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Getinge Series Warming Cabinet (models 5524, 5618, 5624) are designed for the heating and storage of irrieation solutions and/or blankets used in the care of patients in areas such as surgery, recovery, OB/GYN, ICU or ER.

The Getinge Series Warming Cabinets are designed for warm storage of solutions and blankets used for patient care in healthcare facilities. The model designations include 5618, 5624, and 5524. The Getinge Series Warming cabinet is not intended for the storage of injectable fluids, blood or blood products.

The provided text describes a 510(k) premarket notification for the Getinge Series Warming Cabinet. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than providing a detailed study of acceptance criteria and performance as might be seen for more complex medical devices like those involving AI.

Therefore, many of the requested categories for the description of "acceptance criteria and the study that proves the device meets the acceptance criteria" are not fully applicable or are not explicitly detailed in this type of submission.

Here's a breakdown of the available information:

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

The document does not present a formal table of acceptance criteria and reported device performance in the way a clinical trial or performance study for a high-risk device might. Instead, it summarizes "performance testing" and compares features to a predicate device.

However, based on the "Summary of Performance Testing" and the comparison table, we can infer some criteria and reported performance:

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: The document states, "All tests were conducted on current production units." It doesn't specify the number of units tested.
• Data Provenance: The tests appear to be internal performance verification conducted by Getinge Sourcing LLC, based in Rochester, New York, USA. The testing is prospective for the purpose of this submission. It is not patient or clinical data.

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 is not applicable. The device is a warming cabinet, and its performance criteria are primarily engineering and safety standards, not clinical diagnostic accuracy. "Ground truth" in the clinical sense (e.g., confirmed disease diagnosis) is not relevant here. The "ground truth" for this device's performance would be derived from physical measurements and adherence to specified design parameters and referenced safety standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in studies where human readers interpret data, often with disagreements that need resolution (e.g., in medical image analysis). For a warming cabinet's functional and safety testing, the "ground truth" is established by physical measurement equipment and compliance with engineering specifications, not by expert consensus on subjective interpretation.

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 is not applicable. The Getinge Series Warming Cabinet is a physical device for heating and storing solutions/blankets, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and analysis of AI-assisted human reader improvement are entirely irrelevant to this device.

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

This is not applicable. As stated above, this is a warming cabinet, not an algorithm or AI system.

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

The "ground truth" for the performance testing of this device is based on:

• Engineering specifications and measurements: For temperature control, heat-up times, and adherence to design parameters.
• Compliance with recognized standards: Such as IEC 61010-1, 61010-2-010, and 61326-1 for electrical safety and electromagnetic compatibility (EMC).
  The measurements and verification against these standards serve as the "ground truth."

8. The sample size for the training set

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

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

This is not applicable as this is not an AI/machine learning device.

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The Getinge 800HC-E Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.

The Getinge 800HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 800HC-E Series Steam Sterilizer is 833HC-E. The model 833HC-E is available in 2 chamber sizes; 42 inches long (39.6 cu ft) and 76 inches long (72.0 cu ft).

The Getinge 800HC-E Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 17 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.

The Getinge 800HC-E Series Steam Sterilizer is a device designed for the sterilization of heat and moisture-stable materials in healthcare facilities. The pivotal study for this device is the "Summary of Performance Testing" which demonstrates its ability to reliably sterilize under various cycle types and load configurations.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Getinge 800HC-E Series Steam Sterilizer are aligned with the requirements of ANSI/AAMI ST8:2008 Hospital Steam Sterilizers. The device performance is deemed successful if these criteria are met.

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

• Sample Size: The document does not explicitly state a numerical sample size in terms of the number of sterilization cycles or tests performed. However, it indicates that "Factory recommended cycles were tested," and for specific validation types (e.g., liquid loads), it mentions "3 one liter flasks." The implied sample size for each specific test type (empty chamber, fabric packs, instrument packs, liquid loads, Bowie-Dick) would be the minimum required by ANSI/AAMI ST8:2008 to demonstrate a statistically significant number of successful sterilizations to achieve the required Sterility Assurance Level (SAL). Given the nature of sterilization validation, this typically involves multiple successful runs to establish consistency and reliability.
• Data Provenance: The testing was conducted by Getinge Sourcing LLC, the manufacturer, at their facilities. This is considered prospective validation testing performed during the development and verification phase of the device. The country of origin for the data is implicitly the United States, as Getinge Sourcing LLC is located in Rochester, NY, and the submission is to the FDA.

