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The V. Mueller Cosgrove™ Flex Clamps are indicated to occlude a blood vessel temporarily. Used in pulmonary and gastrointestinal procedures and can be used to clamp over indwelling catheters. Also used in minimally invasive and standard open cardiovascular procedures for temporary occlusion of a blood vessel.

Each V. Mueller Cosgrove™ Flex Clamp device consists of a ring handle, flexible shaft and jaw. The design of the flexible shaft allows the end user to bend the shaft following clamping of the blood vessel providing the user a clear field of visualization to the surgical site.

The proposed device and the predicate device have a similar design, the same materials and the same manufacturing and fabrication methods/processes. The main difference between the subject device and the predicate device is a change to the wire configuration of the cable. In addition, the cleaning and sterilization instructions in the instructions for use were updated in accordance with current guidance. These changes do not raise different questions of safety or effectiveness.

The provided text describes a 510(k) premarket notification for a medical device called "V. Mueller Cosgrove Flex Clamps." This device is a vascular clamp used to temporarily occlude blood vessels.

Based on the provided text, there is no information about a study proving the device meets acceptance criteria related to an AI or algorithm-driven system. The document, K210324, is for a physical medical device (vascular clamps) and its substantial equivalence to previously marketed predicate devices. The "Performance Data" section explicitly states: "N/A - No clinical tests were conducted for this submission." and "The results of the non-clinical tests demonstrate the V. Mueller Cosgrove™ Flex Clamps meet all performance requirements and are substantially equivalent to the predicate devices."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/algorithm-driven device, as this document is not about such a device. The "acceptance criteria" and "performance data" discussed in the document relate to the physical properties, reusability, sterilization, and biocompatibility of the vascular clamp itself, as demonstrated by non-clinical tests.

If you intended to ask about a different document or a different type of device, please provide that information.

However, I can extract and present the existing acceptance criteria and performance data for the V. Mueller Cosgrove Flex Clamps as presented in the document, though it won't match the format for an AI/algorithm study:

Acceptance Criteria and Device Performance for V. Mueller Cosgrove Flex Clamps (K210324)

1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical)

Note: These criteria pertain to the physical characteristics and functionality of the vascular clamp, not to an AI or algorithm.

Regarding the other points you requested for an AI/algorithm study, they are not applicable to this document as it concerns a physical medical device:

2. Sample size used for the test set and the data provenance: Not applicable. The performed tests are non-clinical (e.g., strength tests, material biocompatibility tests), not involving data sets like those for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI validation (e.g., expert consensus on medical images) is not relevant here. Device testing would be performed by qualified engineers/technicians according to established protocols.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, "ground truth" would be the engineering specifications and performance standards (e.g., tensile strength, sterilization efficacy), which are determined by established scientific methods and industry standards. It's not a "truth" derived from human interpretation of data in the AI sense.
8. The sample size for the training set: Not applicable. This device is not an AI.
9. How the ground truth for the training set was established: Not applicable. This device is not an AI.

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The Snowden-Pencer MicroLap 3mm Laparoscopic Instruments are indicated to be used in laparoscopic and other minimally invasive procedures for cutting, clamping, suturing and dissecting and to allow high frequency monopolar cutting and coagulation.

Snowden-Pencer MicroLap 3mm Laparoscopic Instruments consists of a handle and insert assembly. The insert assembly contains a shaft and end-effector (jaw pattern). There are several device models that encompass various lengths, diameters and jaw patterns based on the surgeon's needs.

The provided document is a 510(k) summary for the Snowden-Pencer MicroLap 3mm Laparoscopic Instruments. This type of submission is for medical devices that demonstrate substantial equivalence to a legally marketed predicate device, and it typically relies on non-clinical performance data rather than extensive clinical studies as seen with AI/ML devices. Therefore, much of the information requested in your prompt (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance) is not applicable or not found in this document.

However, I can extract the relevant information regarding the device's acceptance criteria and the studies that prove it meets those criteria based on the provided text.

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

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

• Sample Size for Test Set: This document does not specify the sample sizes (i.e., number of instruments tested) for each of the non-clinical performance tests. It states "Results Summary," which typically means the overall outcome for the tested batch/type.
• Data Provenance: Not specified, but these are typically lab-based, internal company tests conducted to industry standards. They are non-clinical and not derived from patient data.

