Search Results

The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizers MST-H, models 9-6-12, 9-6-15, and 9-6-18 are available in a single door (HS1) or double door (HS2) version. The sterilizers are equipped with Pre-vacuum, Gravity, Liquid, Air Leak Test and Bowie-Dick Test cycles.

The provided document describes the Belimed Steam Sterilizer MST-H, not an AI-powered device. Therefore, the questions related to AI-specific criteria (such as effect size of human readers with AI assistance, standalone algorithm performance, number of experts for ground truth, training set information, or a multi-reader, multi-case study) are not applicable.

The document details the acceptance criteria (performance requirements) for the steam sterilizer and summarizes the studies proving it meets these criteria through non-clinical validation.

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

The document presents performance criteria and verified results implicitly throughout the "EFFECTIVENESS" and "NONCLINICAL COMPARISON TO PREDICATE DEVICE" sections by referencing compliance with ANSI/AAMI ST8:2013 and specific outcomes. Here's a structured table:

Ask a specific question about this device

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed for sterilization of non-porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer MST-V, models 6-0-6, 6-0-9, and 6-0-12 are intended for use in hospital and health care facilities and are intended to be used in an identical manner as the Belimed Steam Sterilizers Series 4-8.

Modifications made from the predicate device include:

• Additional Gravity cycles
• Increase of recommended load capacity.
• New version of Programmable Logic control (PLC) and new operating panel (MMI)

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are available as a single door prevacuum/gravity or double door prevacuum/gravity version.

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are designed to be used for the terminal sterilization of porous and non-porous, heat and moisture stabile materials in the healthcare facilities.

Depending of the chosen cycle materials as different as textiles, unwrapped or wrapped instrument trays with single or multiple instruments may be sterilized.

The Belimed Steam Sterilizers MST-V, models 6-0-6, 6-0-9, and 6-0-12 are factory equipped with cycles which have been tested in accordance with ANSI/AAMI ST8:2008 under defined load conditions. The predicate devices with a chamber volume of 305 l, 440 l, and 595 l have been validated previously.

The provided text describes a 510(k) summary for a steam sterilizer, not an AI/ML-enabled medical device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/ML device performance (e.g., sensitivity, specificity, AUC) are not applicable here.

Instead, the acceptance criteria for this sterilizer are based on its ability to effectively sterilize various loads and meet established safety and performance standards. The "study that proves the device meets the acceptance criteria" refers to a series of nonclinical verification studies based on recognized standards.

Here's how to interpret the information provided in the context of a steam sterilizer:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size for Test Set: The document doesn't specify a precise numerical "sample size" in terms of cases or images, as would be typical for an AI/ML study. Instead, it refers to performing tests on various "test packs," "instrument trays," and "empty chambers" for different cycles (PreVac, Gravity, Flash, Bowie-Dick, Leak Test, Warm-up). The number of times each test was performed is not explicitly stated, but the implication is that sufficient repetitions were done to demonstrate consistent performance as per the standards.
• Data Provenance: The tests were conducted by Belimed Sauter AG. The standards referenced (ANSI/AAMI ST8:2008, etc.) are international/US standards. The document doesn't state specific countries of origin for the data or if it was retrospective/prospective in the clinical sense, as these are non-clinical performance tests on a manufactured device. It seems to be a prospective set of tests performed for regulatory submission.

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

• Not applicable in the AI/ML sense. Ground truth here is established by the physical performance of the sterilizer validated against established scientific principles and industry standards (e.g., complete kill of biological indicators, Fo values, temperature and pressure measurements, moisture retention, color change in Bowie-Dick tests).
• The "experts" would be the engineers and technicians at Belimed Sauter AG trained to conduct these specific validation tests according to the standards. No medical experts (like radiologists) are involved in establishing this type of physical ground truth.

4. Adjudication Method for the Test Set:

• Not applicable in the AI/ML sense. The "adjudication" is inherent in successfully meeting the quantitative and qualitative criteria defined by the relevant standards (e.g., reaching a certain Fo value, achieving uniform color change, staying below a certain moisture retention percentage). There's no human "adjudication" of results in the traditional sense; rather, the device either passes or fails the objective performance criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:

• Not applicable. This is a standalone medical device (a sterilizer), not an AI/ML diagnostic or assistive tool. There are no "human readers" to compare performance with or without AI assistance.