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

The document does not specify the "number of experts" or their specific qualifications for establishing the ground truth during the performance testing. However, the ground truth itself is established by adherence to recognized industry standards: ANSI/AAMI ST8:2008 Hospital Steam Sterilizers. This standard defines the methodologies for testing, including the use of Biological Indicators (BIs), F₀ value calculations, and other physical and chemical indicators. Therefore, the "experts" are the developers of the AAMI standard and the trained personnel (e.g., sterilization validation engineers, microbiologists, quality assurance personnel) who conducted the tests according to these established protocols. Their qualification is their adherence to these standards.

4. Adjudication Method for the Test Set:

There is no mention of an "adjudication method" in the context of expert consensus, such as 2+1 or 3+1. For a steam sterilizer, validation is typically based on objective, measurable criteria defined by the AAMI standard. The success or failure of a sterilization cycle is determined by the physical parameters (temperature, pressure, time), the F₀ value, the kill of Biological Indicators (a direct measure of sterility), and physical assessments like moisture retention and wet spots. These are not subject to expert interpretation in the same way clinical image analysis might be.

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

No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices where human readers interpret outputs, and the AI's impact on their performance is being evaluated. The Getinge 800HC-E Series Steam Sterilizer is an automated sterilization device, not an AI-powered diagnostic tool, so such studies are not applicable.

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

Yes, a standalone performance evaluation was conducted. The "Summary of Performance Testing" implicitly describes the standalone performance of the sterilizer. The device's ability to achieve sterilization (complete BI kill, F₀ value, etc.) is assessed based on its own operational cycles and parameters, without human intervention during the sterilization process itself. The "software validation" also attests to the standalone performance of the control algorithms.

7. Type of Ground Truth Used:

The primary ground truth used for the performance testing is a combination of:

• Biological Kill (Microbiological Data): Complete kill of Biological Indicators (BIs) is the ultimate confirmation of sterility, directly demonstrating the achievement of a sterility assurance level (SAL).
• Physical Parameters and F₀ Value (Engineering/Process Data): Achievement of specified temperature, pressure, and time parameters, and calculation of the Fo value, which quantifies the lethality of the steam sterilization process.
• Physical Assessment: Evaluation of moisture retention, presence of wet spots, and water loss, as defined by the AAMI standard.
• Standard Adherence: Compliance with the methodologies and acceptance criteria outlined in ANSI/AAMI ST8:2008 Hospital Steam Sterilizers.

8. Sample Size for the Training Set:

This information is not applicable (N/A). The Getinge 800HC-E Series Steam Sterilizer is a physical electromechanical device for sterilization, which does not employ machine learning or AI models that require "training sets" in the conventional sense of data-driven algorithm development. Its "training" involves engineering design, calibration, and iterative physical testing to optimize its performance before formal validation.

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

This information is not applicable (N/A) for the same reasons as above. The "ground truth" for the device's development relates to fundamental scientific principles of steam sterilization (e.g., thermal death kinetics of microorganisms, heat transfer, pressure dynamics) and engineering design specifications, rather than a labeled dataset for an AI model.

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The Getinge 633HC Steam Sterilizer Air Glide System is intended to provide automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The Air Glide System is used with multiple Getinge Model 633HC 51" steam sterilizers with double-door, pass-through configurations. The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and 2 to 7 Getinge Model 633HC Steam Sterilizers.

The Getinge 633HC Steam Sterilizer Air Glide System is intended to provide automated loading and unloading of instruments requiring sterilization for increasing hospital work flow efficiencies. The Air Glide System is used with multiple Getinge Model 633HC 51" steam sterilizers with double-door, pass-through configurations. The system consists of a single point user interface station, loading conveyor, load transport shuttles, unloading conveyor and 2 to 7 Getinge Model 633HC Steam Sterilizers.

The 633HC AGS is designed to minimize the manual handling of sterilizer loads during transfer, chamber loading and chamber unloading of 633HC steam sterilizers. Users place the load car on the AGS conveyor, scan the load car with a barcode reader, scan the required cycle from the cycle list and click OK to enter the requirements into the AGS system. The AGS now automatically moves the load car to an available sterilizer and automatically loads the sterilizer, signals the sterilizer to run the required cycle and following a successful cycle will automatically unload the sterilizer on the unload end and move the load to the unload conveyor for pick up. Users do not need to load and unload individual sterilizers. The 633HC sterilizer controls the sterilization cycle as it normally would and does not open the unload door unless the cycle completed without error.

