FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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.

Device Description

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AI/ML Overview

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:

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)

*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.

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.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable.
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.
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.
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.
The sample size for the training set
This information is not applicable.
How the ground truth for the training set was established
This information is not applicable.

Summary

Regulation Number and Section

§ 880.6880 Steam sterilizer.

(a)
Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.(b)
Classification. Class II (performance standards).