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The RAPICIDE™ PA Test Strips are chemical indicators used after the disinfection cycle to ensure that the RAPICIDE™ PA High-Level Disinfectant solution is met the minimum recommended concentration of 850ppm peracetic acid. The RAPICIDE PA Test Strips are designed for use by trained personnel who reprocess endoscopes and their accessories in facilities where endoscopies are performed.

Rapicide PA High-Level Disinfectant Test Strip has the ability to measure the disinfectant use solution concentration above 850 ppm Peracetic Acid (PAA). This is the minimum recommended concentration (MRC) of PAA for Rapicide PA high-level disinfectant. If the solution is at or below MRC, the test strip pad will indicate a failure by turning dark grey, blue grey, violet grey, light grey, or white (no change in color). A passing result will be indicated by the test strip pad turning solid black after contact with solution at concentrations of 1100 ppm ± 20 ppm PAA.

The provided FDA 510(k) clearance letter pertains to a chemical indicator device, "Rapicide PA High-Level Disinfection Test Strip Model Ref # = ML02-0118," not an AI/ML-enabled medical device. Therefore, the information regarding the acceptance criteria and study proving its performance is focused on the chemical and physical properties of the test strips, rather than AI model performance metrics like sensitivity, specificity, MRMC studies, or ground truth establishment relevant to AI/ML devices.

Based on the document, I can extract the following information relevant to the device's acceptance criteria and studies:

Device Description and Intended Use:

The Rapicide PA High-Level Disinfection Test Strips are chemical indicators used after the disinfection cycle to verify that the RAPICIDE™ PA High-Level Disinfectant solution has met the Minimum Recommended Concentration (MRC) of 850ppm peracetic acid. A "pass" is indicated by the test strip pad turning solid black when exposed to solutions at concentrations of 1100 ppm ± 20 ppm PAA. A "failure" (solution at or below MRC) is indicated if the pad turns dark grey, blue grey, violet grey, light grey, or white (no color change).

Here's the breakdown of the acceptance criteria and the studies that prove the device meets these criteria, based on the provided text:

Acceptance Criteria and Device Performance

Study Details (Based on available information from the 510(k) Summary)

The provided document is a 510(k) clearance letter and an abbreviated 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed study protocols, raw data, or comprehensive statistical analyses that would be found in a full study report or clinical trial documentation. Therefore, many of the requested details for AI/ML device studies (sample size, data provenance, expert adjudication, MRMC studies, training set details) are not applicable or not provided for this type of chemical indicator device.

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

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the provided document. The 510(k) summary states that "Testing to assess and demonstrate performance of the subject device is summarized below," listing categories like "Dynamic Range," "Comparative Sensitivity and Specificity," etc., and concluding they "Met Acceptance Criteria." However, the exact number of test strips or solution samples used for each test is not disclosed.
   • Data Provenance: Not specified. It can be inferred that the testing was conducted internally by STERIS Corporation, likely in a laboratory setting, to evaluate the chemical performance of the test strips. Retrospective or prospective nature is not mentioned for this type of chemical performance testing.

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

   • Not Applicable / Not Provided: For a chemical indicator device, "ground truth" is typically established by precisely formulated chemical solutions (e.g., 850ppm PAA, 1100ppm PAA ± 20ppm PAA) with known concentrations, verified by analytical chemistry methods, rather than by human expert consensus or annotations as would be the case for medical imaging AI. The document does not mention the use of human experts for establishing ground truth.

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

   • Not Applicable / None: Adjudication methods like 2+1 or 3+1 are used to resolve discrepancies in human expert annotations for complex data (e.g., medical images). For a chemical indicator, the output (color change) is objective and directly correlated with the chemical concentration. The "reading" of the strip is a visual interpretation of a chemical reaction against a defined color standard (solid black for pass, various greys for fail). Discrepancies would likely be addressed through re-testing or instrument calibration, not expert adjudication.

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: MRMC studies are specific to evaluating the impact of AI assistance on human reader performance in tasks like image interpretation. This device is a chemical indicator test strip, not an AI-assisted diagnostic tool.

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

   • Not Applicable: This device is a physical chemical strip, not a software algorithm. Its performance is inherent in its chemical design.

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

   • Known Chemical Concentrations: The ground truth for this device is established by precisely prepared chemical solutions with known, verified concentrations of peracetic acid (e.g., 850ppm MRC, 1100ppm pass threshold). This is a direct physical or chemical measurement, not dependent on expert consensus, pathology, or outcomes data.

7. The sample size for the training set:

   • Not Applicable: This device is a chemical indicator, not an AI/machine learning model that requires a training set. The "design" is based on chemistry and materials science, not data-driven learning.

8. How the ground truth for the training set was established:

   • Not Applicable: As there is no "training set" for a chemical indicator, this question is irrelevant. The "design" and "calibration" involve chemical engineering and materials science, where the components are selected and optimized to react predictably to specific chemical concentrations.

