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The Cassette Autoclave (ACA5) is suitable for the sterilization of dental and medical instruments designed to withstand steam sterilization. The Cassette Autoclave (ACA5) has not been designed to sterilize liquids, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

Please refer to below sterilization cycles for Program Name / Load Description/Sterilization Temperature/Sterilization Time/Drying Time and Load Weight.:

1. Program Name: 134 ℃
   Load Description: Solid objects, small porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped.
   Sterilization Temperature: 134 ℃ (273℉)
   Sterilization Time: 4 minutes
   Drying Time: 60 minutes
   Load Weight: 0.9 kg

2. Program Name: 121℃
   Load Description: Solid objects, small porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped.
   Sterilization Temperature: 121 ℃ (250℉)
   Sterilization Time: 30 minutes
   Drying Time: 60 minutes
   Load Weight: 0.9 kg

The Cassette Autoclave (ACA5) is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. The Cassette Autoclave (ACA5) consists of five modules: water supply, disinfection, air dry, exhaust steam processing and control system.

The main working principle is as follows: The water supply module supplies clean distilled water to the disinfection module. Inside the steam generator, the electric heating element generates high- temperature saturated steam at 121℃ for a period of 4 minutes and 134℃ for a period of 30 minutes. This steam is then utilized within a sealed disinfection box to sterilize instruments. During sterilization, excess high- temperature steam is condensed in the exhaust steam processing module. After the sterilization, high- temperature steam and coolant water remain inside the disinfection box. Air dry cycle works for ventilation and drying. Ultimately, you can get the dry and sterile instruments.

Basic parameters/use conditions/power supply specifications are as follows:

Name: Cassette Autoclave （ACA5）
Machine Dimensions (ABC): 650mm416mm200mm
Cassette Sizes (DEF): 495mm196mm78.5mm
Maximum Load for a Single Sterilization: 1.5kg
Sterilization Chamber Volume: 5.1L
Weight (Without water): 43KG
Rated Operating Temperature: 134℃
Rated Working Pressure: 212kPa（Gauge Pressure）
Relief Valve Pressure Setting: Pressure set: 300kpa (relative pressure), pressure release when exceeded
Operating Temperature Range: 121℃～134℃
Reservoir Volume: 4L
Input Voltage: a.c.110v，60Hz
Rated Power: 1300VA
Fuse(250VH15AT): 10A
Working Medium: Steam
Illumination level: (215±15) lx to (1500±15) lx
Operating Mode: Non--continuous operation, with a maximum of 6 cycles per hour.
Water Supply: Purified water
Noise: Less than 70dB
Service life: 10 years

The provided FDA 510(k) clearance letter is for a Cassette Autoclave (ACA5), which is a steam sterilizer. This type of device is an electromechanical product, not an AI/ML-driven diagnostic device. Therefore, the information typically requested about acceptance criteria and studies for AI/ML performance (such as sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this document.

The document discusses the device's performance in terms of its ability to sterilize medical instruments, adhering to established standards for steam sterilizers.

Here's an analysis based on the information provided, focusing on the relevant acceptance criteria and performance metrics for a sterilizer:

Acceptance Criteria and Device Performance for Cassette Autoclave (ACA5)

This device is a medical instrument sterilizer. The performance criteria provided are related to the physical efficacy of sterilization, electrical safety, and electromagnetic compatibility, not diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact number of cycles or units tested for each performance metric. It states "The device had been validated to comply with the following bench testing." These are laboratory bench tests performed on the physical device itself, not studies on patient data. The provenance of this data is from the manufacturer's non-clinical testing.

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

Not applicable. Ground truth for sterilizer performance is established by metrological standards (temperature, pressure, moisture measurements) and microbiological testing (biological indicators), not by human expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

Not applicable. Performance is measured against physical and biological thresholds, not requiring expert adjudication.

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

Not applicable. This is not an AI/ML diagnostic or image interpretation device.

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

Not applicable. This device is an electromechanical sterilizer. Its "performance" is its ability to meet the physical and biological parameters of sterilization, which is inherently a "standalone" function of the machine.

7. The Type of Ground Truth Used

The ground truth used for this type of device is based on accepted international standards for sterilization and electrical/electromagnetic safety. This includes:

• Precise physical measurements (temperature, pressure, vacuum, moisture content).
• Microbiological challenge tests using biological indicators to confirm the inactivation of spores to a specified sterility assurance level (SAL).

8. The Sample Size for the Training Set

Not applicable. This is a manufactured electromechanical device, not a machine learning algorithm that requires a "training set" of data.

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

Not applicable for the reason stated in point 8.

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The 2545D tabletop Steam Sterilizer is designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities. (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices).

The 2545D was validated for use in:
Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads.

The subject device (model: 2545D) is a table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. The 2545D uses steam as a sterilizing agent, produced by warming up a controlled amount of demineralized water which then flows into the chamber as steam. A heating element wrapped around the chamber maintains the required temperatures and steam. All processes are controlled by the device's computerized control system.

