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The Cenorin 610 and Cenorin 610HT Washer-Pasteurizer/High Level Disinfectors are intended for cleaning and high level disinfection of semi-critical and non-critical medical devices using thermal disinfection by full immersion pasteurization.

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The provided document is a 510(k) clearance letter from the FDA for a medical device called "Cenorin 610 Washer-Pasteurizers/High Level Disinfector and Cenorin 610HT Washer-Pasteurizers/High Level Disinfector."

**This document does not contain any information about acceptance criteria, device performance metrics, sample sizes, expert ground truth establishment, or any details related to a study proving the device meets acceptance criteria. It is a regulatory clearance document, indicating the device has been found substantially equivalent to legally marketed predicate devices.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving device performance from the provided text. The document is about a washer-pasteurizer, not an AI/ML powered device, and thus the acceptance criteria would be very different (e.g., sterilization effectiveness, temperature control accuracy, cycle times, etc.) which are not detailed here.

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The Miele G 7881 Dental Thermal Disinfector is intended to clean and high-level disinfect heat stable reusable dental instruments and accessories using a thermal process. The cycle parameters for high-level disinfection are 93℃ for 10 minutes. The Miele G7881 Dental Thermal Disinfector also has the following cleaning and high-level disinfection cycles:

The G7881 Dental Thermal Disinfector is a washer/disinfector for aqueous cleaning and simultaneous thermal disinfection of dental instruments and accessories. It operates with three spray arms on three different levels. A powerful circulation pump moves 2.8 gallons of water at a rate of 105 gallons/minute. The specially designed jets on the spray arms spray the water onto the wash load at a low pressure (About 13 psi) to prevent any goods from being washed off the racks.

The complete unit is made of electro-polished stainless steel, the exterior is additionally powder coated. The unit is equipped with a microcomputer control. An integrated water softener ensures consistently high water quality; the steam condenser comes standard and minimizes contaminated aerosols and odor affecting the environment.

Acceptance Criteria and Device Performance for Miele G7881 Dental Thermal Disinfector

Based on the provided 510(k) summary, the device is a Miele G7881 Dental Thermal Disinfector, and the review focuses on its "high-level disinfection" capabilities. The crucial point is that the regulatory submission states that the cycle parameters for high-level disinfection have not been changed from the legally marketed predicate device (Miele G7781 Dental Thermal Disinfector, K950518), and therefore, additional testing was not deemed necessary for these specific parameters.

However, the document does refer to prior studies that support the predicate device's performance.

Here's the breakdown of the information requested:

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: Not explicitly stated for this submission (G7881). The document indicates that since the high-level disinfection cycle parameters were not changed from the predicate device (G7781), additional testing for these parameters was not necessary. The 6-log reduction performance refers to studies conducted for the predicate device (K950518). Information regarding the specific sample size of microorganisms or instruments used in those prior studies is not provided in this document.
• Data Provenance: The document states that "additional testing was done in accordance with German Health Authority guidelines Federal Health Report 1980:23:364-35-65." This suggests the efficacy studies, including the log reduction data, may have originated from Germany and were likely prospective studies designed to validate the disinfection parameters according to those guidelines. (Retrospective vs. Prospective is not explicitly stated, but efficacy studies for device clearance are typically prospective.)

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

This information is not provided in the document. Efficacy studies for disinfection devices typically rely on objective laboratory methods (e.g., culturing microorganisms before and after treatment) rather than expert consensus on subjective assessments.

4. Adjudication Method for the Test Set

This information is not applicable to the type of efficacy testing described (microbiological log reduction). Adjudication methods like "2+1" are typically used for subjectively assessed endpoints (e.g., imaging interpretation).

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

No. This type of study is not relevant for a device like a thermal disinfector, which performs a physical or chemical process. MRMC studies are typically used to assess the effectiveness of diagnostic tools where human interpretation of data is involved (e.g., radiologists reading images).

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

Yes, in essence. The performance claims are based on the device's ability to achieve specific physical parameters (temperature and time) and its resulting microbiological reduction, independent of human intervention during the disinfection cycle. The device's efficacy is measured intrinsically, not through human interaction with an algorithm.

7. The Type of Ground Truth Used

• Microbiological Efficacy: The primary ground truth for the "high-level disinfection" claim is direct microbiological testing demonstrating a 6-log reduction of an appropriate myco bacterium species. This is an objective, quantitative measure of microbial inactivation.
• Cleaning Efficacy: The claim that it "cleans instruments contaminated with blood, extremely well" implies visual inspection and possibly other objective assessments of residual soil, though specific methods are not detailed.

