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To dilate the cartilaginous portion of the Eustachian tube for treating tube dysfunction in patients 18 years and older using a transnasal approach.

The Audion ET dilation system (ET is an abbreviation for Eustachian tube) is intended to dilate the Eustachian tube through use of balloon dilation and a transnasal approach. It contains a dilation device, inflation device and inflation lock. The dilation device has a 1.26 mm outer diameter (OD) curved non-malleable shaft with a balloon fixed at the distal end and a 1.91 mm atraumatic polymer ball tip. The dilation device is positioned under endoscopic visualization with the balloon fully retracted. Once the portion of the device from the ball tip to the base of the curve is seated in the Eustachian tube, the balloon is advanced and then inflated. The deployed balloon angle of the dilation device is 45° for optimal treatment of the Eustachian tubes. The distal leg length with balloon extended is 18.5 mm. When the balloon is inflated to 12 atm, the balloon diameter is 6mm and the body length is 20 mm.

The inflation device is an accessory that consists of an inflation syringe and an extension line. The inflation device is designed to deliver a pressure of 12 atm and is used to inflate the balloon on the dilation device.

The inflation lock is an optional accessory that is intended to interface with the Audion dilation device, inflation syringe and extension line connections to hold or release pressure during balloon dilation.

The Audion ET dilation system is provided sterile and is for single patient use only. The dilation device, inflation device and inflation lock are sterilized using ethylene oxide.

The Audion ET dilation system has been tested to withstand multiple inflations in a surgical case

The provided text is a 510(k) summary for the Audion ET dilation system, a medical device for dilating the Eustachian tube. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria based on diagnostic performance (like an AI/imaging device).

Therefore, many of the requested categories (e.g., acceptance criteria table, sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable or cannot be extracted from this document, as they pertain to studies typically performed for AI or diagnostic imaging devices to prove efficacy/accuracy.

This document describes the device itself, its intended use, and its technological characteristics in comparison to a predicate device, along with bench testing to demonstrate performance as intended and meeting design specifications.

Here's what can be extracted and addressed:

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

The document does not present acceptance criteria in a table format with corresponding quantitative performance metrics related to diagnostic accuracy or clinical outcomes. Instead, it states that "Performance testing showed that the device meets design specifications and performs as intended." The "acceptance criteria" here are implied to be the successful completion of various bench tests demonstrating the device's functionality, safety, and compatibility with its intended use, and substantial equivalence to the predicate.

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

• Test Set Sample Size: Not applicable in the context of diagnostic data. The "test set" here refers to physical devices or components subjected to bench testing. The document does not specify the number of units tested for each specific bench test (e.g., how many devices were tested for strength, or how many packaging samples for integrity).
• Data Provenance: The tests are described as "bench testing" and "performance testing," which typically occur in a lab setting. There's no mention of country of origin for clinical data (as there was no clinical study described for efficacy) or whether it was retrospective or prospective. HFE/UE verification involved "ENT physicians."

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

• Number of Experts: Not specified. The document mentions "ENT physicians" were involved in "HFE/UE verification testing" and "design validation." Their role seems to be evaluating the usability and design effectiveness, rather than establishing a "ground truth" for a diagnostic task.
• Qualifications of Experts: "ENT physicians." No further detail (e.g., years of experience, board certification) is provided.

4. Adjudication method for the test set:

Not applicable. There was no clinical study with a "ground truth" requiring adjudication. The document describes bench testing and usability verification, not multi-reader diagnostic interpretation.

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 or diagnostic imaging device submission.

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

Not applicable. This is not an AI or diagnostic imaging device submission.

7. The type of ground truth used:

Not applicable in the context of diagnostic ground truth. The "ground truth" for this device's performance is its ability to meet engineering specifications (e.g., balloon diameter at a certain pressure, shaft strength, sterilization efficacy), which are verified through various physical and chemical tests.

8. The sample size for the training set:

Not applicable. There is no AI component requiring a training set.

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

Not applicable. There is no AI component.

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The LATERA Absorbable Nasal Implant System is indicated for supporting upper and lower lateral nasal cartilage.

