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The AVEA Disposable Expiratory Filter/ Water Trap is an expiratory filter and water trap for use with the AVEA Ventilator.

It would be used in an institutional healthcare environment (e.g., hospitals). It may be used on adult, pediatric, and neonatal patients.

It should be operated by properly trained clinical personnel, under the direction of a physician.

The AVEA disposable expiratory filter/water trap is designed to be used exclusively with the AVEA Ventilator.

This document is a 510(k) clearance letter for the AVEA Disposable Expiratory Filter/Water Trap. It declares the device substantially equivalent to a predicate device and provides the regulatory information. Crucially, it does not describe a clinical study of the device against acceptance criteria for performance; instead, it relies on demonstrating identicality to a previously cleared predicate device.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, and expert details for a test set.
• Ground truth establishment and adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone AI algorithm performance (as this is a physical medical device, not an AI software).
• Training set sample size or ground truth establishment for a training set.

The document explicitly states:

• "The subject and predicate devices are identical in all ways."
• "The subject device and the predicate – AVEA disposable expiratory filter/water trap – K081837 is substantially equivalent based upon identicality."

This means that the study proving the device meets acceptance criteria for this specific 510(k) relies purely on the fact that it is a direct copy of a previously cleared device. The "acceptance criteria" here are essentially "be identical to the predicate device."

Here's what can be extracted from the document related to performance, based on the predicate device's listed performance:

1. Table of Acceptance Criteria (as per predicate device's listed performance) and Reported Device Performance (by virtue of identicality)

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• The FROG device is a hypodermic needle and filter combination intended for use with syringes for general purpose fluid injection/aspiration and filtering.
• The FROG removable filter allows the device to first withdraw medications from glass ampules and filter out glass fragments prior to subsequent administration after the removal of the filter cover.
• The FROG device is intended to be used by health care practitioners supporting medical care of any patient where delivery of drug housed in a glass primary container (where there is potential for glass particulate to get into drug upon opening of said primary container) is required.

The FROG device is a prescription device intended for use by healthcare professionals in a healthcare or outpatient setting. The FROG device incorporates a removable filter, which surrounds the hypodermic needle and allows the filtered aspiration of glass-contaminated drug into the syringe. After aspiration, the filter is removed from the device, permitting injection with the hypodermic needle which is already attached to the syringe. Each package will include an assembled FROG device. The device is intended for single use and provided sterile.

The provided FDA 510(k) clearance letter and documentation for the FROG (Filter Removal of Glass) device focuses on demonstrating substantial equivalence to a predicate device, the BD Precision Glide Needle (K021475). The documentation outlines detailed testing performed to support this claim, especially concerning the unique filter feature of the FROG device.

Here's an analysis of the acceptance criteria and study data based on the provided text, structured as requested:

Acceptance Criteria and Reported Device Performance

The documentation does not explicitly provide a table of quantitative acceptance criteria and corresponding reported device performance values in the typical sense of a clinical study assessing diagnostic accuracy (e.g., sensitivity, specificity). Instead, the performance evaluations are designed to demonstrate the device meets established engineering, biocompatibility, and sterilization standards, and that its unique filtering functionality is effective and comparable to a reference device.

The "Assessment of Equivalence" column in Table 5-1 implicitly serves as a form of "reported device performance" against the predicate and reference devices, indicating whether the FROG device met the functional and safety expectations.

Study Details

The provided document primarily details design verification and validation testing, not a traditional clinical study with patient data.

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

   • The document does not specify sample sizes for individual performance tests (e.g., filtration efficiency, residual volume, needle penetration, biocompatibility). It generally states "Performance Data" and lists categories of tests performed.
   • Data Provenance: The nature of the tests (e.g., ISO standard testing, biocompatibility) implies lab-based testing rather than patient data. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of patient data.

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

   • This concept is not applicable as the studies described are engineering and bench testing rather than clinical or diagnostic studies requiring expert review for ground truth establishment. The ground truth for these tests is defined by international standards (e.g., ISO 7864, ISO 10993-1) and objective measurements.

