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The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes).

The Model 2100 and 3100 are table-top natural convective (static air type) dry heat sterilizers designed for use in healthcare facilities for the sterilization of wrapped and unwrapped metal instruments and glassware. The single sterilization cycle runs at 160°C (320°F) for 1 hour (60 minutes). Items to be sterilized are placed horizontally on the removable trays inside the chamber.

Both models are plug-in units designed to run on standard 115 VAC household current. A thermocouple is used to measure the chamber temperature. All functions of the sterilizer are controlled by an embedded PCB. Access to the heating chamber is through a hinged door on the front of unit. A LED digital display located on the front of the unit indicates chamber temperature and remaining cycle time.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text.

Note: This document describes a medical device (sterilizer), not an AI/ML algorithm. Therefore, many of the requested fields related to AI/ML studies (like training sets, expert ground truth, MRMC studies, and standalone algorithm performance) are not applicable and will be marked as such. The "performance" here refers to the device's ability to sterilize, not an AI's diagnostic performance.

Device Name: Steri-Dent Model 2100 and 3100 (Table Top Dry Heat Sterilizer)

1. Table of Acceptance Criteria and Reported Device Performance

• ANSI/UL 61010-1: Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1 - General Requirements
• CAN/CSA C22.2 No. 61010-1: Electrical Equipment for Measurement, Control, and Laboratory Use; Part 1 - General Requirements
• IEC 61010-2-040: Particular Requirements for Sterilizers and Washer-Disinfectors Used to Treat Medical Materials.
  These are stated to be the same standards the predicate device complied with. |

Study Details (Non-Clinical Performance Data)

This section describes the studies conducted to prove the device meets its acceptance criteria.

1. Sample Size Used for the Test Set and Data Provenance:

   • Effectiveness (Sterile Efficacy Studies): Three full-load half-cycle (30 minute) tests were run on each model (Model 2100 and Model 3100). The total number of test samples (inoculated instruments and BI strips) challenged across these tests was 84.
   • Thermal Profile Studies: Three runs with a small load and three runs with a full load were performed for each sterilizer model.
   • Data Provenance: The studies were performed by SPS Medical. The location/country of origin of the data is not explicitly stated, but given the US-based manufacturer and FDA submission, it's presumed to be within the US or compliant with US standards. The studies were non-clinical performance evaluations, not involving human subjects, so retrospective/prospective distinctions regarding patient data do not apply.

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

   • Not applicable. This is a physical device sterilizer, not an AI/ML algorithm requiring expert review for ground truth establishment. The ground truth (sterility) was established experimentally using biological indicators and growth media.

3. Adjudication Method for the Test Set:

   • Not applicable. This is a physical device sterilizer. Results were based on biological and thermal measurements, not expert consensus on interpretations.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • Not applicable. This is a physical device sterilizer, not an AI-assisted diagnostic tool.

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

   • Not applicable. This is a physical device sterilizer.

6. The Type of Ground Truth Used:

   • Effectiveness: Biological indicators (spores of Bacillus atrophaeus) are the ground truth for sterility. A "negative for growth" result (no bacterial growth) confirmed successful sterilization. Positive controls were used to validate the test.
   • Thermal Profile: Direct temperature measurements using thermocouples confirmed the thermal performance.

7. The Sample Size for the Training Set:

   • Not applicable. This is a physical device sterilizer, not an AI/ML algorithm requiring a training set.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable.

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The DDS 7000 is a countertop convective dry heat sterilizer designed for use in Healthcare facilities for the sterilization of un-bagged dental instruments that can withstand exposure temperatures up to 216°C (420° F). There is a single software-controlled cycle that includes a warm-up and cool down phase in addition to the 3-minute sterilization (exposure) phase. Sterilize (exposure) starts when the RTD/control temperature reaches the operating temperature set point of 190°C (374° F). Complete cycle times average 34-44 minutes and are load dependent. The DDS 7000 achieves optimum results by uniform load distribution utilizing a dedicated rack and tray system as detailed below.