8. The Sample Size for the Training Set

This information is not provided as the Miele G7881 Dental Thermal Disinfector is not an AI/ML-based device that would typically have a "training set" in the context of machine learning. Its performance is based on engineered physical parameters and validated through microbiological testing.

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

This question is not applicable as the device does not employ machine learning or AI that would require a "training set" with established ground truth in the conventional sense. The "ground truth" for its function (disinfection efficacy) is established through laboratory validation of its physical processes and their biological outcomes.

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The STERIS Amsco Reliance Family of Washer / Disinfectors are indicated for use in the cleaning and low-level disinfection of soiled reusable utensils, trays, glassware, bedpans and urinals, rubber and plastic goods, simple hard-surfaced rigid instruments such as forceps and clamp, and other similar and related articles found in healthcare facilities.

The Amsco Reliance Family of Washer/Disinfectors are mechanical, computercontrolled Washer/Disinfectors. They are designed with pre-programmed cycles intended specifically for surgical instruments, delicate instrumentation (gentle cycle), utensils, glassware, plastic goods, anesthesia/respiratory goods and equipment decontamination. Additional cycles are available for customized programming to meet specific operating requirements.

Essentially, the Amsco Reliance Family of Washer/Disinfectors operate as follows: the load items are placed in the chamber where they are exposed to pressurized fluids delivered through a circulation system driven by a pump and controlled by a programmable computer. Injection pumps allow the automatic delivery of the selected chemicals in the sump water. Available configurations include steam or electrical heating of the sump water; and the drying option (electrically heated on some models. steam heated on others). The cabinet, chamber, and circulation system (including the pump) are primarily constructed of stainless steel.

The available cycle phases can be summarized as follows:

• 1. cold tap water pre-wash for the removal of gross soil;
• soaking in an enzymatic solution to break down proteinaceous materials; 2.
• 3. detergent wash to complete the soil removal:
• sonic cleaning to remove fine debris in crevices:
• hot tap water rinse to remove detergent and soil residues:
• thermal rinse to disinfect the load items;
• 7. pure water rinse and instrument lubrication:
• 8. drvina.

Note: Phases 2 and 4 are not offered on all models. Phases 2, 4, 7 and 8 are optional features.

The available accessories include a variety of single and multi-level loading racks, and transfer carts. Some models offer conveyor systems used to automate the loading of racks into the chamber, to initiate the proper cycle by reading a bar code tag located on the loading rack, and to provide queuing capacity.

Here's an analysis of the acceptance criteria and the study presented in the provided text for the Amsco® Reliance® Family of Washer/Disinfectors, structured to address your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document focuses on performance tests for cleaning, residue removal, thermal low-level disinfection, equipment decontamination, and instrument lubrication. The most detailed acceptance criteria and results are given for residue testing.

¹Results obtained with the Amsco Reliance 444 Single-Chamber Washer/Disinfector, considered representative for the family.

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

• Cleaning: The document mentions "covering test items with blood a representative soil" and "colling of Washer/Disinfectors provided soil." It does not specify the exact number of test items or repetitions.
• Residues: The table lists items by category (e.g., "Surgical Instruments," "Micro Surgery Instruments," "Suction Tips," "Respiratory Equipment," "Rigid MIS Instruments"). It does not specify the precise number of individual items tested within each category. The results are presented as single values for each category, suggesting either an average or a single worst-case measurement.
• Thermal Low-Level Disinfection: A "sample test" was conducted using "vials containing known concentrations of microorganisms." No specific number of vials or repetitions is provided. It notes testing was done with the "MIS rack," implying a specific configuration was used.
• Equipment Decontamination: Testing involved "operating the Washer/Disinfector with various loading racks for 3 consecutive weeks" and "swabbing the surfaces of critical areas...on a weekly basis." It does not specify the number of swab samples or types of racks.
• Instrument Lubrication: Testing involved "inoculating hinged instruments with bacterial spores." No specific number of instruments is given.

Data Provenance: The studies were conducted either in STERIS facilities or subcontracted, in keeping with applicable quality systems regulations (Good Laboratory Practice, 21CFR §58). This indicates a controlled laboratory setting. The data is prospective as it involves controlled testing to demonstrate the device's performance. The country of origin for the studies is not explicitly stated beyond being linked to STERIS Corporation (located in Ohio, USA) and adhering to US regulations.

