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510(k) Data Aggregation
(29 days)
The RAS Racks are used in the RAS Cycles of AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors for the effective cleaning, rinsing, drying and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.
The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector. Twelve soiled da Vinci Endowrist® X/Xi, S/Si, or Single-Site instruments and staplers, without prior manual cleaning, are loaded into the appropriate RAS Rack according to the provided instructions for use. The rack is placed in the AMSCO 7052HP or 7053HP Single-Chamber Washer/Disinfector, and the RAS Cycle is selected.
The RAS Cycle performs automated cleaning through a validated series of spraywashing, lumen flushing steps that use Prolystica Ultra Concentrate HP Enzymatic Cleaner alternately with Prolystica Ultra Concentrate HP Neutral Detergent in temperature-controlled solutions. When the series of automated prewash and washing stages are complete, a one-minute rinse occurs. Next the RAS Cycle completes a thermal rinse to achieve intermediate level disinfection of the load before drying it. Upon RAS Cycle completion, the devices are ready to be prepared and packed for steam sterilization.
I am sorry, but the provided text does not contain the acceptance criteria or a study proving that the device meets acceptance criteria. The document is an FDA 510(k) premarket notification for a medical device (STERIS RAS 12 Rack and RAS Cycle), which states that the proposed device is substantially equivalent to a legally marketed predicate device (K190081).
The document details the device's intended use, technological characteristics, and compares it to the predicate device. However, it explicitly states in "Summary of Non-Clinical Performance Testing" that "The purpose of this Special 510(k) is to update labeling based on a labeling revision being enacted by Intuitive Surgical to allow for automated cleaning and intermediate level disinfection... The RAS Racks and associated RAS Cycles were not altered in anyway." This implies that the performance testing was likely conducted for the predicate device (K190081) and is referenced, but the details of such a study are not present in this document.
Therefore, I cannot extract the requested information such as a table of acceptance criteria and reported performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, type of ground truth, or training set details.
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(217 days)
The RAS Racks are used in the RAS Cycles of AMSCO 7052HP and 7053HP Single-Chamber Washer/Disinfectors for the effective cleaning, rinsing, drying and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.
The RAS Racks are designed to enable the mechanical cleaning, rinsing, and disinfection of up to twelve (12) robotic-assisted surgery instruments in a compatible washer-disinfector. Twelve soiled da Vinci Endowrist X/Xi, S/Si, or Single-Site instruments and staplers, without prior manual cleaning, are loaded into the appropriate RAS Rack according to the provided instructions for use. The rack is placed in the AMSCO 7052HP or 7053L Single-Chamber Washer/Disinfector, and the RAS Cycle is selected.
The RAS Cycle performs automated cleaning through a validated series of spraywashing, lumen flushing steps that use Prolystica Ultra Concentrate HP Enzymatic Cleaner alternately with Prolystica Ultra Concentrate HP Neutral Detergent in temperature-controlled solutions. When the series of automated prewash and washing stages are complete, a one-minute rinse occurs. Next the RAS Cycle completes a thermal rinse to achieve intermediate level disinfection of the load before drying it. Upon RAS Cycle completion, the devices are ready to be prepared and packed for steam sterilization.
The provided text describes a 510(k) premarket notification for a medical device (RAS-12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO® 7052HP/7053HP Single Chamber Washer/Disinfector) and its performance testing. However, the information is primarily focused on the cleaning, rinsing, drying, and intermediate level disinfection capabilities of the device for reusable surgical instruments, rather than an AI/ML powered medical device.
Therefore, many of the typical acceptance criteria and study components related to AI/ML device performance (such as sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable or not provided in this document.
The document discusses performance criteria for the washer-disinfector and its accessories, which are mechanical and chemical efficacy tests.