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

• Not applicable. The "ground truth" for non-clinical performance tests like instrument strength or sterilization efficacy is established by adherence to recognized industry standards (e.g., ISO, AAMI, IEC standards), not by expert consensus in the medical sense for diagnostic tasks. The "experts" would be the engineers and technicians performing and verifying the tests in accordance with these standards.

4. Adjudication method for the test set:

• Not applicable. Adjudication methods (like 2+1, 3+1) are typically used for establishing ground truth in diagnostic studies involving human interpretation or clinical outcomes. For performance tests of a physical device, the "adjudication" is the objective measurement against a defined standard.

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:

• No. This is a physical surgical instrument, not an AI/ML diagnostic tool. Therefore, an MRMC study is not relevant or performed.

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

• No. This is a physical surgical instrument, not an algorithm. Standalone performance for an algorithm is not applicable.

7. The type of ground truth used:

• The "ground truth" for these tests is defined by the specific parameters and pass/fail criteria outlined in the referenced national and international performance standards (e.g., IEC 60601 series for electrosurgical safety, ISO 10993 for biocompatibility, AAMI/ANSI standards for cleaning and sterilization). For example, a "strength test" would have a defined force it must withstand without breaking or deforming.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of a physical medical device like a laparoscopic instrument. (This term is relevant for AI/ML algorithms).

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

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

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The Multi-Link Cable and Lead Wire System is intended to transmit ECG signals from patient monitors for monitoring purposes. The Multi-Link Cable and Lead Wire System is limited to indications for use of the connected monitoring equipment. The Multi-Link trunk cables) are reusable, nonsterile and can be reprocessed. The Multi-Link lead wires are available reusable (single patient use). The Multi-Link Cable and Lead Wire System is compatible with GE Healthcare, Philips, Mindray, Spacelabs and Nihon Kohden electrocardiograph monitors.

The Multi-Link X2 ECG Cable and Lead Wire Systems are a combination of reusable ECG trunk cables and single-patient use lead wires (SPUL) used to transmit signals from patient electrodes to various electrocardiograph monitors for monitoring purposes. This type of device is common to both the industry and to most medical establishments. The Multi-Link X2 ECG Cable and Lead Wire Systems are not stand alone devices but are accessories to the host monitoring devices.

The provided text is a 510(k) premarket notification for a medical device called the "Multi-Link X2 ECG Cable and Lead Wire System." This document aims to demonstrate that the new device is substantially equivalent to legally marketed predicate devices. It covers the device's indications for use, technological characteristics, and performance data, primarily focusing on compliance with established medical device standards.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner for specific diagnostic performance metrics (e.g., sensitivity, specificity, AUC). Instead, the device performance is demonstrated through adherence to recognized medical device standards. The "Performance Data" section lists the standards the device was tested against and states that the tests were performed to support substantial equivalence.

The document states, "Successful verification test results ensured that the proposed device does not raise any different question of safety and effectiveness." This indicates that the device met the requirements of the listed standards, and this compliance serves as the "acceptance criteria" for demonstrating substantial equivalence for this type of device (ECG cables and lead wires).

For a device like an ECG cable and lead wire system, performance is primarily assessed through its ability to safely and effectively transmit ECG signals, which is verified through compliance with electrical safety, biocompatibility, and functional standards, rather than diagnostic accuracy metrics typically associated with AI-driven diagnostic devices.

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

The document does not specify a "test set" in the context of clinical data, as it describes a hardware device that transmits signals rather than a diagnostic algorithm. The testing described refers to engineering verification and validation of the device's physical and electrical characteristics against recognized safety and performance standards. Therefore, information about "sample size" for a clinical test set or "data provenance" (country of origin, retrospective/prospective) is not applicable here. The testing would involve a sufficient number of device units or components to demonstrate compliance with the specified standards.

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

This information is not applicable to the presented device and study. The "ground truth" for an ECG cable and lead wire system is its adherence to electrical and material safety standards, which is assessed through laboratory testing and engineering analysis, not through expert clinical consensus on diagnostic findings.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, often with AI systems. The studies here involve objective measurements against technical 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:

This information is not applicable. The device is an ECG cable and lead wire system, which are hardware accessories for patient monitoring. It does not incorporate AI technology, nor is it a diagnostic tool that assists human readers in interpreting results. Therefore, an MRMC comparative effectiveness study with AI assistance is not relevant.

