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The Amsco® V-PRO™ maX Low Temperature Sterilization System, with VAPROXTM HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The three pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO maX Low Temperature Sterilization System's Lumen Cycle, cleared under K062297, can sterilize:

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Medical devices, including rigid endoscopes, with a single stainless steel lumen with:
  • an inside diameter of 1 mm or larger and a length of 125 mm or shorter
  • an insider diameter of 2 mm or larger and a length of 250 mm or shorter
  • an inside diameter of 3 mm or larger and a length of 400 mm or shorter
    The validation testing for all lumen sizes was conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

The Amsco V-PRO maX Low Temperature Sterilization System's Non Lumen Cycle, cleared under K083097, can sterilize:
Non-lumened instruments including non-lumened rigid endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors.
The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs.

The Amsco V-PRO maX Low Temperature Sterilization System's Flexible Cycle, the subject of this submission, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations:

1. Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load.
   The flexible endoscopes may contain either:

• a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
• or two lumens with:
  • one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
  • and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
    The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope).

2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors.
   The flexible endoscope can contain either:

• a single lumen with an inside diameter of 1 mm or larger and a length of 1050 mm or shorter
• or two lumens with:
  • one lumen having an inside diameter of 1 mm or larger and a length of 998 mm or shorter
  • and the other lumen having an inside diameter of 1 mm or larger and a length of 850 mm or shorter
    The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

The Amsco V-PRO maX Low Temperature Sterilization System is a new sterilizer model to be added to the Amsco V-PRO family of sterilizers. The V-PRO product line currently consists of the Amsco V-PRO 1 and Amsco V-PRO 1 Plus Sterilizers.

The V-PRO maX Sterilizer has three pre-programmed cycles: the Lumen Cycle (K062297), the Non Lumen Cycle (K083097) and the Flexible Cycle (K102330). The V-PRO maX Low Temperature Sterilization System is intended for terminal sterilization of cleaned, rinsed, dried and packaged reusable surgical instruments used in healthcare facilities.

The V-PRO maX Sterilizer uses VAPROX HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). Its three preprogrammed cycles all utilize a conditioning phase, a sterilization phase and an aeration phase. The packaged sterilized devices are ready for use at the completion of the cycle; no cool down or aeration period is required.

The Flexible Cycle has been designed to sterilize surgical flexible endoscopes (such as those used in ENT, Urology and Surgical care) and bronchoscopes. The flexible endoscopes can be single or dual channeled and they may be processed in a flexible endoscope-only load or in combination with non-lumened medical instruments. The cycle is approximately 35 minutes long.

The Verify V24 SCBI (K073244 and K09051), Verify VH2O2 Process Indicator (K091174), V-PRO Sterilization Trays (K070769), and Vis-U-All Tyvek pouches (K070765, K071087, and K090371) have been validated for use in the V-PRO maX Sterilizer.

The provided 510(k) summary (K112760) describes a modification to the Amsco V-PRO maX Low Temperature Sterilization System, involving minor software changes to enhance usability. The study submitted for this modification is a Software Validation.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size used for the software validation test set (e.g., number of test cases run, or specific inputs). It only indicates that "Software Validation" was performed.

Regarding data provenance, the document does not specify country of origin for the validation data. The nature of the study (software validation) suggests it would be conducted in a controlled environment, likely by the manufacturer (STERIS Corporation, based in Mentor, Ohio, USA). The study is retrospective in the sense that the software was already developed and then validated.

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

The document does not provide details on the number of experts, their qualifications, or their role in establishing ground truth for the software validation. For a software validation, ground truth would typically be defined by the software requirements and specifications, rather than expert interpretation of data.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the software validation. For software validation, discrepancies (bugs) are typically identified and fixed, not adjudicated by independent parties.

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 typically used for diagnostic devices involving human interpretation of images or other data. The Amsco V-PRO maX is a sterilizer, and its effectiveness is determined by its ability to reliably sterilize medical devices, not by human interpretation of its output in a clinical setting. Therefore, an MRMC study with human readers and AI assistance is not applicable to this device.