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

• Not applicable in the AI/ML sense. The device itself is "standalone" in that it performs its function of sterilization automatically based on programmed cycles. The performance metrics listed are of the device itself (e.g., its ability to maintain specific temperatures, pressures, and times), not of an algorithm generating an output that a human then interprets.

7. The Type of Ground Truth Used:

• Established scientific and engineering principles, and validated industry standards:
  • Biological efficacy: Complete kill of biological indicators, achieving a sterility assurance level (SAL) of 10-6 reduction.
  • Physical parameters: Precise temperature and pressure control, specific exposure times, moisture retention levels, uniform heat distribution (Bowie-Dick test).
  • Compliance with published standards: ANSI/AAMI ST8:2008, ANSI/AAMI ST79:2006+A1:2008, various IEC, EN, ISO, UL, and ASME standards.

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a "training set." The device is designed, manufactured, and then validated against pre-defined performance standards.

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

• Not applicable. As above, no training set for an algorithm. The "ground truth" for the device's design and factory programming is based on extensive engineering knowledge, scientific principles of sterilization, and compliance with the aforementioned industry standards for sterilizer performance.

Ask a specific question about this device

The Belimed Steam Sterilizer TOP 5000, model 5-5-9, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

The Belimed Steam Sterilizer TOP5000 model 5-5-9 is available as a single door prevacuum or a double door prevacuum version.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer TOP 5000 Series 4 -- 8.

The smaller Chamber size incorporates additional flexibility, in comparison to Series 4 -8, and allows to operate the sterilizer in an economical way.

Motorized or manually operated vertical door movement leads to an optimal compact design, and allows the operation of the sterilizer, where space is limited.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is offered in the following size configurations:

21″x 21″ x 38″ (535 mm x 535 mm x 965 mm) Single Door, Prevacuum 21"x 21″ x 38″ (535 mm x 535 mm x 965 mm) Double Door, Prevacuum

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 is designed to be used for the terminal Sterilization of porous and non porous, heat and moisture stabile materials in the healthcare facilities.

Depending of the chosen cycle materials as different as textiles, glassware, unwrapped or wrapped instrument trays with single or multiple instruments.

The Belimed Steam Sterilizer TOP 5000 model 5-5-9 are factory equipped with cycles which has been tested in accordance with AAMI/ANSI ST-8:2001 under defined load conditions.

The provided document is a 510(k) Special Summary for a medical device called the "Belimed Steam Sterilizer TOP 5000 Model 5-5-9." This document focuses on demonstrating the substantial equivalence of the new model to a predicate device (Belimed Steam Sterilizer TOP 5000 Series 4-8) by highlighting minor modifications and verifying that the device still meets established sterilization standards.

However, the document does not describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the way one would typically define these terms for an AI/ML medical device.

Instead, the "effectiveness" section describes the validation of sterilization cycles based on industry standards, ensuring the sterilizer functions as intended for its core purpose. The "acceptance criteria" here refer to achieving specific sterility assurance levels and performance metrics outlined in these standards, rather than the performance of an AI algorithm with metrics like sensitivity or specificity.

Therefore, many of the requested fields are not applicable to the information provided in this regulatory submission for a steam sterilizer.

Here's an attempt to address the request based on the available information, noting where information is not relevant or not present:

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

The device in question, the Belimed Steam Sterilizer TOP 5000 Model 5-5-9, is a steam sterilizer and not an AI/ML-driven device. As such, the "acceptance criteria" and "study" described in the document relate to the validation of its physical sterilization capabilities against established industry standards rather than the performance of an AI algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