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

This information is not applicable. The device is a hardware component; it is not an algorithm and does not operate in a standalone algorithmic capacity.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device is compliance with established international and national medical device standards for electrical safety, biocompatibility, and functional performance (e.g., "60601-2-27:2011," "EC53:2013," "AAMI ANSI ISO 10993"). This is determined through objective engineering tests and material analyses.

8. The Sample Size for the Training Set:

This information is not applicable. The device is an ECG cable and lead wire system, which undergoes engineering verification and validation. It is not an AI algorithm that requires a "training set" of data.

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

This information is not applicable, as there is no "training set" for this hardware device.

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The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to any patient using a heated humidifier. The product is single use device, non-sterile and used in professional healthcare environments under a doctor's supervision and by skilled clinician. The Artofill Humidification Chamber is compatible with the Fisher and Paykel MR850 system.

The AirLife Autofill Humidification Chamber is intended to hold water required to humidify breathing gases delivered to patients.

The provided text describes a 510(k) premarket notification for the AirLife Autofill Humidification Chamber, comparing it to a predicate device (MR290 Humidification Chamber). The document focuses on demonstrating substantial equivalence rather than a study with acceptance criteria and a detailed performance evaluation of an AI-powered device.

Therefore, the requested information components related to AI/algorithm performance, such as sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth was established, are not applicable or available in this document.

The document primarily evaluates the physical and functional characteristics of a medical device (humidification chamber) against recognized standards and a predicate device.

Here's the closest representation of the requested table and related information based only on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly compliance with relevant medical device standards and demonstrating performance comparable to the predicate device. The "acceptance criteria" for each performance characteristic are often defined by the standard itself or by the performance of the predicate device.

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The Genesis™ Low Temperature Sterilization Container System is a device intended to enclose another medical device that is to be sterilized by a health care provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed medical device until used for a maximum of 180 days.

Containers are suitable for various STERRAD and V-PRO low temperature sterilization modalities when used as described in the instructions for use.

Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.

Data cards are used to record information regarding a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evident arrows provide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

The Genesis™ Low Temperature Container System is an assortment of rigid, reusable, stackable containers that are used to enclose other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards.

The container system houses baskets of varying depths and organizing accessory devices that are used to organize and to secure surgical instrumentation and/or other medical devices.

The provided document describes the Genesis™ Low Temperature Reusable Rigid Sterilization Container System, detailing its indications for use and performance data to support its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document provides details of the tests performed but does not explicitly state the exact sample sizes for each test set. For instance:

• Aerosol Challenge: "Containers subjected to an aerosol challenge test with an exposure of 1.0 - 5.0 x 10^6 CFU. Agar vessels placed in each container sample..." implies multiple container samples were used, but the specific number is not given.
• Cycled Aerosol / Limits of Reuse: "After 100 simulated full use cycles or the equivalent followed by an aerosol challenge test with an exposure of 1.0 - 5.0 x 10^6 CFU. Agar vessels placed in each container sample..." again implies multiple samples over 100 cycles, but the number of distinct items tested is not specified.
• Simulated Use: "no recovery of viable challenge organism...from the lumens on the test device after processing within a worst case Genesis Container as part of a worst case cycle simulated use container validation load." This suggests a focus on "worst-case" scenarios, likely involving a limited number of "test devices" and container configurations, but the exact count isn't in the provided text.
• Shelf Life / Package Integrity: "All sample devices remained sterile...following exposure to a full sterilization cycle and weekly rotation events at a 180 day storage duration" implies multiple "sample devices" but the number is not provided.
• Biocompatibility: "Blood hemolysis testing demonstrated that any accessories used..." does not specify the number of accessories or tests performed.

The data provenance is not specified regarding country of origin; however, the context of an FDA 510(k) submission implies testing conducted under relevant regulatory standards. The studies described are prospective in nature, as they involve performing specific tests (e.g., sterilization cycles, aerosol challenges, simulated use, shelf-life studies) to validate performance criteria for the device.

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

The document describes non-clinical performance tests, not clinical studies involving human experts for ground truth establishment. The "ground truth" for these tests is based on objective scientific measurements (e.g., presence/absence of microbial growth, sterility assurance levels, material property changes) as defined by established standards like ANSI AAMI ST 77 2013 and ISO 10993-4 2009. Therefore, there were no human experts establishing ground truth in the way one might for diagnostic imaging.

4. Adjudication Method for the Test Set:

Not applicable, as this is a non-clinical device performance study based on objective measurements against defined standards, not an assessment requiring human interpretation or adjudication for ground truth.

