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The V-PRO maX 2 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 temperature, suitable for processing medical devices without leaving toxic residues.

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

The Non Lumen Cycle can sterilize: †

Non-lumened instruments including non-luments, non-luments, non-lumened rigid, sem-rigid and flexible endoscopes.

t The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The Fast Non Lumen Cycle can sterilize: *

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

• The validation studies were conducted using a validation load consisting of one pouched instrument tray for a total weight of 11 lbs (5 kg).

The Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the 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 single or dual channel lumens that are > 1 mm internal diameter (ID) and ≤ 1050 mm in length. * 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 accessories, mat, and additional instruments. ** The flexible endoscope may contain single or dual channel lumens that are > 1 mm ID and ≤ 1050 mm in length

• Additional instruments may include non-lumened or lumened medical devices with the following configurations:

o Single, dual or triple channel stainless steel lumen that is

· ≥ 0.48 mm ID and ≤ 100 mm in length

** The validation studies were conducted with a flexible endoscope accessories, silicone mat, light cord (if not integral to endoscope) and 5 stainless steel lumens. Also included in the load was a tray with additional instruments, and silicone mat for a total weight of 24 lbs (11 kg).

The Lumen Cycle can sterilize: †

Medical devices with the following configurations:

· Single, dual or triple channeled stainless steel lumen that are:

• ≥ 0.77 mm ID and ≤ 527 mm in length

• ≥ 0.8 mm ID and ≤ 542 mm in length

• ≥ 0.48 mm ID and ≤ 100 mm in length
• · Dead end lumen that is ≥ 1.3 mm ID and ≤ 73 mm in length
• Rigid non-metallic lumen (such as those used in endoscope sheaths, take-apart forceps and trocars) that are:
• ≥ 3 mm ID and ≤ 298 mm in length
• ≥ 4 mm ID and

The V-PRO Low Temperature Sterilization Systems are vaporized hydrogen peroxide sterilizers.

The V-PRO maX 2 sterilizer has the following pre-programmed cycles: the Lumen Cycle, the Non Lumen Cycle, the Flexible Cycle, the Fast Non Lumen Cycle, and the Specialty Cycle. The V-PRO Low Temperature Sterilization Systems are intended for terminal sterilization of cleaned, rinsed, dried, and packaged surgical instruments used in healthcare facilities.

The five pre-programmed cycles all use 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.

VAPROX HC Sterilant is a 59% hydrogen peroxide sterilant used only the V-PRO Low Temperature Sterilization Systems (V-PRO). It was originally cleared for use in K062297 and the cup was modified in K112813. It has also been cleared as part of the various V-PRO Sterilizer models. The most recent Premarket Notifications for each model are identified in Table 1. This Premarket Notification is only for a proposed modification to VAPROX HC; there are no modifications to any of the V-PRO Low Temperature Sterilization Systems listed below:

• V-PRO 1
• V-PRO 1 Plus ●
• V-PRO maX ●
• V-PRO maX 2 ●
• V-PRO 60
• V-PRO s2 ●

The provided text does not describe a study involving an AI/ML device for medical image analysis. Instead, it describes a 510(k) premarket notification for a V-PRO maX 2 Low Temperature Sterilization System, a device used for sterilizing medical instruments. The "acceptance criteria" and "study" described in the document relate to the performance of this sterilization system and its associated sterilant, not to an AI system.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study for an AI/ML medical device based on the provided text. The document is about a sterilization system, not an AI product.

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The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems using VAPROX HC Sterilant are 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 temperature, suitable for processing medical devices without leaving toxic residues.

Each Cycle can sterilize non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors. Only stainless steel or titanium diffusion-restricted spaces should be processed in the Non Lumen Cycle.

The V-PRO 1 Plus and V-PRO maX Sterilizers' Non Lumen Cycle can sterilize: t

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

• The validation studies were conducted using a validation load consisting of two instrument trays for a total weight of 50 lbs (22.7 kg).