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

   • Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for resolving discrepancies in expert interpretations of patient data. This is not relevant to the engineering and bench testing described in this 510(k) summary.

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 MRMC study or any study involving human readers/AI assistance was conducted or described. The device is a physical medical device (hypodermic needle with a filter), not an AI-powered diagnostic tool.

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

   • Not applicable. This is not an algorithm-based device.

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

   • For the engineering and performance tests, the "ground truth" is based on:
     • Defined specifications and standards: Adherence to ISO standards (e.g., ISO 7864 for needle requirements, ISO 10993-1 for biocompatibility).
     • Physical measurements: For parameters like filtration efficiency (e.g., 5-micron particle filtration) and residual volume, these are direct, objective measurements against defined targets.
     • Comparison to a reference device: The BBraun Filter Straw serves as a performance benchmark for the filtering capability and residual volume.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.

8. 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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Single use Needle is intended for use with syringes and injection devices for general purpose fluid injection/aspiration.

Single use Syringe with or without Needle is intended to be used for medical purposes to inject fluid into or withdraw from body.

Membrane Filter Syringe is intended to be used for medical purposes to inject fluid into or withdraw from body. The filter operates when injecting the human body to remove foreign substances from the drug solutions.

Single use Syringe with or without Needle consist of Syringe, Cap, Needle and Hub and Blister paper. Blister paper function to sustain sterilization of the product. The Cap function to protect the needle. This device is single use. This device is provided EO Sterilization, and the syringes of Luer Slip and Luer Lock.

These devices are injecting the medicine with syringes. Biocompatibility testing and performance testing has been completed to support the substantial equivalence of the device.

This document describes a Special 510(k) submission for modifications to the "Sofjec Single use Syringe with or without Needle." The submission primarily addresses the addition of a new 60mL syringe volume and the inclusion of "without needle" options for existing syringe models.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are based on compliance with harmonized international standards for sterile hypodermic syringes and needles. The document does not provide a specific table of numerical acceptance criteria with corresponding performance data. Instead, it states that the device "Complied with ISO 7886-1, ISO 7864, ISO 9626."

• ISO 7886-1: Sterile hypodermic syringes for single use — Part 1: Syringes for manual use. This standard details requirements for material, design, performance, and packaging. Key performance aspects typically include:
  • Absence of air and liquid leakage past the plunger during aspiration and injection.
  • Dimensional accuracy (e.g., barrel capacity, graduations).
  • Smoothness of plunger movement.
  • Resistance to breakage.
  • Sterility.
• ISO 7864: Sterile hypodermic needles for single use. This standard specifies requirements for sterile hypodermic needles. Key performance aspects typically include:
  • Needle dimensions (e.g., gauge, length).
  • Integrity of the bond between needle and hub.
  • Resistance to breakage and corrosion.
  • Patency.
  • Sterility.
• ISO 9626: Stainless steel needle tubing for the manufacture of medical devices — Requirements and test methods. This standard specifies requirements for the tubing used to make hypodermic needles.

The reported device performance, in summary, is that the modified devices complied with these standards. This implies that the devices met all specified requirements within these standards.

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

The document does not specify the exact sample size used for performance testing. It states that "Successful performance testing has been completed using FDA recognized standards." The data provenance is implied to be from the manufacturer, HLB Life Science Co., Ltd., located in the Republic of Korea. The testing conducted is for a "Special 510(k) Premarket Notification" for device modification, which typically involves prospective testing of the modified device to ensure it meets established safety and performance criteria.

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

Not applicable. This is a submission for medical devices (syringes and needles), not an AI/Software as a Medical Device (SaMD). The "ground truth" here is defined by compliance with established international standards for physical device performance and sterility. The evaluation is done through laboratory testing, not expert interpretation of data like in image analysis.

4. Adjudication Method for the Test Set

Not applicable. As this is not an AI/SaMD submission, there is no expert adjudication process for ground truth establishment. Performance is determined by objective laboratory tests against pre-defined criteria in the ISO standards.

