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Endo-Spor Plus™ liquid chemical germicide is intended for the disinfection and sterilization of endoscopic instruments and other heat labile medical and dental instruments.

Endo-Spor Plus™Hyprocide™is a chemical disinfecting and sterilization solution for use on flexible lensed endoscopy instruments, inhalation therapy equipment and instruments and materials that cannot be heat sterilized.

The liquid chemical germicide Endo-Spor Plus™ contains the active ingredients hydrogen peroxide and peracetic acid. The germicide can be used as a high level disinfectant with a contact time of 15 minutes at 20℃ under reuse conditions of up to 14 days.

Here's a breakdown of the acceptance criteria and the study details for the Endo-Spor Plus™/Hyprocide™ Liquid Chemical Germicide, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document does not explicitly state "acceptance criteria" as a separate, quantitative table. Instead, it presents performance results as meeting specific efficacy requirements for various tests. The table below synthesizes this information.

Study Details

1. Sample size used for the test set and the data provenance:

   • Simulated Use Test: Not explicitly stated for each organism.
     • For M. bovis and C. sporogenes contaminated endoscopes, the results refer to 6-log reductions, implying a sufficient number of tests to establish this.
   • Clinical Testing: 15 flexible fiberoptic endoscopic retrograde cholangiopancreatography (ERCP) endoscopes.
   • Residue Testing: A "series of Olympus endoscopes." (Specific number not given).
   • Toxicology Testing:
     • Primary Dermal Irritation: Not specified, but standard tests involve multiple animals (e.g., rabbits).
     • Acute Dermal Toxicity: Not specified.
     • Ocular Irritation: 6 rabbits.
     • Acute Oral Toxicity: Not specified.
     • Skin Sensitization: Not specified.
     • Mutagenicity (Ames test): Not specified, typically uses bacterial strains grown in cultures.
   • Material Compatibility: "a variety of metallic, plastic and rubber endoscope components" (specific number of components/tests not given) and "a number of different adhesives."
   • Data Provenance: The document does not explicitly state the country of origin. Given the submission to the FDA, it's likely part of US regulatory submissions, but the actual lab locations are not provided. The studies appear to be prospective experimental studies.

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

   • This type of device (liquid chemical germicide) relies on laboratory efficacy testing against standardized microorganisms and physical/chemical properties rather than human expert interpretation of images or clinical findings. Therefore, neither a number of experts nor their qualifications for establishing ground truth in the traditional sense (e.g., radiologists reading images) is applicable or provided. The "ground truth" here is the direct, measurable outcome of the microbiological, chemical, and biological tests.

3. Adjudication method for the test set:

   • Not applicable as the study involves objective laboratory measurements and efficacy validation, not subjective expert assessment requiring adjudication.

4. 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/imaging device.

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

   • Not applicable. This is not an AI/imaging device. Its "standalone" performance is its microbicidal efficacy and material compatibility as tested in the lab.

6. The type of ground truth used:

   • Microbiological Efficacy: Laboratory culture results and log reduction measurements.
   • Residue Testing: Chemical analytical measurements (detectable levels of hydrogen peroxide/peracetic acid).
   • Toxicology: In vivo animal model observations for irritation, toxicity, and sensitization, and in vitro Ames test for mutagenicity.
   • Material Compatibility: Visual inspection for damage, weight change, flexibility, adhesion, and corrosion.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning device. The "training" for a chemical germicide comes from chemical formulation and established microbiological testing protocols.

8. How the ground truth for the training set was established:

   • Not applicable. (See #7). The "ground truth" for the effectiveness of the chemical components is based on established scientific principles of germicidal action and empirical data from chemical and microbiological research, not on a "training set" in the machine learning sense. The performance data presented are for the final product evaluation.