The provided document is a 510(k) summary for the Getinge 633HC Steam Sterilizer Air Glide System. It does not include information about acceptance criteria or a study that proves the device meets specific performance metrics in the way a diagnostic software or AI model document would.

Here's why and what information is present:

This device is a hardware system for automated loading/unloading of sterilizers, not a diagnostic or AI software. Therefore, the typical "acceptance criteria" and "study" questions regarding performance metrics (like sensitivity, specificity, etc.), ground truth, expert adjudication, or MRMC studies are not applicable.

Instead, the FDA 510(k) summary focuses on demonstrating substantial equivalence to an existing predicate device (Getinge 633HC Series Vacuum/Gravity Steam Sterilizer, K070657).

Here's a breakdown of the relevant information from the document in relation to your request:

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

• Not applicable in the typical sense for this hardware device.
• The document states that "No clinical data is required for this device classification submission." This indicates that the performance criteria are assessed through other means, likely focusing on engineering specifications, safety, and functionality, rather than clinical performance metrics.
• Implied "Acceptance Criteria" (Substantial Equivalence): The primary "acceptance criteria" for the FDA 510(k) process for this device are demonstrating that it is substantially equivalent to a legally marketed predicate device in terms of intended use, operating principles, safety, and effectiveness.
• Reported Device Performance (as per Substantial Equivalence Comparison):
  • Similarities to Predicate:
    • Intended use of the 633HC Steam Sterilizer is the same (sterilization of wrapped/unwrapped, porous/nonporous items by pressurized steam).
    • Operating Principle of the 633HC Steam Sterilizer is the same (saturated steam as sterilizing agent).
    • No direct patient contact.
    • Cycle Types are the same.
    • Interior of the 633HC Steam Sterilizer and loading car are the same.
  • Differences from Predicate:
    • Software change to the 633HC sterilizer to allow automatic door operation, cycle start, and unload door opening upon successful cycle completion.
    • Addition of a NetCOM card for communication with the Air Glide System.
    • Allows for automated loading and unloading of a bank of multiple 633HC sterilizers, reducing manual handling.
    • Main application is in high-volume, large sterile reprocessing centers.

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

• Not applicable. There is no "test set" in the context of clinical performance data for this device as no clinical data was required. The evaluation is based on engineering and functional equivalence.

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. There is no "ground truth" established by experts for a test set, as this is a hardware system for automation, not a diagnostic or AI algorithm.

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

• Not applicable. No test set or adjudication method is described.

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 hardware automation system, not an AI or diagnostic tool requiring MRMC studies or human reader improvement analysis.

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

• Not applicable. This device integrates an "Air Glide System" with existing sterilizers. While it automates tasks, it's not an algorithm being tested in a standalone diagnostic capacity. The core sterilization function remains within the previously cleared 633HC sterilizer.

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

• Not applicable. No clinical ground truth data is used or discussed. The evaluation focuses on the safety and functional equivalence of the new automated loading/unloading mechanism and its integration with the sterilizer.

8. The sample size for the training set

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

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

• Not applicable. No training set or ground truth for a training set is relevant here.

In summary: The provided document is a 510(k) summary for a Steam Sterilizer Air Glide System (hardware automation), not a diagnostic or AI software. Therefore, the questions related to clinical performance, ground truth, expert opinions, and AI/ML study methodologies are not addressed because they are not relevant to the substantial equivalence determination for this type of device. The focus is on demonstrating that the modifications (automated loading/unloading, software changes) do not raise new questions of safety or effectiveness compared to the predicate device.

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The Getinge 400HC-E/500HC-E Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.

The Getinge 400HC-E/500HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The model designations provided in the 400HC-E/500HC-E Series Steam Sterilizer are 422HC-E. 433HC-E. 522HC-E and 533HC-E.

400HC-E/500HC-E Steam Sterilizer employs both gravity/downward The displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 24 cycles can be easily accessed and custom cvcle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.

This is a 510(k) premarket notification for a Class II medical device, specifically a steam sterilizer. The FDA's 510(k) clearance process is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials to prove efficacy and safety in the same way a PMA (Pre-Market Approval) does. Therefore, typical "acceptance criteria" and "study results" related to diagnostic performance metrics (like sensitivity, specificity, AUC) from a multi-reader, multi-case study are not applicable here.

Instead, the acceptance criteria for this device are based on performance testing to demonstrate that the sterilizer effectively sterilizes various loads according to established industry standards and guidelines. The "study" here refers to validation testing against these standards.

