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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 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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