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The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.

The Relieva Stratus Pro MicroFlow Spacer (Frontal) is a device that maintains an opening at the target sinus for up to 14 days postoperatively. The device can be manually removed during an office follow-up visit.

The provided text describes a 510(k) premarket notification for a medical device, the Relieva Stratus Pro MicroFlow Spacer (Frontal). It highlights the device's purpose, classification, and a summary of its performance data. However, the document does not contain the detailed information requested regarding the acceptance criteria, specific study design, sample sizes, ground truth establishment, or multi-reader multi-case studies as would be expected for an AI/ML powered device.

The information provided is typical for a Class I medical device (manual surgical instrument for general use) where equivalence to a predicate device is established through demonstrating compliance with recognized standards and basic performance requirements. This is not a submission for an AI/ML-powered device.

Therefore, I cannot populate the requested table and sections with the information about acceptance criteria and study data for an AI/ML device because the provided text pertains to a traditional, non-AI medical device.

The "Performance Data" section explicitly states: "The Relieva Stratus Pro MicroFlow Spacer (Frontal) met all performance acceptance criteria." It then lists criteria related to sterilization, sterility assurance level, non-pyrogenicity, ethylene oxide residuals, shelf life, and package integrity, all of which are standard for a physical medical implant, not an AI algorithm.

Here's a breakdown of why I cannot fulfill the request specifically for AI/ML device evaluation criteria based on the provided text:

• No AI/ML Components: The device description ("maintains an opening at the target sinus for up to 14 days postoperatively") and its classification ("Manual surgical instrument for general use") clearly indicate it is a physical device, not an AI/ML algorithm.
• Performance Data Type: The "Performance Data" section discusses:
  • Sterilization (AAMI/ANSI/ISO 11135-1:2007)
  • Sterility Assurance Level (10-6)
  • Non-pyrogenicity (ANSI/AAMI ST72:2002)
  • Ethylene oxide residuals (ISO 10993-7:2008)
  • Shelf life (ASTM F1980-07)
  • Package integrity (ASTM F88-07A, ISTA 2A-08, and ASTM F2096-04)
    These are all physical and biological safety standards, not metrics or studies related to AI/ML prediction or diagnostic performance.
• Absence of AI-Specific Terminology: There is no mention of algorithms, models, datasets, training, testing, ground truth, accuracy, sensitivity, specificity, AUC, human readers, or any other terms associated with AI/ML device evaluation.

Conclusion: The provided document describes a Class I medical device in the context of a 510(k) submission, confirming its substantial equivalence to a predicate device based on standard performance tests for physical implants. It does not provide information relevant to the acceptance criteria or study design for an AI/ML-powered medical device.

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The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.
The MicroFlow Spacer (Ethmoid) is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.

The MicroFlow Spacer is a device that maintains an opening at the target sinus for up to 14 days postoperatively. There are two models of the MicroFlow Spacer: Ethmoid and Frontal. The modified device can be manually removed during an office follow-up visit at any time.

The provided material describes the Relieva Stratus MicroFlow Spacer, a manual surgical instrument. Because this is a physical medical device and not an AI/ML-driven solution, many of the typical acceptance criteria and study components related to software performance (such as sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, and training set details) are not applicable.

The document indicates that the device's performance was evaluated for substantial equivalence to a predicate device, the Relieva Stratus MicroFlow Spacer (K083574).

Here's a breakdown of the relevant information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "The MicroFlow Spacer met all performance acceptance criteria." However, it does not provide a detailed table listing specific acceptance criteria and their corresponding reported performance values. It only offers a general statement of compliance. The focus of this 510(k) summary is on establishing substantial equivalence through relevant performance tests, rather than detailing a specific set of clinical performance metrics.

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

• Sample Size: Not specified. The document refers to "relevant performance tests" but does not detail the size or nature of any test sets.
• Data Provenance: Not specified. As this is a physical device submission focused on substantial equivalence to a predicate, the "data" likely refers to engineering performance testing rather than clinical study data from a specific country or a retrospective/prospective design.

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

This is not applicable as the device is a physical surgical instrument, not an AI/ML system requiring expert-adjudicated ground truth for software performance evaluation. The "ground truth" would relate to engineering specifications and clinical outcomes, likely assessed through standard medical device testing and clinical review, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set:

This is not applicable for the reasons stated above.

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

This is not applicable as the device is a physical surgical instrument, not an AI/ML system intended to assist human readers with interpretation.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

This is not applicable as the device is a physical surgical instrument, not a standalone algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this medical device submission would be based on engineering specifications and potentially clinical outcomes reported in existing literature or previous predicate device data, rather than expert consensus, pathology, or outcomes data specifically generated for a new AI model's ground truth. The primary basis for approval is substantial equivalence to a legally marketed predicate device.

8. Sample Size for the Training Set:

This is not applicable as the device is a physical surgical instrument and does not involve an AI/ML training set.

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

This is not applicable as the device is a physical surgical instrument and does not involve an AI/ML training set.