The LATERA Absorbable Nasal Implant System is intended to support upper and lower lateral cartilage in the nose. The system consists of the LATERA Absorbable Nasal Implant) and Delivery Device (Delivery Device). An Implant Positioning Guide is provided to serve as an external visual planning aid prior to Implant placement. The Implant is composed of a PLLA-PDLA copolymer that is predominantly cylindrical in shape with an approximate diameter of 1mm and lengths of 20mm and 24mm. The distal end of the Implant is forked to facilitate anchoring during implantation and the proximal end is narrower for increased flexibility. The disposable Delivery Device is comprised of a non-patient contacting handle assembly and a medical grade stainless steel 16-gauge delivery cannula. The Delivery Device enables placement of the Implant in a minimally invasive manner. Each Implant length (20mm, 24mm) is compatible with the Delivery Device packaged with the Implant. The LATERA Absorbable Nasal Implant System is provided sterile and is intended for single-use only.

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

This document is a 510(k) summary for the Stryker ENT LATERA Absorbable Nasal Implant System. A 510(k) clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving independent performance against specific acceptance criteria for a novel device. Therefore, the "acceptance criteria" here refer to the design specifications and performance standards met to demonstrate equivalence, and the "study" is the performance testing conducted for that purpose. There is no AI/ML component to this device or its evaluation presented in this document.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for individual tests (e.g., number of implants tested for tensile strength, number of sterilization cycles validated). The testing is generally referred to as "design verification testing and distribution testing to support the additional implant size."

• Test Set Size: Not specified.
• Data Provenance: Not specified, but generally, such testing is conducted internally by the manufacturer or by contract labs in the country of origin of the manufacturer (USA, given the address). The testing is prospective in nature, as it is performed to validate the device's design and manufacturing processes prior to marketing.

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

• Not Applicable. This device is a physical implant, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth for its performance evaluation in the context of this 510(k) summary. Performance is evaluated through engineering and biocompatibility testing against predefined specifications.

4. Adjudication Method for the Test Set

• Not Applicable. As mentioned above, this is basic engineering and biocompatibility testing, not a clinical trial or AI evaluation requiring expert adjudication.

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

• No. This is a physical medical device (nasal implant), not an imaging or diagnostic AI tool. An MRMC study is not relevant to its clearance.

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

• No. This is a physical medical device. There is no algorithm or AI component involved in its function or evaluation as described in this document.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

• Engineering Specifications: Pre-defined design parameters, material properties, and functional requirements.
• Established Test Standards: Adherence to recognized biocompatibility standards, sterilization validation methods, and shelf-life determination protocols.
• Predicate Device Characteristics: The LATERA Absorbable Nasal Implant [K161191] serves as the benchmark for demonstrating "substantial equivalence" in terms of safety and effectiveness, meaning features and performance are shown to be equivalent to an already cleared device.

8. The Sample Size for the Training Set

• Not Applicable. There is no AI/ML component; therefore, no "training set."

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

• Not Applicable. As there is no training set.

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For use in injecting local anesthetics into a patient to provide regional anesthesia.

The Entellus Medical Reinforced Anesthesia Needle is a 3.5" long disposable medical device that allows the user to transnasally administer anesthetic solutions. The Reinforced Anesthesia Needle device is a 27 gauge needle with a reinforcing sleeve which supports the needle to reduce needle flex during administration of anesthetic solutions. A slight bend at the distal end of the needle is designed to improve access to nasal anatomy. The Quincke tip extends approximately 2 mm past the reinforcing sleeve creating a distal stop. The needle hub features a standard luerlock connector.

This document is a 510(k) premarket notification for a medical device called the Entellus Medical Reinforced Anesthesia Needle. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its own performance against pre-defined acceptance criteria with respect to a clinical outcome.

Therefore, much of the requested information cannot be extracted from this document, as it pertains to a different type of device evaluation (a clinical trial or a standalone performance study of an AI/diagnostic device).

However, I can provide what is present in the document about the performance data and the comparison to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify quantitative acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity, accuracy). Instead, it states that the device "meets design specifications and performed as intended" based on various engineering and biocompatibility tests. The "performance" here refers to meeting technical specifications rather than clinical efficacy metrics.

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

• Sample Size: Not applicable. The "test set" in this context refers to the samples used for the engineering, biocompatibility, and sterilization tests, not a clinical data set. The document does not specify the number of devices or units tested for each performance criterion.
• Data Provenance: Not applicable for clinical data. The tests are laboratory-based engineering and biocompatibility tests of the device itself.

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 these types of tests is typically established by laboratory standards and protocols (e.g., ISO standards), rather than expert medical consensus on patient cases.

4. Adjudication method for the test set

Not applicable. This is not a clinical study involving human judgment or adjudication of patient cases.