Here's a breakdown of the requested information based on the provided text:

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)

• Sample Size for Test Set: The document does not specify exact "sample sizes" in terms of number of sterilization runs or individual items tested for each cycle type. Instead, it refers to using "fabric process challenge packs," "wrapped instrument process challenge devices," "unwrapped non-porous process challenge device," "3 one liter flasks," and "Bowie-Dick test pack." The number of items per chamber for each load configuration is specified in the tables (e.g., 2 double-wrapped instrument trays for 433HC-E, 12 fabric packs for 533HC-E), indicating various representative loads were tested.
• Data Provenance: This was "Factory recommended cycles were tested," implying prospective testing performed by the manufacturer, Getinge Sourcing LLC, located in Rochester, NY, USA. The testing was conducted according to US (ANSI/AAMI) standards.

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. For a steam sterilizer, "ground truth" for sterilization efficacy is established through objective biological and physical indicators (e.g., biological indicators (BI) demonstrating complete kill of spores, F₀ value measurements, moisture retention measurements, Bowie-Dick test pack color changes). This is not a diagnostic device relying on expert interpretation.

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

Not applicable, as this is not a diagnostic device involving expert interpretation or adjudication of subjective outcomes. The outcomes are objective measurements of sterilization efficacy.

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 standalone medical device (steam sterilizer), not an AI-powered diagnostic tool, and involves no human "readers" or AI assistance in interpretation.

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

Yes, the performance testing described is for the standalone device (the sterilizer itself) without direct human intervention in the sterilization process once the cycle is initiated. The "algorithm" here would refer to the control system and its programmed cycles. The testing demonstrates the sterilizer's ability to achieve sterilization based on its internal programming and physical processes.

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

The ground truth for sterilization efficacy is defined by objective biological and physical endpoints:

• Complete kill of biological indicators (BI): Absence of viable spores after sterilization.
• Sterility Assurance Level (SAL) of at least 10⁻⁶: A statistical measure of the probability of a single viable microorganism occurring on an item after sterilization (achieved through F₀ values).
• F₀ value of at least 12: A measure of thermal lethality, indicating the equivalent time in minutes at 121.1°C (250°F) delivered to the load.
• Moisture retention percentages: Quantitative measurement of water absorbed by or remaining on sterilized items.
• Bowie-Dick test pack results: Visual indicator change confirming adequate air removal and steam penetration (a physical/chemical indicator).
• Water loss not exceeding 50ml: For liquid loads.

These are objective, scientifically measurable ground truths defined by industry standards (ANSI/AAMI ST8:2008).

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a "training set." Its effectiveness is based on physical and chemical principles of steam sterilization, validated by performance 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.

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The Getinge 700HC-E Series Steam Sterilizer is intended for use by health care facilities to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam. The 700HC-E Series Steam Sterilizer is available in 3 models differentiated by chamber length; 733HC-E 39 inch chamber, 733HC-E 53 inch chamber and 733HC-E 61 inch chamber.

The Getinge 700HC-E Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. The only model designation provided in the 700HC-E Series Steam Sterilizer is 733HC-E. The model 733HC-E is available in 3 chamber sizes; 39 inches long (21.5 cu ft), 53 inches long (29.3 cu ft) and 61 inches long 33.7 cu ft).

The 733HC-E Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 22 cycles can be easily accessed and custom cycle names can be designated by the user (duplicate cycles are provided to allow for user designated names). All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.

The acceptance criteria for the Getinge 700HC-E Series Steam Sterilizer are based on the ability to achieve sterilization of various loads under specified cycle parameters, and dryness of the load where applicable. The study proving the device meets these criteria involved comprehensive performance testing conforming to industry standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Getinge 700HC-E Series Steam Sterilizer are implicitly defined by the successful demonstration of:

• Achieving a sterility assurance level (SAL) of at least 10^-6.
• Complete kill of biological indicators (BIs).
• Moisture retention within specified limits for fabric and wrapped instrument packs.
• Successful Bowie-Dick test for air removal.
• Maintaining steady-state thermal conditions within the chamber.
• Water loss not exceeding 50ml for liquid loads.

The reported device performance, demonstrated through validation testing against these criteria, confirmed that the sterilizer performs as intended.

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The Getinge 400HC/500HC Series Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped, porous and nonporous heat and moisture stable items such as surgical instruments and linens by means of pressurized steam.