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The integrating indicator is designed to chemically react over time with the critical parameters of a steam sterilization cycle within a specified tolerance. The integrating indicator strip is intended to be placed in each pack, pouch, container, tray or other containment device to function as an independent monitor of critical parameters for the following sterilization cycles:

Steam Sterilization Cycles:

• 250°F/121°C, 30 minutes Gravity
• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 5 minutes Dynamic Air Removal
• 270°F/132°C, 6 minutes Dynamic Air Removal
• 270°F/132°C, 7 minutes Dynamic Air Removal
• 270°F/132°C, 8 minutes Dynamic Air Removal
• 270°F/132°C, 9 minutes Dynamic Air Removal
• 270°F/132°C, 10 minutes Dynamic Air Removal
• 270°F/132°C, 15 minutes Gravity
• 273°F/134°C, 4 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 10 minutes Gravity

Steam Sterilization Cycles (IUSS):

• 270°F/132°C, 4 minutes Dynamic Air Removal
• 270°F/132°C, 3 minutes Gravity
• 270°F/132°C, 10 minutes Gravity
• 275°F/135°C, 3 minutes Dynamic Air Removal
• 275°F/135°C, 3 minutes Gravity
• 275°F/135°C, 10 minutes Gravity

The VERIFY STEAM Integrating Indicator is a single use device used by healthcare providers to monitor steam sterilization cycles. The VERIFY STEAM Integrating Indicator is included in a pack, pouch, container, tray or other containment device in a steam sterilizer and the load is processed in accordance with the sterilizer's manufacturer's directions. Prior to the use of the processed items, the integrator is observed. If the dark bar on the device enters the ACCEPT (OK) window, the integrator is read as a PASS to indicate that the steam sterilization criteria for the cycle have been met. If the dark bar on the device does not enter the ACCEPT (OK), the integrator is read as a FAIL, indicating that sufficient steam sterilization criteria has not been met and processed materials should be subjected to another steam sterilization cycle prior to use.

Here's an analysis of the provided FDA 510(k) clearance letter, focusing on the acceptance criteria and the study proving the device meets them:

The VERIFY STEAM Integrating Indicator (K243876) is a chemical indicator designed to monitor steam sterilization cycles. It is intended to be placed within containment devices (packs, pouches, etc.) during sterilization to independently verify that critical parameters have been met. The device is considered to "pass" if a dark bar on the indicator enters the "ACCEPT (OK)" window.

Acceptance Criteria and Reported Device Performance

Study Details

The provided document describes non-clinical testing performed to evaluate the performance of the VERIFY STEAM Integrating Indicator and demonstrate its substantial equivalence to a predicate device (K213412).

1. Sample sized used for the test set and the data provenance:

• The document does not specify the exact sample sizes (number of indicators) used for each individual test (Stated Value, Simulated Use, Stability, Comparison with Biological Indicator).
• The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, given the context of a 510(k) submission for a medical device, it is highly likely that these were prospective, laboratory-based studies conducted by the manufacturer (STERIS Corporation, Franklin Park, IL, USA) to evaluate the device's performance under controlled conditions.

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

• This device is a chemical indicator that produces a visual change (dark bar entering an "ACCEPT (OK)" window) based on exposure to sterilization parameters. The "ground truth" for these tests is established by the controlled sterilization cycle conditions (temperature, time, presence of steam) and the objective physical change of the indicator, rather than subjective expert interpretation.
• Therefore, no human experts were used to establish the ground truth for the test set in the way radiologists or pathologists would interpret an image. The performance is assessed against defined physical and chemical criteria.

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

• As the "ground truth" is determined by objective physical and chemical changes under controlled conditions, and the outcome (pass/fail) is a direct observation of the indicator's state, no adjudication method involving human experts was necessary for the test set.

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:

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, sometimes with AI assistance. The VERIFY STEAM Integrating Indicator is a simple chemical indicator, not an AI-powered diagnostic tool, and its primary function is to react chemically, not to be "read" in a complex interpretive sense by multiple human readers.

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

• This question is not applicable in the context of a chemical indicator. The device is entirely standalone in its function – it reacts chemically without any human intervention or an algorithm. Its "performance" is its physical color change, which is then observed by a human. There is no separate "algorithm" to evaluate.

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

• The ground truth for these tests is based on objective physical and chemical properties and predefined standards. Specifically:
  • Controlled Sterilization Parameters: The cycles are run at precisely defined temperatures and times, and the presence of steam is controlled. The "truth" is whether these parameters were met or not.
  • ANSI/AAMI/ISO 11140-1:2014: This international standard defines the performance requirements for chemical indicators, providing the objective benchmarks against which the device is evaluated.
  • Biological Indicator Inactivation: For comparison testing, the inactivation of a biological indicator (a highly resistant microorganism) serves as an objective "gold standard" for sterilization efficacy.