The V-PRO maX Sterilizer's Flexible Cycle can sterilize:

Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of the two 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 that is ≥ 1 mm internal diameter (ID) and ≤ 1050 mm in length
  • Or two lumens with:

• One lumen that is ≥ 1 mm ID and ≤ 990 mm in length

• And the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length

• 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. ++ The flexible endoscope may contain either:

· A single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length

• Or two lumens with:
  • One lumen that is ≥ 1 mm ID and ≤ 990 mm in length
  • And the other lumen is ≥ 1 mm ID and ≤ 850 mm in length.

** 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 weight of 24 lbs (11 kg).

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Sterilizers' Lumen Cycle can sterilize: *

Medical devices (including single, dual and triple channeled rigid endoscopes) with the following configurations:

• Single channeled devices with a stainless lumen that is > 0.77 mm ID and ≤ 500 mm in length
• Dual channeled devices with stainless lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
• · Triple channeled devices with stainless lumens that are either:

≥ 1.2 mm ID and ≤ 275 mm in length ≥ 1.8 mm ID and ≤ 310 mm in length or

2.8 mm ID and 1 mm (~3/64") ID and 1.8 mm (~5/64") ID and

The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems, using VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). 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 V-PRO 1, V-PRO 1 Plus, and the V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems are programmed to enact one (the Lumen Cycle), two (the Lumen Cycle and the Non Lumen Cycle) or three (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycles, respectively.

The provided text describes the acceptance criteria and supporting studies for the STERIS Amsco V-PRO Low Temperature Sterilization Systems.

Here's the breakdown:

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

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 primarily describes validation studies for the V-PRO sterilization systems, which are typically performed in a prospective manner.

• Determination of Worst Case Material for VHP: This refers to previous submissions, but the current document specifically highlights Kraton as the "most resistant material." No specific sample size is given for how many materials were evaluated to determine Kraton as the worst case in previous studies.
• Medical Device Material Compatibility: "20 materials" were tested.
• Cytotoxicity Evaluation of Medical Devices: "various medical devices containing [unspecified material components]" were tested.
• Hydrogen Peroxide Residual Analysis of Processed Medical Devices: "19 proposed compatible materials" were tested across "three (3), worst case, back-to-back Lumen Cycles" in the V-PRO 60 Sterilizer.

The provenance of the data (country of origin) is not explicitly stated, but as this is an FDA submission for a U.S. company (STERIS Corporation, Mentor, OH), it's highly probable the studies were conducted in the U.S. or at facilities compliant with U.S. regulatory standards.

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 type of information is not applicable to the studies described. The studies are engineering and chemical validation tests for a sterilization system, not diagnostic device studies that would require expert human review or interpretation of medical images or patient data to establish ground truth.

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

This information is not applicable as the studies are not diagnostic assessments requiring adjudication of human reader interpretations. The acceptance criteria are based on measurable physical and chemical properties and biological effects (sterilization efficacy, material integrity, cytotoxicity, residuals).

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

This is not applicable. The device is a sterilization system, not an AI-powered diagnostic tool used by human readers. Therefore, no MRMC study or AI assistance improvement metrics are relevant.

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

This is not applicable. The device is a sterilization system and there is no algorithm or AI component involved in its operation or performance evaluation.

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

The "ground truth" in these validation studies is established by objective scientific and engineering measurements and standards:

• Sterilization effectiveness: Implicit in the "Worst Case Material" determination, where the goal is sterilization. Sterilization is typically confirmed by biological indicators demonstrating the inactivation of a specific resistant microorganism (e.g., Geobacillus stearothermophilus) to a defined sterility assurance level (SAL). While not explicitly detailed here, this is a standard method for sterilization validation.
• Material compatibility: Visual inspection for defects (crazing, cracks, chipping) and functional testing of devices after processing.
• Cytotoxicity: In vitro assays to assess cellular toxicity, with controls to ensure assay validity.
• Hydrogen peroxide residual analysis: Chemical analytical methods to quantify residual hydrogen peroxide, compared against established biological tolerance limits for mucosal and internal tissue contact.

8. The sample size for the training set

This is not applicable. The device is a sterilization system, not a machine learning model. There is no concept of a "training set."

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

This is not applicable as there is no training set.

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The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and are thus suitable for processing medical devices sensitive to heat and moisture.

