cycles.

The data provenance is not explicitly mentioned (e.g., country of origin, specific test sites). The studies were non-clinical validation studies described in the submission to the FDA. The nature of the studies ("Non-Clinical Testing") suggests they were conducted in a controlled laboratory environment. The document implies a prospective study design as it describes validation studies conducted to demonstrate the device's performance for specific new and existing cycles.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not mention the use of experts to establish a "ground truth" in the traditional sense of medical image analysis or diagnostic performance. Instead, the ground truth for sterilization efficacy is established through standardized microbiological testing methods (e.g., biological indicators) as dictated by the ANSI/AAMI ST55 standard. Therefore, the "experts" would be the technicians or scientists conducting these validated sterilization efficacy tests, and their qualifications would be expertise in microbiology and sterilization validation protocols.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the determination of successful sterilization is based on objective, standardized microbiological test results, not on subjective expert opinion or adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a medical device for sterilization, not a diagnostic imaging or AI-assisted system that involves human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. The device is a physical sterilizer and its performance is assessed directly, not through an algorithm's output. The "performance" is the physical sterilization process itself.

7. Type of Ground Truth Used:

The ground truth used is based on the results of sterilization efficacy tests, specifically adhering to the ANSI/AAMI ST55 standard. This standard typically involves using biological indicators (BIs) containing highly resistant bacterial spores (e.g., Geobacillus stearothermophilus). "Successful sterilization" means the complete killing of all spores on the BI, indicating a specific Sterility Assurance Level (SAL).

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/ML algorithm that requires a training set. Its performance is based on the physical parameters of steam sterilization.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this device.

Ask a specific question about this device

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.

"Based upon test data submitted, Tuttnauer E Series Table-top autoclaves effectively sterilize up to 5 dental handpieces contained within them during normal autoclave operation." |
| Maintenance of pre-programmed sterilization cycle parameters (134°C at 4 minutes for unwrapped, 134°C at 8 minutes for wrapped, 121°C at 30 minutes for liquids) | "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 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." |
| Conformance to ASME code (for pressure chamber, door, and locking device) | "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." |
| Functional equivalence to predicate device (K920478), with the change being labeling and ability to sterilize dental handpieces. | "The modified Tuttnaver E Series Electronic Table-top Autoclave is substantially equivalent to the following currently cleared and legally marketed autoclave: Tuttnauer USA Co. Ltd. E Series Electronic Autoclave K920478. With the exception of changes to the automated program cycle times and the labeling to allow sterilization of dental handpieces, the modified devices are identical to the Model E cleared under K920478."

"The modified E Series exhibits the same technological characteristics as the Tuttnauer E Series Electronic Table top Autoclave, its predicate device. All of the components that may be found in the unmodified Model E are identical to those in the modified version." |

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.

Ask a specific question about this device

The Tuttnauer Mini Container and Standard Case Cassettes are general dental/medical instrument cassettes intended to hold instruments and accessories in place during the sterilization cycle. The devices are indicated for use in both gravity and pre-vacuum steam sterilization.

The Tuttnauer Mini Container Cassette and Tuttnauer Standard Case Cassette are sterilization cassettes that are designed to allow steam to pass through the device to ensure effective sterilization. The Mini Container and Standard Case Cassettes are small to medium-sized trays with silicone mats that are useful in the organization, containment and transport of medical and dental instruments. An array of Mini Container sizes are available to accommodate various instrument sizes. The Mini Container also offers an integrated instrument holder and are designed to hold hand-held instruments 2.5mm to 8mm in diameter.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the Tuttnauer Mini Container Cassette and Tuttnauer Standard Case Cassette, based on the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Test Set Sample Size: For the efficacy portion of the non-clinical testing, three half-cycle tests were performed on each cassette for each method of sterilization (gravity and prevacuum steam). This implies at least 6 tests per cassette type (3 for gravity, 3 for prevacuum), and likely 12 tests in total since both "Mini Container" and "Standard Case" cassettes were tested. The number of physical cassettes tested isn't explicitly stated beyond "each cassette."
• Data Provenance: The document does not specify the country of origin of the data. The study was conducted by Tuttnauer, a U.S. company. The study is prospective as it describes specific validation studies performed by the manufacturer for the purpose of this submission.