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

No. This document pertains to the performance validation of a sterilization container system, which is a physical medical device, not an AI or diagnostic imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable.

6. Standalone (Algorithm Only) Performance:

No. This is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

The ground truth used in these studies is objective, measurable criteria defined by recognized scientific standards and validated laboratory methods. This includes:

• Microbiological Negativity: Absence of microbial growth (biological indicators, indicator organisms in aerosol challenge) to establish sterility.
• Sterility Assurance Level (SAL): Quantitative measure (10^-6) of sterilization effectiveness.
• Physical and Mechanical Integrity: Maintaining filter properties (BFE, tear strength, burst strength), container integrity.
• Biocompatibility: Demonstrating no harmful interactions with blood (hemolysis testing).

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device undergoing performance validation, not a machine learning model requiring a training set.

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

Not applicable, as there is no training set for a physical device.

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Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments are designed to transmit cutting, clamping, grasping, suturing and dissecting force to working tips in minimally invasive surgeries such as plastic and general laparoscopic procedures.

Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments consists of a handle, shaft and insert. The insert contains an end-effector (jaw pattern). There are several device models that encompass various lengths, diameters and jaw patterns based on the surgeon's needs.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol-Grip Laparoscopic Instruments:

Based on the provided 510(k) Summary (K151036), this document describes a medical device modification (design change from single-piece to take-apart) rather than an AI/algorithm-based product. Therefore, many of the requested points related to AI/algorithm studies (like human-in-the-loop performance, training sets, etc.) are not applicable to this submission.

The acceptance criteria and supporting study are focused on ensuring the modified physical device maintains its safety and effectiveness compared to its predicate.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the exact sample sizes (e.g., number of instruments tested) for each non-clinical performance test. It only states that the tests were conducted and the device "PASSED" the criteria.

Data provenance: Not explicitly stated, but these are typically retrospective non-clinical engineering and laboratory tests conducted by the manufacturer, CareFusion 2200 Inc. The country of origin of the data would likely be the location where CareFusion performs its product testing, which can be global, but typically for FDA submissions, the testing adheres to international (ISO) and US (AAMI, ANSI) standards.

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

This question is not applicable. The "ground truth" for physical device performance tests like strength, pull, force, reliability, cleaning validation, and biocompatibility is established by engineering specifications, recognized national and international standards (e.g., AAMI, ANSI, ISO), and regulatory requirements, not by expert medical opinion in the same way an AI model's diagnostic accuracy might be judged. These tests are objective measurements against defined thresholds.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are typically used for subjective assessments or when there's ambiguity in classifying clinical data for ground truth establishment. For the objective non-clinical performance tests mentioned, the results are typically quantitative measurements that either meet or fail pre-defined acceptance limits based on standards and engineering requirements.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "N/A - No clinical tests were conducted for this submission." MRMC studies are typically for evaluating diagnostic accuracy or clinical effectiveness, often involving human readers and AI assistance, neither of which is present in this submission.

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

No, a standalone study (referring to an algorithm's performance) was not done. This submission is for a physical surgical instrument, not an AI or algorithm-based device.

7. Type of Ground Truth Used

The "ground truth" for the performance tests undertaken are:

• Engineering Specifications and Design Requirements: For parameters like instrument strength, inadvertent disassembly, ease of disassembly/reassembly, handle reusability, and handle compatibility. These are defined by the manufacturer based on expected operational loads and user interaction.
• National and International Standards: For aspects like cleanability and sterilizability (e.g., AAMI TIR12, AAMI TIR30, ANSI AAMI ST79, ANSI AAMI ST81, ISO 11138, ISO 17664, ISO 17665) and biocompatibility (ISO 10993). These standards provide objective criteria and methodologies for testing.

8. Sample Size for the Training Set

This question is not applicable. There is no AI/algorithm, so there is no training set for an algorithm.

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

This question is not applicable, as there is no AI/algorithm and thus no training set.

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The Genesis Reusable Rigid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.

Containers are suitable for dynamic air re-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.

Reusable baskets and accessory items (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.

Data cards are used to recording a specific sterilization process load. Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evide a visual indication that the container system has not been inadvertently opened prior to use. Each arrow contains a modality-specific external process indication indication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are single use only.

The Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards. The container system houses baskets of varying depths and organizing accessory devices that are used to organize and to secure surgical instrumentation and/or other medical devices.