The V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle can sterilize:(a)

• Lumened and non-luments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• · Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: (a)
  • o single channeled devices with a stainless lumen that is ≥ 0.77 mm internal diameter (ID) and ≤ 500 mm in length
  • o dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 527 mm in length
  • o triple channeled devices with stainless steel lumens that are
    • ≥ 1.2 mm ID and ≤ 275 mm in length
    • ≥ 1.8 mm ID and ≤ 310 mm in length
    • or

    • 2.8 mm ID and 1 mm ID and 1 mm ID and 1 mm ID and 1 mm (~3/64") ID and

The V-PRO 1, V-PRO 1 Plus, V-PRO maX and V-PRO 60 Low Temperature Sterilization Systems, with VAPROX® HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried metal and nonmetal medical devices used in healthcare facilities. The Sterilizers use VAPROX® HC Sterilant to sterilize the intended devices through exposure to vaporized hydrogen peroxide (VHP). 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 V-PRO 1, V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems are programmed to enact one (the Lumen Cycle), two (the Lumen Cycle and the Non Lumen Cycle) or three (the Lumen Cycle, the Non Lumen Cycle and the Flexible Cycle) cycles, respectively.

The V-PRO 60 Low Temperature Sterilization System, with VAPROX® HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried 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 STERIS V-PRO Low Temperature Sterilization Systems were studied to verify two modifications: the removal of eye-contacting limitations and the addition of polyurethane as a compatible material for the Lumen Cycle.

Here's a breakdown of the acceptance criteria and study details:

1. Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the exact "sample size for the test set" in terms of number of unique devices or materials for each specific test. However, it indicates:

• For residual hydrogen peroxide and cytotoxicity comparison: "materials" were processed.
• For in-device cytotoxicity and tissue residue: "medical devices" were processed.
• For ocular irritation: "Materials coupons" were processed.
• For polyurethane compatibility: "polyurethane-containing device" and "polyurethane material" were evaluated.

Data Provenance: The studies were conducted by STERIS Corporation for a 510(k) premarket notification. This implies the data is prospective for the purpose of demonstrating the safety and effectiveness of the proposed changes. The country of origin of the data is not specified but is presumably the USA, where STERIS Corporation is based.

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

This information is not provided in the document. The tests described are primarily laboratory-based evaluations of chemical residues, cytotoxicity, material compatibility, and biological irritation, rather than assessments requiring interpretation by clinical experts. For biocompatibility tests like ocular irritation per ISO 10993-10, trained toxicologists or evaluators would interpret the results.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are laboratory-based experimental validations, not clinical studies requiring independent interpretation or adjudication of outcomes by multiple experts.

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

A MRMC comparative effectiveness study was not done. This type of study is typically performed to evaluate the diagnostic accuracy of imaging or other interpretive devices, often with and without AI assistance to human readers. The STERIS V-PRO System is a sterilizer, and its performance is evaluated through physical, chemical, and biological efficacy studies, not reader interpretation.

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

A standalone study was not done because the device itself is a sterilizer, not an algorithm. Its performance is inherent in its operation (sterilization efficacy, material compatibility, residue levels), not in an algorithmic output.

7. Type of Ground Truth Used

The ground truth used in these studies is based on:

• Quantitative measurements: Residual hydrogen peroxide levels (chemical analysis).
• Biological assays: Cytotoxicity tests (e.g., using live cells to detect toxic effects), ocular irritation tests (per ISO 10993-10 guidelines, likely involving animal models or in vitro alternatives).
• Visual assessment: Material degradation or cosmetic changes.
• Sterilization efficacy: Implied to be based on inactivation of biological indicators with a known sterility assurance level (SAL).

8. Sample Size for the Training Set

This information is not applicable as the V-PRO Sterilization System is a physical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable as there is no training set for this device type.