To use, the operator fills the water reservoir with water (distilled or purified), loads the trays with cleaned instruments, and manually closes the chamber door. The operator then selects the appropriate sterilization cycle on the user interface. Once "Start" is pressed, the sterilizer automatically performs all necessary operations, including Filling, Heating, Sterilization, Venting, and Drying. Sterilization parameters and process status are displayed on the screen.

The 2545D is designed with the following external ports and printing functions:

• One built-in USB port to enable the operation of an external USB device to record sterilization cycles.
• Built-in report printer to print sterilization records.
• Built-in memory to record up to 16000 sterilization cycles, which can be exported to a USB device.
• Built-in label printer to print labels with a unique cycle ID barcode, Program name, and expiry dates (optional additions).

The chamber and door are made of corrosion-resistant 304L stainless steel. It features an LCD Display and touch pad user interface, High Temperature Silicon Rubber door gaskets, a manual door lock, and a door safety interlock. It also has an ASME pressure relief valve and an Overheat Protection (Thermostat@250°C). The device is powered by AC 120V 60 Hz 1750VA. The operation principle is sterilization by heating a controlled amount of demineralized water to generate steam and maintaining its temperature with a heating element. It includes a vacuum mechanism for air removal and drying.

The provided FDA 510(k) clearance letter is for a Steam Sterilizer (2545D), which is a Class II device. This type of device does not involve Artificial Intelligence (AI) and therefore the questions related to AI-specific performance, human reader studies, and effect sizes of AI assistance are not applicable.

The acceptance criteria and study information provided in the document are focused on the safety and performance of the steam sterilizer in meeting sterilization standards.

Here's the breakdown of the information as requested:

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

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

The document does not explicitly state the specific sample sizes for tests such as Bowie & Dick, air leaks, temperature control, biological performance, or moisture retention. The performance is assessed against the requirements of the standards (e.g., ANSI/AAMI ST55:2016), which typically define the number of test cycles or items required for validation.

The data provenance is not specified regarding country of origin or whether it was retrospective or prospective. It is implied that the tests were conducted as part of the device's validation process.

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 product is a steam sterilizer, not a diagnostic device that relies on expert interpretation for ground truth. The "ground truth" for its performance is established by objective measurements and biological indicators adhering to recognized standards for sterilization effectiveness (e.g., absence of microbial growth, specific temperature ranges, acceptable moisture levels). Therefore, experts in the sense of medical diagnosticians are not applicable here. The experts involved would be those qualified to conduct and interpret the results of physical and biological sterilization tests according to the cited standards. Their number and specific qualifications are not detailed in the document.

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

Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations of medical images or data. This is not applicable to the performance testing of a steam sterilizer, which relies on objective physical and microbiological endpoints.

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. The device is a steam sterilizer, not an AI-powered diagnostic tool.

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

Not applicable. The device is a steam sterilizer. Its performance is inherent to its design and operation and is a "standalone" mechanical/software system, but not in the context of an AI algorithm.

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

The ground truth for the sterilizer's performance is based on well-established scientific principles and objective measurements defined by industry standards for sterilization. This includes:

• Physical Measurements: Temperature (within specified range), pressure, leak rates (within limits).
• Chemical Indicators: Bowie-Dick test color change indicating proper air removal.
• Biological Indicators: Absence of microbial growth to confirm sterility (e.g., 10^-6^ SAL) for biological performance tests.
• Weight Measurements: To assess moisture retention performance.

This is a form of "outcomes data" in the sense of directly observing and measuring the physical and biological outcomes of the sterilization process.

8. The sample size for the training set

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

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

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

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The Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.

The Fort Defiance Industries FRONT-LINE Field Sterilizer, model FL135, is an autoclave designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities. The device uses electrical resistive heaters to produce steam as the sterilizing agent. The device adheres to sterilization processes and requirements that are universally accepted sterilization standards for Tabletop Steam Sterilizers. A touchscreen controller is used for monitoring and control of the device.

The provided text describes the 510(k) summary for the Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) and its modifications. The key changes involve reducing the dry times for wrapped instruments, textiles, and handpieces cycles. The study provided focuses on the sterilizer's performance and safety and is not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML studies (such as MRMC studies, number of experts for ground truth, sample sizes for training sets, etc.) are not applicable to this submission.

The acceptance criteria and performance data are primarily based on the sterilizer's ability to achieve and maintain sterility, as well as its moisture retention characteristics, according to the AAMI ST55:2016 standard.

Here's a breakdown of the available information:

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

The acceptance criteria are derived from ANSI/AAMI ST55:2016. The reported device performance is indicated by "PASS" for each test.

