(29 days)
The RAPICIDE™ PA Test Strips are chemical indicators used after the disinfection cycle to ensure that the RAPICIDE™ PA High-Level Disinfectant solution is met the minimum recommended concentration of 850ppm peracetic acid. The RAPICIDE PA Test Strips are designed for use by trained personnel who reprocess endoscopes and their accessories in facilities where endoscopies are performed.
Rapicide PA High-Level Disinfectant Test Strip has the ability to measure the disinfectant use solution concentration above 850 ppm Peracetic Acid (PAA). This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high-level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, blue grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black after contact with solution at concentrations of 1100 ppm ± 20 ppm PAA.
The provided FDA 510(k) clearance letter pertains to a chemical indicator device, "Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118," not an AI/ML-enabled medical device. Therefore, the information regarding the acceptance criteria and study proving its performance is focused on the chemical and physical properties of the test strips, rather than AI model performance metrics like sensitivity, specificity, MRMC studies, or ground truth establishment relevant to AI/ML devices.
Based on the document, I can extract the following information relevant to the device's acceptance criteria and studies:
Device Description and Intended Use:
The Rapicide PA High-Level Disinfection Test Strips are chemical indicators used after the disinfection cycle to verify that the RAPICIDE™ PA High-Level Disinfectant solution has met the Minimum Recommended Concentration (MRC) of 850ppm peracetic acid. A "pass" is indicated by the test strip pad turning solid black when exposed to solutions at concentrations of 1100 ppm ± 20 ppm PAA. A "failure" (solution at or below MRC) is indicated if the pad turns dark grey, blue grey, violet grey, light grey, or white (no color change).
Here's the breakdown of the acceptance criteria and the studies that prove the device meets these criteria, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Minimum Recommended Concentration (MRC) Recognition | The device must reliably indicate that the RAPICIDE™ PA HLD solution has met the MRC of 850ppm peracetic acid. |
| "Pass" Endpoint Specification | The test strip pad must turn solid black when the solution is at concentrations above 850ppm and specifically at 1100 ppm ± 20 ppm PAA. |
| "Fail" Endpoint Specification | The test strip pad must indicate failure (e.g., turn dark grey, blue grey, violet grey, light grey, or white) when the solution is at or below the MRC of 850ppm PAA. |
| Dynamic Range | The device must perform within its specified detection range for peracetic acid concentration. |
| Comparative Sensitivity and Specificity | The device must demonstrate appropriate sensitivity and specificity in detecting the target peracetic acid concentration against a known standard. |
| Analytic Specificity – Contaminants | The device's performance should not be adversely affected by common contaminants that might be present in the use environment. |
| Analytic Specificity – Other Germicides | The device should not cross-react or provide false readings due to the presence of other germicides. |
| Shelf Life | The device must maintain its specified performance characteristics for the stated shelf life (18 Months). |
| In-Use (Open Bottle) Stability | The device must maintain its specified performance characteristics for the stated open bottle shelf life (4 months). |
Study Details (Based on available information from the 510(k) Summary)
The provided document is a 510(k) clearance letter and an abbreviated 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study protocols, raw data, or comprehensive statistical analyses that would be found in a full study report or clinical trial documentation. Therefore, many of the requested details for AI/ML device studies (sample size, data provenance, expert adjudication, MRMC studies, training set details) are not applicable or not provided for this type of chemical indicator device.
Here's a breakdown of the requested information based on the provided text:
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in the provided document. The 510(k) summary states that "Testing to assess and demonstrate performance of the subject device is summarized below," listing categories like "Dynamic Range," "Comparative Sensitivity and Specificity," etc., and concluding they "Met Acceptance Criteria." However, the exact number of test strips or solution samples used for each test is not disclosed.
- Data Provenance: Not specified. It can be inferred that the testing was conducted internally by STERIS Corporation, likely in a laboratory setting, to evaluate the chemical performance of the test strips. Retrospective or prospective nature is not mentioned for this type of chemical performance testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided: For a chemical indicator device, "ground truth" is typically established by precisely formulated chemical solutions (e.g., 850ppm PAA, 1100ppm PAA ± 20ppm PAA) with known concentrations, verified by analytical chemistry methods, rather than by human expert consensus or annotations as would be the case for medical imaging AI. The document does not mention the use of human experts for establishing ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / None: Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in human expert annotations for complex data (e.g., medical images). For a chemical indicator, the output (color change) is objective and directly correlated with the chemical concentration. The "reading" of the strip is a visual interpretation of a chemical reaction against a defined color standard (solid black for pass, various greys for fail). Discrepancies would likely be addressed through re-testing or instrument calibration, not expert adjudication.
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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: MRMC studies are specific to evaluating the impact of AI assistance on human reader performance in tasks like image interpretation. This device is a chemical indicator test strip, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not Applicable: This device is a physical chemical strip, not a software algorithm. Its performance is inherent in its chemical design.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Known Chemical Concentrations: The ground truth for this device is established by precisely prepared chemical solutions with known, verified concentrations of peracetic acid (e.g., 850ppm MRC, 1100ppm pass threshold). This is a direct physical or chemical measurement, not dependent on expert consensus, pathology, or outcomes data.
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The sample size for the training set:
- Not Applicable: This device is a chemical indicator, not an AI/machine learning model that requires a training set. The "design" is based on chemistry and materials science, not data-driven learning.
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How the ground truth for the training set was established:
- Not Applicable: As there is no "training set" for a chemical indicator, this question is irrelevant. The "design" and "calibration" involve chemical engineering and materials science, where the components are selected and optimized to react predictably to specific chemical concentrations.
§ 880.2800 Sterilization process indicator.
(a)
Biological sterilization process indicator —(1)Identification. A biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.(2)
Classification. Class II (performance standards).(b)
Physical/chemical sterilization process indicator —(1)Identification. A physical/chemical sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization process. The adequacy of the sterilization conditions as measured by these parameters is indicated by a visible change in the device.(2)
Classification. Class II (performance standards).