7. The sample size for the training set:

• The document does not mention a "training set" in the context of device development. This concept is typically associated with machine learning or AI models. For a chemical indicator, the "development" involves chemical formulation, material science, and engineering to achieve the desired reaction kinetics and visual endpoint. There isn't a "training set" in the computational sense.

8. How the ground truth for the training set was established:

• As there is no "training set" in the conventional sense for this type of device, this question is not applicable. The development of such an indicator would involve extensive research and development in chemistry and material science, where performance is iteratively optimized against the physical/chemical principles of sterilization and the requirements of relevant standards.

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The PADLOCK CLIP™ EFTR Device is an electrosurgical device that is designed for a flexible endoscope. It is intended for diagnostic tissue acquisition and full thickness resection through the removal of lesions in the colon and rectum.

The PADLOCK CLIP™ EFTR Device is indicated for the resection of lesions less than 3cm in the colon and rectum. Resection sizes may be less than 3cm due to targeted tissue thickness and degree of fibrosis.

The disposable RAPTOR Grasping Device is intended to be used to grasp tissue and/or retrieve foreign bodies, excised tissue and stents during endoscopic procedures.

The TOUCHSOFT Coagulator is used to provide monopolar therapeutic hemostasis and tissue ablation in the gastrointestinal tract through a flexible endoscope by a trained physician or clinician.

The PADLOCK CLIP Endoscopic Full Thickness Resection (EFTR) Device is an electrosurgical, single use tissue resection system. The system is part of a kit that consists of a preloaded, radiopaque, Super Elastic NiTi (Nitinol) single use clip within a mechanical delivery system along with a preloaded snare for tissue resection. The PADLOCK CLIP EFTR Device is mounted over the distal tip of a flexible endoscope. The linking cables run along the outside of the endoscope and are attached to the handle. The PADLOCK CLIP EFTR Device includes a tissue chamber that resides on the distal tip of the endoscope.

The kit's two additional devices, the TOUCHSOFT Coagulator Monopolar Single Use Device, and RAPTOR Grasping Device are used in conjunction with the PADLOCK CLIP EFTR Device through the flexible endoscope's accessory channel. The TOUCHSOFT Coagulator Monopolar Single Use Device (ablation device) will be used to mark a lesion by ablating the lesion's perimeter, thereby indicating the area for resection. Instructions for Use for the TOUCHSOFT Coagulator Monopolar Single Use Device are included within the kit. The RAPTOR Grasping Device will be used to grasp and retract the target lesion into the tissue chamber. Instructions for Use for the RAPTOR are included within the kit.

These devices are used for colorectal lesions that would otherwise not be resectable by standard polypectomy techniques.

The PADLOCK CLIP EFTR Device includes a resection clip made of super elastic nitinol and a snare made of stainless steel. The PADLOCK CLIP EFTR Device also includes handle components molded from ABS material, Stainless Steel drive wires, HDPE catheter, and a scope attachment assembly made of TPE and Polycarbonate.

This document is a 510(k) clearance letter for a medical device (PADLOCK CLIP EFTR Kit). It does not contain information about an AI/ML medical device, clinical study performance metrics, or the specific details typically requested for AI/ML device approval. The 510(k) is for a physical electrosurgical device and states that the proposed device is "the same device with an updated Instructions for Use" as its predicate.

Therefore, many of the requested points related to AI/ML device study design, such as expert ground truth, MRMC studies, training set details, etc., are not applicable to this document.

However, based on the provided text, I can extract the following information about the device's acceptance criteria and the (non-AI/ML) study that proves it meets those criteria:

Acceptance Criteria and Device Performance for PADLOCK CLIP EFTR Kit

This document describes the 510(k) clearance for a physical electrosurgical device, not an AI/ML-driven device. Therefore, the "study" described is verification testing for a physical modification (updated Instruction for Use) rather than a clinical performance study with human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes "Verification Testing" on "simulated tissue." It does not specify a numerical sample size for this test. Since it's a physical device verification using simulated tissue and not clinical data, "data provenance" in terms of country of origin or retrospective/prospective is not applicable.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable. This is a physical device verification, not a study requiring expert ground truth for diagnostic or interpretative tasks. The "ground truth" here is the objective functional success of the device (clip deploys and snare closes on simulated tissue).

4. Adjudication Method for the Test Set

Not Applicable. This is a physical device verification test. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in image interpretation studies, which is not relevant here. The "Pass" result suggests direct observation of the device's functionality.

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

No. An MRMC study is relevant for AI/ML devices or diagnostic tools where human interpretation is a key component. This document pertains to a physical electrosurgical device used for tissue resection.

6. If a Standalone (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 used was the functional success of the device's mechanical actions on simulated tissue. Specifically, the acceptance criterion was whether the "Clip deploys, and the snare closes on the simulated tissue."

8. The Sample Size for the Training Set

Not Applicable. This is a physical medical device, not an AI/ML model that requires a training set. The "testing" referred to is product verification testing to ensure the device performs as intended with updated instructions, not the training of a predictive model.