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

Not applicable. This is not an AI/SaMD product.

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

Not applicable. This is not an AI/SaMD product.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is established by compliance with recognized international consensus standards (ISO 7886-1, ISO 7864, ISO 9626). This means the device's physical and functional properties were tested against the objective specifications outlined in these standards.

8. Sample Size for the Training Set

Not applicable. This is not an AI/SaMD product; therefore, there is no "training set" in the context of machine learning.

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

Not applicable. As there is no training set, the concept of establishing ground truth for it does not apply.

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The device is indicated for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

The device is indicated to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device is indicated for use for 6 hours or less.

KIDS Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and they can be used up to 6 hours.

The KIDS Arterial Filters are the modified version of the disposables currently marketed in the D130 PH.I.S.I.O. Dideco Kids Neonatal Arterial Filter (K063255) and the D131 PH.I.S.I.O. Dideco Kids Infant Arterial Filter (K072308).

The provided text is a 510(k) premarket notification for a medical device called "KIDS Arterial Filters." It describes the device, its intended use, and its substantial equivalence to a predicate device. However, the document does not contain any information about acceptance criteria, device performance metrics (such as sensitivity, specificity, accuracy), sample sizes for test or training sets, expert review processes, or any form of AI/ML performance study.

The document explicitly states:

• "No clinical testing was conducted in support of the KIDS Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use." (Page 7, Section VIII. Clinical Performance Data)
• The performance data is described as "Non-Clinical Performance Data" and states: "Sorin Group Italia S.r.l. has conducted extensive verification and validation testing of the KIDS Arterial Filters... The KIDS Arterial Filters comply with all the applicable voluntary standards related to Arterial Filters. The devices passed all the testing in accordance with national and international standards." (Page 7, Section VII. Non-Clinical Performance Data)

Therefore, based on the provided text, I cannot answer the questions related to the acceptance criteria and the study proving the device meets these criteria in the context of AI/ML device performance or clinical study results.

The device is a physical medical device (an arterial filter), not an AI/ML software device, and its approval is based on substantial equivalence to existing devices through non-clinical testing and adherence to standards, not through clinical performance metrics or AI algorithm validation.

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The devices are recommended for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass.

The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised.

MICRO Arterial Filters are single-use, non-toxic, no pyrogenic fluid path devices and supplied sterile and individually packaged. They are devices made of plastic material (mainly PVC) and a silicon filtering net and they are recommended for use in the arterial line of an extracorporeal circuit during any procedure that requires cardiopulmonary bvpass.

These filters are used to trap and remove gaseous emboli that may be introduced through the arterial line and thev can be used up to 6 hours.

The MICRO Arterial Filters are the modified version of the following currently marketed devices:

a) the D734 Micro 40 included in the Dideco Micro 20 & 40 Adult Arterial Filter (K952270) and in the Dideco MICRO 40 Ph.I.S.I.O. Adult Arterial Filter (K040184); b) the D736 Micro 40 included into the Dideco Newborn/Infant Arterial Filters, 20/40 Micron (K961869) and in the D735 MICRO 20, Dideco D735 Micro 20 Newborn-Infant Arterial Filter with 20 micron screen and for D736 MICRO 40, DIdeco D736 Micro 40 Newborn-Infant Arterial Filter with 40 micron screen (K033987);

c) the D733 Micro 40 included in the D731 Micro 20 and D733 Micro 40 Pediatric Arterial Filters (K041061) and in the D731 MICRO 27 Ph.I.S.I.O. and D733 MICRO 40 Ph.I.S.I.O. Arterial Filters (K112525).

This document is a 510(k) summary for the MICRO Arterial Filters, detailing their substantial equivalence to previously cleared predicate devices. It focuses on the device's technical characteristics and non-clinical performance data, rather than providing specific acceptance criteria and study results in the context of an AI/human reader performance study.

Therefore, most of the requested information regarding acceptance criteria, study design for AI evaluation, sample sizes, expert ground truth establishment, MRMC studies, and training set details for an AI-powered device cannot be extracted from this document because it describes a hardware medical device (a filter), not an AI/software as a medical device (SaMD).