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

The document does not mention the use of human experts to establish ground truth for the test set. The ground truth was established through objective measurements and scientific protocols rather than expert consensus on subjective observations. For example:

• Cleaning: Visual inspection for residual soil (an objective assessment against a "no visible residual soil" criterion).
• Residues: Conductivity measurements and enzyme activity assays.
• Thermal Low-Level Disinfection: Measuring logarithmic reductions of known concentrations of microorganisms.
• Equipment Decontamination: Culturing swabs for biofilm or microbial growth.
• Instrument Lubrication: Sterility testing for bacterial growth.

4. Adjudication Method for the Test Set

Not applicable. As noted in point 3, the ground truth was established through objective laboratory testing and measurements, not subjective evaluations requiring expert adjudication.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data, where AI provides assistance to human readers. The Amsco Reliance Washer/Disinfector is a cleaning and disinfection device, not a diagnostic tool requiring human-in-the-loop interpretation.

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

Yes, the studies conducted were standalone performance evaluations. The device's cleaning, disinfection, and residue removal capabilities were assessed directly without human intervention in the operational cycle or in the interpretation of the primary performance metrics (e.g., amount of residue, log reduction of microbes). The "computer-controlled" nature of the device inherently means its core operation is algorithmic.

7. Type of Ground Truth Used

The ground truth used in these studies was primarily objective laboratory measurements and scientific principles, including:

• Chemical assays: For residue levels (conductivity increase, enzyme activity to relieve color).
• Microbiological testing: For disinfection efficacy (logarithmic reduction of test organisms) and equipment decontamination (culturing for microbial growth/biofilm).
• Visual inspection: For cleanliness (absence of visible soil).
• Sterility testing: For lubricated instruments (absence of bacterial growth).

These are empirical measures against established scientific and safety standards.

8. Sample Size for the Training Set

Not applicable. This device is a mechanical, computer-controlled washer/disinfector, not an AI or machine learning algorithm that requires a "training set" in the conventional sense (i.e., data for machine learning model development). The "pre-programmed cycles" are based on engineering design and validated protocols, not adaptive learning from a dataset.

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

Not applicable, as there is no "training set" in the context of an AI/ML model for this device. The operational parameters and control logic for the device's cycles were established through engineering design, scientific principles, and validation testing (the performance tests detailed in the document), rather than through a machine learning training process.

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Machine for pasteurizing (high-level disinfection) respiratory therapy and anesthesia parts, in a health care setting by health care workers.

The Olympic Mini-Pasteurmatic is a small, compact machine. which makes use of pasteurization to achieve high-level disinfection of respiratory therapy and anesthesia breathing circuit parts. After hand washing, the parts are placed in the drum shaped "basket." The basket is submerged in hot water and rotated vertically. This vertical rotation flushes water through tubes and other hollow parts, allowing air to escape and improving water contact with all surfaces of the parts. The Mini-Pasteurmatic is filled with water, which is heated to pasteurizing temperature by internal heaters.

Here's an analysis of the provided text to extract the requested information about the device's acceptance criteria and studies:

Acceptance Criteria and Device Performance for Olympic Mini-Pasteurmatic

Study Information:

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

   • Sample Size: Not specified in the provided document.
   • Data Provenance: Not specified. The document only mentions "Tests were performed to verify the following," without detailing the source or nature of the data.

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

   • Not applicable/Not specified. This device cleans and disinfects, so "ground truth" would likely be based on physical measurements and microbiological testing rather than expert-derived interpretations.

3. Adjudication method for the test set:

   • Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., image interpretation), which is not relevant for this device's testing.

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:

   • No. This is a medical device for pasteurization (disinfection), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study is not relevant.

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

   • Yes, in essence. The "tests performed" (water temperature, thermostat, cold water start time) evaluate the device's inherent functional performance independently, without human interaction influencing the core disinfection process. This is a standalone performance assessment of the hardware.

6. The type of ground truth used:

   • Engineering/Performance Specifications and Physical Measurements: The ground truth for the tests (water temperature, thermostat performance, cold water start time) would be based on the device's design specifications and measurable physical properties. For "high-level disinfection," the ultimate ground truth would be the microbial reduction achieved, though the document only lists engineering verification.

7. The sample size for the training set:

   • Not applicable/Not specified. There is no mention of a "training set" as this is not an AI/machine learning device.

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

   • Not applicable. There is no training set mentioned or implied.

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