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 type of testing performed (half-cycle sterilization validation) typically involves laboratory-based methods and the use of biological or chemical indicators to assess sterility, rather than expert human interpretation of results in the traditional sense of medical imaging or diagnostic devices. Someone performed the tests and evaluated the indicators for "successful sterilization," but their qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not applicable/provided as the study describes physical performance testing (sterilization efficacy) rather than human interpretation of data requiring adjudication. The assessment of "successful sterilization" would be based on objective indicators rather than subjective expert consensus.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical instrument cassette, not an AI-powered diagnostic or assistive tool, so such a study would be irrelevant.

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

Not applicable. This device is a physical product (a sterilization cassette), not an algorithm or software. Therefore, standalone algorithm performance testing is not relevant or described.

7. The Type of Ground Truth Used

The ground truth used for the sterilization efficacy tests was likely based on:

• Biological Indicators (BIs): These contain highly resistant bacterial spores; their inactivation after a sterilization cycle confirms sterility.
• Chemical Indicators (CIs): These change color or form upon exposure to specific sterilization parameters (e.g., steam, temperature, time).
• Physical Monitoring: Readings from sterilizer gauges or printouts (temperature, pressure, time).

The combination of these, particularly the BIs, would establish the "successful sterilization" ground truth.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve machine learning or AI, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, this question is not relevant.

Ask a specific question about this device

Tuttnauer electronic controlled pre-vacuum autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 5 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); liquids (121°C at 30 minutes and 16 psi); Bowie Dick test program (134°C at 3.5 minutes and 29 psi); and a free program with adjustable sterilization times and temperatures. With the exception of the free program, all of these cycles are pre-programmed, requiring no user input. The free program allows the user to select their own sterilization parameters, however, the operations manual warns that sterilization has not been validated for user selected settings, and cautions the user that they must validate sterilization. These 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 EPV series autoclave is a table-top steam sterilizer that includes as its main components a vacuum pump, water reservoir, heat source and sealed chamber. As with the predicate device, the EPV has three pre-programmed sterilization cycles, one user definable cycle and a Bowie-Dick test cycle. The three pre-programmed cycles are for unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes) and liquids (121°C at 30 minutes). The Model EPV autoclave is produced in two sizes, the 2340EPV with a chamber size of 9" x 18.5" and the 2540EPV with a chamber size of 10" x 18.7". 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.

The provided 510(k) summary for the Tuttnauer Model EPV Pre-vacuum Autoclave (K962282) states that "Evaluations have been completed to validate the safety and effectiveness of these devices." However, it does not provide specific numerical acceptance criteria for performance metrics, nor does it detail the results of a specific study in a quantifiable manner to demonstrate that these criteria were met.

Instead, the summary focuses on demonstrating substantial equivalence to a predicate device (Tuttnauer Model E series autoclave, K920478) and compliance with various safety standards. The performance aspects are described descriptively rather than with numerical targets and results.

Given the information provided, here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria were not explicitly stated in the provided text. The performance is described qualitatively.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document mentions "half-cycle and total kill endpoint analysis" and testing "under in-use, worst-case and simulated use conditions" but does not provide the number of sterilization cycles, loads, or biological indicators used in these tests.
• Data Provenance: The document does not explicitly state the country of origin for the data or whether it was retrospective or prospective. Given that Tuttnauer USA Co. LTD. is based in New York, and the device adheres to "domestic and international safety standards," it's highly likely that testing involved a combination of internal validation and compliance with specified standards, potentially involving recognized testing laboratories. The nature of sterilizer validation implies prospective testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: The document does not describe the use of human experts to establish "ground truth" for the test set in the context often seen with AI/clinical decision support devices. Sterilizer validation typically relies on standardized biological and chemical indicators, calibrated equipment, and established protocols rather than expert human interpretation of results in the same way clinical imaging or diagnostic devices might.

4. Adjudication Method for the Test Set

• Not applicable in the conventional sense for this type of device. The "ground truth" for sterilization effectiveness is determined by objective measures like biological indicator kill, chemical indicator changes, and physical parameters rather than expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or clinical decision support devices where human readers (e.g., radiologists, pathologists) interpret data with and without AI assistance. The Tuttnauer Model EPV is a medical device for sterilization, not a diagnostic or AI-powered interpretative system.