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

Not Applicable. As there is no AI/ML model or training set, there is no corresponding ground truth establishment process.

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The Defendo Fujifilm 700 Single Use Cleaning Adapter is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

This device is intended to be used only to pre-clean the endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

The Defendo Fujifilm 700 Single Use Cleaning Adapter is a single use, non-sterile disposable valve that fits onto the air/water cylinder of Fujifilm endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are nonpatient contacting. The Defendo Fujifilm 700 Single Use Cleaning Adapter assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.

This document is a 510(k) premarket notification from the FDA for a medical device. It is not a study demonstrating the performance of an AI/ML powered device. Most of the requested information regarding AI/ML study design and results is therefore not applicable.

The device is the "Defendo Fujifilm 700 Single Use Cleaning Adapter," which is a non-sterile, single-use disposable valve intended to pre-clean endoscope air/water channels post-procedure. The submission is a "Special 510(k)" to obtain clearance for a non-sterile version of a previously cleared sterile device (K232329).

Here's the relevant information based on the provided text, with explanations why certain points are not applicable:

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

The document provides a summary table of non-clinical performance testing. The "Acceptance Criteria" column consistently states "Meet acceptance criteria" without detailing the specific numeric or qualitative thresholds for each test. However, the "Results" column consistently states "Pass," indicating that the device met these (undisclosed) criteria for all tests.

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

• Sample Size: The document does not specify the sample size for any of the non-clinical tests conducted.
• Data Provenance: The document does not specify the country of origin of the data or whether the tests were retrospective or prospective. Given that these are benchtop "non-clinical" performance tests for a physical device, the concepts of retrospective/prospective clinical data or patient data provenance do not apply.

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 is not applicable. The device is a mechanical cleaning adapter, not an AI/ML-powered diagnostic tool. "Ground truth" in the context of expert consensus or clinical diagnosis is not relevant to its performance testing. The "truth" here is objective physical measurements and functional performance as per engineering specifications.

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

Not applicable. As noted above, this is not a study requiring expert adjudication of clinical findings.

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, nor is it a clinical study involving human readers.

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.

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

The "ground truth" for this device's performance testing consists of engineering specifications, material properties, and functional requirements (e.g., specific flow rates, force thresholds, leak prevention). It is established through physical measurements and bench testing against predefined criteria, not against clinical expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an AI/ML model.

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

Not applicable. This device does not involve a training set for an AI/ML model.

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Use the Celerity Incubator to incubate and automatically read STERIS Celerity Biological Indicators for Steam and Vaporized Hydrogen Peroxide sterilization at 55°C - 60°C for a fluorescent result.

The Celerity Incubator incubates and reads fluorescent Vaporized Hydrogen Peroxide (VHP) and Steam Biological Indicators (BIs). The BI is incubated at 59° C with an acceptable tolerance of -4°C/+1°C. During incubation, the BI is monitored for a potential fluorescence signal generated as a result of the production of a-glucosidase. When a growth response has been detected or when the required incubation time has elapsed, the incubator indicates the results to the user.

The provided text describes the Celerity Incubator, a Class II medical device, and its performance testing to demonstrate substantial equivalence to a predicate device. This device is designed to incubate and automatically read STERIS Celerity Biological Indicators for sterilization processes.

Here's a breakdown of the acceptance criteria and the study information based on the provided document:

1. Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The document does not explicitly state the specific sample sizes used for each test (e.g., how many biological indicators were tested for the Qualification Testing or how many barcodes were tested for recognition).

• Data Provenance: The document generally refers to "performance testing" conducted by STERIS Corporation for their 510(k) submission. It does not specify the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission for a new device, the testing would typically be prospective, conducted under controlled laboratory conditions to demonstrate performance.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide details on the number of experts used or their qualifications for establishing ground truth, as the ground truth appears to be based on physical biological indicator growth ("7-day grow out") rather than expert review of complex images or data.

4. Adjudication Method for the Test Set

Not applicable. The "ground truth" for the biological indicator test is the physical 7-day grow out, which is an objective measure, not a subjective interpretation requiring adjudication among experts.

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

Not applicable. The Celerity Incubator is a device that automates the reading of biological indicators, not an AI system assisting human readers with interpretation. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone Performance (Algorithm Only)

Yes, the testing described appears to be a standalone performance evaluation of the Celerity Incubator's ability to accurately read biological indicators, without human intervention in the reading process itself. The incubator performs the incubation and optical reading automatically.

7. Type of Ground Truth Used

The primary ground truth for the "Qualification Testing with intended Biological Indicators" is 7-day grow out of the biological indicators. This is an objective measure where biological indicators are incubated for a standard 7-day period to definitively determine if microbial growth occurred, which signifies a sterilization failure. The fluorescent reading from the Celerity Incubator is then compared against this established 7-day grow out result. For "Software Validation" and "Recognition of additional barcodes," the ground truth would be based on the intended functional specifications and correct barcode decoding, respectively.

