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The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA and SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact.

The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is a table-top steam sterilizers that uses saturated steam at high pressures and temperatures and kills infectious bio-organisms. The steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to the established time, temperature, and pressure parameters. Items to be sterilized are placed in the sterilization chamber. The user selects a sterilization cycle, and presses the start switch to initiate the cycle. The sterilizer will automatically fill water into the chamber, heat the water into steam, introduce steam-flush and pressure-pulses, hold at a set pressure, temperature, and time to sterilize the items, and automatically vent the steam and cool the chamber down after the sterilization is complete.

This document describes the acceptance criteria and the study that proves the device, STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R), meets those criteria.

Key takeaway: This submission (K231489) is for a modification of an already cleared device (K181993). The primary modifications are a change in the pressure vessel supplier, some operational feature optimizations, and reduced air removal and dry times. The performance claims for sterilization and drying are maintained. Therefore, the acceptance criteria and study primarily focus on demonstrating that these modifications do not negatively impact the previously established safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a submission for a modified device, the acceptance criteria are generally that the modified device performs "as well as or better than" the predicate device and meets relevant industry standards. The performance data presented demonstrates this equivalence or improvement.

• No growth at half cycle with validation loads
• Includes textile PCD, wrapped instrument PCD, and dental handpieces
• Compliance with ANSI/AAMI ST55:2016 |
  | Moisture Retention | Meets moisture retention test criteria in ANSI/AAMI ST55:2016 for:
• Textile test packs
• Wrapped instrument test trays
• Paper-plastic peel pouches |
  | Empty Chamber Temperature Mapping | Capable of providing steady-state thermal conditions within the chamber consistent with the desired SAL in the load. (Compliance with ANSI/AAMI ST55:2016) |
  | Air Removal Performance (Bowie-Dick Test) | Verified air removal performance. (Compliance with ANSI/AAMI ST55:2016) |
  | Electrical Safety | Meets all applicable safety requirements for electrical equipment specified in UL 61010-1 3.1 Ed., and IEC 61010-2-040 3rd Ed. 2020-05. |
  | Electromagnetic Compatibility (EMC) & Electrical Safety | Meets all applicable electromagnetic compatibility and electrical safety requirements for electrical equipment specified in EN IEC 61326-1:2021 and associated standards. |
  | Software Verification & Validation | Software meets safety and functional requirements and fulfills user needs. |
  | Cycle Times (Example: Drying Cycle) | Reduced Drying Times:
• Unwrapped instruments: 20 minutes (previously 30 min)
• Wrapped instruments (pouches): 20 minutes (previously 30 min)
• Handpieces: 20 minutes (previously 30 min)
  Note: Wrapped instruments (Packs) drying cycle remains 30 minutes. The drying performance has been successfully verified using the reduced dry time. |
  | Safety (Pressure Relief) Valve Setting | Equivalent to predicate: 40 psi (275.8 kPa) to 41 psi (282.7 kPa) Max. ASME approved. |
  | Sterilization Method | Equivalent to predicate: Dynamic-air-removal steam sterilizer with 2 steam-flush pressure-pulses (previously 4). |

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

The document does not specify exact sample sizes for each non-clinical test (e.g., number of sterilization cycles performed for biological performance, number of Bowie-Dick tests). It refers to compliance with standards like ANSI/AAMI ST55:2016, which would dictate appropriate sample sizes for validation.

The data provenance is not explicitly stated as "country of origin," but given the submitter's address (STURDY Industrial CO., LTD., New Taipei City, Taiwan), it's highly probable the testing was conducted in Taiwan or by a contracted lab following international standards. The studies were retrospective in the sense that they were performed to validate design changes on an existing device, rather than a de novo clinical trial.

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

This device, a steam sterilizer, does not involve diagnostic interpretation or human-in-the-loop performance. Therefore, "ground truth" is established through objective engineering and microbiology performance metrics (e.g., spore kill, temperature and pressure readings, moisture levels, electrical safety standards compliance). There are no "experts" in the sense of clinicians or radiologists adjudicating results, but rather qualified test engineers and microbiologists performing and analyzing the validation tests according to established international standards (e.g., ANSI/AAMI, IEC, UL). The document does not specify the exact number or individual qualifications of these testing personnel.

4. Adjudication Method for the Test Set

Not applicable. As described above, the acceptance is based on objective measurements against pre-defined engineering and microbiological standards, not subjective human interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a steam sterilizer, not an AI-assisted diagnostic imaging device for human readers. No MRMC study was performed.

