(126 days)
The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisturestable medical, dental, and surgical materials, including wrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities.
The Fort Defiance Industries FRONT-LINE Field Sterilizers are autoclaves designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials, including wrapped and unwrapped, solid, porous, and hollow items (e.g., dental handpieces, suction pipes) in healthcare facilities. The devices use electrical resistive heaters to produce steam as the sterilizing agent. The devices adhere to sterilization processes and requirements that are universally accepted sterilization standards for Tabletop Steam Sterilizers. A touchscreen controller is used for monitoring and control of the device.
The devices are equipped with multiple safety features. The door includes a safety locking mechanism and door switch. The door switch does not permit cycle operation unless the door is sealed closed and does not permit the door to be opened until the internal chamber pressure is at atmospheric pressure. Additional safety features include electronic overtemperature and overpressure protection, an independent high temperature cutoff switch, and a pressure safety relief valve for the pressure vessel.
Only United States Food and Drug Administration cleared sterilization accessories should be used with these autoclaves.
The Fort Defiance Industries FRONT-LINE Field Sterilizers FL120 and FL135 are autoclaves designed for sterilizing heat- and moisture-stable medical, dental, and surgical materials. The device's performance was evaluated against the ANSI/AAMI ST55:2016 standard.
1. Table of Acceptance Criteria and the Reported Device Performance
| Test Procedure | AAMI ST55:2016 Requirements | Measured Performance |
|---|---|---|
| Sterilizer Temperature Control & Pressure Measurement (TP-5070) | 4.4.2.1 Temperature monitoring4.4.2.2 Relationship between RTD and chamber cold point4.4.2.4 Temperature graduations of 1°C or less4.4.3 -0/+6°F temp control4.4.5.1 Pressure gauge of +/- 3% of full scale, resolution of 1 PSIG or less | PASS |
| Temperature Accuracy (TP-5240) | 4.4.2.3 temperature accuracy of +/- 1℃ over designated range | PASS |
| Air Removal (TP-5080) | 4.6.1 Air removal for dynamic air removal sterilizers | PASS |
| Software Verification and Validation (TP-5100, TP-5110, TP-5120, TP-5130) | 4.4.7 Sterilizer fault conditions4.4.8 Cycle documentation | PASS |
| Biological Performance - Textiles (TP-5141) | 4.5 Biological performance of sterilizers | PASS |
| Biological Performance - Wrapped Instrument (TP-5160) | 4.5 Biological performance of sterilizers | PASS |
| Biological Performance - Dental Handpieces (TP-5170) | 4.5 Biological performance of sterilizers | PASS |
| Moisture Retention – Textiles (TP-5190) | 4.7 Moisture Retention | PASS |
| Moisture Retention – Wrapped Instrument (TP-5200) | 4.7 Moisture Retention | PASS |
| Moisture Retention – Pouches Drying Test (TP-5210) | 4.7 Moisture Retention | PASS |
| Endotoxin and Water Quality (TP-5220) | A.4.2.6 Water supply reservoir | PASS |
| Labeling (TP-5010) (FDI) | AAMI ST55:2016 - 4.1.1 Device MarkingsAAMI ST55:2016 - 4.1.2 Information ManualAAMI ST55:2016 - 4.1.3 Service Manual | PASS |
| Sterilizer Safety (TP-5050) (FDI) | AAMI ST55:2016 - 4.3.1 InterlockAAMI ST55:2016 - 4.3.2 Thermal hazardsAAMI ST55:2016 - 4.3.3 Aborting cycles | PASS |
| General Inspection (TP-5060) (FDI) | 4.2.1 & 4.2.2 Pressure vessel requirements4.2.4 Corrosion resistance4.2.5 Air filters4.2.6 Water supply reservoir4.4.4 Sterilizer exposure timer4.4.6 Cycle completion | PASS |
| 3rd Party Testing Electrical Safety | IEC 61010-1 Edition 3.1 2017-01 | PASS |
| 3rd Party Testing Electrical/Sterilizer Specific Safety | IEC 61010-2-040:2020 | PASS |
| 3rd Party Testing EMC/EMI | IEC 61326-1:2020 | PASS |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a numerical sample size for the test set. However, a series of performance effectiveness tests were conducted for each cycle type (Immediate Use, Textiles, Wrapped Instruments/Pouches, Handpieces) across both FL120 and FL135 models. These tests were performed "by passing 3 successive cycles at half the programmed exposure time." This indicates that at least three runs were conducted for each sterilization cycle condition for both models.
The data provenance is from Fort Defiance Industries LLC itself, conducting validation studies in accordance with AAMI/ANSI ST55:2016. This suggests that the studies were internal, likely prospective laboratory testing. No information on country of origin of the data is provided beyond Fort Defiance Industries being a US company.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device is established through meeting the sterilizing performance criteria defined by the ANSI/AAMI ST55:2016 standard, specifically achieving a sterility assurance level (SAL) of at least 10^-6, and safety standards like IEC and ASME. This is a technical performance measurement rather than an expert interpretation of data.
4. Adjudication method for the test set
Not applicable. The evaluation is based on objective measurements and compliance with established performance standards for sterilization, rather than subjective interpretation 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 device is a medical sterilizer, not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in concept, the performance testing described is "standalone" for the device, meaning the sterilizer's effectiveness is evaluated on its own based on its ability to sterilize according to predefined biological and physical parameters. There is no human-in-the-loop performance aspect for a sterilizer.
7. The type of ground truth used
The ground truth used for the performance effectiveness of the sterilizer cycles is based on:
- Biological performance: Achieving a sterility assurance level (SAL) of at least 10^-6, demonstrated by the "overkill method" using biological indicators.
- Physical and technical parameters: Compliance with predefined temperature accuracy, pressure measurement, air removal, moisture retention, software functionality, and electrical/safety standards as outlined in ANSI/AAMI ST55:2016, IEC 61010-1, IEC 61326-1, IEC 61010-2-040, and ASME Boiler and Pressure Vessel Code.
8. The sample size for the training set
Not applicable. This device is a medical sterilizer and does not involve machine learning or AI models that require a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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).