8. Sample Size for the Training Set

Not applicable. This device is an automated incubator and reader, not an AI/ML device that requires a "training set" in the context of machine learning model development. Its function relies on established physical and optical principles for detecting fluorescence, not on learning from a large dataset.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for this device in the context of AI/ML.

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Celerity 5 HP Biological Indicator (LCB052), Celerity 5 HP Challenge Pack (LCB059), Celerity 20 HP Biological Indicator (LCB044), Celerity 20 HP Challenge Pack (LCB045)

Celerity 5 HP Biological Indicator

The Celerity 5 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX, maX, maX, maX, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems

· Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear®

· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterlizer with or without ALLClear®.

When used in conjunction with the Celerity® Incubator, the Incubator provides a fluorescent result within 5 minutes.

Celerity 5 HP Challenge Pack

The Celerity 5 HP Challenge Pack is intended for qualification testing of the V-PRO Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The Challenge Pack is placed in an otherwise empty sterilizer chamber; a hospital-defined chad is not included. The Challenge Pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 20 HP Biological Indicator

The Celerity 20 HP Biological Indicator (BI) is intended for routine monitoring of the following sterilizer cycles:

· Lumen, Non-Lumen, Fast, Flexible and Specialty Cycles of the V-PRO 1, 1 Plus, maX, maX 2, 60 and s2 Low Temperature Sterilization Systems.

· Standard and Advanced Cycles of the STERRAD® NX® Sterilizer with or without ALLClear

· Standard, FLEX, Express and DUO Cycles of the STERRAD® 100NX® Sterilizer with or without ALLClear® When used in conjunction with the Celerity HP Incubator, the Celerity 20 HP BI provides a fluorescent result within 20 minutes.

Celerity 20 HP Challenge Pack

The Celerity 20 HP Challenge Pack is intended for qualification testing of the V-PRO® Low Temperature Sterilization System following installation, relocation, malfunctions or major repairs and for routine requalification testing. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined chaded. The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the Sterilizers.

Celerity 5 HP BI

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity Incubator, within 5 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

Celerity 5 HP Challenge Pack

The Celerity 5 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator and a layer of absorptive foam within a Tyvek pouch.

Celerity 20 HP BI

The product is intended to monitor the vapor phased hydrogen peroxide sterilization cycles described in the indications for use. It produces an optical change (signal) that is detected by the STERIS proprietary reader, STERIS Celerity Incubator, within 20 minutes to confirm the viability of the biological indicator at the end of a sterilization process. The product consists of Geobacillus stearothermophilus spores and a defined nutrient media in a plastic vial. A reporter enzyme, which is produced by the organism, reacts with a fluorogenic substrate within the defined nutrient media to produce a fluorescent moiety.

Celerity 20 HP Challenge Pack

The Celerity 20 HP Challenge Pack is used in the sterile processing department, usually by service technicians or biomedical technicians to qualify the unit following installation, relocation, malfunctions or major repairs and for routine requalification testing. It consists of a Celerity 5 HP Biological Indicator and a layer of absorptive foam within a Tyvek pouch.

The provided document is a 510(k) summary for STERIS Corporation's Celerity 5 HP and Celerity 20 HP Biological Indicators and Challenge Packs. It details non-clinical tests conducted to demonstrate substantial equivalence to predicate devices, rather than a clinical study involving human readers or AI algorithms for diagnostic purposes.

Therefore, many of the requested criteria, such as "Sample size used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "MRMC comparative effectiveness study," and "Standalone (i.e. algorithm only without human-in-the-loop performance) was done," are not applicable to the information contained in this document. This document describes the performance of a physical medical device (Biological Indicator) intended to monitor sterilization cycles, not a software-based diagnostic tool or AI.

However, I can extract and present the relevant acceptance criteria and reported device performance from the provided tables.

Acceptance Criteria and Reported Device Performance

The document presents non-clinical performance testing for two sets of devices: Celerity 5 HP Biological Indicator/Challenge Pack and Celerity 20 HP Biological Indicator/Challenge Pack. The tables below combine the acceptance criteria and results for both, as they largely follow similar testing methodologies.

Celerity 5 HP Biological Indicator and Challenge Pack (Table 3)

Celerity 20 HP Biological Indicator and Challenge Pack (Table 6)

Study Details (Based on available information)

As noted, many elements of the request are not applicable as this document pertains to a physical biological indicator, not an AI or imaging diagnostic device.

1. Sample size used for the test set and the data provenance: The document uses terms like "All BI lots" and refers to testing of the biological indicators themselves rather than a "test set" of patient data. Specific sample sizes for each non-clinical test are not explicitly stated in this summary. The data provenance is from non-clinical laboratory testing performed by STERIS Corporation. There is no indication of country of origin of data or whether it was retrospective/prospective in a clinical sense.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for biological indicators in sterilization involves laboratory-based microbiology (e.g., presence or absence of spore growth in controlled environments), not expert human interpretation like radiologists for images.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is a non-clinical device performance study, not a human reader study requiring adjudication.