1. Maximum recommended loads validated for the DDS 7000-115 sterilizer: -
   a) Maximum load for a four (4)-rack configuration is four (4) plier racks each holding nine (9) orthodontic pliers each for a total of thirty-six (36) pliers. Other maximum load configuration options are: 32 pliers on eight mini vertical racks; or 20 pliers and hand instruments on four Combo Racks -(OR)-
   b) Maximum load for a full tray configuration is one (1) Horizontal Tray each holding up to six (6) orthodontic pliers or up to (12) single-handle hand instruments. Other maximum load combinations include: (5) orthodontic pliers with up to (2) single-handle hand instruments; or (4) orthodontic pliers with up to (4) single-handle hand instruments; or (3) orthodontic pliers with up to (6) single-handle hand instruments, or (2) Orthodontic pliers with up to (8) single-handle hand instruments; or (1) Orthodontic pliers with up to (10) single-handle hand instruments. - (OR)-
   c) Maximum load for the one (1) half tray and two (2) racks is one (1) Half Tray holding three (3) Orthodontic pliers or six (6) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks. Other maximum load combinations include: (2) orthodontic pliers with up to (2) single-handle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks; or (1) orthodontic pliers with up to (4) singlehandle hand instruments in combination with two (2) plier racks capable of holding nine (9) pliers each for a total of eighteen (18) pliers on plier racks.

The DDS 7000, like the DDS 5000 is a convective dry heat batch sterilizer capable of sterilizing un-bagged dental instruments and cooling them for immediate use. It is designed for use with a dedicated rack system that provides for uniform loading to achieve optimum load distribution.
The DDS 7000 is equipped with a replaceable HEPA filter to comply with ANSI/AAMI ST50: 2004 cooling requirements. The HEPA filter has a filtration efficiency of 99.7% for 0.3-micron particles.
The DDS 7000 is a software-controlled device that allows for the user to preprogram options such as display units (Celsius or Fahrenheit), audible alarm enabled/disabled and safety interlock enabled/disabled The DDS 7000 monitors the entire cycle and will provide diagnostic error codes in the event of any failure or disruption to the sterilization cycle. A printable log is available for the most recently performed cycle that includes pass/fail notification and error codes if applicable

The Dentronix "DDS 7000" Rapid Dry Heat Sterilizer Sterilization System is designed for the dry heat sterilization of un-bagged dental instruments that can withstand exposure temperatures up to 216℃ (420° F).

Here's an analysis of its acceptance criteria and the study proving it:

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: The document mentions "Performance testing of the DDS 7000 was performed using Bacillus atrophaeus spore strips and inoculated tools." While the specific number of spore strips or inoculated tools used is not quantified, it implies a sufficient sample was used to demonstrate a 12-log reduction of spores. Full, partial, and empty chambers were also included in temperature studies.
• Data Provenance: The study was conducted by Coltene/Whaledent Incorporated for the purpose of a 510(k) premarket notification to the FDA. The data provenance is internal testing performed by the manufacturer in the USA (Cuyahoga Falls, Ohio). It is a prospective study as it involves specific performance testing of the device.

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

This type of device (sterilizer) relies on established microbiological and engineering principles rather than clinical expert consensus for its "ground truth."

• Experts: Not applicable in the sense of medical image interpretation or diagnosis. The "ground truth" for sterilization efficacy is typically defined by microbiologists who assess the viability of biological indicators (spore strips) after exposure to the sterilization cycle.
• Qualifications: While not explicitly stated, it is assumed that personnel with expertise in microbiology, sterilization science, and engineering were involved in designing, executing, and analyzing the performance tests.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation (e.g., radiology reads where multiple experts evaluate cases and discrepancies are resolved). For sterilizer performance, the assessment is objective, based on laboratory results (e.g., no growth of Bacillus atrophaeus spores).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where the performance of human readers, with and without AI assistance, is compared. The DDS 7000 is a sterilization device, not a diagnostic imaging device.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance):

Yes, a standalone performance study was done. The performance testing described (using Bacillus atrophaeus spore strips and inoculated tools) is a direct evaluation of the device's ability to sterilize, independent of human interaction during the sterilization cycle itself (though human operation is required to initiate the cycle). The study directly assesses the sterilizer's efficacy.

7. Type of Ground Truth Used:

The ground truth used is microbiological evidence. Specifically, the absence or reduction of viable microorganisms (spores of Bacillus atrophaeus) on biological indicators and inoculated tools after the sterilization cycle. This is an objective measure of sterilization efficacy.

8. Sample Size for the Training Set:

Not applicable. The DDS 7000 is a hardware device (dry heat sterilizer) with software controls, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "software validation" mentioned refers to ensuring the software correctly controls the device and functions as intended, not to training a predictive model.

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

Not applicable, as there is no "training set" for an AI or machine learning model in this context. The "software" validation principles refer to ensuring appropriate design, development, and testing of the control software to meet functional and safety requirements, as per FDA guidance documents.

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