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

• Sample Size for Test Set: The document mentions "3 successive cycles at half the programmed exposure time" for the overkill method to guarantee a sterility assurance level (SAL) of at least 10^-6. It also mentions validation studies were conducted. However, the exact sample sizes for each specific test (e.g., number of textile packs, wrapped instruments, or handpieces tested) are not explicitly stated in the provided summary.
• Data Provenance: The studies were conducted by Fort Defiance Industries LLC which is based in Loudon, Tennessee, USA. The studies appear to be prospective validation studies performed to support the 510(k) submission for the device modifications.

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

• Not Applicable. This is a hardware medical device (steam sterilizer) and the ground truth is established through physical and biological indicators, not human expert consensus on interpretations of images or data. The validation is against established engineering and sterilization standards (ANSI/AAMI ST55:2016).

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

• Not Applicable. As above, this is not an AI/ML or diagnostic study requiring human expert adjudication. The performance is objectively measured against physical and biological parameters.

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/ML device, and no human reader comparative effectiveness studies were performed or are relevant.

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

• Not Applicable. This is not an AI/ML algorithm. The performance is the standalone performance of the sterilizer itself. The summary evaluates the device's ability to sterilize and dry items on its own, based on programmed cycles.

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

• The ground truth for sterilizer performance is based on established industry standards and scientific principles of sterilization. This includes:
  • Biological Indicators: Used in the "overkill method" to demonstrate a Sterility Assurance Level (SAL) of at least 10^-6. This typically involves challenging the sterilizer with a high concentration of resistant microorganisms, and "ground truth" is established by their survival or inactivation.
  • Physical Parameters: Temperature and pressure measurements throughout the cycle, as defined by ANSI/AAMI ST55:2016 (e.g., -0/+6°F temp control).
  • Moisture Retention: Empirical measurements of water remaining on processed items, compared against defined limits in the AAMI standard.

8. The sample size for the training set

• Not Applicable. This device uses pre-programmed cycles based on engineering design and validation against recognized standards, not machine learning models that require a training set.

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

• Not Applicable. No training set for an AI/ML model.

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The Midmark Smart M9® and Smart M11® Sterilizers can be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable items (including dental handpieces) that are compatible with steam sterilization. Refer to Standard Cycle Parameters for detailed information.

The Midmark Smart M9® and Smart M11® Sterilizers utilize steam flush pressure pulse (SFPP) technology to achieve sterilization on heat and moisture stable items (including dental handbieces) that are compatible with steam sterilization.

The Midmark Smart M9® and Smart M11® Sterilizers are compact, self-contained portable units. They can be placed on any level support surface where an electrical outlet is available with no other installation required. The M9 sterilizer models are the smaller of the models with a 9 in (22.9 cm) diameter x 15 in (38.1 cm) deep stainless-steel chamber. The M 1 sterilizer models have an 11" (27.9 cm) diameter x 18" (45.7 cm) deep stainless-steel chamber.

The Midmark Smart M9® and Smart M11® Sterilizers use saturated steam at high pressure and temperature as the sterilizing agent to kill infectious bio-organisms on items placed in the chamber for processing. They use the dynamic Steam Flush Pressure Pulse (SFPP) cycle type for the pre-set cycles that include a 4-minute 270°F and a 3-minute 275°F cycle for wrapped or pouched instruments (including dental handpieces) and cassettes, a 30-minute 250°F cvcle for textiles and instrument packs requiring a lower temperature. and a 3-minute 270°F cycle for unwrapped instruments. The 3-minute 275°F is added to align with Table B.2 in AAMI TIR12:2020. In the SFPP type cycle, residual air is removed from the chamber and its contents by a series of controlled pressure pulses and steam flushes.

The Midmark Smart M9® and Smart M11® Sterilizers are designed to automate the sterilization process, to the extent possible, and the user interface on the subject models extends this capability to include sterilization record keeping. To use the sterilizer, the operator fills the water reservoir with water (distilled or purified) and loads the included trays with properly cleaned and prepped instruments for sterilization. The loaded trays are then placed inside the chamber, and the chamber door is manually closed by the operator. Based on the cycle parameters that are appropriate for the type of load being processed, the operator then selects the appropriate sterilization cycle on the user interface. On the subject units there are options for the user to enter load type and indicator information. Once the cycle is selected and the operator presses "Start," there is an option to capture the identification of the operator. The sterilizer then automatically performs all the operations necessary to complete the sterilization process without further interaction from the operator. The sterilization cycle is composed of several phases which include Filling, Heating, Sterilization, Venting, and Drying, Audible signals indicate cycle initiation, completion, and/or interruption, and the user interface provides visual communication of device status, operator instructions, and troubleshooting information. The LED light bar also provides an estimate of the cycle progression. At the conclusion of the cycle there is another option to capture the identification of the operator that unloads and approves or rejects the results of the sterilization cycle.

