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The Getinge GSS610N21 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 steam sterilizer is used 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 Getinge GSS610N21 Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.

Here's a breakdown of the acceptance criteria and study information for the Getinge GSS610N21 Series Steam Sterilizer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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The Getinge GSS610N 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 GSS610N Series Steam Sterilizer is available in 3 models differentiated by chamber length: GSS610N Model 610N10 (40.9 inch chamber), GSS610N Model 610N14 (51.1 inch chamber), and GSS610N Model 610N15 (60.6 inch chamber).

The steam sterilizer is used 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 Getinge GSS610N Series Steam Sterilizer employs both with gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters

This document is about the FDA 510(k) clearance for the Getinge GSS610N Series Steam Sterilizer (K201927). It describes the device, its intended use, and the non-clinical testing performed to demonstrate its substantial equivalence to a predicate device.

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

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

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The Getinge GSS67N 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 GSS67N Series Steam Sterilizer is available in 3 models differentiated by chamber length; GSS67N Model 6710 (39 inch chamber), GSS67N Model 6713 (51 inch chamber) and GSS67N Model 6717 (67 inch chamber).

The Getinge GSS67N Series Steam Sterilizer is designed for sterilization of heat and moisture stable materials used in healthcare facilities. There are three model designations to identify three different chamber lengths. The model 6710 is 1000 mm (39") long, model 6713 is 1300 mm (51") long and model 6717 is 1700 mm (67") lona.

The Getinge GSS67N Series Steam Sterilizer employs both gravity/downward displacement with positive pulse conditioning and pressure/vacuum pulsing for dynamic air removal. Up to 11 standard cycles can be easily accessed and custom cycle names can be designated by the user. All cycle phases are sequenced and monitored by the control system, providing both audible and visual notification of deviation from certain operating parameters.

This document pertains to the Maquet GmbH Getinge GSS67N Series Steam Sterilizer (K172159).

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the GSS67N Series Steam Sterilizer are derived from the ANSI/AAMI ST8:2013 Hospital Steam Sterilizers standard. The reported device performance indicates that the sterilizer meets these requirements.

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

The document does not explicitly state a specific "sample size" in terms of number of sterilizers or distinct test runs for the validation of each cycle. However, the performance testing was conducted according to ANSI/AAMI ST8:2013 Hospital Steam Sterilizers, which outlines rigorous testing protocols. For each cycle type (PREVAC, GRAVITY, IUSS, Liquids, Bowie-Dick), validation was performed using specific process challenge devices and configurations as detailed in the standard.

• Data Provenance: The testing was carried out by Maquet GmbH, the manufacturer, to demonstrate compliance with the ANSI/AAMI ST8:2013 standard. The data is prospective as it involves validation testing specifically for this device series, rather than retrospective analysis of existing data. The country of origin of the data is implicitly Germany (manufacturer location).

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

This document does not provide information on the "number of experts" or their specific "qualifications" for establishing ground truth for the test set. For steam sterilizers, the "ground truth" is typically established by physical and biological indicators showing successful sterilization, rather than expert judgment in interpreting images or clinical outcomes. The adherence to the ANSI/AAMI ST8:2013 standard itself implies that the methodologies for determining effective sterilization are standardized and technically validated.

4. Adjudication Method for the Test Set:

Not applicable in the context of sterilizer performance validation. The outcomes of sterilization cycles are determined by objective measurements (temperature, time, pressure) and biological indicator analysis. There is no subjective interpretation or "adjudication" in the sense of expert review of discrepancies.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No. This is not a diagnostic device that involves human readers interpreting data.

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

Yes, in essence. The device (steam sterilizer) operates autonomously based on its programmed cycles. The performance validation assessed the sterilizer's ability to achieve sterilization without human intervention in the sterilization process itself. Human involvement is in operating the device and loading/unloading items, but the sterilization process is automated ("algorithm only" in the context of its defined cycles).