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/CAD device.

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

Not applicable. This is not an AI/CAD device.

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

The "ground truth" for the performance tests conducted (biocompatibility, sterilization, dimensional accuracy, strength, HFE/UE) would be established by the relevant engineering and medical device standards (e.g., ISO, internal design specifications) rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

Not applicable. This is not an AI/CAD device, and therefore no "training set" in the context of machine learning was used.

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

Not applicable. See point 8.

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To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

To dilate the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction in patients 18 years and older using a transnasal approach.

The XprESS ENT Dilation System is intended to recreate the sinus outflow tract and dilate the Eustachian tube by transnasal balloon dilation. The XprESS device combines features of a curved suction tip and an ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device into the sinuses and Eustachian tubes using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses and Eustachian tubes within the same patient.

The XprESS device curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS ENT Dilation System is provided sterile and for single use only.

The Xpress ENT Dilation System includes the XprESS device, Inflation Syringe, Bending Tool, and two Extension Lines. The XprESS LoProfile and Ultra ENT Dilation Systems also include the PathAssist LED Light Fiber. The XprESS Pro ENT Dilation System also includes a Tuohy Adapter.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. The document is a 510(k) summary for a medical device (XprESS ENT Dilation System) and does not contain acceptance criteria or a detailed study description in the specified format.

The document states that "The primary efficacy endpoint was met with Eustachian tube balloon dilation demonstrating superiority over medical management for improvement in ETDQ-7 symptom scores (p

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To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The XprESS Multi-Sinus Dilation System is intended to recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient. The XprESS curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS Multi-Sinus Dilation System is provided sterile and for single use only. The Xpress Multi-Sinus Dilation System includes the XprESS device, Inflation Syringe, Bending Tool and two Extension Lines. The XprESS LoProfile and Ultra Multi-Sinus Dilation Systems also include the PathAssist LED Light Fiber. The XprESS Pro Multi-Sinus Dilation System also includes a Tuohy Adapter.

Here's an analysis of the provided text regarding the acceptance criteria and study for the XprESS Multi-Sinus Dilation System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA clearance document doesn't explicitly state quantitative acceptance criteria in a typical tabular format with specific thresholds to be met (e.g., "Success Rate > 90%"). Instead, the performance claims are presented as achieved outcomes.

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

• Sample Size (Test Set): 50 subjects (with 157 attempted sinus dilations).
• Data Provenance: Prospective, multicenter, single-arm study conducted in the United States.

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

The document does not specify the number of experts used to establish ground truth or their qualifications. The study focused on procedural success and complication rates, which were likely determined by the treating physicians and reported in the clinical study. It's not a diagnostic AI device where external expert review of outputs for ground truth is typically required.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Given it's a procedural device study focusing on success and complications, data would typically be collected and reported by the clinical sites and then aggregated and analyzed.

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

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging or AI-assisted interpretation devices to compare human performance with and without AI assistance. The XprESS device is a surgical instrument.

6. If a Standalone (Algorithm Only) Performance Study Was Done

No, a standalone (algorithm only) performance study was not done. The XprESS Multi-Sinus Dilation System is a physical medical device, not an algorithm or AI. Its performance is tied to its physical use.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to the outcomes measured in the clinical study:

• Procedural Technical Success: This would be determined by direct observation during the procedure by the treating physician(s) – i.e., whether the dilation was successfully completed.
• Complication Rate: Recorded by clinical staff and physicians based on adverse events occurring during or after the procedure.

8. The Sample Size for the Training Set

Not applicable. The XprESS Multi-Sinus Dilation System is a physical medical device, not an AI or algorithm that requires 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 medical device.

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To locate, illuminate within, and transilluminate across nasal and sinus structures.

The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Light Fiber is provided sterile and is for single use only. The device consists of a flexible illumination fiber, a protective sheath and an integrated battery powered LED light source. When the LED Light Fiber is activated the fiber will emit red light from the distal tip for over 60 minutes. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.375mm (0.015").

The PathAssist LED Light Fiber is packaged alone or may be packaged with XprESS (LoProfile or Ultra).

Here's a breakdown of the acceptance criteria and study information for the PathAssist LED Light Fiber, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): 50 subjects, resulting in 129 sinus illuminations/transilluminations attempted.
• Data Provenance: Prospective, multicenter, single-arm study conducted in the United States.

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

The document does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, given the nature of a clinical study, it would implicitly involve clinical investigators/physicians proficient in ENT procedures to assess the procedural technical success and identify complications.