All sterilizer cycle and user maintenance (Routine Care) records are stored internally on an SD card. Midmark has developed a Digital Ecosystem Connectivity Module that is incorporated into the Midmark Smart M9® and Smart M11® Sterilizers which adds the ability to transfer electronic sterilization records to the Midmark cloud and to remotely view the current status of, or cycle history for multiple sterilizers. Optional features and settings that may be distributed to multiple sterilizers from the cloud include distribution of software updates to the connectivity module, compliance settings, and entering the results of biological indicator tests. Connectivity is not needed to perform the sterlizer's intended use, and connecting a sterilizer does not change the intended use.

The provided document is a 510(k) summary for the Midmark Smart M9® and Smart M11® Sterilizers. It details the device's characteristics and its non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are based on its ability to perform sterilization effectively and safely according to established standards. The reported device performance is indicated by its compliance with these standards.

Table of Acceptance Criteria and Reported Device Performance

Study Details:

The document states that non-clinical evaluations were performed for the Midmark Smart M9® and Smart M11® Sterilizer. The purpose of these evaluations was to demonstrate compliance with recognized standards for safety and performance, thereby proving substantial equivalence to a legally marketed predicate device.

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

   • The document does not specify a sample size for the test set (e.g., number of sterilization cycles tested, number of units tested).
   • The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given that it concerns a medical device seeking FDA clearance, it's implied that the testing was conducted under controlled conditions to regulatory standards.

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

   • This information is not applicable to this type of device and study. The ground truth for a sterilizer is established through physical and biological indicators demonstrating the elimination of microorganisms, not through expert consensus on image interpretation or diagnosis. The "experts" implicit in this context are the testing laboratories and their personnel following the specified scientific and engineering standards.

3. Adjudication method for the test set:

   • This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies. For device performance testing against engineering standards, the results are objective measurements (e.g., temperature, pressure, biological indicator kill) that either pass or fail the predefined criteria.

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

   • No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging AI/CAD systems that assist human readers. The Midmark Smart M9® and Smart M11® Sterilizers are steam sterilizers, and their performance is evaluated directly against physical, chemical, and biological sterilization parameters, not through human interpretation of cases.

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

   • This question is not applicable in the conventional sense of AI/algorithm performance. The device is a physical sterilizer with automated cycles. Its "performance" is inherently "standalone" in that it performs its function without human intervention during the sterilization cycle once initiated. The evaluations listed are standalone device performance tests.

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

   • The ground truth for a sterilizer's performance is objectively defined by the complete kill of specific biological indicators (e.g., bacterial spores known to be highly resistant to sterilization processes) under specified conditions (temperature, pressure, time). It also includes measured physical parameters (e.g., temperature and pressure profiles over time) matching the standards, and the successful completion of cycles without errors. This is a scientific and engineering ground truth, not based on human consensus or pathology from patient outcomes.

7. The sample size for the training set:

   • The document does not mention a "training set" in the context of machine learning or AI. This device is a traditional medical device (steam sterilizer), not a deep learning or AI-based diagnostic tool that requires a training set. The design and validation of the sterilizer are based on established engineering principles and extensive physical and biological testing.

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

   • This question is not applicable as there is no mention of a training set for an AI/ML algorithm.

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Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam.

The Lexa MNI has not been designed to sterlize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Key program features, including sterilization time, temperature and recommended load type are listed in the following:

• Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)

• Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 1bs)

• Low Temperature (250°C/121°C): 30' sterilization time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)

• Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 1bs / Lexa MINI RIS-305: 3.3 Ibs)

Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam.

The Lexa MNI has not been designed to sterlize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave. Key program features, including sterilization time, temperature and recommended load type are listed in the following:

• Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)

• Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 1bs)

• Low Temperature (250°C/121°C): 30' sterilization time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 lbs / Lexa MINI RIS-305: 3.3 lbs); wrapped Porous/Textile load (0.22 lbs)

• Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 1bs / Lexa MINI RIS-305: 3.3 Ibs)

The provided text is related to an FDA 510(k) clearance for a steam sterilizer (Lexa MINI), not a device that involves AI/ML, human readers, or a test set with ground truth established by experts.

Therefore, the requested information about acceptance criteria, reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the given document. These are typical requirements for evaluating the performance of AI/ML-driven medical devices, which the Lexa MINI sterilizer is not.

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The PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operating temperatures should not be sterilized using the PRIMUS Healthcare Sterilizer.

The PRIMUS Healthcare Sterilizer model PSS11-HA & PSS11-HB are designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer models PSS11-HA and PSS11-HB are used with eleven standard pre-programmed cycles (factory preset), which are listed in Table 2 All cycles in the PSS11-HA and PSS11-HB are validated and compliant with AAMI ST8:2013/(R) 2018. The unit is manufactured in compliance with ISO 13485:2016 and the FDA's Good Manufacturing Practice (GMP) for Medical Devices. The sterilizer unit is equipped with a height-adjustable steel floor stand. On freestanding units, stainless steel cabinet side panels enclose the sterilizer body and piping. A Back Cabinet Panel is provided as an optional feature on single-door freestanding units where the unit is accessible on all sides.