The provided document is a 510(k) premarket notification for a medical device (Genesis™ Reusable Rigid Sterilization Container System). It outlines the device's indications for use, comparison to a predicate device, and a summary of non-clinical performance tests.

Here's an analysis of the acceptance criteria and study information provided, focusing on the available details:

Description of Acceptance Criteria and Device Performance

The device under review is the Genesis™ Reusable Rigid Sterilization Container System. The primary function of this system is to enclose other medical devices for sterilization and maintain their sterility for up to 180 days. The acceptance criteria for this device revolve around demonstrating its efficacy in sterilization and maintaining sterility under various conditions.

The study presented focuses on non-clinical performance testing to validate the sterilization efficacy and dry time of the container system for specific sterilization modalities and contents.

1. Table of Acceptance Criteria and the Reported Device Performance:

Additional Performance Parameters and Conditions (from "Sterilization Parameters for the Genesis™ Reusable Rigid Container System by Modality" and "Accessories and Device Challenges by Sterilization Modality and Container Style" tables):

• Pre-conditioning Pulses: 3
• Exposure Time: 4 Minutes
• Dry Time Cycle: 30 minutes (Regular)
• Minimum Cool Time: 60 minutes (Regular)
• Stack Height: Max 3
• Total System Weight: 25 lbs.
• Lumen Devices: 2.68 mm x 450 mm (Qty 16), 1.37 mm x 242 mm (Qty 10), 3 mm x 400 mm (Qty 2) | Demonstrated efficacy for Solid and Perforated Bottom Containers, Stacking/Non-Stacking Baskets, various Lumen Devices (specified quantities), Devices with conjoined surfaces, Silicone Support Bars/Mats, Laparoscopic Racks, Optional Protective Plates. Materials include Metals, Polymers, Composites. (Performance is "Yes" for all listed components/configurations under these steam methods). |
  | 100% Ethylene Oxide | - EO Sterilant Conc: 100% EO, 725 mg/L
• Pre-Conditioning Time: 30 mins
• Temperature: 130°F (55°C)
• Exposure Time: 60 mins
• Relative Humidity: 50-80%
• Aeration: 8 hours @ 109.4°F (43°C)
• No stacking
• Total System Weight: 15 lbs.
• Lumen Devices: 3.0 mm x 400 mm (Qty 5) | Demonstrated efficacy for Perforated Bottom Containers (except CD2-10BDL and DINCD2-8B), Non-Stacking Baskets, Lumen Devices (specified quantity), Devices with conjoined surfaces, Silicone Support Bars, Laparoscopic Racks. Materials include Stainless Steel, Aluminum, Silicone, Radel. (Performance is "Yes" for listed components/configurations under EO). |

The document explicitly states: "The Genesis Reusable Rigid Container System has been validated to meet the established performance criteria." This indicates that for all the criteria mentioned in the tables, the device successfully demonstrated compliance through the stated non-clinical tests.

2. Sample size(s) used for the test set and the data provenance:

• The document mentions "Testing" for sterilization efficacy and dry time but does not specify the exact sample sizes (number of containers, number of cycles, number of biological indicators, etc.) for the test sets.
• Data provenance is not explicitly stated regarding country of origin or whether the tests were retrospective or prospective. Given it's a 510(k) submission for a medical device by a US-based company (CareFusion 2200 Inc, Vernon Hills, IL), and referring to an FDA guidance document (ST 77 2013), it is prospective testing conducted in a controlled laboratory setting, likely within the US.

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

• This document describes non-clinical performance testing of a sterilization container, not a diagnostic or AI-driven medical imaging device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologists) is not applicable.
• The "ground truth" for sterilization efficacy is established by scientific principles and validated biological indicators (BI) and sterility assurance levels (SAL) as per recognized standards (ST 77 2013). The validation of dry time is based on the "absence of visible moisture." These are objective measurements rather than subjective expert consensus.

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

• As this is non-clinical performance testing, adjudication methods typically used for subjective clinical assessments are not applicable. The results are based on objective laboratory measurements and adherence to specified performance 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:

• No, this is not applicable. The document is for a physical medical device (sterilization container), not an AI algorithm or a diagnostic tool involving human readers.

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

• No, this is not applicable. This document pertains to a physical sterilization container.