• Demonstrated a sterility assurance level (SAL) of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle.
• Moisture retention: less than 3% increase in pre-sterilization test pack weight.
• Exhibited no wet spots. |
  | PREVAC cycles (Full Load Instrument Trays) acc. AAMI/ANSI-ST8:2001 Section 5.5.4 | - Qualified according to section 5.5.4 of ANSI/AAMI-ST8:2001.
• Demonstrated a SAL of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle.
• Moisture retention: less than 20% increase in pre-sterilization weight of the towel.
• Exhibited no wet spots on the outer wrapper. |
  | FLASH cycles (Unwrapped Instrument Tray) acc. AAMI/ANSI-ST8:2001 Section 5.5.5.1 and ANSI/AAMI ST37:1996 Section 7.7.3 | - Qualified according to the specified sections.
• Demonstrated a SAL of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle.
• Exhibited no wet spots. |
  | LIQUID cycles (Three 1'000 ml flasks) acc. AAMI/ANSI-ST8:2001 Section 5.5.3 | - Qualified according to section 5.5.3.5.
• Demonstrated a SAL of at least 10⁻⁶ through an F₀ of at least 12 by ½ cycle.
• Water loss: not exceeding 50 ml.
• Automatic sealing of the flask closure.
• Temperature of 121°C achieved and maintained in the liquid for at least 12 minutes. |
  | Bowie-Dick (BD) cycle acc. AAMI/ANSI-ST8 Section 5.6 | - Verified using the Bowie-Dick Test Pack.
• Demonstrated a uniform color change throughout the test sheet. |
  | Software Validation | - Performed according to FDA's moderate level of concern recommendations in "Guidance for the Content for Pre-market Submissions for Software Contained in Medical Devices (May 2005)".
• The technology includes microprocessor controller safeguards that abort the cycle and provide signals/warnings for unmet conditions or malfunctions. |
  | Safety and Performance Requirements | - Designed, constructed, and tested to meet UL 61010A-1:2002, UL 61010A-2-041:2002, CSA C22.2 No. 1010-1 (IEC61010-1.2001), and ASME Section VIII, Division 1 for unfired pressure vessels: 2004. |

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

• Test Set Description: The "test set" in this context refers to the defined load conditions and biological indicators used during the validation experiments.
• Sample Size: The document does not explicitly state the number of validation runs or specific biological indicators used for each cycle. It mentions using a "fabric test pack," "full load instruments trays," "unwrapped instrument tray," and "three 1'000 ml flasks."
• Data Provenance: The studies were conducted by SAUTER AG to validate its sterilization cycles using recommended practices, standards, and guidelines developed by organizations such as AAMI. The origin is Switzerland (Sauter AG). The studies are inherently "prospective" in the sense that they were conducted to validate the new device.

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

• Not Applicable. The "ground truth" for a sterilizer is defined by scientific principles of sterilization (e.g., complete kill of biological indicators, achieving specific F₀ values, temperature profiles) and adherence to recognized industry standards (like AAMI/ANSI ST-8:2001). This doesn't involve human expert consensus in the way an AI/ML diagnosis would.

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

• Not Applicable. Adjudication methods like 2+1 are used for reconciling expert disagreements in AI/ML model ground truth establishment. This is not relevant for a sterilizer validation.

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 steam sterilizer, not a device involving human readers or AI assistance in interpretation.

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

• Partially Applicable (in a different sense): The device (sterilizer) operates in a standalone manner according to its programmed cycles. Its "performance" is assessed directly against the physical and biological outcomes of sterilization, without human intervention in the sterilization process itself once initiated. The software validation was done independently against FDA guidance, representing an assessment of the algorithm (software logic) on its own.

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

• The ground truth for the sterilizer's effectiveness is established through:
  • Biological Indicators: Demonstrated complete kill of biological indicators.
  • Physical Parameters: Achievement of specific time-at-temperature sufficient to produce a required F₀ (e.g., F₀ of at least 12 by ½ cycle).
  • Moisture Retention: Specific limits for moisture increase (e.g.,

Ask a specific question about this device

The Belimed Steam Sterilizer TOP 5000, series 4-8, is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities. The Belimed Steam Sterilizer TOP 5000 Series 4 - 8 is equipped with the following factory-programmed Sterilization cycles and cycle values (Table 1).

The Belimed Steam Sterilizer TOP 5000 Series 4 – 8 is intended for use in hospital and health care facilities and is intended to be used in an identical manner as the Belimed Steam Sterilizer TOP 5000 Series 9 - 18. The smaller Chamber size incorporates additional flexibility, in comparison to Series 9 -- 18, and allows to operate the sterilizer in an economical way. Motorized vertical door movement leads to an optimal compact design, and allows the operation of the sterilizer, where space is limited.