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

Information that CAN be extracted:

• Device Name: MICRO Arterial Filters
• Regulation Number/Name: 21 CFR 870.4260, Cardiopulmonary Bypass Arterial Line Blood Filter
• Regulatory Class: Class II
• Product Code: DTM
• Applicant: SORIN GROUP ITALIA S.R.L.
• Indications for Use: "The devices are recommended for use on the arterial line of the extracorporeal circuit during any procedure that requires cardiopulmonary bypass. The filters are used to trap and remove gaseous emboli as well as particulate debris that may be introduced through the arterial line. The device should not be used longer than 6 hours. Contact with blood for longer period is not advised."
• Device Description: Single-use, non-toxic, non-pyrogenic fluid path devices, sterile and individually packaged, made of plastic (mainly PVC) and a silicon filtering net. Used for up to 6 hours. Modified versions of existing devices, with changes to tubing material (removal of DEHP) and silicon formulation of the valve's diaphragm. Ethylene oxide sterilized.
• Predicate Devices: Multiple predicate devices listed by 510(k) number and trade name (e.g., K952270 DIDECO ADULT ARTERIAL FILTERS).
• Type of Study (General): Non-clinical performance data (verification and validation testing) was conducted to demonstrate substantial equivalence.
• Clinical Performance Data: "No clinical testing was conducted in support of the MICRO Arterial Filters, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use."
• Ground Truth Type (for this device's testing): Implied to be based on adherence to applicable voluntary standards and "proven safety and efficacy" of predicate devices through non-clinical testing.

Information that CANNOT be extracted (as this is not an AI/SaMD submission):

• A table of acceptance criteria and the reported device performance (in the context of AI metrics like sensitivity, specificity, AUC): Not applicable for this hardware device. Acceptance criteria would relate to physical performance (e.g., filtration efficiency, pressure drop, biocompatibility), which are not explicitly detailed here beyond a general statement of compliance.
• Sample sizes used for the test set and the data provenance: Not applicable. Testing was likely bench testing, not a clinical study on human data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a filter device is based on engineering specifications and material science, not expert image interpretation.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 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.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While "ground truth" exists for the filter's performance, it's not in the AI/clinical interpretation sense. It's about meeting engineering and biocompatibility standards.
• The sample size for the training set: Not applicable (no AI model).
• How the ground truth for the training set was established: Not applicable (no AI model).

To summarize, this document describes the FDA clearance of a medical device (an arterial filter) based on "substantial equivalence" to existing hardware devices, primarily through non-clinical performance testing (bench-top testing, material compatibility, etc.). It does not involve any AI/machine learning components or associated studies on human or expert annotated data.

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Besmed HME Filter (Heat and Moisture Exchange) is intended to decrease the transmission of bacteria and viruses to/from a patient, and to maintain moisture levels in the patient's respiratory tract while administering anesthesia gas, providing artificial respiration, or assisting with ventilation.

The Besmed HME Filter is typically placed at the patient's end of the breathing system, specifically between the circuits Y - piece and either the catheter mount or patient airway device. It is essential to note that the Besmed HME Filter is intended for single-use only and should be used on a single patient for up to 24 hours.

Besmed HME Filter is intended to be used within critical care and hospital/ institutional environments by qualified personnel.

Besmed Bacterial Filter

The purpose of the Besmed Bacterial Filter is to diminish the passage of bacteria and viruses to patients receiving anesthesia gas. Besmed Bacterial Filter is designed for utilization with ventilators, anesthesia machines, and open flow systems where there is a need for filtration of inhaled gases.

The Besmed Bacterial Filter is a disposable device intended for the exclusive use of a single patient within a 24-hour timeframe. Bacterial Filter is designed for utilization in hospital environments by medical professionals who possess adequate training in the operation of mechanical ventilators, respiratory systems, and humidification systems.