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

• The ground truth for the performance of the sterilization container is based on objective measurements of sterilization efficacy and dryness as defined by recognized industry standards (ST 77 2013).
  • For sterilization efficacy: achieving a 12 log reduction and a Sterility Assurance Level (SAL) of 10^-6 using biological indicators (overkill method).
  • For dry time: absence of visible moisture.

8. The sample size for the training set:

• Not applicable. This relates to a physical device evaluated through non-clinical performance testing, not an AI model that requires a training set.

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

• Not applicable. As indicated in point 8, there is no training set for this type of device evaluation.

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The Genesis Reusable Rugid Sterilization Container System is a device intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It allows sterilization of the enclosed medical device and maintains sterility of the enclosed device until used for a maximum of 180 days.

Containers are suitable for dynamic air removal (pre-vacuum) steam sterilization, immediate use pre-vacuum steam sterilization and 100% ethylene oxide sterilization when used as described in the instructions for use.

Reusable baskets and accessory ttems (pins, dividers, mats, etc.) are intended to organize and secure enclosed medical devices during sterilization and storage of the container.

Data cards are used to record information a specific sterilization process load, Filter media allows ingress and egress of sterilant while providing a microbial barrier. Tamper evide a visual indication that the container system has not been madvertently opened prior to use. Each arrow contains a modality-specific external process indicator that serves as a visual ndication that the system has been exposed to a specific sterilization cycle parameter. Data cards, filters and tamper evident arrows are sungle use only.

The Genesis Reusable Rigid Container System is an assortment of rigid, reusable, stackable containers that are used to sterilize other medical devices and maintain sterility of these devices until used. The container system is comprised of a lid, bottom, filter, tamper evident arrows, and data cards.

The container system houses baskets of varying depths and organizing accessory devices that are used to organize and to secure surgical instrumentation and/or other medical devices.

Here's an analysis of the provided text regarding the Genesis Reusable Rigid Container System's acceptance criteria and the study proving it, formatted to address your specific points.

This document describes a medical device, a sterilization container system, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device. It does not contain information about an AI/ML powered device, therefore, some of your requested points related to AI/ML studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document specifies non-clinical performance testing. It does not provide explicit details on test sample sizes for each specific test (e.g., how many container cycles were tested for sterilization efficacy or dry time).

• Sample Size: Not explicitly stated as a number of distinct "cases" or "samples" for each test. The testing is reported as demonstrating the specified reductions or absence of moisture, implying a sufficient number of tests were conducted to validate the performance.
• Data Provenance: The document does not specify a country of origin for the data. The tests are non-clinical, likely conducted in a laboratory setting as part of the device manufacturer's validation process. The study is retrospective in the sense that the results are being reported for a previously conducted validation. It is not a prospective clinical trial.

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

This information is not applicable as the document describes non-clinical performance testing of a medical device (sterilization container), not an AI/ML powered device requiring expert ground truth for interpretation or diagnosis. The "ground truth" for these tests comes from objective laboratory measurements (e.g., biological indicators for sterility assurance, measurement of moisture, chemical analysis for leaching).

4. Adjudication Method for the Test Set

This information is not applicable. Since this is non-clinical performance testing with objective measurements (e.g., lab analysis for sterility, visual inspection for moisture, chemical analysis for extractables), adjudication by human experts is not relevant. The results are directly measured against pre-defined scientific criteria.

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 information is not applicable. The device is a sterilization container system, not an AI/ML diagnostic or assistive technology. Therefore, no MRMC study or AI assistance evaluation was performed.

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

This information is not applicable. The device is a physical sterilization container, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the performance testing is based on objective laboratory measurements and scientific standards:

• Sterilization Efficacy: Biological indicators (BI) and their ability to demonstrate a 12 log reduction and a sterility assurance level (SAL) of 10-6, which is aligned with industry standard ST 77 2013 (Containment Devices for Reusable Medical Device Sterilization).
• Dry Time: Absence of visible moisture, observed after the dry time cycle. This is an objective physical characteristic.
• Leaching of Colorants: Chemical evaluation to determine "significant levels" of extractable material, implying quantitative chemical analysis.
• Material Compatibility: The physical properties of the materials and their ability to withstand the sterilization processes without degradation or compromising the sterility of the enclosed devices.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as this is not an AI/ML powered device. The device itself (the container system) is subjected to validation testing to ensure it meets performance requirements.

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

This information is not applicable as there is no training set for an AI/ML model.