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 is not an AI-assisted diagnostic device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical biological indicator. The performance is assessed in a laboratory setting. The "Celerity Incubator" detects the fluorescent signal, but this is a device accessory, not an AI algorithm.

6. The type of ground truth used: The ground truth for the biological indicators is based on the viability of Geobacillus stearothermophilus spores, determined by their ability to grow and produce a fluorescent signal (or lack thereof) under specific, controlled laboratory conditions after exposure to sterilization processes. This is a direct microbiological assessment.

7. The sample size for the training set: Not applicable. This is a physical device that undergoes performance testing, not a machine learning model requiring a training set.

8. How the ground truth for the training set was established: Not applicable. As above, there is no "training set" in the context of this device.

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The enspire 3000 Chemical Indicator is a peracetic acid concentration indicator for routine monitoring of the liquid chemical sterilization cycle of the enspire 3000 employing S40 Sterilant.

The unprocessed enspire 3000 Chemical Indicator is blue. When exposed in the enspire 3000 processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 - 60°C, the indicator color changes from the start to the pass color. See reference colors on the bottle.

The enspire 3000 Chemical Indicator is a chemical indicator strip consisting of indicator ink containing the reactive chemicals printed on one end of a polypropylene strip. The product is manufactured by application of the indicator ink by screen printing to a substrate with the indicator ink printed thereon. A clear, sterilant-permeable polyether block amide laminate is adhesively bonded to the polypropylene strip following printing of the ink, completely covering the ink.

Modification for Which Clearance is Being Sought: There were no physical changes to the device and are no new indications for use. The labeling was modified to include an additional pass reference color and a gradient between the original and new pass reference colors to improve user interpretation of chemical indicator.

The provided FDA 510(k) Premarket Notification summary describes a Chemical Indicator for the enspire CLCSPS (LCC015). The device is substantially equivalent to a predicate device (K240032). The key difference is a modification to the labeling to include an additional pass reference color and a gradient to improve user interpretation.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states "Users performed all critical tasks successfully" as the acceptance criteria for the Human Factors Study, and the result was "PASS". However, the sample size for the test set is not specified, nor is the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document mentions a "Human Factors Study" but does not specify the number of experts (users) involved in this study or their qualifications. The nature of the device (a chemical indicator for sterilization monitoring) suggests that "experts" in this context would likely be healthcare professionals or sterilization technicians who would use such indicators.

4. Adjudication Method for the Test Set

The document does not provide details on any specific adjudication method (e.g., 2+1, 3+1). For a human factors study, this would typically involve observing user performance and possibly qualitative feedback, rather than formal expert adjudication of results.

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

No MRMC comparative effectiveness study was done or reported. The study described is a Human Factors Study related to user interpretation of the chemical indicator's color change, not a comparative effectiveness study with AI assistance.

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

This device is a physical chemical indicator, not an algorithm or AI. Therefore, the concept of "standalone performance (algorithm only without human-in-the-loop performance)" is not applicable. The device's function inherently involves human interpretation of a chemical reaction (color change).

7. Type of Ground Truth Used

For the Human Factors Study, the "ground truth" would implicitly be the correct interpretation of the chemical indicator's color change according to the established visual reference provided by the manufacturer. The acceptance criteria suggest that the ground truth was that users could correctly identify the "pass" condition based on the newly designed labeling.

8. Sample Size for the Training Set

Not applicable. This device is a physical chemical indicator, and there is no "training set" in the context of machine learning or algorithms. The device itself is designed based on known chemical reactions and visual communication principles. The human factors study evaluates the effectiveness of the labeling in conveying the correct interpretation to human users.

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

Not applicable. As there is no training set mentioned for the device itself (it's a physical indicator), this question is not relevant. The ground truth for the performance evaluation (Human Factors Study) is the correct interpretation of the indicator's state as defined by the manufacturer's specified color reference for a "pass" condition.

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The enspire™ 3000 Series Cleaning and Liquid Chemical Sterilant Processing System is intended to effectively provide a pressure monitor, clean, provide liquid chemical sterilization, rinse, and air purge validated immersible, reusable, semi-critical, heat sensitive medical devices such as flexible endoscopes and their accessories.

The validated cleaning process replaces cleaning for endoscopes other than duodenoscopes. Manual cleaning of duodenoscopes according to the manufacturer's written instructions for use is required prior to placement in the enspire™ 3000 Series Processor.

The enspire™ 3000 Series Processor uses only Revital-Ox 2X Concentrate Enzymatic detergent to clean and S40 Sterilant Concentrate to liquid chemically sterilize medical devices. It automatically dilutes the S40 Sterilant Concentrate to its use dilution (> 1820 mg/L peracetic acid), liquid chemically sterilizes the load during a controlled 6-minute exposure at 46.6 to 55°C and rinses the load with 0.2-micron filtered water.

The enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (CLCSPS) is a medical device processing system used for cleaning and liquid chemically sterilizing immersible, reusable, semi-critical, heat-sensitive devices such as flexible endoscopes and their accessories. The system consists of the enspire 3000 Processor, Revital-Ox 2X Concentrate Enzymatic Detergent, S40 Sterilant Concentrate and Max Flow Connectors.

The enspire 3000 Cleaning and LCSPS is an automated, self-contained device for the effective cleaning and liquid chemical sterilization of semi-critical medical devices and their accessories. The devices will not require manual cleaning prior to processing in the enspire 3000 Processor with the exception of duodenoscopes which must be manually cleaned per the manufacturer's instructions for use. In addition, prior to placement in the enspire 3000 processor, the device will undergo a manual leak test and the user will ensure the lumens are not blocked. If the device has internal channels or lumens, Max Flow Connectors are used to facilitate the delivery of detergent, sterilant use-solution and rinse water to internal channels.

Once the device is positioned in the enspire 3000 processor, the unit will create and maintain the conditions necessary for effective cleaning and liquid chemical sterilization of the load. At the beginning of the processing cycle, automated pressure monitoring is performed to confirm the integrity of the flexible endoscope throughout the process. The enspire 3000 processor maintains inflation of the processed device to prevent ingress of fluid during processing and the pressure monitoring is repeated at the end of the processing cycle to ensure that the device is leak tight after cleaning and liquid chemical sterilization. At the end of the processing cycle, the cleaned and liquid chemically sterilized devices are rinsed with 0.2 micron filtered potable water followed by a HEPA-filtered air purge to aid in drying the endoscope. The processor, which is computer controlled and continually monitored, provides documentation of each cycle.

The enspire 3000 processor utilizes Revital-Ox 2X Concentrate Enzymatic Detergent for cleaning and S40 Sterilant Concentrate for liquid chemical sterilization. S40 Sterilant Concentrate is a single use chemical sterilant concentrate; its active ingredient, peracetic acid, is combined with inert ingredients (builders) to form a use dilution which inhibits corrosion of metals, polymers and other materials.

The provided text is an FDA 510(k) summary for a medical device called the "enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System." This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for a modification to the existing device (changing materials in the Chemical Delivery System).

As such, the document does not describe a study involving human readers, AI assistance, ground truth labels from experts for diagnostic tasks, or a training set for an AI model. The "device" in question is not an AI/ML algorithm for image analysis or diagnosis. Instead, it's a machine for sterilizing endoscopes.

Therefore, many of the requested points, such as sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone AI performance, and AI model training details, are not applicable to this type of device and the information provided in the document.

However, I can extract the acceptance criteria and performance related to the modification of this physical device.

Here's the relevant information based on the provided text:

Acceptance Criteria and Device Performance for the Modified Enspire 3000 System

The study described is not for an AI/ML diagnostic device, but rather for a physical medical device (an endoscope reprocessor) that has undergone a material change in one of its components. The acceptance criteria and performance relate to the safety and efficacy of the modified reprocessing system.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, which is primarily relevant for AI/ML diagnostic devices, it is not found in this document because the device is not an AI/ML system.

Here's why each point is Not Applicable (N/A) in this context:

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

  • N/A: The "test set" here refers to physical tests conducted on the modified device and its components, not a dataset of medical images or patient data. The document mentions "multiple processing cycles" and "representative endoscope" but no specific numeric sample sizes for these qualitative/quantitative tests. Data provenance in terms of country of origin or retrospective/prospective is not relevant for this type of device testing.

• 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)

  • N/A: Ground truth for diagnostic AI models is established by human experts (e.g., radiologists). For this device, "ground truth" is based on established engineering and chemical standards (e.g., ISO standards, acceptable chemical residual levels, non-cytotoxicity). No human experts are described as "establishing ground truth" in the way they would for a diagnostic AI study.

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

  • N/A: Adjudication methods are used in AI studies where multiple human readers disagree on a diagnosis or annotation. This is a physical device subject to engineering and chemical validation tests.

• 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

  • N/A: An MRMC study is relevant for evaluating the impact of AI assistance on human diagnostic performance. This device is an endoscope reprocessor, having no direct interaction with human diagnostic reading.

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

  • N/A: "Standalone performance" refers to the accuracy of an AI algorithm in performing a diagnostic task without human intervention. This device performs a physical reprocessing function, not a diagnostic one.

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

  • N/A: As explained in point 3, the "ground truth" for this device's performance relies on engineering specifications, chemical analysis, and biocompatibility standards rather than medical diagnostic ground truth sources like pathology or patient outcomes.

• 8. The sample size for the training set

  • N/A: This device is a physical machine, not an AI/ML model that requires a "training set."

