(241 days)
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
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied from Testing) | Reported Device Performance (Tristel OPH) |
|---|---|---|
| Potency - Bactericidal | Bactericidal against Pseudomonas aeruginosa, Staphylococcus aureus, Salmonella enterica in 2.0 minutes exposure at 20°C (AOAC 955.15, 964.02, 955.14). | Bactericidal against Pseudomonas aeruginosa, Staphylococcus aureus, and Salmonella enterica in 2.0 minutes exposure at 20°C. |
| Potency - Fungicidal | Fungicidal against Trichophyton interdigitale in 1.0 minute exposure at 20°C (AOAC 955.17). | Fungicidal against Trichophyton interdigitale in 1.0 minute exposure at 20°C. |
| Potency - Virucidal | Virucidal against Poliovirus type 1, Herpes simplex virus type 1, Adenovirus type 5, and Feline calicivirus in 30 seconds exposure at 20°C (ASTM E1053). | Virucidal against Poliovirus type 1, Herpes simplex virus type 1, Adenovirus type 5, and Feline calicivirus in 30 seconds exposure at 20°C. |
| Potency - Mycobactericidal | Mycobactericidal against Mycobacterium terrae in 1.0 minute exposure at 20°C (Ascenzi et al., 1987). | Mycobactericidal against Mycobacterium terrae in 1.0 minute exposure at 20°C. |
| Potency - Sporicidal | Sporicidal against Clostridium sporogenes and Bacillus subtilis in 12 hours exposure at 20°C (AOAC 966.04). | Sporicidal against Clostridium sporogenes and Bacillus subtilis in 12 hours exposure at 20°C. |
| Potency - Additional Clinically Relevant Efficacy | Passing AOAC and ASTM1053 against specified clinically relevant bacteria, fungi, and viruses, and inactivation of HPV types 16 & 18. | Passed AOAC and ASTM1053 against Candida albicans, Aspergillus brasiliensis, Streptococcus agalacticae, Carbapenem-resistant Klebsiella pneumoniae, Extended Spectrum Beta-Lactamase (ESBL) Escherichia coli, Haemophilus influenza, Vancomycin-Resistant Enterococcus faecalis (VRE), Multi-Drug Resistant Streptococcus pneumoniae, Staphylococcus epidermidis, Human Coronovirus SARS-CoV-2, Human hepatitis B virus surrogate (duck hepatitis B virus), Human immunodeficiency virus type 1, Influenza A Virus. Inactivates Human papillomavirus (HPV) type 16 and type 18. |
| Simulated-Use | >6 log reduction mycobactericidal efficacy on worst-case inoculated devices in 6 log reduction mycobactericidal efficacy on worst-case inoculated devices in 6 log reduction) of specific viable microorganisms after exposure to the disinfectant. |
- 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).
N/A