The Getinge Models 422HC, 433HC, 522HC and 533HC steam sterilizers are the same model designations as the predicate device (K012573). Modifications to the device have been made to include control software updates, vessel material change and the options for a vacuum pump system (in place of water ejector) and stainless steel piping and components (in place of brass piping and components). The modifications made to the 400HC/500HC series Steam Sterilizer do not affect the intended use of the device and do not alter the fundamental science technology of the device. The modifications were made under the procedures and processes of the documented design control process. Performance testing of the modified device models was to ANSI/AAMI ST8:2008.

The Getinge Model 400HC/500HC Series Steam Sterilizer (K103504) is a Class II medical device intended for sterilizing heat and moisture-stable items in healthcare facilities via pressurized steam. The submission describes modifications to a previously cleared device (K012573), including control software updates, a vessel material change, and options for a vacuum pump system and stainless steel piping.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Acceptance Criteria and Reported Device Performance:

The device's performance aligns with the requirements of ANSI/AAMI ST8:2008. While explicit "acceptance criteria" tables with numerical targets are not directly provided, the overall implication is that the sterilizer cycles performed as specified in the "Steam Sterilizer Cycles and Load Chart" and effectively sterilized the described loads within the given parameters (exposure temperature, exposure time, dry time).

The tables in the submission (K103504, pages {1} and {2}) detail the various sterilization cycles, their factory settings (temperature, time, dry time), and the maximum load configurations applicable to each sterilizer model (433HC, 533HC, 422HC, 522HC).

For example, a "PREVAC 1 (vac)" cycle for the 433HC/533HC models has reported performance parameters of:

• Exposure Temp: 275°F (135°C)
• Exposure Time: 3 min
• Dry Time: 16 min
• Load Configuration: Double-wrapped instrument trays (up to 25 lb per tray), Fabric packs
• Maximum Items: 2 (433HC)/3 (533HC) instrument trays, or 4 (433HC)/12 (533HC) fabric packs.

The statement in the conclusion ({3}) indicates: "This steam sterilizer meets the applicable requirements of AAMI ST8:2008 performance standards." This implies that the device successfully met the sterilization efficacy, safety, and performance criteria outlined in the ANSI/AAMI ST8:2008 standard.

Table of Acceptance Criteria (Implied) and Reported Device Performance:

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

The document describes "Performance testing of the modified device models was to ANSI/AAMI ST8:2008" ({0}) and "Load configurations during testing validations follow AAMI Standard ST8 Hospital Steam Sterilizers where applicable." ({2}). It also mentions "All Fabric Packs and instrument trays formulated as described in AAMI Standard ST8 Hospital Steam Sterilizers." ({2}).

The specific numerical sample size for the test set (number of sterilization cycles, number of test devices, etc.) is not explicitly stated. However, it would have followed the recommendations and requirements for validation testing as outlined in ANSI/AAMI ST8:2008 for each specified cycle and load configuration.

The provenance of the data is that it was generated through prospective performance testing and validation conducted by Getinge Sourcing LLC according to an industry standard (ANSI/AAMI ST8:2008). The country of origin of the data is not explicitly mentioned but is presumably the United States, given the company's address and submission to the FDA.

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

This information is not provided in the submission. For a steam sterilizer, the "ground truth" for sterilization efficacy is typically established through the use of biological indicators (BIs) and physical/chemical indicators, which are standardized and provide an objective measure of microbial kill. Expert human review might be involved in interpreting these results, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set:

This information is not provided. Given that the "ground truth" for sterilization is established through standardized indicators and physical measurements, a traditional medical image "adjudication" process (like 2+1 or 3+1) is not applicable or described for this type of device.

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 comparing human readers with and without AI assistance is relevant for diagnostic imaging devices, not for a steam sterilizer.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in essence, the performance testing described is "standalone" for the device's function. The sterilizer operates automatically based on its programmed cycles. The performance validation (to ANSI/AAMI ST8:2008) assesses the device's ability to achieve and maintain the necessary sterilization parameters and efficacy independently. There is no "human-in-the-loop performance" in the context of the sterilization process itself; humans load and unload the device and initiate cycles.

7. The Type of Ground Truth Used:

The ground truth used for verifying the steam sterilizer's performance is based on sterilization efficacy confirmation using standardized biological indicators (BIs) and physical/chemical indicators as per the requirements of ANSI/AAMI ST8:2008. This standard outlines methods for validating that sterilization parameters (temperature, time, pressure, steam quality) are met and that a sufficient level of microbial inactivation (typically a sterility assurance level, SAL, of 10^-6) is achieved.