Besmed HMEF

The Besmed HME Filter absorbs the heat and moisture exhaled by the patients. Upon inhalation, it releases the previously retained heat and humidity to the dry inhalation gases. The HME filter is designed with electrostatic cotton for filtration, as well as a heat-preserved and moisture-absorbed paper roll for maintaining the warmth and humidity of the airway in a respiratory system. Additionally, it eliminates bacterial and viral contaminants from the breathing circuit gas. To ensure passive humidification treatment, it is recommended to install the Heat and Moisture Exchanger Filter (HMEF) on the patient's end. Besmed HME Filter is intended for adult and child patients with the tidal volume between 150ml-1000ml.

Besmed Bacterial Filter

Besmed Bacterial Filter is for single-use purpose. The intended use is achieved through the implementation of an electrostatic filtration mechanism. Transparent and compact housing material makes it easy to check the surface of the filter media for a foreign substance.

The provided text describes the acceptance criteria and the results of non-clinical testing for the "Besmed Bacterial Filter and HMEF." This summary focuses on the non-clinical test results, as no clinical testing was performed or required.

Acceptance Criteria and Reported Device Performance

The device's performance was evaluated against a set of predetermined acceptance criteria across various standards. The table below summarizes these criteria and the reported results.

Study Details

The provided document describes a non-clinical testing summary to support the substantial equivalence of the "Besmed Bacterial Filter and HMEF."

1. Sample Size used for the test set and the data provenance: The document does not specify the exact sample sizes (number of devices) used for each individual test. The data provenance is implied to be from internal testing conducted by Besmed Health Business Corp., likely in Taiwan (New Taipei City, Taiwan is their address). The nature of the tests (performance, packaging, biocompatibility) indicates that these were prospective evaluations of manufactured devices.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not applicable as the studies are non-clinical, laboratory-based tests against established international and ASTM standards. Ground truth would be defined by the criteria within these standards, which are met if the device passes the specified thresholds. No human expert consensus for "ground truth" in clinical interpretation is relevant here.

3. Adjudication method for the test set: Not applicable for non-clinical, objective laboratory tests against defined standards.

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: This is not applicable as the device is a physical medical device (breathing circuit bacterial filter and HMEF), not an AI-powered diagnostic or assistive technology.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This is not applicable as the device is a physical medical device, not an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these tests is based on the acceptance criteria defined by international standards (ISO) and ASTM standards. These standards provide objective, measurable thresholds for performance, safety, and biocompatibility.

7. The sample size for the training set: This is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established: This is not applicable for the same reason as above.

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The Option™ELITE Filter is indicated for the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava (IVC) in the following conditions:

· Pulmonary thromboembolism when anticoagulants are contraindicated

• Failure of anticoagulant therapy in thromboembolic disease

· Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced

· Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entitled "Optional Procedure for Filter Retrieval" in patients who no longer require a filter can only be performed by the jugular approach.

The Option™ELITE Vena Cava Filter 100cm System is indicated for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following conditions:

· Pulmonary thromboembolism when anticoagulants are contraindicated

· Failure of anticoagulant therapy in thromboembolic disease

· Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced

· Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated

The Option™ELITE Filter may be removed according to the instructions supplied in the Section IX, entional Procedure for Filter Retrieval" in patients who no longer require a filter in patients who no longer require a filter. Retrieval of the filter can only be performed by the jugular approach.

The Option™ELITE Vena Cava Filter is designed for the prevention of recurrent pulmonary embolism via percutaneous delivery in the inferior vena cava (IVC).

The Option™ELITE Vena Cava Filter 100cm System is designed for IVC filter insertion, delivery, deployment and placement via the popliteal and antecubital approach.

The self-centering Option™ELITE Filter is laser cut from nickel - titanium alloy (Nitinol) tubing. The Option™ELITE Filter consists of shape memory Nitinol struts emanating from a central location and is designed for optimal clot capture. Retention anchors (retention hooks) are located at the caudal portion of the filter. These anchors are intended for filter fixation to the vessel wall. The Option™ELITE Filter is intended to be used in caval diameters up to 30mm. A retrieval hook is centrally located at the cranial extremity.

