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The V-PRO® s2 Low Temperature Sterilization System using VAPROX® HC Sterilant is intended for use in the terminal sterilization of properly prepared (cleaned, rinsed and dried) medical devices in Healthcare Facilities. The preprogrammed sterilization cycles operate at low pressure and low temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments and instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors.

The V-PRO s2 Sterilizer Non Lumen Cycle can sterilize: t
Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

• The validation studies were conducted using a validation load consisting of one instrument tray for a total weight of 25 lbs (11.3 kg).

The V-PRO s2 Sterilizer Fast Cycle can sterilize:*
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• Single or dual channeled devices with stainless steel lumens that are ● > 0.77 mm (~1/32") internal diameter (ID) and ≤ 410 mm (~16-9/64") in length
• ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
• Triple channeled devices with stainless steel lumens that are either: ● ≥ 1.2 mm (~3/64") ID and ≤ 275 mm (~10-53/64") in length

• 1.8 mm (~5/64") ID and ≤ 310 mm (~12-13/64") in length or

• ≥ 2.8 mm (~7/64") ID and ≤ 317 (12-31/64") mm in length

Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.

• Validation testing for all lumen sizes was conducted using a maximum of eight (8) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. Validation testing was conducted using a validation load consisting of one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg).

The V-PRO s2 Sterilizer Flexible Cycle can sterilize: ®
One surgical flexible endoscope (such as those used in ENT, Urology and Surgical Care) or bronchoscope with light cord (if not integral to endoscope), mat, and additional load.

• The flexible endoscope may be a single or dual lumen device with lumens that are ≥ 1 mm (~3/64") ID and ≤ 990 mm (38-63/64") in length.
• Additional load, up to 11 lb (5 kg) can include stainless steel lumens with ● the following dimensions
  ≥ 0.76 mm (~1/32") ID and ≤ 233 mm (~9 11/64") in length
• ≥ 1.0 mm (~3/64") ID and ≤ 254 mm (~10") in length
• ≥ 1.8 mm (~5/64") ID and ≤ 542 mm (~21 5/16") in length

@ The validation studies were conducted using a validation load consisting of two instrument travs. One tray contained one flexible endoscope, with silicone mat. instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg). Hospital loads should not exceed the maximum number of lumens validated by this testing.

The V-PRO s2 Sterilizer Lumen Cycle can sterilize: ^
Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations:

• . Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm internal diameter (ID) and ≤ 410 mm in length and ≥ 1.8 mm (~5/64") ID x ≤ 542 mm (21 5/16") in length.
• Triple channeled devices with stainless steel lumens that are either: . > 1.2 mm (~3/64") ID and 1.8 mm (~5/64") ID and 1.8 mm (~5/64") ID x ≤ 542 mm (~21-5/16") in length.
• Triple channeled devices with stainless steel lumens that are either: ● > 1.2 mm (~3/64") ID and

The V-PRO s2 Sterilizer contains the same three sterilization cycles as V-PRO 60 Sterilizer (the Lumen. Non Lumen and Flexible Cycles) with one additional cycle (the Fast Cycle). The V-PRO s2 Sterilizer contains a cabinetry modification and is free-standing as opposed to the cart-mounted V-PRO 60 Sterilizer.

The V-PRO 60 Low Temperature Sterilization System is a vaporized hydrogen peroxide sterilizer model that currently exists in the STERIS V-PRO family of sterilizers. The current proposed device claims are intended to modify the indications for use statement.

The V-PRO s2 and V-PRO 60 Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried and packaged surgical instruments used in healthcare facilities and utilizes VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). The pre-programmed cycles all utilize a conditioning phase, a sterilize 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 following completion of the cycle.

The document describes the V-PRO® 60 Low Temperature Sterilization System and V-PRO® s2 Low Temperature Sterilization System, which are intended for terminal sterilization of medical devices. The submission (K190917) is for modifications to the indications for use of these systems.

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

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

The document does not explicitly state "acceptance criteria" in a quantitative format for the sterilization effectiveness. However, the study concludes with "PASS" for both tests, indicating that a predefined, unstated acceptance criterion for sterilization efficacy was met.

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

The document provides details about validation loads used, which can be considered the test sets for device performance:

• V-PRO s2/60 Sterilizer Non Lumen Cycle: one instrument tray for a total weight of 25 lbs (11.3 kg).
• V-PRO s2 Sterilizer Fast Cycle: one pouched instrument tray and two pouched devices outside of the tray with a total weight of 4.0 lbs (~1.8kg). Maximum of eight (8) lumens per load.
• V-PRO s2/60 Sterilizer Flexible Cycle: two instrument trays. One tray contained one flexible endoscope, with silicone mat, instrument organizers and light cord (if not integral to scope), and the second tray contained additional load and twelve (12) stainless steel lumens for a total load weight of 11 lbs (5 kg).
• V-PRO s2/60 Sterilizer Lumen Cycle: one instrument tray and two pouches for a total weight of 11 lbs (5.0 kg). Maximum of twelve (12) stainless steel lumens per load.

The data provenance is not explicitly stated regarding country of origin or whether it's retrospective or prospective. Given it's a 510(k) submission for device modification, the studies are typically prospective validation studies performed by the manufacturer (STERIS Corporation, based in Mentor, OH, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a sterilizer, and its performance (sterilization) is typically assessed through biological indicators (e.g., spore strips) or chemical indicators, not by human expert interpretation of an image or data. The "ground truth" for sterilization is the complete inactivation of microorganisms.

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

Not applicable, as the evaluation is based on objective biological and chemical indicator results, not expert 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 for sterilization, not an AI-assisted diagnostic or triaging tool.

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

Not applicable. The device is a physical sterilizer system.

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

The ground truth for sterilization studies is typically the complete kill of highly resistant bacterial spores (often Geobacillus stearothermophilus) in biological indicators. The ½ Cycle Modified Total Kill Endpoint Verification and Simulated Use Test rely on this concept to confirm sterility.

8. The sample size for the training set

Not applicable. The device is a physical sterilizer system, not a machine learning model that requires a training set.

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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