The PRIMUS Healthcare Steam Sterilizer consists of the following components and accessories:

1. Jacket Assembly (sterilizer vessel)
2. Chamber Finish
3. Chamber Door
4. Insulation
5. Chamber Drain System
6. Drain Water Quench (Piping System)
7. Vacuum system
8. Steam Source
9. Control system: PRIMUS Healthcare Sterilizer model PSS11-HA and PSS11-HB can use either the IDEC FC6A Microsystem or the Allen Bradley CompactLogix system platforms, depending on availability. The PSS11-H PRIMATIC 100 control software remains the same, and all functional and software specifications remain consistent between the platforms. The programmable logic controller (PLC) provides process control, while the human-machine interface (HMI) serves as the interface between the operator and the PLC.

The provided document describes the PRIMUS Healthcare Sterilizer (Models PSS11-HA and PSS11-HB) and its non-clinical testing to demonstrate substantial equivalence to a predicate device (PRIMUS Healthcare Sterilizer, Model PSS11-HC, K221474).

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

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

The document does not specify general "samples" in terms of number of devices for these tests. Instead, it states that the performance testing was conducted on "all the cycles in the PRIMUS healthcare steam sterilizer." This implies that the tests were performed on the device models (PSS11-HA and PSS11-HB) and their defined sterilization cycles as per the standards.

The document indicates "Design verification and validation activities have been carried both in-house and by outsourcing to appropriate third-party vendors." It does not provide information on the country of origin of the data or whether it was retrospective or prospective.

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

This information is not applicable and not provided in the document. The "ground truth" for a medical device like a sterilizer is typically established by recognized national and international standards (e.g., ANSI/AAMI ST8, ASME codes, IEC standards) and their specified testing methodologies, rather than expert consensus on individual cases. The tests described are engineering and performance validation tests against these established standards.

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

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving subjective human assessment of diagnostic output, particularly for AI/machine learning devices. The document concerns a steam sterilizer, and the tests are objective engineering and performance validations against predefined standards.

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 information is not applicable. The device is a steam sterilizer, not an AI-assisted diagnostic or imaging device that would involve human readers.

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

This information is not applicable. The device is a steam sterilizer, not an algorithm, and its performance is assessed directly, not through an algorithm in a standalone capacity.

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

The ground truth for the performance of the PRIMUS Healthcare Sterilizer is based on compliance with established national and international standards. Specifically, for performance testing, it is "Compliance to performance requirements defined in ANSI/AAMI/ST8:2013 (R2018)." Other ground truths are compliance with relevant electrical safety (UL, CSA), EMC (IEC), control panel (UL), and pressure vessel (ASME) standards.

8. The sample size for the training set

This information is not applicable. The device is a hardware sterilizer, not a machine learning or AI model that requires a training set.

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

This information is not applicable as there is no training set for this type of device.

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The T-Top 10 & T-Top 11 tabletop autoclaves are designed for the sterilization of medical and surgical goods such as wrapped and unwrapped solid, hollow, and porous loads used in health care facilities (e.g., hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical & dental offices).

The T-Top 10 and T-Top 11 devices are validated for use in:

• · Unwrapped instruments, wrapped instruments and dental handpieces (Class S cycles).
• · Unwrapped instruments, wrapped instruments, sterilizing dental handpieces and textiles/porous loads (Class B cycles).

The autoclave is fully automatic (a computerized control unit ensures a fully automatic sterilization cycle, control and monitoring of physical parameters and a clear documentation of the sterilization cycle. Drying is performed with the door closed).

This autoclave uses steam as a sterilizing agent.

The steam is produced by warming up a controlled amount of water inserted to a pipe heating element, and then to the chamber. This technique saves energy and water consumption.

The autoclave is equipped with a Pipe heating element and with chamber heaters to maintain the steam inside the chamber.

The autoclave is equipped with a vacuum system, which supports and improves:

• . Removal of residual air from packs and porous load and most kinds of tubes (rubber, plastic etc.) by vacuum at the first stage of the cycle.
• . Steam penetration into the load; resulting in effective sterilization.
• . Temperature uniformity.
• . Post sterilization drying phase

A touchscreen is used for monitoring and control purposes.

The device has 2 built -in USB ports to enable the operation of an external optional barcode printer:

• The barcode printer can print labels with a unique cycle ID barcode, operator name, . sterilization and expiry dates
• . One barcode printer can be connected to the machine.
• The printer connection to the machine, by using a USB socket, with a dedicated cable .
• Barcode printer power supply voltage can range between 100-240V (external power . supply - not from the USB socket).
• . A barcode printer is an optional addition to the autoclave

The device features built-in memory to record up to 500 sterilization cycles. These can be exported to a USB device to be transferred to a PC.