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

Yes, a standalone study was performed. The "Software Validation" is an assessment of the algorithm (software)'s performance against its specifications and intended function without human intervention in its operation other than initiating the process and evaluating the outcome of the software's execution.

7. Type of Ground Truth Used

For the "Software Validation," the ground truth would be defined by the software requirements and specifications. The software's performance is validated against these pre-defined functional and non-functional requirements to ensure it operates as intended.

8. Sample Size for the Training Set

The document does not mention a "training set" because this is a software validation for a sterilizer. The software for a sterilizer is typically developed based on engineering principles and verified through testing against specifications, rather than being "trained" on a dataset like a machine learning algorithm.

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

As there is no mention of a training set, the establishment of ground truth for a training set is not applicable to this submission.

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The Verify® V24 Self-Contained Biological Indicator is intended as a standard method for frequent monitoring of the Amsco® V-PRO™ 1 Low Temperature Sterilization System.

The Verify V24 Self-Contained Biological Indicator (SCBI) is used by healthcare providers to monitor the Amsco® V-PROTM 1 Low Temperature Sterilizer. It is designed to accompany medical devices placed in the sterilizer. The user places the packaged Verify V24 SCBI into the V-PRO 1 Low Temperature Sterilization System and performs a sterilization cycle. After cycle completion, the SCBI can either be immediately activated or it can be held at room temperature for a maximum of 72 hours (3 days) prior to activation. The SCBI is activated by sealing the vial and rupturing the medium ampoule using the STERIS Verify SCBI HP activator. The activator automatically seals the SCBI vial and releases the growth media. The activated SCBI is incubated at 55 - 60 ℃. The SCBI indicates a pass if the media remains orange and non-turbid. The SCBI indicates a failure of sterilization if the media changes from orange to yellow and/or if the media is turbid. The modified Verify V24 Self-Contained Biological Indicator is identical in design to the original K073244 device with exception of the media formulation. It is identical with respect to performance specifications with exception of the incubation time.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Acceptance Criteria and Device Performance for Verify® V24 Self-Contained Biological Indicator

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for each individual test (Growth Inhibition, Incubation Time Validation, Media Performance, Media Stability). It reports results in a summary format ("Pass").

The data provenance is not explicitly stated in terms of country of origin. Given the submission is to the US FDA, it is highly likely the studies were conducted in the US or under US regulatory standards. The studies are non-clinical tests conducted to confirm the performance of the modified culture media, implying they are prospective experimental studies designed to evaluate the modified device.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of clinical or diagnostic evaluations. The testing described focuses on the intrinsic performance of the biological indicator (e.g., microbial growth, color change, stability) under controlled laboratory conditions, rather than interpreting complex human-generated data. Therefore, the concept of qualified experts establishing ground truth as in a diagnostic imaging study is not applicable here.

4. Adjudication Method for the Test Set:

No adjudication method is described. The tests are laboratory-based and likely involve objective measurements (e.g., observation of color change, presence/absence of growth, incubation time).

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

No MRMC study was done, as this is a biological indicator designed to provide a direct readout of sterilization efficacy, not to be interpreted by human readers for diagnostic purposes where human variability would be a factor.

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

Yes, a standalone performance evaluation was conducted. The described tests (Growth Inhibition, Incubation Time Validation, Media Performance, Media Stability) are all objective, laboratory-based assessments of the biological indicator's performance without human interpretation or intervention in the result generation process. The device itself changes color or fails to change color as its "output," which is then directly observed.

7. Type of Ground Truth Used:

The ground truth for these tests is based on controlled experimental conditions and objective biological/chemical outcomes. For example:

• Sterility: Absence of microbial growth in uninoculated controls.
• Viability/Growth: Presence of microbial growth in inoculated controls.
• Incubation Time: Observed time to positive growth.
• Media Stability: Maintenance of expected performance over time.
  These are not based on expert consensus, pathology, or outcomes data in a clinical sense, but rather on established microbiological and chemical principles.

8. Sample Size for the Training Set:

The document does not mention a "training set" as this device does not utilize machine learning or AI that would require such a dataset. The biological indicator's function is based on a direct biological response, not a learned pattern.

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

Not applicable, as there is no training set for this type of device.

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