Search Results

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.

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

Not applicable, as this is a physical device and the tests are for its physical and functional characteristics, not an AI algorithm. There is no "test set" in the sense of a dataset for an algorithm. The "tests" refer to laboratory evaluations of the device's physical properties.

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)

Not applicable. The "ground truth" for a physical medical device typically refers to engineering specifications, performance standards, and the capabilities of a predicate device, not expert consensus on interpretations of data.

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

Not applicable. This is not a study involving human adjudication of results from an AI algorithm.

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-powered device or a study involving human readers.

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

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

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

The "ground truth" in this context is based on established medical device standards (e.g., ISO, IEC) and the performance characteristics of a legally marketed predicate device (MR290 Humidification Chamber).

8. The sample size for the training set

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

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

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

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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 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 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 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.

Here's a summary of the acceptance criteria and study information for the Genesis Reusable Rigid Container System, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

The provided document describes non-clinical performance testing for the Genesis Reusable Rigid Container System.

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

   • Test Set Sample Size: Not explicitly stated. The document refers to "Testing" and "studies" but does not quantify the number of units or cycles tested for each characteristic.
   • Data Provenance: The studies are described as "non-clinical tests" and "Performance Test Summary-New Device". The manufacturer is CareFusion, based in McGaw Park, IL, USA. This suggests the data is likely from internal laboratory testing conducted by the manufacturer. It is prospective testing for the purpose of validating the new/modified device.

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

   • This information is not provided as the ground truth appears to be established through standardized methods for sterilization efficacy (biological indicators, microbial challenges) rather than expert consensus on observational data.

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

   • This information is not applicable as the ground truth is determined by objective laboratory measurements and standardized biological/microbial tests, not by human adjudication of subjective assessments.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

   • No, an MRMC comparative effectiveness study was not done. This type of study typically involves human readers assessing cases with and without AI assistance for diagnostic accuracy. The Genesis Reusable Rigid Container System is a sterilization container, not a diagnostic imaging device, so such a study would not be relevant.

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

   • Yes, implicitly. The reported performance data for sterilization efficacy, shelf life, and microbial challenge are "standalone" in the sense that they are objective measurements of the device's ability to perform its intended function (sterilization and maintaining sterility) without human intervention in the outcome assessment (beyond setting up the tests). The device itself is not an algorithm, but its function is evaluated without a human-in-the-loop interacting with its core sterilizing mechanism.

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

   • The ground truth is established through objective biological and microbiological testing standards. Specifically:
     • Sterilization Efficacy: Achieved a 12 log reduction and SAL of 10⁻⁶ using biological indicators (BI) and an overkill method, as per ST 77:2006.
     • Microbial Challenge: Demonstrated 100% negative growth following exposure to a specified concentration of Bacillus atrophaeus CFU via aerosol, also as per ST 77:2006.
     • Shelf Life: Sterility maintenance demonstrated over 180 days.

7. The sample size for the training set:

   • This information is not applicable. The device is a physical sterilization container, not a software algorithm that requires a training set. The performance is validated through physical and biological testing.

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

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

Ask a specific question about this device

Diamond-Flex® Graspers and Dissectors are designed to transmit grasping force through delicate working tips in both minimally invasive and open surgical procedures.

Each Diamond-Flex® Grasper and Dissector is comprised of a handle assembly, an elongate shaft and a 'distal end' which comprises a segmented flexible portion and the end-effector or jaw pattern.

Here's an analysis of the provided information regarding the Diamond-Flex® Graspers, focusing on the acceptance criteria and the study proving its performance:

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 used for each of the non-clinical tests. It only lists the tests performed and their outcomes ("PASS").

Regarding data provenance, these are non-clinical bench tests and simulations, not human clinical data. Therefore, concepts like country of origin for data or retrospective/prospective study design are not applicable in this context.

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

For the "Customer Evaluation Report" which assesses customer needs for grasping, dissecting, and rigidity, it implies feedback from users (customers). However, the document does not specify the number of "experts" (e.g., surgeons, medical professionals) involved in this evaluation, nor their specific qualifications.

For the other tests (Pneumo-peritoneum, Shape Forming, Crimp Strength, Repeated Simulated Use), the "ground truth" is established by direct measurement against engineering specifications and performance standards. No human experts are explicitly mentioned as establishing ground truth for these objective functional tests.

4. Adjudication Method for the Test Set

The document does not mention any adjudication method for the test set. Given that most tests are objective engineering performance tests with pass/fail criteria, an adjudication method for conflicting results would likely not be necessary unless specific subjective assessments were performed by multiple individuals.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. This type of study is typically for image-based diagnostic or screening devices to assess human reader performance with and without AI assistance. This device is a surgical instrument.

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

This device, the Diamond-Flex® Graspers, is a physical surgical instrument, not an algorithm or AI system. Therefore, the concept of a "standalone" or "algorithm only" performance study is not applicable. The performance studies conducted evaluate the mechanical and functional integrity of the instrument itself.

7. Type of Ground Truth Used

The ground truth for the tests used in this submission are primarily:

• Engineering Specifications / Performance Standards: For tests like pneumoperitoneum, articulation system strength, actuation system strength, and repeated simulated use, the "ground truth" is defined by pre-established performance metrics and thresholds that the device must meet to be considered functional, safe, and effective.
• Customer Needs/Feedback: For the "Customer Evaluation Report," the ground truth is derived from the stated or perceived needs and expectations of the end-users (customers/surgeons) regarding the device's functional performance in a surgical context.

8. Sample Size for the Training Set

This device is a physical medical instrument developed through engineering and manufacturing processes, not an AI/ML algorithm that requires training data. Therefore, the concept of a "training set" and its sample size is not applicable to this 510(k) submission.

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

As explained above, there is no training set for this type of device. Therefore, the method for establishing ground truth for a training set is not applicable.

Ask a specific question about this device