The T-Top 10 autoclave has one configuration only, whereas T-Top 11 has two configurations (available upon request) - a manually filled reservoir of demineralized water or an automatic / direct inlet of demineralized water from the water supply system. The T-Top 10 has a manually filled reservoir of demineralized water only.

There is a demineralized water overflow outlet at the rear, and a demineralized water overflow, and wastewater outlet is located on front.

Automatic water quality checking will alert the user of poor water quality, protecting the autoclave chamber from corrosive minerals found in poor quality water.

The T-Top 10 & T-Top 11 feature a built-in memory to record up to 500 sterilization cycles. The T-Top 10 & T-Top 11 have a built-in USB port to enable exporting this data to a USB device, to be transferred to a PC.

The built-in USB port also enables the operation of an external, optional barcode printer, by using a dedicated cable - the barcode printer can print labels with a unique cycle ID barcode, operator's name, sterilization and expiry dates. One barcode printer can be connected to the machine.

There is Wi-Fi connection available to customers (optional). If the unit is connected to Wi-Fi, this enables remote diagnostics and issue resolution from Tuttnauer. The software has been validated and cybersecurity has been considered for this option - see software reports in the 510(k) file.

The chamber is made of a corrosion-resistant 304L stainless steel, and the door is made of corrosion-resistant 304L stainless steel. The outer covers are made of polycarbonate.

The provided text describes the regulatory clearance of a steam sterilizer (T-Top 10 & T-Top 11) and its performance testing against established standards. It does not contain information about an AI/ML-driven medical device, nor does it detail a clinical study involving human readers or the establishment of ground truth by multiple experts. Therefore, many of the requested categories are not applicable to the provided document.

However, I can extract and present the information regarding the device's acceptance criteria and the study that proves it meets those criteria, based on the provided text.

Here's the relevant information:

Acceptance Criteria and Device Performance Study for T-Top 10 & T-Top 11 Steam Sterilizer

The T-Top 10 & T-Top 11 are steam sterilizers, and their performance is evaluated based on their ability to consistently achieve sterilization parameters and operate safely according to recognized standards. The "study" proving this involves various performance tests, not a clinical trial in the sense of AI/ML device evaluation.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not specify a "sample size" in the conventional sense of a clinical trial (e.g., number of patients/images). Instead, performance testing of a sterilizer involves a series of runs or cycles under specific conditions. The provenance is internal laboratory testing against established standards, not necessarily geographical (e.g., country of origin of data). It is retrospective in the sense that the tests were conducted prior to the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. The "ground truth" for a steam sterilizer's performance is objective and defined by established physical and biological parameters (temperature, pressure, time, sterility assurance level) as per industry standards (e.g., ANSI/AAMI ST-55). It does not involve expert interpretation or consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the assessment is based on objective measurements and predefined pass/fail criteria, not subjective human judgment requiring adjudication.

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

Not applicable. This type of study is relevant for AI/ML devices that assist human readers in tasks like image interpretation. A steam sterilizer does not involve human reading or AI assistance in its primary function.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical sterilizer and not an algorithm in the context of AI/ML. Its performance is inherent to its physical operation and design conforming to engineering and sterilization standards.

7. Type of Ground Truth Used

The ground truth used for this device is based on pre-established industry standards and scientific principles for sterilization, including:

• Physical parameters: Temperature, pressure, and exposure time, measured by calibrated instruments.
• Biological indicators (BIs): Spore strips containing highly resistant microorganisms (e.g., Geobacillus stearothermophilus) which, when inactivated, demonstrate a required sterility assurance level (SAL) (usually 10^-6^).
• Chemical indicators (CIs): Devices (like Bowie-Dick test sheets) that react to specific sterilization conditions (e.g., steam penetration, air removal) with a visible color change.
• Engineering specifications: Electrical safety, electromagnetic compatibility, pressure vessel integrity.

8. Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set" in the context of machine learning. The device's design and operation are based on engineering principles and validated through the performance tests outlined above.

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

Not applicable. There is no training set or ground truth in the AI/ML sense. The "training" for such a device is its design and manufacturing process to meet the specified performance metrics.

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The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA and SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact.

The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is a table-top steam sterilizers that uses saturated steam at high pressures and temperatures and kills infectious bio-organisms. The steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to the established time, temperature, and pressure parameters. Items to be sterilized are placed in the sterilization chamber. The user selects a sterilization cycle, and presses the start switch to initiate the cycle. The sterilizer will automatically fill water into the chamber, heat the water into steam, introduce steam-flush and pressure-pulses, hold at a set pressure, temperature, and time to sterilize the items, and automatically vent the steam and cool the chamber down after the sterilization is complete.

This document describes the acceptance criteria and the study that proves the device, STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R), meets those criteria.