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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 Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems, with VAPROX HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO 1 Cycle, which is identical to the V-PRO 1 Plus Lumen Cycle, was cleared under K062297 and can sterilize: *

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors .
• Medical devices with a single stainless steel lumen with: .
  • o an inside diameter of 1 mm or larger and a length of a 125 mm or shorter o an insider diameter of 2 mm or larger and a length of 250 mm or shorter o 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 1 Plus Low Temperature Sterilization System's Non Lumen Cycle was cleared under K083097 and can sterilize: **

Non-lumened instruments including non-luments 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 1 and V-PRO 1 Plus Low Temperature Sterilizers are selfcontained stand-alone devices using vaporized hydrogen peroxide. These devices are intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizers operate at low pressure and low temperature and are therefore suitable for processing medical devices sensitive to heat and moisture.

Here's an analysis of the provided text regarding the acceptance criteria and study for the STERIS® Amsco® V-PRO™ 1 and V-PRO™ 1 Plus Low Temperature Sterilization Systems:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Odor Filter: Implied sample size based on "running continuous Non-Lumen cycles." No specific number of cycles or devices is given.
• Vacuum pump oil: Testing was performed "concurrently with the ARS Filter testing." No specific number of devices or cycles is given.
• ARS Filter: "Nine filters of each variety were run either until an oil smell was detected or 750 cycles were reached."
• Gas Ballast Filter: "The proposed filters (a total of 5) was tested by running until a failure was detected."
• Software Modifications: No specific sample size mentioned, just "Software Validation."

Data Provenance: The document does not specify the country of origin for the data. The studies appear to be prospective, as they involve testing proposed modifications against existing versions to determine equivalency or improvement.

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

The document does not mention the use of experts to establish ground truth for this set of performance tests. The acceptance criteria are objective and measurable (e.g., presence of oil smell, performance comparison, software validation).

4. Adjudication Method for the Test Set

No adjudication method is described, as the testing involves objective measurement against pre-defined criteria rather than expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not done. These tests are focused on the hardware and software performance of a sterilization system, not on human interpretation or diagnostic efficacy.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

This concept is not applicable here. The device is a sterilization system, not an algorithm, and its performance is inherently standalone in its function (sterilizing medical devices). The tests described evaluate the device's components and software in isolation from human intervention in the sterilization process itself.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on objective performance metrics and pre-defined standards comparing the modified components/software against the existing, predicate device components/software. For example:

• Absence/presence of oil smell
• Equal or better performance of filters
• Appropriate verification and validation of software

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable to the performance testing of a physical sterilization device and its components/software. These tests are evaluations, not machine learning model training.

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

As there is no training set in the context of this device's performance evaluation, this question is not applicable.

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The sterilization mats are intended to be used in conjunction with the V-PRO™ Sterilization Trays (K070769) to cushion and stabilize instruments during sterilization in the Amsco V-PRO Low Temperature Sterilization Systems.

The sterilization mats have been validated for use in the three pre-programmed V-PRO sterilization cycles [Lumen Cycle (the only cycle of the V-PRO 1 Sterilizer), Non Lumen Cycle, and Flexible Cycle].

The sterilization mats are used to cushion and stabilize devices placed into the V-PRO Sterilization Trays (K070769). The mats are available in sizes to fit the four V-PRO Sterilization Trays. The mats are a diamond grid design with fingers that extend from each corner of the diamond and at the midpoint of each diamond side. The fingers cushion and stabilize instruments, helping to prevent the instruments from freely moving in the tray during packaging, sterilization and storage. The cushioning and stabilization qualities help protect delicate instruments placed into the V-PRO Trays.

The mats are designed to allow sterilization of cleaned and dried medical devices during the V-PRO Lumen (K062297), Non Lumen (K083097) and Flexible (K102330) Cycles in the V-PRO Sterilizers.

This document describes the acceptance criteria and study proving the STERIS Sterilization Mats meet these criteria for use in V-PRO Sterilizers.

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 size for each test category. However, it does provide details about the validation loads used in the sterilization efficacy tests for the various V-PRO cycles:

• Lumen Cycle: Validation load consisted of two instrument trays (containing two mats and 20 instrument organizers) and two pouches for a total weight of 19.65 lbs. This testing used a maximum of twenty (20) lumens per load.
• Non Lumen Cycle: Validation load consisted of two instrument trays containing two mats, and 20 instrument organizers and two pouches for a total weight of 19.65 lbs.
• Flexible Cycle (Configuration 1 - Two endoscopes): Two flexible endoscopes with a light cord (if not integral to endoscope) and mat with no additional load. Each endoscope was packaged into a tray with a silicone mat, 20 instrument organizers, and a light cord.
• Flexible Cycle (Configuration 2 - One endoscope + non-lumened instruments): One flexible endoscope in a tray with a silicone mat, 20 instrument organizers, and a light cord. Also included was an additional instrument tray (containing a mat and 20 instrument organizers) and one pouch for a total load weight of 24.0 lbs.