The provided text describes the acceptance criteria and the study that proves the device meets those criteria for the Belimed Steam Sterilizer TOP 5000 Series 4-8.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document indicates that the sterilizer's cycles were "validated to meet the requirements of AAMI/ANSI-5T8-2001" and that "verification studies" were performed.

• Test Set Sample Size:
  • PREVAC cycles (fabric test pack): "verified using the fabric test pack, as described in Section 5,5.2 AAMI/ANSI-ST8:2001". The specific number of fabric test packs used is not explicitly stated.
  • PREVAC cycles (full load instrument trays): "verified using full load instruments trays [...] according to section 5.5.4 of ANSI/AAMI-ST8: 2001". The specific number of instrument trays used is not explicitly stated.
  • FLASH cycles: "verified using the unwrapped instrument tray [...] according to section 5.5.5.1 AAMI/ANSI-ST8:2001 and ANSI/AAMI ST37:1996 section 7.7.3". The specific number of unwrapped instrument trays is not explicitly stated.
  • LIQUID cycles: "verified using three 1'000 ml flasks, as described in section 5.5.3 of AAMI/ANSIe ST8:2001". This indicates a minimum of three 1'000 ml flasks were used per test.
  • BD cycle: "verified using the Bowie-Dick Test Pack were qualified according to section 5.6 . of AAMI/ANSI-ST8". The number of Bowie-Dick Test Packs is not explicitly stated but implies standard usage per the referenced section.
• Data Provenance: The studies were conducted by SAUTER AG. The data provenance is internal testing and validation performed by the manufacturer in accordance with recognized industry standards (AAMI/ANSI-ST8:2001, ANSI/AAMI ST37:1996, EN285:1996). The context suggests this was prospective testing conducted to validate the device's performance. The country of origin of the data would be associated with the manufacturer, Sauter AG, based in Switzerland.

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

This section is not applicable as the device is a steam sterilizer, not an AI or diagnostic imaging device that requires human expert review for ground truth in the typical sense. The ground truth is established through physical measurements and biological indicator kill rates as defined by established standards (e.g., AAMI/ANSI-ST8:2001).

4. Adjudication method for the test set

This section is not applicable. As stated above, the device's performance is assessed against physical and biological criteria defined by standards, not by human interpretation requiring 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

This section is not applicable. The device is a steam sterilizer, not an AI-assisted diagnostic or interpretation system.

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

The performance described is standalone. The sterilizer operates autonomously based on its programmed cycles, and its effectiveness is validated through its ability to achieve specific physical and biological endpoints (e.g., SAL, temperature, moisture retention). There is no "human-in-the-loop" performance validation in the sense of an algorithm, other than operators configuring and starting the cycles.

7. The type of ground truth used

The ground truth used for the sterilizer's performance validation is based on objective physical and biological parameters defined by recognized standards:

• Sterility Assurance Level (SAL) of 10^-6: Demonstrated via complete kill of biological indicators and calculation of F0 values.
• Time-at-temperature achievement: Verification that specified temperatures were reached and maintained for the required duration.
• Moisture retention: Quantitative measurement of weight increase (for fabric/towel) and visual inspection for wet spots.
• Water loss: Quantitative measurement for liquid cycles.
• Automatic sealing of flask closure: Observed performance for liquid cycles.
• Uniform color change: For the Bowie-Dick test.
• Compliance with safety standards (UL, CSA, ASME).

These are empirical measurements and outcomes directly observable or measurable against defined benchmarks, not subjective expert consensus.

8. The sample size for the training set

This section is not applicable. The Belimed Steam Sterilizer TOP 5000 Series 4-8 is a hardware device with programmed cycles, not an AI/ML algorithm that undergoes "training" on a data set. The cycles are "factory-programmed" and validated through engineering design and physical testing.

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

This section is not applicable for the reasons stated in point 8.

Ask a specific question about this device

The Belimed Steam Sterilizer TOP 5000 is designed for sterilization of non porous and porous heat and moisture-stable materials used in healthcare facilities.