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

  • N/A: As this is not an AI/ML model, there is no training set or associated ground truth to establish in that context.

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The Single Use Cleaning Adapter is intended to be used only to pre-clean an endoscope's air/water channel post-procedure, and not to be used during a patient procedure.

This device is intended as part of the pre-cleaning process, to help clear the air/water channel of Olympus GI endoscopes post procedure.

The Defendo Single Use Cleaning Adapter for Olympus Endoscopes is a single use, sterile disposable valve that fits onto the air/water cylinder of Olympus endoscopes (that do not contain a balloon channel). It allows air and water to be flushed through the endoscope's air/water channels after an endoscopic procedure is completed to remove debris. The adapter is not intended to be used with patients and a warning tag comes with the device providing this information. The materials of the valve are nonpatient contacting. The adapter is used post-procedure to pre-clean the endoscope before it goes through high-level disinfection and/or sterilization. The adapter is attached to the air/water channel of an endoscope. When the adapter is attached to the endoscope, air can flow down the channel of the endoscope. If water is desired to flow down the channel, the device is depressed. When released, air will once again flow down the endoscope channel. The Defendo Single Use Cleaning Adapter for Olympus Endoscopes assembly consists of a cap, a spring, a spring cup, an overmolded boot, the cleaning valve stem, the valve stem backflow umbrella valve, and valve stem sealing gaskets and a warning label.

The provided document is a 510(k) premarket notification from STERIS Corporation to the FDA for a medical device called "Defendo Single Use Cleaning Adapter for Olympus Endoscopes." However, this document does not contain information about an AI/ML-driven device or studies related to AI/ML performance.

The listed tests (Button cycling/leak test, Fluid Flow Path, Air Flow Rate, CO2 Flow Rate, Water Flow Rate, Backpressure Hold Test, Valve to Port Attachment Force, Valve to Port Removal Force, Valve Depression Force, Cap breakage strength, Sterile Barrier: Visual Inspection, Sterile Barrier: Dye Penetration) are all related to the mechanical and physical performance of a cleaning adapter, not to the performance of an AI algorithm.

Therefore, I cannot extract the information requested about acceptance criteria and studies proving the device meets criteria in the context of an AI/ML device. The document describes a physical medical device (a cleaning adapter) and its non-clinical performance testing.

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The DEFENDO EUS Air/Water Valve is intended to be used to control the air/water function of an endoscope during an GI Endoscopic procedure.

The DEFENDO EUS Suction Valve is intended to be used to control the suction function of an endoscope during a GI Endoscopic procedure.

The DEFENDO EUS Air/Water Valve and the DEFENDO EUS Suction Valve are accessories to an echoendoscope.

The EUS Air/Water valve allows the end user to control air or CO2 insufflation down the endoscope's accessory channel, control water used to wash the lens of the endoscope and insufflate a balloon at the distal end of the echoendoscope

The DEFENDO EUS Suction valve allows the user to control suction through the echoendoscope's accessory channel and suction to the balloon at the distal end of the echoendoscope.

Both devices are single-use devices, supplied sterile.

The provided document is a 510(k) summary for a medical device called "DEFENDO Single Use Valve Kit AW/S Valves - 2pc for OLYMPUS EUS". This document primarily focuses on demonstrating substantial equivalence to a predicate device, specifically for an extended shelf life. It is not a study proving the device meets acceptance criteria in the context of an Artificial Intelligence (AI) or machine learning (ML) enabled medical device, where terms like "ground truth," "expert consensus," "MRMC study," and "training set" are core to the evaluation.

Therefore, I cannot fulfill all parts of your request based on the provided text. The document describes a biological/mechanical device and its non-clinical performance testing for an extended shelf life, not the performance of an AI/ML algorithm.

However, I can extract the information related to the acceptance criteria and study results that are present for this specific type of device.

Here's what can be extracted and what cannot:

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

This information is present for the non-clinical performance testing of the mechanical device.

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 states that "Identical testing was conducted on both the predicate (cleared) 1 year version of the device and proposed 3 year shelf life version of the device." It then clarifies, "The three year shelf life summary is below." However, the specific sample size (N) for each test is not provided. The testing is physical/mechanical in nature, not data-driven in the sense of patient data. Therefore, "country of origin of the data" or "retrospective/prospective" are not applicable.

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 is not applicable as the document describes non-clinical performance testing of a physical medical device, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis.

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

This is not applicable for the same reason as point 3.

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 as the document is not about an AI-assisted device.

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

This is not applicable as the document is not about an AI algorithm.

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

This is not applicable in the context of AI/ML. For this mechanical device, the "ground truth" for each test is a direct measurement against a predefined physical, mechanical, or functional standard (e.g., does it leak? does the spring compress within range?).

8. The sample size for the training set

This is not applicable as the document does not describe an AI/ML device with a training set.

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

This is not applicable as the document does not describe an AI/ML device with a training set or ground truth in that context.

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