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Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to high level disinfect devices that may contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, A-scan and B-scan probes.

Tristel OPH is a high level disinfectant when used in accordance with the Directions for Use, including a disinfection contact time of 2 minutes, at room temperature and a concentration at or above Minimum Recommended Concentration (MRC).

Tristel OPH Foam must be applied on the surface of an ophthalmic device using Tristel OPH Wipes.

Tristel OPH Wipes are intended for application of Tristel OPH Foam on the surface of ophthalmic devices and to remove residue of the foam after high level disinfection.

Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single use.

The semi-critical ophthalmic devices processed by Tristel OPH must first be cleaned according to a validated cleaning protocol or standard and following the device manufacturers' instructions. Tristel OPH Foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC.

Minimum Recommended Concentration (MRC): ~90% v/v (~280ppm) at point of use. MRC of Tristel OPH may be verified using Tristel Test Strips.

Tristel OPH is a high level disinfectant foam for reprocessing ophthalmic devices. It can be used to high level disinfect devices that may contact mucous membranes during use, such as diagnostic and laser lenses, tonometer prisms, pachymeters, retinal imaging probes, and A-scan and B-scan probes.
Tristel OPH Foam is packaged in a hand-held dispenser bottle. Tristel OPH Foam is made of two solutions, Tristel OPH Activator solution and Tristel OPH Base solution, which are mixed when dispensed to generate active ingredient chlorine dioxide. In-use concentration of chlorine dioxide (ClO2) is 0.032% (320ppm).
Tristel OPH Foam Activator and Base solutions are contained in a dual compartment bottle with a dispenser pump and are ready to use.
Tristel OPH Foam is supplied with Tristel OPH Wipes. Tristel OPH Wipes are dry wipes made of a non-woven and low-linting material. Tristel OPH Wipes are intended to apply Tristel OPH Foam on the surface of ophthalmic devices and to remove residue of the foam after high level disinfection once the contact time of 2 minutes has elapsed.
Each dose of Tristel OPH Foam and each Tristel OPH Wipe are single-use.
Minimum Recommended Concentration (MRC): ~90% v/v (~280ppm) at point of use. MRC of Tristel OPH may be verified using Tristel Test Strips.

The provided FDA 510(k) clearance letter and its attachments describe the device Tristel OPH, a high-level disinfectant foam. However, the document focuses on demonstrating substantial equivalence to a predicate device (Tristel Duo ULT) through non-clinical performance testing. It meticulously compares the two devices based on their indications for use, technological characteristics, and performance data from various laboratory efficacy tests (bactericidal, fungicidal, virucidal, mycobactericidal, sporicidal, and additional clinically relevant efficacy) as well as simulated-use, in-use, compatibility, biocompatibility, residue, and inhalation studies.

Crucially, the document does not describe a study that involves analyzing a test set of data with ground truth, nor does it refer to acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC) for a medical image analysis or AI/ML device.

The "acceptance criteria" referred to in the document are primarily the performance benchmarks met during chemical and microbiological efficacy testing, as well as safety and compatibility tests. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical, in-vitro, and simulated-use laboratory studies designed to demonstrate the disinfectant's potency, safety, and proper functioning.

Therefore, many of the requested elements in your prompt, which are typical for studies evaluating AI/ML-based diagnostic devices, cannot be extracted from this document. I will focus on the information that is available.

Here's an interpretation of the provided information, framed to address as many of your prompt's points as possible within the context of a disinfectant's clearance:

Acceptance Criteria and Device Performance for Tristel OPH (High-Level Disinfectant)

The "acceptance criteria" for Tristel OPH are not diagnostic performance metrics, but rather the successful demonstration of its high-level disinfection capabilities, safety, and functional equivalence to its predicate device under various laboratory and simulated-use conditions.

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

• Chemical Analysis: Measurement of residual chemicals, concentration of active ingredients.
• Physical Observation: Assessment of material integrity (corrosion, damage).
• Environmental Monitoring: Measurement of airborne chemical concentrations.
  These are all objective, laboratory-derived measurements based on established scientific methodologies and standards.

8. The sample size for the training set

Not applicable. This device is a chemical disinfectant, not an AI/ML algorithm that requires a training set.

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

Not applicable (as above).

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Tristel Duo ULT is a high level disinfect foam for reprocessing ultrasound probes. It can be used to high level disinfect endocavity transvaginal and transrectal probes, and skin surface transducers that may contact non-intact skin during use.

Tristel Duo ULT is a high level disinfectant when used in accordance with the directions for use, including a disinfection contact time of 2 minutes, at room temperature and a concentration at or above Minimum Recommended Concentration (MRC).

Tristel Duo ULT must be applied on the surface of an ultrasound probe using Duo Wipes.

Duo Wipes are intended to apply Tristel Duo ULT foam on the surface of ultrasound probes and to remove residue of the foam after high level disinfection.

Each dose of Tristel Duo ULT foam and each Duo Wipe are single use.

The semi-critical ultrasound probes reprocessed by Tristel Duo ULT must first be cleaned according to a validated cleaning protocol or standard and following the device manufacturers' instructions.

Tristel Duo ULT foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC.

MRC: ~90% v/v (~280ppm) at point of use. MRC of Tristel Duo ULT may be verified using Duo Test Strips.

Tristel Duo ULT is intended to be marketed for prescription use.