Key takeaway: This submission (K231489) is for a modification of an already cleared device (K181993). The primary modifications are a change in the pressure vessel supplier, some operational feature optimizations, and reduced air removal and dry times. The performance claims for sterilization and drying are maintained. Therefore, the acceptance criteria and study primarily focus on demonstrating that these modifications do not negatively impact the previously established safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a modified device, the acceptance criteria are generally that the modified device performs "as well as or better than" the predicate device and meets relevant industry standards. The performance data presented demonstrates this equivalence or improvement.

• No growth at half cycle with validation loads
• Includes textile PCD, wrapped instrument PCD, and dental handpieces
• Compliance with ANSI/AAMI ST55:2016 |
  | Moisture Retention | Meets moisture retention test criteria in ANSI/AAMI ST55:2016 for:
• Textile test packs
• Wrapped instrument test trays
• Paper-plastic peel pouches |
  | Empty Chamber Temperature Mapping | Capable of providing steady-state thermal conditions within the chamber consistent with the desired SAL in the load. (Compliance with ANSI/AAMI ST55:2016) |
  | Air Removal Performance (Bowie-Dick Test) | Verified air removal performance. (Compliance with ANSI/AAMI ST55:2016) |
  | Electrical Safety | Meets all applicable safety requirements for electrical equipment specified in UL 61010-1 3.1 Ed., and IEC 61010-2-040 3rd Ed. 2020-05. |
  | Electromagnetic Compatibility (EMC) & Electrical Safety | Meets all applicable electromagnetic compatibility and electrical safety requirements for electrical equipment specified in EN IEC 61326-1:2021 and associated standards. |
  | Software Verification & Validation | Software meets safety and functional requirements and fulfills user needs. |
  | Cycle Times (Example: Drying Cycle) | Reduced Drying Times:
• Unwrapped instruments: 20 minutes (previously 30 min)
• Wrapped instruments (pouches): 20 minutes (previously 30 min)
• Handpieces: 20 minutes (previously 30 min)
  Note: Wrapped instruments (Packs) drying cycle remains 30 minutes. The drying performance has been successfully verified using the reduced dry time. |
  | Safety (Pressure Relief) Valve Setting | Equivalent to predicate: 40 psi (275.8 kPa) to 41 psi (282.7 kPa) Max. ASME approved. |
  | Sterilization Method | Equivalent to predicate: Dynamic-air-removal steam sterilizer with 2 steam-flush pressure-pulses (previously 4). |

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

The document does not specify exact sample sizes for each non-clinical test (e.g., number of sterilization cycles performed for biological performance, number of Bowie-Dick tests). It refers to compliance with standards like ANSI/AAMI ST55:2016, which would dictate appropriate sample sizes for validation.

The data provenance is not explicitly stated as "country of origin," but given the submitter's address (STURDY Industrial CO., LTD., New Taipei City, Taiwan), it's highly probable the testing was conducted in Taiwan or by a contracted lab following international standards. The studies were retrospective in the sense that they were performed to validate design changes on an existing device, rather than a de novo clinical trial.

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

This device, a steam sterilizer, does not involve diagnostic interpretation or human-in-the-loop performance. Therefore, "ground truth" is established through objective engineering and microbiology performance metrics (e.g., spore kill, temperature and pressure readings, moisture levels, electrical safety standards compliance). There are no "experts" in the sense of clinicians or radiologists adjudicating results, but rather qualified test engineers and microbiologists performing and analyzing the validation tests according to established international standards (e.g., ANSI/AAMI, IEC, UL). The document does not specify the exact number or individual qualifications of these testing personnel.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance is based on objective measurements against pre-defined engineering and microbiological standards, not subjective human interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a steam sterilizer, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was performed.

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

The entire performance evaluation for this device is effectively "standalone" in the sense of the sterilizer's function without continuous human intervention during a sterilization cycle. The device's performance (sterilization efficacy, drying, etc.) is objectively measured and validated against standards, independent of human operators' real-time judgment during the sterilizing process.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on:

• Microbiological Standards: Demonstrated sterility (SAL of 10^-6) through biological indicator challenges and growth/no-growth results, a fundamental requirement for sterilizers.
• Physical Parameters: Objective measurements of temperature, pressure, and time profiles within the sterilization chamber during cycles, ensuring they meet the required conditions for sterilization.
• Engineering Standards: Compliance with relevant safety (electrical, pressure vessel), electromagnetic compatibility, and performance standards (e.g., ANSI/AAMI ST55:2016 for sterilizer performance, IEC and UL for electrical safety).
• Performance Metrics: Measurements of residual moisture content and verification of clean air removal (Bowie-Dick test).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The "training" for such a device would be its historical design and manufacturing processes, which are validated through adherence to quality systems and standards, not a specific data training set in the AI sense.

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

Not applicable, as this is not an AI/machine learning device requiring a discrete training data set with established ground truth. The "ground truth" for the predicate device's design (K181993) and the modifications in K231489 are established through adherence to recognized consensus standards for medical device design, manufacturing, and performance.