The data provenance is not explicitly stated (e.g., country of origin). The studies appear to be prospective performance tests conducted by the manufacturer, STERIS Corporation, to demonstrate the device's efficacy and safety.

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

This type of submission (510(k) for sterilization accessories) typically relies on standardized test methods and quantitative measurements (e.g., microbial lethality assays, chemical analysis for residuals, visual inspection for material compatibility). Therefore, the "ground truth" is established through objective scientific measurements and established protocols, rather than expert consensus on diagnostic images or clinical outcomes. The document does not mention the involvement of external experts to establish ground truth for the test set.

4. Adjudication Method for the Test Set

Given the nature of the tests (sterilization efficacy, biocompatibility, material compatibility, cleaning evaluation), an adjudication method like 2+1 or 3+1 typically used for subjective diagnostic assessments is not applicable. The results are based on direct measurements and qualitative observations against predefined scientific criteria. A "PASS" or "FAIL" determination is likely made based on whether the measured outcomes meet the quantitative or qualitative acceptance criteria.

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

No, an MRMC comparative effectiveness study was not conducted. This type of study is relevant for diagnostic devices where human readers interpret output (e.g., medical images) with and without AI assistance. The STERIS Sterilization Mats are a sterilization accessory, and their performance is assessed through objective physical and biological tests, not through human interpretation of diagnostic output.

6. Standalone Performance Study

Yes, the studies described are standalone performance studies (i.e., algorithm only without human-in-the-loop performance). The tests evaluate the performance of the sterilization mats themselves within the context of the V-PRO sterilization cycles, independent of human operators assisting an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for these studies is based on:

• Sterilization Efficacy: Demonstrated by reproducible sterilization of worst-case test articles under worst-case ½ cycle conditions. This implies the use of biological indicators or similar methods to confirm microbial kill, which is an objective outcome measure.
• Biocompatibility: Measured by assessing cytotoxicity and residual hydrogen peroxide levels. These are objective laboratory tests.
• Material Compatibility: Assessed by observing the absence of incompatibilities (e.g., degradation, discoloration) after exposure to multiple cleaning and sterilization cycles. This is based on qualitative visual assessment against established standards for material integrity.
• Cleaning Evaluation: Assessed by the ease of cleaning, likely through standardized cleaning protocols and visual inspection for cleanliness.

In summary, the ground truth is primarily based on objective scientific measurements, established chemical and biological testing protocols, and qualitative assessments of physical and material integrity.

8. Sample Size for the Training Set

The document does not mention a training set or any machine learning components. This device is a physical accessory evaluated through traditional engineering and biological performance testing, not an AI-powered device. Therefore, the concept of a "training set" is not applicable here.

9. How Ground Truth for the Training Set Was Established

As there is no mention of a training set or AI component, the ground truth for a training set was not applicable and therefore not established.

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The Amsco V-PRO 1 Plus Low Temperature Sterilization System, with VAPROX 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 two pre-programmed sterilization cycles; the Lumen and the Non Lumen Cycles operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture.

The Amsco V-PRO 1 Plus Low Temperature Sterilizer System's (Lumen Cycle) was cleared under (K062297) can sterilize *:

• Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
• Medical devices with a single stainless steel lumen with:
  • an inside diameter of 1 mm or larger and a length of a 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 Ibs.

The Amsco V-PRO 1 Plus Low Temperature Sterilization System's (Non Lumen Cycle) the subject of this (K083097) can sterilize**:
Non-lumened instruments including non-luments 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 1 Plus Low Temperature Sterilizer is a self-contained standalone device using vaporized hydrogen peroxide. This device is intended for use in terminal sterilization of cleaned, rinsed and dried, reusable medical devices used in healthcare facilities. The sterilizer operates at low pressure and low temperature and is therefore suitable for processing medical devices sensitive to heat and moisture.