The constrained Option™ELITE Filter is flexible and expands to the internal diameter of the IVC upon deployment. The Option™ELITE Filter imparts an outward radial force on the luminal surface of the vena cava to ensure proper positioning and stability. The Option™ ELITE Filter is designed to prevent pulmonary embolism while maintaining caval patency through central filtration.

The introduction kit is comprised of a filter housed in a filter cartridge. Catheter Sheath Introducer (5F ID). Angiographic Vessel Dilator with an open end, and a Pusher with deployment marker.

The Angiographic Vessel Dilator has side holes and 2 radiopaque markers, separated by 32mm (between the marker bands), that provide linear measurement of the inferior vena cava and assists in angiographic visualization when radiopaque contrast is delivered. The pusher advances the filter through the Catheter Sheath Introducer up to the deployment marker, and is then used to fix the filter in place during uncovering. The location of the distal end of the Catheter Sheath Introducer can be controlled by rotating the entire device to position the Catheter Sheath Introducer in the center of the vena cava. The Filter Cartridge houses the Option™ELITE Filter. The body of the Cartridge has text and colored arrows printed on it that identify assembly orientation, femoral is printed in green and jugular is printed in blue. The arrow of the desired access site will point into the Catheter Sheath Introducer hub. The Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when used in conjunction with the delivery of radiopaque contrast media to the vena cava.

This document describes a 510(k) premarket notification for the Option™ELITE Vena Cava Filter System and Option™ELITE Vena Cava Filter 100cm System. The purpose of the submission is to incorporate results from the PRESERVE study summary data into the Instructions for Use (IFU).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not include a specific table of acceptance criteria or reported device performance metrics in the traditional sense of a performance study. This submission is for incorporating existing clinical study results (PRESERVE study) into the device's labeling, rather than presenting new performance data for a modified device. The document explicitly states:

"No new operating principles have been introduced with the subject device. The subject device operates using the identical fundamental scientific technology as the predicate device; therefore, no performance testing was necessary nor was any performed. The clinical testing was previously provided to FDA under the Investigational Device Exemption and the PRESERVE study."

Because no new performance testing was conducted for this specific 510(k) submission, there are no new device performance metrics to report against an acceptance criterion in this document. The existing performance would be based on the prior clearance of the predicate devices and the PRESERVE study.

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

The document refers to the "PRESERVE study." However, it does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for this study within the provided text. To obtain this information, one would need to consult the original PRESERVE study documentation.

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

The provided document does not contain information on the number of experts used to establish ground truth or their qualifications for the PRESERVE study's test set.

4. Adjudication Method for the Test Set

The provided document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set of the PRESERVE study.

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

An MRMC comparative effectiveness study is typically used for AI-assisted diagnostic devices to assess the impact of AI on human reader performance. Since the device is a Vena Cava Filter System, it is a physical medical device, not a diagnostic imaging AI algorithm. Therefore, no MRMC comparative effectiveness study was done for this device.

6. Standalone (Algorithm Only) Performance

The device is a physical Vena Cava Filter System, not an algorithm or software-only device. Therefore, the concept of "standalone performance" for an algorithm does not apply to this device.

7. Type of Ground Truth Used

Given that this is a physical medical device (vena cava filter) and the PRESERVE study would be a clinical trial, the "ground truth" would likely be derived from patient outcomes, imaging data, and clinical assessments related to the filter's effectiveness in preventing pulmonary embolism and its safety profile. However, the document does not explicitly state the type of ground truth used for the PRESERVE study.

8. Sample Size for the Training Set

The concept of a "training set" typically applies to machine learning algorithms. Since the device is a physical medical device and not an AI/ML product, no training set was used in the context of algorithm development. Clinical trials, like PRESERVE, gather data for validation and effectiveness, not for training an algorithm.

9. How Ground Truth for the Training Set Was Established

As noted above, no training set was used in the context of an algorithm for this physical device. Therefore, how ground truth for a training set was established is not applicable.