Here's an attempt to extract the relevant information based on the provided text, and point out where information typically associated with AI/ML device studies is absent:
Device Studied: RAS-12 Rack, RAS 12 Long Rack; RAS Cycle of AMSCO® 7052HP/7053HP Single Chamber Washer/Disinfector
Purpose of the Study: To demonstrate the substantial equivalence of the subject device to a legally marketed predicate device (da Vinci SonicPro Cleaning System: K073112) for the cleaning, rinsing, drying, and intermediate level disinfection of reusable da Vinci EndoWrist® X/Xi, S/Si, and Single-Site instruments and staplers.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use Testing | Endowrist instruments identified as master devices for their most challenging features were soiled and allowed to dry for at least one hour. They were processed in triplicate trials using the RAS Cycle to the end of the initial rinse (prior to thermal rinse), then examined visually and sampled for quantitation of two soil markers: protein <6.4 µg/cm², TOC <12 µg/cm². | PASS |
| In-Use Testing | Clinically used Endowrist instruments were installed in the Rack according to its IFU, the rack was placed in the washer/disinfector, and the RAS Cycle was run to the end of initial rinse (prior to thermal rinse). Instruments were examined visually and sampled for quantitation of two soil markers: protein <6.4 µg/cm², TOC <12 µg/cm². | PASS |
| Rinsing Efficacy and Biocompatibility | Two EndoWrist instruments were processed three (3) consecutive times in full loads using double cleaner concentrations. Rinse water and device extracts were tested for cytotoxicity. Device extracts were analyzed to verify that the chemical residual level is not cytotoxic. | PASS |
| Thermal Disinfection | Achieves greater than 6-log reduction of each organism in a mixed suspension of vegetative organisms, and greater than 3-log reduction of mycobacterium species. | PASS |
| W/D Physical Performance | Chemical injection control operates within specifications. Temperature control operates within specifications. Pump maintains high speed performance as designed. Drying is achieved by the RAS Cycle. | PASS |
| Human Factors | Typical users were capable of following the written instructions for use to correctly configure and load the RAS Rack and to select the correct cycle of the washer/disinfector. | PASS |
| Electrical Safety Conformance | Conformance to UL 61010-1, UL 61010-2-040, IEC 61326-1:2012, and FCC Part 15. | PASS |
| Software Validation | The software that controls the system was validated and determined to operate effectively and as designed. | PASS |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- Simulated Use Testing: "triplicate trials" of Endowrist instruments. The exact number of instruments per trial is not specified, but it's implied to be multiple (up to 12 instruments can be processed per cycle, as per "Technological Characteristics Comparison Table").
- In-Use Testing: "Clinically used Endowrist instruments" were tested. The specific number of instruments is not quantified.
- Rinsing Efficacy and Biocompatibility: "Two EndoWrist instruments" processed "three (3) consecutive times."
- Thermal Disinfection: Not explicitly stated regarding the number of instruments, but refers to log reduction of organisms.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing described as "Simulated Use Testing" and "In-Use Testing" suggests a mix of laboratory efficacy testing and, for "In-Use Testing," potentially real-world clinical usage scenarios, but it's not specified if these were retrospective or prospective studies in a clinical setting. Given this is a 510(k) for a washer-disinfector, the "in-use" testing likely refers to instruments soiled from clinical use rather than a full prospective clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not Applicable: This study is evaluating the mechanical and chemical cleaning and disinfection efficacy of a device, not interpreting medical images or data that would require a ground truth established by medical experts (like radiologists). The ground truth is objective cleanliness/disinfection metrics (e.g., protein/TOC levels, log reduction of organisms) determined by laboratory assays. The "Human Factors" test involves typical users, but not "experts" establishing a ground truth.
4. Adjudication Method for the Test Set
- Not Applicable: Given the nature of the tests (objective measurements of cleanliness, disinfection, and functional performance), there is no mention or need for an adjudication method for human 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
- Not Applicable: This is not an AI/ML powered medical device, therefore MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI/ML powered medical device. The tests, particularly "Simulated Use Testing" and "In-Use Testing," represent the "standalone" performance of the washer-disinfector system itself in achieving cleaning and disinfection.
7. The Type of Ground Truth Used
- Objective Laboratory Measurements:
- Cleaning Efficacy: Quantitation of soil markers (protein <6.4 µg/cm², TOC <12 µg/cm²) based on laboratory analysis. Visual examination was also used.
- Disinfection Efficacy: Log reduction of specified vegetative organisms and mycobacterium species based on microbiological testing.
- Biocompatibility: Cytotoxicity testing of device extracts and verification of chemical residual levels.
- Physical Performance: Measurements against internal specifications (e.g., chemical injection control, temperature control, pump performance, drying).
- Human Factors: Observation of user capability to follow instructions.
- Safety/Software: Conformance to established safety standards and internal software validation.
8. The Sample Size for the Training Set
- Not Applicable: This is not an AI/ML device that requires a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable: As above, this is not an AI/ML device.
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