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

• Yes, a form of standalone performance evaluation was done. The device's "standalone" performance, in this context, refers to its ability to achieve sterilization outcomes independently without human intervention during the sterilization cycle itself. The testing described ("half-cycle and total kill endpoint analysis," "in-use, worst-case and simulated use conditions") evaluates the sterilizer's effectiveness on its own. The software controls the cycle parameters without human-in-the-loop decision-making during operation.

7. The Type of Ground Truth Used

The ground truth for sterilization efficacy is established through:

• Biological Indicators (BI): These contain highly resistant bacterial spores (e.g., Geobacillus stearothermophilus) that are killed only if proper sterilization conditions are met. A negative BI result (no growth) indicates sterilization. This is implicitly the "total kill endpoint analysis" mentioned.
• Chemical Indicators (CI): These change color or form when exposed to specific sterilant parameters (e.g., steam, temperature, time). They provide immediate confirmation of exposure to sterilant.
• Physical Monitoring: This involves monitoring and recording parameters directly from the sterilizer's sensors, such as temperature, pressure, and time.
• Pathology/Outcomes Data: Not typically used as primary ground truth for sterilizer validation; rather, the successful kill of microorganisms (as determined by BIs) is the direct measure of effectiveness.

8. The Sample Size for the Training Set

• Not applicable / Not specified. The Tuttnauer Model EPV is not an AI/machine learning device that requires a "training set" in the conventional sense. Its software controls predefined sterilization cycles based on fixed parameters, not adaptive learning from data. The software was "validated to ensure compliance with all applicable requirements," implying software testing and verification, but not machine learning training.

9. How the Ground Truth for the Training Set was Established

• Not applicable. As the device does not employ machine learning with a distinct "training set," the concept of establishing ground truth for such a set is not relevant. The software logic and control parameters are based on established scientific principles of sterilization and engineering design, not on a data-driven training process.

Ask a specific question about this device

Tuttnauer electronic and manual controlled autoclaves are intended to be used for sterilization of solid metal instruments, solid metal hinged instruments and other materials that will withstand temperatures and pressure required for sterilization. The sterilizers have 3 cycles: unwrapped instruments (134°C at 3 minutes and 29 psi); wrapped instruments (134°C at 7 minutes and 29 psi); and liquids (121°C at 30 minutes and 16 psi). In the "E" Series; these cycles are pre-programmed, whereas in the "M" Series the user must manually set the parameters, however, these parameters are recommended in the labeling. These 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 M series autoclave is a table-top steam sterilizer that includes as its main components a multi-valve control assembly & timer, water reservoir, heat source and sealed chamber. The M can sterilize unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes) and liquids (121°C at 30 minutes). The Model M 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" and the 2540 with a chamber size of 10" x 18.7". The 3870, which has a chamber size of 15" x 27", is not subject to this corrective action.

The provided document describes a 510(k) submission for a corrective action to a previously cleared device, not a new device or an AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design for performance, MRMC studies, standalone performance, and extensive details about ground truth and training sets for an AI/software product is not applicable.

This submission focuses on demonstrating substantial equivalence of a modified version of an existing device (Tuttnauer Manual Autoclave Models M, MK, MP) to its predicate device, primarily due to a change in a single mechanical component: the door closure mechanism's thrust bearing.

Here's an attempt to answer the questions based on the available information, noting where sections are not applicable:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