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

The entire performance evaluation for this device is effectively "standalone" in the sense of the sterilizer's function without continuous human intervention during a sterilization cycle. The device's performance (sterilization efficacy, drying, etc.) is objectively measured and validated against standards, independent of human operators' real-time judgment during the sterilizing process.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on:

• Microbiological Standards: Demonstrated sterility (SAL of 10^-6) through biological indicator challenges and growth/no-growth results, a fundamental requirement for sterilizers.
• Physical Parameters: Objective measurements of temperature, pressure, and time profiles within the sterilization chamber during cycles, ensuring they meet the required conditions for sterilization.
• Engineering Standards: Compliance with relevant safety (electrical, pressure vessel), electromagnetic compatibility, and performance standards (e.g., ANSI/AAMI ST55:2016 for sterilizer performance, IEC and UL for electrical safety).
• Performance Metrics: Measurements of residual moisture content and verification of clean air removal (Bowie-Dick test).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device. The "training" for such a device would be its historical design and manufacturing processes, which are validated through adherence to quality systems and standards, not a specific data training set in the AI sense.

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

Not applicable, as this is not an AI/machine learning device requiring a discrete training data set with established ground truth. The "ground truth" for the predicate device's design (K181993) and the modifications in K231489 are established through adherence to recognized consensus standards for medical device design, manufacturing, and performance.

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The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is intended to be used in medical and dental offices, hospitals, clinics, nursing homes, laboratories, and other facilities to sterilize heat and moisture stable reusable equipment. Dental handpieces can be sterilized in the models SA-260MA-R. The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) is not recommended for sterilization of liquid intended for direct patient contact.

The STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) uses saturated steam at high pressures and temperatures and kills infectious bio-organisms. This steam is generated inside the sterilization chamber by an electric heating element. The sterilizer's electronic control system is pre-programmed to complete sterilization cycles according to established time, temperature and pressure parameters. Devices to be sterilized are placed in the sterilization chamber. The operator chooses a sterilization cycle and presses the appropriate switch. The sterilizer automatically fills the chamber, heats the water into steam, four times pulse sterilizes the items, and automatically vents the steam and cools the chamber after sterilization is complete.

This document describes the non-clinical testing performed to demonstrate that the STURDY Autoclave Super Microm (models SA-260MA and SA-260MA-R) meets specified acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

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

   The document does not explicitly state the exact sample sizes (e.g., number of test cycles, specific items tested) for each non-clinical test. It generally describes the "worst-case maximum load condition" for biological performance testing.
   The provenance of the data is from non-clinical laboratory testing performed by Sturdy Industrial Co., Ltd. for the purpose of demonstrating substantial equivalence to a predicate device (Midmark M11 Ultraclave Steam Sterilizer, K990189). This is a retrospective evaluation of the device's performance against established standards.

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

   This information is not provided in the document. The testing described is non-clinical performance testing against recognized standards rather than human-read image interpretation.

4. Adjudication method for the test set:

   Not applicable. The tests are objective measurements against predefined criteria in recognized standards, not subjective interpretations requiring 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 medical device (steam sterilizer) and not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.

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

   Not applicable. This is a steam sterilizer device. There is no algorithm-only performance to assess.

7. The type of ground truth used:

   The ground truth for this device's performance is established by the acceptance criteria defined within the referenced ANSI/AAMI ST55:2016 standard and other relevant standards. These standards specify quantifiable performance metrics (e.g., temperature ranges, moisture retention percentages, biological indicator growth/no growth, uniform color change for Bowie-Dick test).

8. The sample size for the training set:

   Not applicable. The device is a steam sterilizer, not a machine learning model, so there is no training set in the context of AI.

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

   Not applicable for the same reason as point 8.

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The STURDY Manual Resuscitator is intended for manually-powered controlled or assisted ventilation with ambient air with or without additional oxygen. The child model is intended for patients weighing less than 30kg. The adult model is intended for patients weighing more than 30kg.

Not Found

This is a 510(k) premarket notification for a medical device (STURDY Manual Resuscitator), not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study details, expert involvement, ground truth, and training sets is not applicable in this context.

The document indicates that the device has been found substantially equivalent to legally marketed predicate devices, meaning it meets the safety and effectiveness standards without requiring extensive de novo studies like those typically associated with new AI/ML technologies.

The acceptance criteria for a traditional medical device like a manual resuscitator would typically involve performance specifications for characteristics such as:

• Volume delivery: The amount of air delivered per squeeze.
• Leakage: Ensuring no significant air leakage from the device.
• Operating pressure: The pressure generated during manual ventilation.
• Patient valve resistance: Resistance to airflow through the patient valve.
• Exhalation valve function: Proper operation of the exhalation valve.
• Material biocompatibility: Ensuring materials are safe for patient contact.
• Sterilization efficacy (if applicable): For reusable devices, the ability to be effectively sterilized.
• Durability and functional life: How long the device can perform as intended.

These criteria are typically established through recognized standards (e.g., ISO standards for medical devices) and verified through bench testing, mechanical testing, and potentially some limited human factors or simulated use testing, rather than the types of clinical studies and expert reviews you'd see for AI/ML diagnostic tools.

Since this is not an AI/ML device, the specific questions about sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types are not relevant to this submission.

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