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The Kahn Uterine Trigger Cannula, Jarcho Self-Retaining Uterine Cannula, and Neal Fallopian Cannula are indicated to test the patency (lack of obstruction) of the fallopian tubes by pressurizing the uterus and filling them with carbon dioxide gas.

The V. Mueller® Uterine Cannula devices are constructed with a stopcock, finger ring control, an elongate shaft and a distal end with a rubber acorn.

The provided text describes the 510(k) summary for Uterine Cannulas, focusing on demonstrating substantial equivalence to a predicate device due to a "material modification". This submission is for a medical device, not an AI/ML powered device, so many of the requested categories (e.g., sample size for test/training sets, number of experts, MRMC studies, standalone algorithm performance) are not applicable.

However, I can extract the relevant acceptance criteria and study information provided for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This submission concerns a physical medical device (Uterine Cannula) and its material modification, not an AI/ML algorithm requiring a test set of data. The performance evaluations are based on non-clinical tests (biocompatibility and functionality).

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

Not applicable. Ground truth as typically understood for AI/ML device evaluations (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's performance is established by adherence to recognized standards for biocompatibility and engineering analysis for functionality.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is not an AI/ML device requiring adjudication of results from a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth for the device's performance is based on established international standards for biocompatibility (ISO 10993-1:2009 / AC 2010) and engineering analysis (Plating Thickness Analysis) for functionality.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI/ML device, there is no "training set."

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

Not applicable. There is no training set for this physical medical device.

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The Snowden-Pencer Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument indicated to be used in general laparoscopic and gynecologic procedures to allow high frequency monopolar cutting and coagulation. The reposable scissors are indicated to mechanically cut tissue and suture.

The Snowden-Pencer™ Laparoscopic Ergonomic Reposable Scissors is a monopolar electrosurgical instrument that is intended to produce a specific tissue effect such as dissecting, cutting, or coagulation by directing a variety of electrical high frequency currents through to a target tissue without causing damage to non-target tissue. The scissors are designed to fit through a 5 mm trocar and are intended to cut, dissect and coagulate tissue during general laparoscopic and gynecological procedures. The device can be used in either the electrified or non-electrified state. The device has a disposable shaft and scissors tip (scissors insert) and a reusable handle. The scissors are available in three lengths 24, 36 and 45 cm and three blade designs: curved metzenbaum, mini-metzenbaum and hook. The disposable scissors insert is provided sterile and is for single use only. The handle can be reused following cleaning and sterilization and is supplied non sterile.

The provided text describes a 510(k) summary for the Snowden-Pencer™ Laparoscopic Ergonomic Reposable Scissors. This document focuses on demonstrating the substantial equivalence of the modified device to existing predicate devices, rather than detailing a study proving the device meets specific acceptance criteria in the sense of a clinical trial for a novel AI device.

However, I can extract the "acceptance criteria" from the performance tests conducted and the "reported device performance" from the testing conclusions for this medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other requested information, the document is for a medical device (surgical scissors) and not an AI device. Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory submission.

Here's an attempt to address the other points, noting their inapplicability where relevant:

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

• Sample Size: Not explicitly stated in terms of a "test set" for performance metrics like cutting, coagulation, and electrosurgical safety. For biocompatibility and sterilization, the "sample size" would relate to the number of units tested, but this detail is not provided.
• Data Provenance: The tests are described as "Bench top and design validation testing." This implies internal testing conducted by the manufacturer (CareFusion 2200 Inc., McGaw Park, IL, USA). The data is retrospective in the sense that it was generated prior to submission for regulatory clearance.

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

• Not applicable. This is not an AI study requiring expert ground truth labeling. Performance tests for electrosurgical devices typically involve objective measurements against established standards rather than subjective expert assessment of outputs.

4. Adjudication method for the test set:

• Not applicable. This is not an AI study involving human expert judgment. Performance is assessed against quantitative 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 not an AI device. No MRMC study was performed. The document explicitly states: "N/A - No clinical tests were conducted for this submission."

6. 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. Benchtop tests are inherently "standalone" in the sense that they assess the device's inherent physical and electrical properties.

7. The type of ground truth used:

• The "ground truth" for this device's performance tests would be established by:
  • Objective measurement against engineering specifications (e.g., electrical rating, cutting force, coagulation effectiveness).
  • Compliance with recognized international standards (IEC, ISO) for medical device safety and performance.
  • Material properties and biological response based on standardized biocompatibility tests.
  • Sterility Assurance Level (SAL) based on validated sterilization protocols.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device that requires a training set.

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