The provided document is a 510(k) Summary for the Amsco V-PRO 1 Plus Low Temperature Sterilization System, focusing on the addition of a Non Lumen Cycle. It describes the device's validation against established criteria for sterilization effectiveness and safety.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information:

The document describes "Performance Testing - Bench" and "Effectiveness" studies.

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

• Test Set Sample Size: The document does not explicitly state a numerical sample size for the test set in terms of number of instruments or specific configurations beyond the validation load. For the Non Lumen Cycle, it states: "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." This load represents the challenge in the sterility effectiveness tests. The number of biological indicators (BIs) used is not specified.
• Data Provenance: The studies are described as "Performance Testing - Bench" and "verification studies." There is no mention of country of origin of the data or whether the studies were retrospective or prospective, but given the nature of a 510(k) submission for a sterilizer, these would typically be prospective, controlled bench studies and laboratory tests conducted by the manufacturer (STERIS Corporation, USA).

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

• The document does not specify the number of experts used or their qualifications for establishing ground truth. For sterilization efficacy, ground truth is typically established by laboratory methods demonstrating the complete kill of highly resistant biological indicators, rather than human expert interpretation of device performance.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical imaging diagnostics) where there might be disagreement among readers. For sterilization efficacy, the outcome (kill/no kill of BIs) is objectively measured in a laboratory setting, not subject to human adjudication in the same way.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study is not relevant for a sterilizer's performance evaluation. This type of study assesses how human readers' performance (e.g., diagnostic accuracy) is affected by AI assistance, which is not applicable here as the device is a sterilization system, not a diagnostic tool that involves human interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

• Yes, effectively. The performance testing described (complete kill of biological indicators, verifying SAL, meeting FDA guidance) evaluates the sterilizer system's ability to achieve sterility on its own without human intervention influencing the sterilization outcome. While human operators load the device and select cycles, the performance of the sterilization process itself is measured as a standalone function of the device.

7. The Type of Ground Truth Used

• The primary ground truth for sterilization effectiveness is the complete kill of biological indicators (BIs) which are highly resistant microorganisms (spores) placed in challenging locations. This is an objective, laboratory-based physical/biological measure, designed to demonstrate a high Sterility Assurance Level (SAL) (at least 10⁻⁶). This is a direct measure of microbial inactivation.

8. The Sample Size for the Training Set

• Not applicable. The Amsco V-PRO 1 Plus Low Temperature Sterilization System is a physical sterilization device, not an AI software/algorithm that requires a "training set" in the machine learning sense. Its design and operation are based on validated physical and chemical principles, not learned patterns from data.

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

• Not applicable. As explained above, there is no "training set" for this type of medical device. The device's performance is established through rigorous validation studies based on scientific and regulatory standards.

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The Vis-U-All Heat-Seal Pouch and Tubing have been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized in the AMSCO V-Pro 1 Low Temperature Sterilizer. The system is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

The proposed Vis-U-All Heat Seal Pouch is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider by the AMSCO® V-PRO 1 Low Temperature Sterilization System. The purpose of this submission is to demonstrate the Vis-U-All Heat Seal Pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer. The 510(k) number for the AMSCO® V-PRO 1 Low Temperature Sterilizer is K062297 cleared on October 4, 2007.

The provided document is a 510(k) premarket notification for a medical device (Vis-U-All Heat Seal Pouch and Tubing), which is a sterilization wrap. It discusses the device's substantial equivalence to predicate devices and its intended use. However, it does not include detailed information on specific acceptance criteria and a study proving those criteria were met in the format requested.

The document states: "Performance testing of the Vis-U-All Heat Seal Pouch and Tubing demonstrated that the proposed pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer and is as safe, as effective, and performs the same as the predicate device." This is a general statement of compliance, not a detailed breakdown of acceptance criteria and performance data.

Therefore, I cannot fulfill your request for the specific table and study details (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types and establishment for training sets) because this information is not present in the provided text.