8. The Sample Size for the Training Set:

This information is not applicable or not provided in the context of this submission. The device is a physical steam sterilizer, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the device refers to its design, engineering, and manufacturing to meet specified performance standards and safety requirements.

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

This information is not applicable or not provided since there isn't a "training set" in the AI/ML context. The device's design and operating parameters are established through engineering principles, adherence to recognized standards (like ANSI/AAMI ST8:2008), and potentially iterative testing and refinement during development.

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The Model 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use by health care facilities and to be used to sterilize wrapped and unwrapped surgical instruments, linens and liquids not intended for direct patient contact) by means of pressurized steam.

The 633HC Series Vacuum/Gravity Steam Sterilizer is intended for use in hospital and health care facilities. The device is an intermediate sized sterilizer within our product offering, it has a vertical sliding power door, upgraded control system and offers similar overall features as those on the Getinge 400HC/500HC Steam Sterilizers including a control panel (user interface) that incorporates a color display with soft key menu navigation, has the same cycle types with similar number of preset cycle types offered.

The provided documentation describes the 510(k) Pre-Market Notification for the Getinge 633HC Series Vacuum/Gravity Steam Sterilizer (K070657), which is a device for sterilizing medical instruments, linens, and liquids in healthcare facilities.

This document is a marketing submission seeking substantial equivalence to a predicate device, not a study report demonstrating the device meets performance criteria through specific, detailed testing. As such, information regarding acceptance criteria and a study proving performance, as typically found in clinical validation studies for AI/ML devices or novel medical devices, is largely not applicable or not present in the context of this 510(k) submission for a steam sterilizer.

However, I can extract information related to the device's functionality and regulatory compliance as presented.

Here's a breakdown based on the provided text, addressing your points where possible and noting where information is not available:

Description of Acceptance Criteria and Device Performance (Steam Sterilizer)

For a steam sterilizer, "acceptance criteria" and "device performance" are typically defined by its ability to reliably achieve sterilization under specified conditions (temperature, pressure, time) for various loads. The documentation confirms that the device meets applicable performance standards.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Load Chart (Excerpt from the document provided as "device performance"):

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

• Not Applicable / Not Provided. This document is a 510(k) summary for a steam sterilizer, which typically relies on established engineering principles, adherence to recognized performance standards (like AAMI ST8, CSA-Z314.7), and comparison to a predicate device. It does not involve a "test set" in the sense of a data set for AI/ML validation or a clinical trial with human subjects. The performance testing would involve physical validation of the sterilizer's cycles using biological indicators and thermometric probes, typically conducted by the manufacturer in a controlled environment. Details of such specific test runs (e.g., number of cycles performed) are not included in this summary.

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

• Not Applicable. As noted above, there isn't a "test set" with "ground truth" established by experts in the context of this 510(k) submission for a steam sterilizer. Sterilizer efficacy is validated by standard microbiological and physical testing methods, not expert human interpretation.

4. Adjudication method for the test set

• Not Applicable. No expert adjudication method is relevant for this type of device and 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 a hardware medical device (steam sterilizer), not an AI/ML diagnostic or assistive tool. No such study would be performed for this device.

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

• Not Applicable. This is a hardware medical device. There is no algorithm in the sense of an AI/ML system to evaluate in standalone mode. The sterilizer operates automatically based on programmed cycles, and its "performance" is its ability to meet those physical parameters.

7. The type of ground truth used

• Engineering and Performance Standards/Physical Measurements: The "ground truth" for a steam sterilizer's effectiveness is based on scientific principles of sterilization (e.g., lethality achieved by sustained temperature and pressure), microbiological validation (e.g., biological indicators showing kill of highly resistant spores), and adherence to recognized industry standards (AAMI ST8, CSA-Z314.7). The device's ability to maintain specified temperature, pressure, and time, and thus render items sterile, is the core of its performance. This is typically verified through physical measurements and biological indicator tests.

8. The sample size for the training set

• Not Applicable / Not Provided. This is a hardware device. There is no "training set" in the context of machine learning. The device design and validation relies on engineering principles and performance testing.

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

• Not Applicable. There is no "training set" for establishing ground truth in this submission. The "ground truth" for acceptable sterilizer parameters is established by scientific consensus in microbiology and healthcare standards organizations (e.g., AAMI, ISO) over many years of research and practice in infection control.

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