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The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.

It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

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This document describes a 510(k) premarket notification for the "STATCLAVE G4 CHAMBER AUTOCLAVE," a steam sterilizer. The FDA has determined it is substantially equivalent to legally marketed predicate devices.

The document outlines the device's indications for use: "The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be steam." It's explicitly stated that the device "has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization."

The document includes a table of program descriptions, cycle times, temperature, and dry times for various load types.

Based on the provided text, the following information regarding acceptance criteria and a study to prove device performance can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides performance parameters for different sterilization programs. While not explicitly labeled as "acceptance criteria" in a formal sense, these are the validated operational parameters for the device's intended use. The "reported device performance" is implicitly that the device operates according to these specifications to achieve sterilization.

Note: The acceptance criteria for a sterilizer would typically involve demonstrating a Sterility Assurance Level (SAL) of 10^-6 or better for microbial inactivation, along with meeting physical parameters like temperature, pressure, and biological indicator (BI) kill rates. These specific details are not provided in this regulatory letter, which focuses on substantial equivalence to a predicate device. The table above reflects the operational parameters of the device as cleared.

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

• Sample size for test set: Not specified in the provided text.
• Data provenance: Not specified in the provided text. This document is an FDA 510(k) clearance letter, not the study report itself. It refers to a "premarket notification," which usually includes performance data, but that data is not detailed here. It's highly probable the data would be prospective studies conducted by the manufacturer for validation.

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

• This information is not applicable and not provided. Sterilizer validation typically involves microbiological testing (e.g., biological indicators, inoculated product) and physical parameter monitoring, rather than expert consensus on images or interpretations.

4. Adjudication method for the test set:

• Not applicable and not provided. (See point 3).

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 medical device (sterilizer) and not an AI/imaging diagnostic tool that involves human readers or AI assistance in interpretation.

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

• Not applicable. This is a standalone medical device (sterilizer), and its performance is assessed directly through its physical and microbiological efficacy, not through an algorithm's classification or diagnostic ability.

7. The type of ground truth used:

• While not explicitly stated in this document, the ground truth for sterilizers is typically established through microbiological validation methods, such as:
  • Biological Indicators (BIs): Spore strips or suspensions are placed in worst-case locations within the load and chamber. After the cycle, these BIs are incubated, and the absence of growth (i.e., kill of highly resistant spores) serves as the ground truth for sterility.
  • Direct Inoculation: Instruments or materials are intentionally inoculated with high concentrations of resistant microorganisms and then processed. Subsequent culturing determines if all microbes were killed.
  • Physical Parameters: Monitoring and verification of temperature, pressure, and steam penetration throughout the cycle against validated ranges.
• The "acceptance criteria" implicitly include achieving a validated sterile outcome based on these scientific ground truths.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the context of machine learning or AI. Its development and validation are based on engineering principles, material science, and microbiology.

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

• Not applicable. (See point 8).

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The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.

It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

Not Found

The provided text describes a steam sterilizer (STATCLAVE G4 Chamber Autoclave), not an AI-powered medical device that requires a study to prove its performance based on AI/human interaction, ground truth, or statistical metrics like sensitivity/specificity.

Therefore, many of the requested categories are not applicable. I will extract the relevant information regarding the device's performance based on the provided text.

Here's the information as applicable:

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

   The device's performance is described by its sterilization programs, temperatures, exposure times, and minimum drying times for various load types. This constitutes the operational criteria and expected performance.

   Program	Load Description	Sterilization Temperature / Exposure Time	Minimum Drying Time**	Maximum Load	Reported Device Performance (Operational Parameters)
   Solid/Unwrapped	IUSS CYCLE* for unwrapped solid instruments (mirrors, explorers), hinged instruments (hemostats) on trays.	132°C / 270°F for 4 minutes	Not Applicable	6.0 Kg / 13.2 lbs	Meets the specified temperature and time for sterilization.
   Solid/Wrapped	Wrapped IMS cassettes with solid instruments, rigid sterilization containers with solid instruments or single-pouched solid instruments on a pouch rack.	132°C / 270°F for 4 minutes	25 minutes (up to 6 kg / 13.2 lbs)

15 minutes (up to 1.4 kg / 3 lbs**) | 6.0 Kg / 13.2 lbs | Meets the specified temperature, time, and drying for sterilization. |
| Hollow/Unwrapped | IUSS CYCLE* for unwrapped dental handpieces on trays. | 132°C / 270°F for 4 minutes | Not Applicable | 6.0 Kg / 13.2 lbs | Meets the specified temperature and time for sterilization. |
| Hollow/Wrapped | Single-pouched dental handpieces on a pouch rack. | 132°C / 270°F for 4 minutes | 25 minutes (up to 6 kg / 13.2 lbs)
15 minutes (up to 1.4 kg / 3 lbs) | 6.0 Kg / 13.2 lbs | Meets the specified temperature, time, and drying for sterilization. |
| Textiles/Porous Wrapped | Textiles | 132°C / 270°F for 4 minutes | 20 minutes | 2.0 Kg / 4.4 lbs | Meets the specified temperature, time, and drying for sterilization. |
| Rubber & Plastic | IUSS CYCLE* for unwrapped solid or hollow instrument | 121 °C / 250°F for 20 minutes | Not Applicable | 2.0 Kg / 4.4 lbs | Meets the specified temperature and time for sterilization. |

*IUSS: Immediate Use Steam Sterilization cycle.
**For optimal drying of these loads, SciCan recommends using only one pouch rack loaded on the second from top rail.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes a steam sterilizer, not an AI/diagnostic device that relies on a test set of data.

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. Sterilizers are validated through engineering and microbiological testing, not expert interpretation of outputs.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   This information is not applicable.

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
   This information is not applicable.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   This information is not applicable. The device operates as a standalone sterilizer, but the concept of "standalone performance" as it applies to an AI algorithm is not relevant here. Its performance is inherent to its mechanical and thermodynamic operation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
   The "ground truth" for a steam sterilizer would be the achievement of sterility according to validated microbiological standards (e.g., sterilization of biological indicators), and the physical parameters (temperature, pressure, time) being met. This document does not detail the specific validation studies but rather presents the approved operational parameters once those validations are complete.

8. The sample size for the training set
   This information is not applicable.

9. How the ground truth for the training set was established
   This information is not applicable.

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