Based on the information given, I can only report that:

• Acceptance Criteria (Implied): The device must be "qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer" and demonstrate it is "as safe, as effective, and performs the same as the predicate device."
• Reported Device Performance: The device "demonstrated that the proposed pouch is qualified for use" and "is as safe, as effective, and performs the same as the predicate device."

All other requested details (sample sizes, expert qualifications, etc.) are not available in this document.

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The Vis-U-All Self Seal Pouch is a sterilization containment pouch designed for devices to be sterilized by the AMSCO V-Pro 1 Low Temperature Sterilization System. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

The proposed Vis-U-All Self Seal Pouch is a Tyvek/plastic film sterilization containment pouch designed for devices to be sterilized by the health care provider by the AMSCO® V-PRO 1 Low Temperature Sterilization System. It permits sealing of the pouch without need of heat-sealing equipment. The purpose of this submission is to demonstrate the Vis-U-All Self Seal Pouch is qualified for use in the AMSCO® V-PRO 1 Low Temperature Sterilizer. The 510(k) number for the AMSCO® V-PRO 1 Low Temperature Sterilizer is K062297, cleared on October 4, 2007.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Vis-U-All Self Seal Pouch:

This document is a 510(k) premarket notification for a sterilization pouch, which is a low-risk device. As such, it does not involve AI or complex software, and therefore, many of the requested categories (like sample size for test set, number of experts, MRMC studies, training set details) are not applicable or not provided in this type of regulatory submission. The assessment focuses on the physical and functional performance of the pouch itself in the context of sterilization.

Acceptance Criteria and Reported Device Performance

Study Details

Given the nature of the device (sterilization pouch) and the type of regulatory submission (510(k) premarket notification), this is not a study involving AI or human interpretation of medical images. Instead, it relies on performance testing of the physical product.

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

   • Sample Size: Not explicitly stated in the provided text. This type of information would typically be detailed in the full test reports referenced in the submission, but not in this summary.
   • Data Provenance: Not explicitly stated. The company, STERIS, Corporation, is based in Mentor, Ohio, USA, which implies the testing likely occurred in the USA or through US-based labs, but this is an inference. The data would be prospective, as it involves testing the newly designed pouch.

2. 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):

   • Not applicable in the context of this device. Ground truth is established through physical and microbiological testing (e.g., sterility testing, barrier integrity testing) conforming to established standards for sterilization pouches, not through expert human interpretation.

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

   • Not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, typically in medical imaging or diagnostic contexts. Here, device performance is objectively measured.

4. 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 not an AI-powered diagnostic tool, and therefore, an MRMC study is irrelevant.

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

   • Not applicable. This is a physical medical device, not an algorithm.

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

   • The "ground truth" for this device is based on performance standards and objective measurements demonstrating:
     • Sterilization efficacy: The ability of the pouch to allow sterilant penetration and kill microorganisms when processed in the AMSCO® V-PRO 1 Low Temperature Sterilization System. This is often verified using biological indicators (BIs) or chemical indicators (CIs) in challenge tests (though the device itself has no CIs).
     • Sterility maintenance: The barrier integrity of the pouch in preventing microbial recontamination post-sterilization, often assessed through microbial challenge tests and physical performance tests (e.g., seal strength, burst strength, material integrity after sterilization cycles).
     • Material compatibility: Ensuring the materials withstand the sterilization process without degradation that would compromise integrity.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI model requiring a training set.

8. 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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The V-PROTM Sterilization Tray is used to contain reusable medical devices for sterilization in the Amsco® V-PRO™ 1 Low Temperature Sterilizer and to maintain sterility of properly processed medical devices during normal handling and storage until they are removed for use. The trays must be wrapped with a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PRO™ 1 Low Temperature Sterilizer prior to placing in the Sterilizer.

The V-PRO "M Sterilization Tray can be used with V-PRO "10 Instrument Organizers to allow stabilization of various cylindrical medical devices during processing. The medical device organizers attach to the V-PROTM Sterilization Tray bottom and stabilize cylindrical medical instruments.