4. Adjudication Method for the Test Set

The document does not explicitly mention an adjudication method (such as 2+1 or 3+1) for the test set. It describes a single-arm study where outcomes were assessed, likely by the treating physicians or study coordinators participating in the multicenter trial.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly described. The study was a single-arm study focused on the device's performance, not a comparative study against other methods or human readers with and without AI assistance.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-loop Performance) Was Done

This question is not applicable as the device described, the PathAssist LED Light Fiber, is a manual surgical instrument (a light fiber) used directly by a clinician, not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The ground truth was established through clinical assessment during the prospective study.

• Technical Success: Assessed by the clinical investigators performing the procedure, based on their ability to "locate, illuminate within, and transilluminate across nasal and sinus structures" using the device.
• Complications/Adverse Events: Clinical observation and reporting by the investigators.

8. The Sample Size for the Training Set

The document does not provide information about a separate "training set" or "training data." This is consistent with the nature of the device; it's a physical medical instrument, not a machine learning algorithm that requires a training set. The clinical study described served as the primary performance evaluation for regulatory submission.

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

As there is no mention of a "training set" for an AI algorithm, this information is not applicable to the PathAssist LED Light Fiber.

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To access and treat the frontal recesses, sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium seeker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient.

The XprESS curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation.

The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.

This document is a 510(k) premarket notification for a medical device called the "XprESS Multi-Sinus Dilation Tool". It is a submission to the FDA seeking clearance to market the device, claiming substantial equivalence to a previously cleared predicate device.

Here's an analysis of the provided information, focusing on acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a typical format. Instead, it discusses the outcomes of various tests. Based on the "Performance Data" section (Page 4), the implicit acceptance criteria are that the device meets design specifications and performs as intended.

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

• The document mentions "simulated use in a cadaver model." However, it does not specify the sample size (e.g., number of cadavers or number of procedures performed).
• The data provenance is retrospective/simulated, as it was done in a cadaver model, not live patients. The country of origin for the cadaver model data is not explicitly stated.

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

• The document does not provide information regarding the number of experts or their qualifications for establishing ground truth in the simulated use testing. For a device like this, ground truth would likely be based on successful access, dilation, and lack of damage in the cadaveric sinuses, assessed by qualified medical professionals (e.g., ENT surgeons).

4. Adjudication Method for the Test Set

• The document does not describe any formal adjudication method for the simulated use testing.

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

• No, an MRMC comparative effectiveness study was not done. The device is a surgical tool, not an AI diagnostic imaging device that would typically involve human readers interpreting images. The evaluation primarily focuses on the device's physical performance, safety, and functionality.

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

• This question is not applicable to the XprESS Multi-Sinus Dilation Tool. This is a manual surgical instrument, not an AI algorithm. Its performance is always with a human (surgeon) in the loop.

7. The Type of Ground Truth Used

• The ground truth for the performance testing (e.g., in the cadaver model) would have been based on direct observation and assessment of the physical outcomes (e.g., successful dilation, structural integrity, absence of damage) within the simulated environment by qualified personnel. It's a functional ground truth rather than a diagnostic one like pathology or expert consensus on an image. For biocompatibility, the ground truth is established by standardized testing protocols for material safety.

8. The Sample Size for the Training Set

• This question is not applicable. The XprESS Multi-Sinus Dilation Tool is a mechanical surgical instrument, not a machine learning model. Therefore, there is no "training set" in the context of AI.

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

• This question is not applicable as there is no training set for a mechanical surgical instrument.

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To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.

The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Light Fiber is provided sterile and is for single use only. The device consists of a flexible illumination fiber, a protective sheath and an integrated battery powered LED light source. When the LED Light Fiber is activated the fiber will emit red light from the distal tip for over 60 minutes. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.375mm (0.015").

The PathAssist LED Light Fiber is packaged alone or may be packaged with XprESS (LoProfile suction tip).

This document describes the PathAssist LED Light Fiber, a device intended to locate, illuminate within, and transilluminate across nasal and sinus structures. The document is a 510(k) summary submitted to the FDA, indicating a claim of substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria. Therefore, the information provided focuses on demonstrating equivalence to an existing device rather than presenting detailed acceptance criteria and a study proving the device meets them in a conventional sense.

