Search Results

Is a general for repose as interfact For use in health care settings for low and intermediate level disinfection of hard, non-porsus, increase in the contra suffaces of wheelchairs, medical beds, patient transfer iffs, cruiches, instrument trays, operating tables, surfaces of Pricolonalic, modical paintal chairs, medical lamps, whilipool bathing units, and other medical devices that require low or internediate level disinfection. This product may be used to preclaan or decontaminate attical or non-citical medical devices prior to sterilization or high-loved disintedion. The effectiveness of this product has been documented at a temperature of 68°F (20°C), with a ten minute contact time on the surface being treated.

Device Description

Low pH Phenolic 256 is a liquid germicidal detergent formulated to clean, disinfect, and deodorize any washable, non-porous surface in one easy step. Low pH Phenolic 256 is recommended for use by hospitals, nursing homes, and other health care institutions that are dedicated to controlling cross-contamination in their establishments. Low pH Phenolic 256 is for use on any hard, inanimate surfaces such as door handles, medical bed surfaces, springs, wheelchairs, walls, floors, light switches, linen carts, stretcher wheels, toilet bowl surfaces, showers, bathtubs, bed frames, patient transfer lifts, patient scales, examination tables, dental chairs, stethoscopes, bedpans, blood donor chairs, and other hard, non-porous surfaces that need disinfection.

AI/ML Overview

This document describes a 510(k) submission for a device called "Low pH Phenolic 256" (also referred to as "Cen-pHene"), which is a liquid germicidal detergent designed for intermediate-level disinfection. The submission does not describe an AI/ML powered medical device, therefore questions regarding sample size for test/training set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, and data provenance are not applicable.

Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets those criteria:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this disinfectant are defined by its efficacy against specific microorganisms under specified conditions. The reported device performance indicates it met these criteria.

Acceptance Criteria (Microorganism & Condition)	Reported Device Performance
Bactericidal Efficacy (in presence of organic soil - 5% blood serum):
- Mycobacterium tuberculosis (BCG) at 20℃, 10-minute contact time	Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Mycobacterium tuberculosis (BCG) at 20℃.
- Staphylococcus aureus (in presence of 5% blood serum)	Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Staphylococcus aureus.
- Salmonella cholerasuis (in presence of 5% blood serum)	Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Salmonella cholerasuis.
- Pseudomonas aeruginosa (in presence of 5% blood serum)	Low pH Phenolic 256 demonstrates effective disinfectant efficacy against Pseudomonas aeruginosa.
Virucidal Efficacy:
- HIV-1 (associated with AIDS) on pre-cleaned environmental surfaces/objects previously soiled with blood/body fluids in health care settings relevant to potential for transmission of HIV-1.	Exhibits effective virucidal activity against HIV-1 (associated with AIDS).
Fungicidal Efficacy:
- Trichophyton mentagrophytes (Athlete's Foot Fungus) on hard surfaces found in bathrooms, shower stalls, locker rooms, or other clean, non-porous, hard surfaces commonly contacted by bare feet.	Is fungicidal against Trichophyton mentagrophytes (Athlete's Foot Fungus) when used as directed on hard surfaces, as found in bathrooms, shower stalls, locker rooms, or other clean, non-porous, hard surfaces commonly contacted by bare feet.
Physical Characteristics:
- Appearance (Concentrate)	Clear light amber liquid
- Odor	Slight alcohol
- Percent of Phenolics (Concentrate)	14.735%
- pH (concentrate)	2.25 ± 0.50
- pH (use-dilution)	3.50 ± 0.50
- Specific Gravity (25°C)	1.089 ± 0.01
- Flash Point	None
- Detergency	Excellent
- Phosphate Content	None
- Testing Standard	Tested according to A.O.A.C. in Hard Water up to 400 ppm in the presence of 5% organic soil load.

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 does not specify the explicit "sample size" in terms of number of treated surfaces or biological replicates for the efficacy tests. The data provenance (country of origin, retrospective/prospective) is not mentioned.

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 information is not applicable as the device is a chemical disinfectant, not an AI/ML powered medical device that requires expert ground truth for interpretation. Efficacy is determined through standardized microbiological testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Efficacy is determined through standardized microbiological testing, not human-based adjudication.

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 a chemical disinfectant, not an AI-powered diagnostic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a chemical disinfectant, not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's efficacy is the reduction or inactivation of specified microorganisms (bacteria, viruses, fungi) to acceptable levels, as determined by standardized laboratory microbiological testing methods (specifically, A.O.A.C. methods as stated).