The V-PRO™ Sterilization Tray is available in various sizes, 10''x 10" x 21" to accommodate the loads to be processed. The tray contains two handles that remain internalized during wrapping/processing and a lid with two clamping mechanisms for securing to the tray. There are numerous 0.01" diameter holes in the lid and tray for sterilant penetration. The tray is categorized as a cassette and requires complete enclosure in a legally marketed, FDA cleared sterilization wrap for use in the Amsco® V-PROTM 1 Low Temperature Sterilizer to maintain sterility of the devices.

The tray can contain medical device organizers to allow stabilization of various cylindrical medical devices during processing. Each organizer consists of a device holding element and lock base that attach to the V-PRO™ Sterilization Tray. The sizes for the device holding element range from a 5 mm diameter and 6 mm stem height to a 19 mm diameter and 25 mm stem height. For attachment to the tray, each device holding element is positioned over one of the numerous holes at the inner tray surface and pushed into a lock base located at the respective tray hole on the outer tray surface. A minimum of two, aligned organizers should be used for each device requiring stabilization. Once the device is placed into the organizers, it is secured by each organizer's twist lock.

This document is a 510(k) summary for the V-PRO™ Sterilization Tray and Instrument Organizers, which is a medical device intended to hold, transport, and store sterilized medical devices. It is a premarket notification to the FDA, and it focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a detailed study with acceptance criteria and device performance in the way one might expect for a novel therapeutic or diagnostic device.

Therefore, the requested information, specifically regarding acceptance criteria and a study proving the device meets those criteria in detail, including sample sizes, expert qualifications, and specific adjudication methods, is not explicitly provided in this 510(k) summary.

However, I can extract the information that is implicitly or explicitly stated about the device's performance and the general nature of its qualification.

Summary of Device Qualification (based on the provided text):

The V-PRO™ Sterilization Tray (and instrument organizers) underwent qualification testing to support its suitability for use in the Amsco® V-PRO™ 1 Low Temperature Sterilization System. The goal was to demonstrate that it is safe and effective and has the same intended use and characteristics as its predicate devices.

The performance specifications mentioned are:

• Demonstrate sterilization of devices when wrapped.
• Material compatibility with various healthcare processing chemistries and Vaprox HC Sterilant.
• Cleaning efficacy.
• Inability to emit harmful substances after processing.

Missing Information:

• Specific numerical acceptance criteria for "sterilization of devices," "cleaning efficacy," or "inability to emit harmful substances."
• Detailed study protocols, blinding, sample sizes for specific tests, data provenance for these tests, or expert involvement in establishing ground truth.
• No Multi-Reader Multi-Case (MRMC) or standalone algorithm performance studies are applicable as this is a physical medical device, not an AI/software device.

Here's the best I can construct based on the provided text, acknowledging the significant gaps in the requested details for this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Study Information (Based on interpretation of a 510(k) submission for a physical device, which typically relies on internal testing and comparison to predicates):

2. Sample size used for the test set and the data provenance

• Sample Size: Not specified. The document mentions "qualification testing data," but does not detail the number of units or cycles tested.
• Data Provenance: The testing was "performed by STERIS Corporation." This indicates proprietary in-house testing. Country of origin of the data is implicitly USA, where STERIS Corporation is located. The nature of testing would be prospective, as it's qualification testing for a new product.

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

• Not applicable/Not specified in this type of submission. Ground truth for sterilization efficacy, material compatibility, and cleaning efficacy would typically be established through validated internal laboratory protocols, rather than expert human review of a "test set" in the diagnostic sense.

4. Adjudication method for the test set

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 typically refer to expert review for diagnostic AI studies. For physical device qualification, results are determined by objective measurements against established standards.

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 physical sterilization tray and instrument organizer, not an AI or diagnostic device.

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

• The "ground truth" for the performance specifications would be based on objective laboratory measurements and validated test methods according to relevant industry standards (e.g., for sterilization, material compatibility, cleaning). For example, demonstrating "sterilization of devices" would involve sterility testing (e.g., absence of microbial growth) after sterilization cycles.

8. The sample size for the training set

• Not applicable. This is a physical device, not a machine learning model. There is no "training set."

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

• Not applicable. As above, no training set. The "ground truth" for demonstrating the device works as intended would be through established scientific and engineering principles applied in controlled laboratory settings for device performance testing.

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