The Belimed Steam Sterilizer TOP 5000 is equipped with the following factory-programmed sterilization cycles and cycle values (Table 1)

Table 1: Factory programmed Sterilization Cycles

The Belimed Steam Sterilizer TOP 5000 is a Class II medical device as defined by 21 CFR §880.6880. The Belimed Steam Sterilizer TOP 5000 is intended for the terminal sterilization of heat and moisturestable materials in healthcare facilities. The device is equipped with factory-programmed sterilization cycles. It is offered in various medium-size configurations with single or double doors and prevacuum or floor flush designs. The device includes microprocessor controller safeguards that abort the cycle and provide signals, alerts, and warnings when required conditions are not met or a malfunction occurs.

Here's a breakdown of the acceptance criteria and the study that proves the Belimed Steam Sterilizer TOP 5000 meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

Note: The sterilizer is designed to achieve a Sterility Assurance Level (SAL) of at least 10^-6, meaning a one-in-a-million chance of a non-sterile item. The F0 value of at least 12 represents heat delivered equivalent to 12 minutes at 121°C (250°F) for microbial kill.

The Study Proving Acceptance Criteria

The studies demonstrating the device meets the acceptance criteria are referred to as "verification studies." These studies were conducted internally by SAUTER AG prior to the device's release.

Key Details of the Study:

1. 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 numerical sample size (e.g., number of test cycles performed for each type). However, it refers to using specific configurations for testing:
     • "fabric test pack, as described in Section 5.5.1 AAMI/ANSI-ST8"
     • "full load instruments trays"
     • "unwrapped instrument tray"
     • "three 1'000 ml flasks, as described in section 5.5.2.1 of AAMI/ANSI-ST8"
     • "Bowie-Dick Test Pack"
   • Data Provenance: The studies were conducted by SAUTER AG, a Swiss company. The exact country where the tests took place is not specified but is presumably Switzerland. The studies were prospective as they were conducted to validate the device prior to release.

2. 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 information is not provided. The ground truth (sterility, F0 value, moisture retention, etc.) was established through scientific measurements and biological indicator testing against and according to AAMI/ANSI-ST8 standards. These are objective measures rather than expert consensus based on subjective assessment.

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

   • Not applicable. The "ground truth" for sterilizers is determined by adherence to established sterilization standards and objective measurements (e.g., temperature probes, biological indicator kill, weight measurements, visual inspection for wetness or color change), not by human adjudication of an output.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • Not applicable. This device is a steam sterilizer, not an AI-powered diagnostic or assistive tool for human readers. Its effectiveness is based on its ability to sterilize, not on improving human interpretation.

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

   • Yes, in a sense. The "performance" of the sterilizer is its standalone ability to achieve sterilization parameters and kill biological indicators. The testing described (e.g., F0 value, moisture retention, biological indicator kill) evaluates the device's intrinsic function without direct human intervention in the sterilization process itself (though humans operate and monitor the device). The software validation was also standalone, verifying the algorithm's control of the cycle.

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

   • The ground truth relied on standards-based objective measurements and biological indicators.
     • Biological Indicators: Used to confirm the complete kill of spores, providing direct evidence of sterility.
     • Physical Measurements: Time-at-temperature measurement to calculate F0 values; weight measurements for moisture retention; temperature probes for liquid cycles (achieving 121°C for 12 minutes); visual inspection for wet spots and Bowie-Dick test pack color change.
     • Standard Reference: All validations were performed "according to AAMI/ANSI-ST8" (Association for Advancement of Medical Instrumentation / American National Standards Institute - Sterilization of Health Care Products - Steam). This standard defines accepted methods and criteria for validating steam sterilizers.

7. The sample size for the training set:

   • Not applicable. This device is a physical sterilizer, not a machine learning or AI algorithm that requires a "training set" in the computational sense. The "training" of the device is its engineering design and manufacturing to specification.

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

   • Not applicable, as there is no "training set" in the AI/ML context. The operational parameters and control logic were designed based on established principles of steam sterilization thermodynamics and microbiology, codified in standards like AAMI/ANSI-ST8.

Ask a specific question about this device