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Vapocide" is a sterilant solution intended to be used only in the Harvey Chemiclave Sterilizer to sterilize medical and dental surgical instruments and equipment. Vapocide is intended to be a direct substitute for Vapo-Sterli. Vapocide is recomended for use in the following Chemiclave series sterilizer models: Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000, 6000, 7000, 8000, and in Chemiclave cycle parameters as follows. Model E, 4000, 5000, 5500, 6000, EM 5000, EM 5500, EM 6000, - Operating pressure: 20-40 psi (1.41-2.82 kg/cm²) - Temperature: 132 ± 2°C (270 ± 5°F) - Maximum load: models with 8 and 10 in. diameter chambers Model 7000 and 8000 - Operating pressure: approximately 25 psi - Operating Temperature: 132 + 6, -0°C - Maximum load: 3.3 pounds (1.5 kg) Vapocide is compatible with but not limited to the following material types; - Surgical and cutting instruments, handpieces, and similar items - Plastic materials recommended are: Polysulfone, Phenolic, Epoxy, Polyphenylene, Oxide, Polyester, Polypropylene Vapocide" is not compatible with the following materials: - Linen, textiles or fabrics - Liquids and agars - Items contained in tightly woven packs or wraps - Plastics that cannot tolerate temperature in excess of 132ºC (270ºF) - Nylon tubing & bags inhibit penetration of chemical vapors Vapocide is not recommended for use for "flash" sterilization cycles.

Vapocide™ is a liquid sterilant solution designed for use in Harvey Chemiclave sterilizers only. Vapocide™ and the Harvey Chemiclave function as a sustem to sterilize medical and dental surgical instruments and equipment. Vapocide™ is a sterilant solution intended to be used in the Harvey Chemiclave which is a unsaturated chemical vapor sterilizer. Unsaturated chemical vapor sterilizers function by using heat, water, and chemical synergism to sterilize medical and dental equipment. Vapocide™ is made of formaldehyde and ethanol. This formulation when heated under pressure, results in a relatively unsaturated and totally effective sterilization vapor which does not have deleterious effects one mark surfaces.

Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Vapocide™ Liquid Chemical Sterilant.

Important Note: The provided document is a 510(k) Summary from 1997. The level of detail regarding acceptance criteria, study design, and statistical analysis is significantly less comprehensive than what would be expected for a modern medical device submission. Many of the specific details requested in your prompt (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, training set details) are simply not present in this type of summary from that era.

Acceptance Criteria and Reported Device Performance for Vapocide™ Liquid Chemical Sterilant

The acceptance criteria for Vapocide™ are primarily based on its performance as a sterilant, specifically its sporicidal effectiveness and material compatibility, when used in conjunction with Harvey Chemiclave Sterilizers. The device aims to demonstrate substantial equivalence to the predicate device, Vapo-Steril.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not explicitly stated in the summary document for any of the performance tests. The AOAC Sporicidal Test Protocol is a standard method, so its inherent sample sizes would have been followed, but specific numbers are not provided.
  • For Simulated Use Testing, it mentions "inoculated dental Handpieces" but no number.
  • For Material Compatibility, it lists categories of instruments (e.g., "orthopedic pliers, hand instruments, carbon steel burrs, high speed Handpieces, plastic resin cassettes") but does not quantify the number of items tested within each category or the total.
  • For Toxicity Testing:
    • Skin Irritation: Albino rabbits (number not specified, but typically 3-6 for such tests).
    • Ocular Irritation: Six rabbits.
    • Sensitization: Guinea pigs (number not specified).
    • Mutagenicity: Five tester strains of auxotrophic Salmonella typhimurium.
    • Acute Dermal Toxicity: Rabbits (number not specified, but typically 5-10 for LD50 tests).
• Data Provenance: The studies were conducted by "Sterilization Technical Services" and "Gibraltar Laboratories." The document doesn't specify countries of origin for these facilities, but given the US FDA submission, it's highly probable these are US-based laboratories. The data appears to be prospective as it describes specific testing performed to evaluate Vapocide™.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The testing was performed by contract laboratories (Sterilization Technical Services, Gibraltar Laboratories). It's assumed their personnel (e.g., microbiologists, toxicologists) established the "ground truth" based on standard protocols, but no specific number or detailed qualifications are provided.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. This type of device (chemical sterilant) doesn't typically involve human reader adjudication like image analysis AI devices. The "ground truth" for sporicidal efficacy is determined by laboratory culture methods (e.g., absence of growth), and for material compatibility, by visual inspection or microscopy by qualified personnel.