1. Table of Acceptance Criteria and Reported Device Performance

• "The Tuttnauer Model M complies with domestic and international safety standards including Underwriter's Laboratories UL 544, Canadian Standards Association (CSA) medical device standards, European TUV standards and Japanese safety standards."
• "The pressure chamber complies with ASME standards for pressure vessels and Canadian CRN requirements."
• "Additionally, each pressure vessel is individually tested for conformance prior to release."
• "Based upon the engineering calculations and ASME testing, the modification to the door closure assembly provides safe operation for these devices." |
  | - Conformance to relevant safety and pressure vessel standards (UL 544, CSA, TUV, Japanese safety standards, ASME, CRN). | - Explicitly stated compliance: UL 544, CSA, European TUV, Japanese safety standards.
• Pressure chamber complies with ASME standards and Canadian CRN requirements. |
  | - Safe operation of the door closure assembly. | - "Based upon the engineering calculations and ASME testing, the modification to the door closure assembly provides safe operation for these devices." |
  | Effectiveness: | |
  | - Maintain sterilization effectiveness equivalent to predicate device. | - "Because modification of the thrust bearing on the door closure mechanism does not effect the autoclave's sterilization parameters, the modified Model M series presents an identical sterilization profile."
• Maintans ability to sterilize unwrapped instruments (134°C at 3 minutes), wrapped instruments (134°C at 7 minutes), and liquids (121°C at 30 minutes). |
  | Substantial Equivalence: | |
  | - Demonstrate substantial equivalence to the predicate device (Tuttnauer Model M series autoclave, K833837). | - "It is Tuttnauer USA Co. Ltd.'s conclusion that the modified Model M series autoclave is substantially equivalent to its predicate device, the Tuttnauer Model M series autoclave, 510(k) number K833837."
• "With the exception of the change from a ball-type thrust bearing to a solid type thrust bearing in the door closure mechanism, the modified devices are identical to the Model M cleared under K833837."
• "The modified Model M exhibits the same technological characteristics as the Model M, its predicate device." |

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

• Not applicable in the context of an AI/software device performance study. This submission is for a physical device modification.
• The document mentions "individually tested for conformance prior to release" for each pressure vessel, implying a manufacturing quality control process, but not a formal clinical or performance study with a defined sample size for a "test set" in the sense of evaluating an algorithm. The evidence presented appears to be based on engineering calculations and ASME testing of the door closure assembly, and the assumption that changing one mechanical component (the thrust bearing) does not alter the fundamental sterilization parameters of the device.

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)

• Not applicable. This is not an AI/software device requiring expert-established ground truth for a diagnostic performance evaluation. The "ground truth" for a sterilizer is its ability to effectively sterilize, which is evaluated through physical and microbiological validation methods, not expert consensus on images or data. The document does not detail specific microbiological validation studies for this modification, relying instead on the argument that the mechanical change does not affect sterilization parameters.

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

• Not applicable. No adjudication method is mentioned or relevant for this type of submission.

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 not an AI-assisted diagnostic device.

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

• Not applicable. This is not an algorithm.

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

• Not applicable in the context of an AI/software device. For this mechanical modification, the "ground truth" for safety and effectiveness is implicitly based on adherence to engineering principles, material specifications, and the established physical and biological performance characteristics of the predicate device. The claim is that the modification does not alter these established characteristics.

8. The sample size for the training set

• Not applicable. There is no training set as this is not an AI/software device.

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

• Not applicable. There is no training set as this is not an AI/software device.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as presented for this 510(k) submission):

The "study" or evidence provided to support the substantial equivalence claim for the modified Tuttnauer M series autoclaves is based on:

1. Engineering Evaluation: The core argument is that the change from a "ball-type thrust bearing to a solid type thrust bearing in the door closure mechanism" is a minor modification that "does not effect the autoclave's sterilization parameters." This implies an engineering assessment that the mechanical change does not impart new risks or alter the fundamental function related to sterilization.
2. Compliance with Established Standards: The device's safety is supported by its compliance with various domestic and international safety standards (UL 544, CSA, European TUV, Japanese safety standards) and pressure vessel standards (ASME, Canadian CRN). The submission asserts that the modification does not compromise this compliance.
3. Individual Testing: Each pressure vessel is "individually tested for conformance prior to release."
4. Reference to Predicate Device: The modified device is declared "identical to the Model M cleared under K833837" with the single exception of the thrust bearing, and it "exhibits the same technological characteristics." The performance of the predicate device (K833837) implicitly forms the benchmark for the modified device's expected safety and effectiveness, which is claimed to be unchanged.

Essentially, the "study" is a justification that the specific, limited mechanical change does not negate the established safety and effectiveness profile of the original device, relying on engineering principles and continued adherence to standards rather than new performance testing for sterilization efficacy.

Ask a specific question about this device