In summary, the provided FDA 510(k) clearance letter and summary primarily focus on demonstrating substantial equivalence to a predicate device and incorporating pre-existing clinical study (PRESERVE study) data into the device's labeling. It does not present new performance data or detail the methodology of the PRESERVE study in the way one might expect for a new device's initial clearance or an AI/ML product. To get specific details about the PRESERVE study (sample size, ground truth, expert involvement, etc.), one would need to refer to its full study report or publications.

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This product is intended for delivery of respiratory gases to adult patients in a hospital.
This product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This product can be used for pre-oxygenation, short-term supplemental oxygenation (up to 10 minutes) during intubation, and allows an anesthesia mask to be placed over the nasal interface to perform mask ventilation. by individuals who perform anesthesia care or airway management.
This product is not intended for apneic ventilation
This product is not indicated for use during CPR.

Fisher & Paykel Healthcare has designed the F&P Optiflow™ System with Optiflow Switch interface that allows for mask ventilation without the need to remove the nasal interface from the patient during therapy.
To support this function, an Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility and Flow Diverter is required. The subject device in this 510(k) is the Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility that is also referred to in this submission as the Optiflow Switch interface.
The product is intended for delivery of respiratory gases to adult patients in a hospital. The product is indicated for the delivery of nasal high flow (NHF) and low flow oxygen by appropriately qualified healthcare professionals.
This is a prescription-only device provided in a non-sterile state. It has a flow range of 5 to 70 L/min. The device will be offered in three sizes, small (S), medium (M), and large (L).
It is intended to be used in combination with a compatible respiratory humidifier. Optiflow Oxygen Kit and the Optiflow Flow Diverter (AA520J).

This document is a 510(k) Premarket Notification from Fisher & Paykel Healthcare Ltd for a medical device called the F&P Optiflow Filtered Nasal Interface with Anesthesia Mask Compatibility (AA041J). The purpose of this submission is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device (Optiflow Nasal Oxygen Cannula with CO2 Sampling, K201723).

The document details the device's indications for use, its design and technological characteristics, and provides a summary of non-clinical tests performed to support its substantial equivalence. It does not contain information about acceptance criteria or a study that specifically "proves the device meets acceptance criteria" in terms of performance metrics like sensitivity, specificity, or reader improvement with AI assistance, as this is a medical device for respiratory gas delivery, not an AI/software device with diagnostic capabilities.

Therefore, many of the requested items (e.g., effect size of human readers with AI, standalone algorithm performance, number of experts for ground truth establishment) are not applicable to this type of device submission.

Here's an analysis based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the format of performance metrics against a target value for a diagnostic device. Instead, substantial equivalence is claimed based on non-clinical testing against relevant international and national standards, and a comparison of technological characteristics with the predicate device. The performance data is summarized as conforming to these standards.

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

• Sample Size: Not specified. The document refers to "performance testing" and "non-clinical tests" but does not detail the number of units tested.
• Data Provenance: Not specified. Given the nature of the tests (biological evaluation, safety, performance, usability), the data would likely be from manufacturer-conducted in-house or contracted laboratory testing rather than patient data from a specific country. This would be prospective testing of device samples.

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

This is not applicable as the device is not an AI/diagnostic software. Ground truth in this context would be defined by the technical specifications and standards it must meet, not by expert consensus on diagnostic images or clinical outcomes.

4. Adjudication method for the test set:

Not applicable. There's no diagnostic component requiring adjudication of human-interpreted results. Test results are against engineering specifications and standard requirements.

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 a respiratory gas delivery interface, not an AI-powered diagnostic tool.

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

Not applicable. This is not an algorithm or software device.

7. The type of ground truth used:

The "ground truth" for this device would be defined by the technical specifications of the device itself and the requirements of the international and national standards (e.g., ISO 10993, ISO 80601-2-74, IEC 60601-1, ISO 5356-1, IEC 62366-1). For example, a flow range test would compare the device's actual flow output against its stated specification of 5-70 L/min.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

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