Tristel Duo ULT is a high level disinfectant foam intended to disinfect cleaned, reusable, nonlumened ultrasound probes. Tristel Duo ULT is intended to be used by qualified healthcare personnel. Tristel Duo ULT does not sterilize.

Tristel Duo ULT generates chlorine dioxide foam from two "precursor" solutions (Base Solution and Activator Solution), which are packaged separately within two individual containers and secured together within a single dispenser apparatus known as the "pump" shown in Figure 2. When depressed, the pump dispenses these solutions at equal volumes.

The components of the Base and Activator solutions chemically react. This reaction generates chlorine dioxide in liquid solution, which is the active germicidal ingredient. A mesher present in the applicator pump causes the formulation to be dispensed as a ready-to-use foam.

The active ingredient in Tristel Duo ULT high level disinfectant is chlorine dioxide, which is generated in situ from the Activator and Base solutions. Tristel Duo ULT also contains other (D) CI (b) 49 ingredients, such as sodium chlorite, citric acid monohydrate. (0) 49)

The Duo bottle configuration consists of the two bottles (containers), a single pump head with two thread neck closures and a cap. Each Duo bottle contains 125 milliliters (mL)/4.40 fl oz of Base Solution and 125 mL/4.40 fl oz of Activator Solution. The left and right containers are made to the same specification, with the difference in the orientation of the neck thread. The bottle is handheld. Shown in Figures 3 and 4.

An 80% V/V dilution of Duo was determined as the Minimum Effective Concentration (MEC) for Duo.

Duo Wipes are dry, non-woven, low-linting wipes. They are specifically designed to apply the Tristel Duo ULT foam onto the surface of a medical device. A user lays the Duo Wipe in one hand and applies 4 doses of the Tristel Duo ULT foam before closing their hand around the wipe and waiting for 10 seconds. The wipe can then be used to spread the foam in a massaging motion from one end of the device to the other 4 times. After the device is wiped, it is left undisturbed for 2 minutes.

The Duo Test Strips are semi-quantitative chemical indicators used to determine whether the concentration of the Tristel Duo ULT high level disinfectant foam is above or below the minimum recommended concentration (MRC) (~90% v/v /~280 ppm).

Tristel Duo ULT foam bottle is designed in a way that ensures measured dose delivery with each application generating active ingredient above the MRC.

The Duo Test Strips, when used in accordance with directions for use detect the MRC and above giving a color indication of a "PASS" and if the concentration is below the MRC a color indication of a "FAIL".

This document describes the regulatory acceptance of a medical device, a high-level disinfectant, not an AI/ML-driven diagnostic device. Therefore, many of the requested criteria related to AI/ML study design (e.g., sample size for test/training sets, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, etc.) are not applicable to the Tristel Duo ULT disinfectant.

However, I can extract and present the acceptance criteria and the study performance for the disinfectant, re-framing the questions where relevant to fit the context of a chemical disinfectant.

Device Name: Tristel Duo ULT high level disinfectant

Device Type: Foam or gel chemical sterilant/high level disinfectant

Regulatory Class: Class II

Acceptance Criteria and Reported Device Performance

The acceptance criteria for a chemical high-level disinfectant are primarily demonstrated through a series of performance efficacy tests, biocompatibility, and human factors evaluations. The "performance" in this context refers to the device's ability to effectively disinfect, maintain stability, and be safely used.

Here's a table summarizing the acceptance criteria (often stated as special controls and performance tests required) and the reported device performance for Tristel Duo ULT:

Given that this is a chemical disinfectant and not an AI/ML diagnostic device, the following points are generally not applicable or are addressed in a different manner than for an AI/ML system:

2. Sample size used for the test set and the data provenance: Not applicable in the context of an AI test set. Performance is based on standardized microbiological and chemical tests and human factors studies. For simulated use, "six skin surface ultrasound probes and a total of seven endocavity ultrasound probes were tested in triplicate." For in-use testing, "wild type bacteria and fungi from patient contaminated BK Medical endocavity ultrasound probes" were used. Data provenance is implied to be from laboratory testing and clinical settings relevant to the device's use.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" for a disinfectant is established by validated microbiological methods (e.g., AOAC standards) and chemical analyses, not expert consensus on medical images. Expertise lies in microbiology, chemistry, and regulatory science.
4. Adjudication method for the test set: Not applicable. Performance is measured objectively by laboratory assays (e.g., log reduction of microorganisms).
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Not an algorithm. Its performance is inherent to its chemical properties and use protocol (human-in-the-loop for proper application).
7. The type of ground truth used:
   • Microbiological Efficacy: Ground truth established via validated culture methods demonstrating log reduction of specified microorganisms (spores, mycobacteria, fungi, bacteria, viruses) under controlled laboratory conditions.
   • Chemical Stability/Concentration: Ground truth established via analytical chemistry methods to determine active ingredient concentration over time and under various conditions.
   • Biocompatibility: Ground truth established via ISO 10993 series of biological evaluation tests.
   • Human Factors: Ground truth established through observation of user performance on critical tasks during simulated use scenarios, assessing task completion and identification of use errors.
8. The sample size for the training set: Not applicable. This is not an AI/ML device; there is no "training set" in the computational sense. Development involves formulation and iterative testing.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text robustly details the experimental evidence required for a chemical high-level disinfectant, emphasizing its efficacy against various microbes, its stability, material compatibility, user safety (biocompatibility and human factors), and appropriate labeling. The "acceptance criteria" are the special controls and performance testing elements outlined, and the "proof" is the successful completion and positive results of all the specified studies.

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