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Lexa MINI is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a healthcare provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of medical and dental instruments that are validated to be sterilized by steam. The Lexa MINI has not been designed to sterilize liquid loads, biomedical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and/or damage to the autoclave.

Key program features, including sterilization time, temperature and recommended load type are listed in the following:

• Wrapped & Porous (270°F/132°C): 4' sterilization time; 10' drying time (recom.); for all types of load; wrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs); wrapped Porous/ Textile load (0.22 lbs)

• Wrapped (270°F/132°C): 4' sterilization time; 10' drying time (recom.) for all types of load; except porous/textile load; wrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs)

• Unwrapped (270°F/132°C): 4' sterilization time, 1' drying time (recom.) for all types of load; except porous/textile load; unwrapped items (Lexa MINI RIS-303: 2.2 Ibs / Lexa MINI RIS-305: 3.3 Ibs)

Not Found

The provided text is a 510(k) summary for the Lexa MINI steam sterilizer, a Class II medical device. It does not contain information about the acceptance criteria or a study proving that the device meets those criteria, as one would typically find for an AI/ML-driven device.

The document focuses on the FDA's decision to clear the device for market, based on its substantial equivalence to predicate devices, and outlines regulatory requirements for the manufacturer. It specifies the intended use of the sterilizer, its operating parameters (sterilization time, temperature, drying time, and recommended load types), and its classification as an Over-The-Counter Use device.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, ground truth establishment, expert involvement, or MRMC studies from the provided text. This type of information is typically found in performance studies or clinical validation sections of a 510(k) submission, not in the FDA's clearance letter and indications for use.

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The PRIMUS Healthcare Sterilizer (Model PSS11-HC) is designed for use in surgery, central sterile, and surgery centers. The PRIMUS Healthcare Sterilizer provides efficient steam sterilization of non-porous and moisture stable materials. The sterilizer can be used on various materials that withstand operating temperatures; however, the materials that cannot withstand operatures should not be sterilized using the PRIMUS Healthcare Sterilizer.

PRIMUS Healthcare Sterilizers are compliant with AAMI ST8:2013 and manufactured in compliance with ISO 13485:2016 and FDA's Good Manufacturing Practice (GMP) for Medical Devices. Each sterilizer is equipped with a height-adjustable, steel floor stand. On freestanding units, stainless steel cabinet side panels enclose the sterilizer body and piping. A Back Cabinet Panel is provided as an optional feature on single door, freestanding units where the unit is accessible on all sides. The PRIMUS Healthcare Series Steam Sterilizer consists of the following components and accessories: 1. Jacket Assembly (sterilizer vessel), 2. Chamber Finish, 3. Chamber Door, 4. Insulation, 5. Chamber Drain System, 6. Drain Water Quench (Piping System), 7. Vacuum system, 8. Steam Source, 9. Control system.

The provided text describes the acceptance criteria and the study that proves the PRIMUS Healthcare Sterilizer (Model PSS11-HC) meets these criteria. It's important to note that this document is for a steam sterilizer, not an AI/ML medical device, so some of the requested information (like number of experts for ground truth, MRMC study, training set details) are not applicable as they relate to AI/ML diagnostic or prognostic devices.

Here's the breakdown based on the provided information:

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a "sample size" in the context of a test set for data (like images or patient records) as this device is a physical sterilizer. Instead, testing involves the sterilizer itself and its components.

• Sample Size: Not applicable in the traditional sense of data samples. The testing relates to the device itself and its processes.
• Data Provenance: Not applicable. The testing is based on engineering and performance validation of a manufactured device against established standards.

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

Not applicable. For a physical sterilizer, "ground truth" is established by adherence to engineering and performance standards (e.g., specific temperatures, pressures, biological indicator kill rates). There is no "expert consensus" on ground truth for diagnostic image interpretation in this context. The validation is against defined physical and biological parameters.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for medical image interpretation tasks where human readers might disagree. For a sterilizer, the tests are objective: either the device meets the physical parameters and sterilization efficacy requirements, or it does not.

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

No. An MRMC study is relevant for diagnostic or prognostic AI/ML medical devices where human readers' performance with and without AI assistance is compared. This document concerns a physical steam sterilizer.

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

Not applicable. This is not an algorithm, but a physical device. Its "performance" is inherently "standalone" in that it performs its function (sterilization) independently, but its use requires human interaction (loading, initiating cycles, maintenance).

7. The Type of Ground Truth Used

The "ground truth" for the PRIMUS Healthcare Sterilizer is based on established industry and regulatory standards for steam sterilization. This includes:

• Physical parameters (temperature, pressure, time) according to specific cycles.
• Demonstrated sterilization efficacy (implied by compliance with standards like ANSI/AAMI ST8), which typically involves biological and chemical indicator testing.
• Compliance with electrical safety, EMC, and pressure vessel codes.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product and does not have a "training set" in the machine learning sense.

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

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

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