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Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is intended for sterilization or high level disinfection of medical and surgical instruments that require submersion. SSDS is intended for reprocessing only heat-sensitive medical devices.

Sporicidin® Sterilizing and Disinfecting Solution (SSDS) should be used under the following contact conditions:

SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its Minimum Recommended Concentration (MRC). The glutaraldehyde MRC is 0.6%; the phenol MRC is 1.3%.

Sporicidin Indicator Strips are intended for verifying the MRC of glutaraldehyde and phenol in SSDS during use. Sporicidin Indicator strips should be used before each use of SSDS.

Sporicidin® Sterilizing and Disinfecting Solution (SSDS) is a liquid chemical sterilant and high level disinfectant. The product contains two solutions: a buffer containing 1.7% phenol/phenate, and an activator containing 25% glutaraldehyde. When the two solutions are mixed, or activated, SSDS contains 0.95 % glutaraldehyde and 1.64% phenol/phenate. The solutions are combined at the user level, resulting in the activated germicide.

SSDS is a liquid chemical sterilant and a high level disinfectant when used or reused according to the DIRECTIONS FOR USE included in the package insert. SSDS can be reused for a maximum of 7 days or until Sporicidin Test Strips indicate that either the glutaraldehyde or phenol level falls below its Minimum Recommended Concentration (MRC). The MRC for glutaraldehyde is 0.6%, and 1.3% for phenol/phenate.

Sporicidin® Sterilizing and Disinfecting Solution (SSDS) must be used with Sporicidin Indicator Strips, used to verify that the MRC of active ingredients is present. It is recommended that SSDS be tested with Sporicidin Indicator Strips prior to each use.

The provided documentation describes the efficacy testing and acceptance criteria for Sporicidin® Sterilizing and Disinfecting Solution (SSDS).

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for SSDS are based on its ability to act as a liquid chemical sterilant and high-level disinfectant. The performance is assessed against various microorganisms under specified conditions. The Minimum Recommended Concentration (MRC) levels for glutaraldehyde (0.6%) and phenol (1.3%) are also key acceptance criteria, along with specific contact times and temperatures.

2. Sample size used for the test set and the data provenance

• Microbiological Testing: The document does not specify a precise sample size in terms of number of organisms tested per run, but it states that testing was conducted under "worst case conditions with solution batches that were at the end of, or beyond, their two year expiration dates."
• Simulated In-Use Testing (Endoscopes):
  • Sample Size: Mentions "Flexible fiber endoscopes made of a variety of material types were used." No specific number provided.
  • Data Provenance: Retrospective (implied, as the tests were conducted for market submission). The country of origin is not specified, but the submission is to the FDA in the USA.
• Clinical (In-Use) Testing (Endoscopes):
  • Sample Size: Refers to "Lower GI endoscopes used in patient care." No specific number provided.
  • Data Provenance: Prospective (implied, "under actual use conditions" of patient care). The country of origin is not specified.
• Residue Testing:
  • Sample Size: "devices were soaked". No specific number provided.
  • Data Provenance: Retrospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The document describes laboratory efficacy testing rather than studies requiring expert adjudication for ground truth (e.g., image interpretation). Therefore, no information is provided on the number or qualifications of experts for establishing ground truth as it would be understood in a diagnostic accuracy study. The "ground truth" for the microbiological efficacy studies would be the established methods for determining microbial kill and reduction.

4. Adjudication method for the test set

Not applicable, as the studies are primarily laboratory efficacy tests and chemical residue analysis, not requiring expert adjudication in the manner of diagnostic accuracy studies.

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 submission for a chemical sterilant/disinfectant, not an AI-assisted diagnostic device.

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

Not applicable. This is a chemical product, not an algorithm. The product itself, when used according to instructions, is "standalone."

7. The type of ground truth used

The ground truth used for efficacy testing is based on microbiological assay results (e.g., reduction in microbial count, complete kill) following standardized testing procedures. For residue testing, the ground truth is established by chemical analysis (e.g., HPLC, spectroscopy) to detect and quantify residues.

8. The sample size for the training set

Not applicable. This is a chemical sterilant/disinfectant, not a machine learning model. There is no concept of a "training set" in this context.

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

Not applicable. No training set was used.

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