7. The Type of Ground Truth Used:

The ground truth used for performance validation is based on:

• Biological Indicators (BI kill): Complete kill of biological indicators is a primary ground truth for sterility.
• Physical/Chemical Indicators: Achievement of sufficient Fo value (a measure of sterilization lethality related to time and temperature).
• Physical Measurements: Temperature, pressure, and time parameters are monitored.
• Moisture Retention: Quantitative measurement of weight increase and qualitative assessment of wet spots.
• Bowie-Dick Test Pack: Changes indicating proper air removal and steam penetration.
• Water Loss: Quantitative measurement for liquid cycles.

These are objective, outcome-based measurements directly demonstrating the physical and biological effectiveness of the sterilization process according to established industry standards.

8. The Sample Size for the Training Set:

Not applicable. This device is a hardware sterilizer, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "training" for the device would be its engineering design and validation processes against established standards.

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

Not applicable, as there is no training set in the context of AI/ML. The device's "ground truth" for its operation is established by adherence to the physical and biological principles of steam sterilization, codified in standards like ANSI/AAMI ST8:2013, and confirmed through extensive engineering design and testing.

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The Bora UP 2080, BORA UP 2080 OP and BORA UP 2080 MOUNTING are intended as extraction suction units for aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient's bedside.

The MEDAP BORA is a high performance, low-noise suction pump designed for continuous operation and suitable for high flow/high vacuum. The vacuum for the MEDAP BORA is produced by an electrically driven pump unit. The pump must be operated with an overflow protection device. The overflow protection device with float prevents the unit from oversuction. In the event of a high filling level, the float rises, closes the suction line and prevents liquid from discharging. In addition, the hydrophobic bacterial and viral filter prevents the penetration of particles and liquid into the suction unit. A bacterial filter paper in the exhaust air area guarantees additional safety for patients and operators. The unit is equipped with a hydrophobic bacterial and viral filter to protect the inside of the pump from bacterial contamination. This hydrophobic bacterial and viral filter must be used when treating infectious patients. The vacuum can be set from 0 to -90kPa (0 to -675 mmHg) using a regulation switch and is controlled using a vacuum gauge.

This 510(k) premarket notification for the Maquet GmbH & Co. KG MEDAP BORA device does not contain information about specific acceptance criteria, device performance results, or a study design in the way one would typically find for an AI/ML-driven medical device. Instead, it describes a traditional medical device (a powered suction pump) and focuses on establishing substantial equivalence to a predicate device.

Therefore, many of the requested categories are not applicable to the provided document. I will fill in the available information and explicitly state when information is not present or not relevant for this type of submission.

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

"The BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting incorporate similar fundamental scientific technology as its predicate device."

"The performance data of BORA UP 2080, BORA UP 2080 OP, BORA UP 2080 Mounting are equivalent to the predicate device." |
| - Intended Use | - Intended use is presented as equivalent (as extraction suction units for aspiration and removal of fluids and infectious material). |
| - Principles of Operation | - Operates as a high-performance, low-noise suction pump with an electrically driven unit, overflow protection, and bacterial/viral filters, similar to the predicate. |
| - Design | - Design is presented as equivalent to the predicate. |
| - Physical Characteristics | - Physical characteristics are presented as equivalent to the predicate. |
| - Performance (e.g., vacuum range, flow rate, safety features) | - Vacuum can be set from 0 to -90kPa (0 to -675 mmHg). Performance data stated as equivalent to the predicate device. Specific quantitative performance metrics beyond vacuum range are not detailed in this summary. Product features like overflow protection, hydrophobic bacterial/viral filters, and bacterial filter paper for exhaust air are mentioned as safety features. |
| - Safety | - Safety features (overflow protection, bacterial/viral filters) are described, and overall safety is presented as equivalent to the predicate. |

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

• This document describes a traditional medical device (powered suction pump) and does not involve AI/ML technology. Therefore, there is no "test set" in the context of evaluating an algorithm's performance on data. The evaluation is based on engineering principles, design specifications, and comparison to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This is not an AI/ML device requiring expert ground truth for a test set.

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

• Not applicable. This is not an AI/ML device requiring data adjudication.

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.

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

• Not applicable. This is not an AI/ML device.

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

• Not applicable. The "ground truth" for this device would be its ability to meet engineering specifications (e.g., vacuum pressure, flow rates, safety mechanisms) which are established through bench testing and compliance with relevant standards, rather than clinical ground truth as understood for AI/ML.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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