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The Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) is an autoclave designed for sterilizing heat- and moisture-stable 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 Sterilizer, model FL135, is an autoclave 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 device uses electrical resistive heaters to produce steam as the sterilizing agent. The device adheres 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 provided text describes the 510(k) summary for the Fort Defiance Industries FRONT-LINE Field Sterilizer (FL135) and its modifications. The key changes involve reducing the dry times for wrapped instruments, textiles, and handpieces cycles. The study provided focuses on the sterilizer's performance and safety and is not an AI/ML-driven device. Therefore, many of the requested criteria related to AI/ML studies (such as MRMC studies, number of experts for ground truth, sample sizes for training sets, etc.) are not applicable to this submission.

The acceptance criteria and performance data are primarily based on the sterilizer's ability to achieve and maintain sterility, as well as its moisture retention characteristics, according to the AAMI ST55:2016 standard.

Here's a breakdown of the available information:

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

The acceptance criteria are derived from ANSI/AAMI ST55:2016. The reported device performance is indicated by "PASS" for each test.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: The document mentions "3 successive cycles at half the programmed exposure time" for the overkill method to guarantee a sterility assurance level (SAL) of at least 10^-6. It also mentions validation studies were conducted. However, the exact sample sizes for each specific test (e.g., number of textile packs, wrapped instruments, or handpieces tested) are not explicitly stated in the provided summary.
• Data Provenance: The studies were conducted by Fort Defiance Industries LLC which is based in Loudon, Tennessee, USA. The studies appear to be prospective validation studies performed to support the 510(k) submission for the device modifications.

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

• Not Applicable. This is a hardware medical device (steam sterilizer) and the ground truth is established through physical and biological indicators, not human expert consensus on interpretations of images or data. The validation is against established engineering and sterilization standards (ANSI/AAMI ST55:2016).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As above, this is not an AI/ML or diagnostic study requiring human expert adjudication. The performance is objectively measured against physical and biological parameters.

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 not an AI/ML device, and no human reader comparative effectiveness studies were performed or are relevant.

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

• Not Applicable. This is not an AI/ML algorithm. The performance is the standalone performance of the sterilizer itself. The summary evaluates the device's ability to sterilize and dry items on its own, based on programmed cycles.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• The ground truth for sterilizer performance is based on established industry standards and scientific principles of sterilization. This includes:
  • Biological Indicators: Used in the "overkill method" to demonstrate a Sterility Assurance Level (SAL) of at least 10^-6. This typically involves challenging the sterilizer with a high concentration of resistant microorganisms, and "ground truth" is established by their survival or inactivation.
  • Physical Parameters: Temperature and pressure measurements throughout the cycle, as defined by ANSI/AAMI ST55:2016 (e.g., -0/+6°F temp control).
  • Moisture Retention: Empirical measurements of water remaining on processed items, compared against defined limits in the AAMI standard.

8. The sample size for the training set

• Not Applicable. This device uses pre-programmed cycles based on engineering design and validation against recognized standards, not machine learning models that require a training set.

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

• Not Applicable. No training set for an AI/ML model.

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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

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.

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