Here's a breakdown based on the provided text, addressing the requested information to the extent possible:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" for novel performance metrics are not explicitly stated in this document. Instead, the focus is on meeting "design specifications" and performing "as intended," which is implicitly tied to the performance of the predicate device.

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

The document states: "Performance testing of the PathAssist LED Light Fiber consisted of design verification testing to support the device modifications." It does not specify a "test set" in the context of clinical or large-scale comparative studies. The testing described is primarily benchtop design verification.

• Sample Size: Not specified for individual tests.
• Data Provenance: Not applicable in the context of clinical data. It's internal company design verification data. This is retrospective in the sense that it evaluates the modified device's adherence to design specifications.

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

This information is not applicable as the document describes design verification testing, not a clinical study involving human readers or expert ground truth panels.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "test set" in the context of expert review or clinical trial adjudication. Design verification results are typically evaluated against established engineering specifications.

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

A MRMC comparative effectiveness study was not done. The document explicitly states: "animal and clinical data were not submitted."

6. Standalone Performance Study

A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done in the clinical sense. The "performance data" refers to "design verification testing" (functional, mechanical, compatibility, thermal safety), which assesses the device's physical and operational characteristics, not its clinical efficacy in a standalone context.

7. Type of Ground Truth Used

The "ground truth" for the design verification testing would be the engineering design specifications and established quality control parameters for the device's physical and functional attributes.

8. Sample Size for the Training Set

This information is not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as point 8.

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The PathAssist Light Seeker is intended to locate, illuminate within, and transilluminate across nasal and sinus structures, including the frontal, ethmoid and maxillary sinuses, in patients aged 18 and over.

The PathAssist™ Light Seeker™ is a fiber optic based, manually operated, reusable sinus seeker that can be connected to a light source to emit light from its distal end. It is labeled non-sterile and must be cleaned and sterilized or cleaned and high level disinfected prior to each use. The Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm - 3.5mm light guides (cables).

Here's an analysis of the provided text regarding the acceptance criteria and study for the Entellus Medical PathAssist™ Light Seeker™:

This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving device effectiveness through extensive clinical trials. Therefore, the "acceptance criteria" discussed are primarily related to design specifications, safety, and equivalence to the predicate, not clinical performance metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not describe a "test set" in the context of clinical performance data. The performance testing focused on design verification, biocompatibility, and packaging. These tests would have involved specific units of the device or its components for each test (e.g., a certain number of devices for dimensional checks, samples of materials for biocompatibility, packaged units for shipping tests), but the exact sample sizes are not specified in this summary.

Data Provenance: The data is generated internally by Entellus Medical, Inc. based on their design, manufacturing, and testing processes. No external data provenance (e.g., country of origin, retrospective/prospective) is applicable in the sense of clinical data.

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

Not applicable. This submission does not involve a clinical "test set" requiring expert ground truth in the way a diagnostic AI device would. The "ground truth" for design verification tests would be established by engineering specifications and industry standards.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical "test set" requiring adjudication.

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

Not applicable. This device is a manual surgical instrument, not an AI-assisted diagnostic tool.

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

Not applicable. This is a physical, manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

For the engineering and safety tests performed:

• Design Verification (Dimensional, Thermal Safety): Ground truth is established by the device's own engineering design specifications, industry standards, and test protocols.
• Biocompatibility: Ground truth is established by the criteria and methods outlined in ISO 10993-1.
• Packaging: Ground truth is established by the specified standards in ASTM D4169-09.

8. The Sample Size for the Training Set

Not applicable. This device does not use machine learning or AI, so 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 type of device.

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To access and treat the frontal recesses. sphenoid sinus ostia and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.

The XprESS Multi-Sinus Dilation Tool is intended to remodel or recreate the sinus outflow tract via trans-nasal balloon dilation. The XprESS device combines features of a curved suction tip and a frontal ostium secker with the tissue expansion effect of balloon dilation. The familiar features of this device enable a physician to track the device to the sinus ostium using endoscopic visualization. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient. The XprESS curved suction tip has an atraumatic ball tip. A suction tube may be connected to the proximal barbed fitting to provide active suction by covering the suction vent. An Extension Line connected to a syringe may be connected to the proximal barbed fitting to provide irrigation. The device was designed to prevent fluid from exiting the suction vent during irrigation. The XprESS Multi-Sinus Dilation Tool is provided sterile and for single use only.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria for the "XprESS Multi-Sinus Dilation Tool". The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

Therefore, I cannot fulfill your request to provide:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information on standalone performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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