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

• MRMC Comparative Effectiveness Study: No. This type of study is irrelevant for a chemical sterilant. MRMC studies are typically used for diagnostic or screening devices where human readers (e.g., radiologists) interpret images or data, and the AI assists in this interpretation.

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

• Standalone Performance: Not applicable. Vapocide™ is a chemical sterilant, not an algorithm. Its "performance" is inherently "standalone" in the sense that the chemical itself performs the sterilization, with the human component being proper use in the Chemiclave.

7. The Type of Ground Truth Used

The ground truth for the various tests was established through:

• Microbiological Culture: For sporicidal effectiveness, the ground truth is the presence or absence of microbial growth after exposure to the sterilant, indicating successful sterilization or failure. This is standard for sterilization validation.
• Direct Observation/Microscopy: For material compatibility, the ground truth was visual and microscopic assessment for damage (corrosion, pitting, crazing, cracking).
• Chemical Analysis: For residue testing, the ground truth would be quantitative chemical analysis for formaldehyde.
• Biological Assays (in vivo/in vitro): For toxicity studies, the ground truth was determined by standardized animal models or in vitro assays (e.g., skin/ocular irritation in rabbits, sensitization in guinea pigs, mutagenicity in bacteria).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. Vapocide™ is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable. As Vapocide™ is not an AI/ML device, there is no training set or ground truth in that context.

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The Cottrell, Ltd., ProChek® G Glutaraldehyde Concentration Level Indicator is a 1.5% minimum effective concentration (MEC) monitor intended for use in 2-3.5% activated glutaraldehyde solutions.

The ProChek® G Glutaraldehyde Concentration Level Indicator is a chemical indicator strip with a minimum effective concentration of 1.5% glutaraldehyde designed to monitor solutions, containing up to 3.5% activated glutaraldehyde. The indicator pad changes from yellow to purple, indicating a pass, if the active glutaraldehyde concentration in the solution being tested is greater than or equal to 1.75%.

The provided text describes a medical device called the ProChek® G Glutaraldehyde Concentration Level Indicator, but it does not contain the information needed to fill out most of the requested fields regarding acceptance criteria and a study proving the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical or performance study with acceptance criteria. The "TESTING" section describes packaging permeability, not the device's functional performance in detecting glutaraldehyde.

Therefore, many fields below will be marked as "Not provided in the text".

Here's a breakdown of the requested information based on the provided text:

Acceptance Criteria and Device Performance

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

Note: The text states the device is a "1.5% minimum effective concentration (MEC) monitor" but that the indicator "changes from yellow to purple, indicating a pass, if the active glutaraldehyde concentration...is greater than or equal to 1.75%." This suggests the functional threshold for a "pass" is 1.75%, which aligns with the "reported performance" as described. The 1.5% MEC refers to the threshold for the glutaraldehyde solution itself to be considered effective, which the device monitors against. The device's performance is tied to its ability to accurately reflect reaching or exceeding a specific concentration.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample size for test set: Not provided in the text. The "TESTING" section describes permeability testing of shipping containers, not performance testing of the indicator itself.
• Data provenance: Not provided in the text.

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)

• Not applicable as no performance study on the indicator itself is described. The "ground truth" for glutaraldehyde concentration would typically be established by chemical analysis, not expert consensus.

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

• Not applicable as no performance study on the indicator itself is described.

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 device is a chemical indicator, not an AI-assisted diagnostic tool requiring human readers.

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

• Not applicable. This device is a chemical indicator, not an algorithm. Its performance is inherent in its chemical reaction. The text implies the device's functionality is directly tied to the predicate device, which is also a chemical indicator.

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

• The ground truth for the performance of such a device would typically be the actual chemical concentration of glutaraldehyde in a solution, determined by a recognized analytical method (e.g., titration, spectrophotometry). This information is not explicitly detailed in the provided text for the indicator's performance. The "TESTING" section only addresses packaging permeability.

8. The sample size for the training set

• Not applicable/Not provided in the text. This is a chemical indicator, not a machine learning model requiring a training set.

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

• Not applicable/Not provided in the text. This is a chemical indicator, not a machine learning model.

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