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510(k) Data Aggregation
(264 days)
The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.
The Ultraphon Chemical Indicator is used exclusively for monitoring the High Level Disinfection process when placed within the Nanosonics trophon® EPR and trophon® 2 chambers. The color of the Ultraphon Chemical Indicator changes from red to yellow when exposed to hydrogen peroxide, the active ingredient used in trophon® EPR and trophon® 2 disinfectant. This occurs above the minimum effective concentration (MEC) established for this solution.
The device is a qualitative, single use, disc (26 mm in diameter) that has a hydrogen peroxide sensitive chemical indicating ink applied to a Tyvek® substrate (Product Code: TRO-T) or polypropylene substrate (Product Code: TRO-B). The hydrogen peroxide sensitive chemical indicating ink has been designed to transition from an initial red color to a signal yellow color when subjected to sources of hydrogen peroxide.
The provided text describes the acceptance criteria and a summary of non-clinical testing for the Ultraphon Chemical Indicator (TRO-T and TRO-B). Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Name of Test | Acceptance Criteria | Subject Device Result |
|---|---|---|
| Performance Testing | Pass result when hydrogen peroxide solution is above the MEC (signal color achieved for all product codes) and fail color when hydrogen peroxide solution is at MEC achieved when exposed to the HLD cycle in combination of a worst-case load: trophon® EPR and trophon® 2 HLD Systems | PASS |
| End Point Stability | 1 month | PASS |
| Offset/Transference | The chemical indicators shall not offset or bleed, penetrate the substrate to which it is applied, or materials in which it is in contact before, during or after the sterilization cycles for which it is designed. | PASS |
| Chemical Indicator Performance Testing in the Presence of Contaminated Ultrasound Probes | Hydrogen Peroxide 31.5% (1.8g): More yellow than MEC Hydrogen Peroxide 31.5% (1.0g): Equal to MEC or more red | PASS |
| Color Analysis (X-Rite Spectrophotometer) | More yellow than the MEC using 31.5%, 1.8 grams Equal to or more red than MEC using 31.5%, 1.0 gram More red than MEC using 31.5%, 0.8 grams More Yellow than MEC using 31.5%, 1.2 grams | PASS |
| Sensitivity, Specificity, Accuracy, and Precision of Performance Data | Comparative Sensitivity: > 0.95 Analytic Sensitivity (31.5% H2O2): 1.8 g H2O2 solution: 0.56 - 0.58 g H2O2 1.2 g H2O2 solution: 0.37 - 0.39 g H2O2 1.0 g H2O2 solution: 0.31 – 0.33 g H2O2 0.8 g H2O2 solution: 0.25 - 0.27 g H2O2 Comparative Specificity: > 0.95 Accuracy: > 0.95 Precision: < 1 ΔΕ using X-Rite spectrophotometer Analytic Specificity Exposure to Bleach Wipe - Yellow Exposure to Lysol - Yellow Exposure to IPA (70%) - Yellow Dry Heat Exposure 100°C, 15 min - Red UV Exposure - 2 hours - Light Red Ethylene Oxide Exposure 20 min. 54° C 600 ppm, 60%RH - Red | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "multiple lots of the subject devices (TRO-T and TRO-B chemical indicators)" were used for testing, but does not specify the exact sample size for the test set. The data provenance (country of origin, retrospective/prospective) is also not explicitly stated.
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)
This product is a chemical indicator, not an AI or imaging device requiring human interpretation for ground truth. Therefore, no
experts were used in this context. The "ground truth" is determined by the chemical reaction and concentration of hydrogen peroxide.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Since this is a chemical indicator, the ground truth is based on the chemical reaction and color change, not human interpretation. Therefore, no adjudication method was used for a test set in the traditional sense of expert consensus.
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
No MRMC comparative effectiveness study was done. This device is a chemical indicator, not intended to assist human readers in interpreting medical images or data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This product is a standalone chemical indicator. Its performance is evaluated based on its color change in response to hydrogen peroxide without human interpretation being part of its core function or acceptance criteria.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for this device is based on chemical reactions and concentrations of hydrogen peroxide. Specifically, the "minimum effective concentration (MEC)" of hydrogen peroxide (1.0 gram of 31.5% hydrogen peroxide) is the key reference point for expected color change.
8. The sample size for the training set
The document does not specify a training set sample size. As a chemical indicator, it likely does not involve machine learning or traditional "training sets" in the same way an AI algorithm would. Its performance is based on the inherent chemical properties and manufacturing consistency.
9. How the ground truth for the training set was established
Since there is no mention of a training set for machine learning, the establishment of ground truth in that context is not applicable. The underlying "ground truth" for the device's function is the known chemical reaction between the indicator ink and hydrogen peroxide at specific concentrations.
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