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The MicroFlow Spacer (Frontal) is indicated for use as a postoperative spacer to maintain an opening to the frontal sinuses within the first 14 days following surgery. The MicroFlow Spacer also helps to prevent obstruction.

The Frontal Sinus Spacer is a device that maintains an opening at the frontal sinus for up to 14 days postoperatively. The subject device can be manually removed during an office follow-up visit at any time.

The provided document is a 510(k) summary for the Acclarent Relieva Stratus MicroFlow Spacer. However, it does not contain the detailed performance data or study information required to answer your specific questions about acceptance criteria and study design.

The document states:

• "The Frontal Sinus Spacer met all performance acceptance criteria."
• "The Frontal Sinus Spacer is substantially equivalent to the predicate device as confirmed through relevant performance tests."

This indicates that internal performance testing was conducted, and the device met the pre-defined criteria. However, the summary does not provide the actual acceptance criteria, the reported device performance metrics, or any details about the study design (e.g., sample size, ground truth, expert qualifications, adjudication methods, or a multi-reader multi-case comparative effectiveness study).

Therefore, I cannot populate the table or provide specific answers to questions 2 through 9 based solely on the provided text. To get that information, you would typically need to consult a more detailed document, such as the full 510(k) submission or a dedicated performance study report, which are not included here.

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The Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the nasal sinuses within the first 14 days following surgery. The Sinus Spacer also helps to prevent obstructions.

The Sinus Spacer is a device that maintains an opening at the intended sinus not to exceed 14 days postoperatively. The subject device can be manually removed during an office follow-up visit at any time.

The provided document is a 510(k) Summary for a medical device called "Sinus Spacer". It is a regulatory submission to the FDA, and as such, it does not contain the detailed study information typically associated with establishing acceptance criteria and proving device performance in a clinical or scientific study. The document states in a general manner that "The Sinus Spacer met all performance acceptance criteria" and "The Sinus Spacer is substantially equivalent to the predicate devices as confirmed through relevant performance tests."

However, it does not provide the specific acceptance criteria, the detailed results from a study, or the methodology to fulfill the request. The 510(k) summary focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed independent clinical study with specific performance metrics.

Therefore, many of the requested fields cannot be filled based on the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in the document.
• Reported Device Performance: Not explicitly stated with quantifiable metrics. The document only states: "The Sinus Spacer met all performance acceptance criteria."

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

• Sample Size for Test Set: Not mentioned.
• Data Provenance: Not mentioned.

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 as no such test set or ground truth establishment is described for a clinical study.

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

• Not applicable as no such test set or adjudication is described.

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 physical "Sinus Spacer" and not an AI or imaging diagnostic tool that would typically involve human readers.

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

• Not applicable. This device is a physical "Sinus Spacer" and not an algorithm.

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

• Not applicable as no ground truth is described for a clinical study on this device. Performance tests mentioned are likely engineering/bench tests related to material properties, retention mechanism, etc., rather than clinical outcomes with a ground truth.

8. The sample size for the training set

• Not applicable as this is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable as this is a physical medical device, not a machine learning model requiring a training set.

Summary Table (based on available information):

Study Context:
The document is a 510(k) premarket notification for regulatory clearance. For devices classified as Class I exempt that are substantially equivalent to existing predicates, the FDA often relies on bench testing, material characterization, and comparison to predicate devices, rather than extensive clinical efficacy studies with human subjects that establish "ground truth" in the way an AI diagnostic device would. The "performance data" mentioned would typically refer to non-clinical tests (e.g., biocompatibility, sterilization validation, mechanical strength, retention capability in an in vitro model).

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Relieva Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

Relieva Acella Sinus Balloon Catheter is an instrument intended to dilate sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures. For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.

The Relieva Sinus Balloon Catheter is a catheter designed to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.

The Relieva Acella Sinus Balloon Catheter is a catheter designed to access and to dilate the sinus ostia and paranasal spaces in adults and maxillary sinus spaces in children.

The provided FDA 510(k) summary for the Acclarent Relieva™ Sinus Balloon Catheter and Relieva Acella™ Sinus Balloon Catheter indicates that the devices met all performance acceptance criteria. However, due to the nature of this submission (a traditional 510(k) for a medical device that does not involve AI/software for diagnostic purposes), the detailed information typically associated with AI/software performance studies is not present.

Here's an analysis of what can and cannot be extracted from the document based on your request:

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

Reasoning: The document states, "The Relieva Sinus Balloon Catheter met all performance acceptance criteria. The Relieva Acella Sinus Balloon Catheter met all performance criteria." However, it does not elaborate on what those specific criteria were. This is typical for a 510(k) summary for a physical medical device. The criteria would likely involve physical performance metrics like burst pressure, inflation/deflation times, material biocompatibility, and sterilization effectiveness, rather than diagnostic accuracy metrics.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified. The document focuses on the physical device and its equivalence to predicates, not on clinical data in the way an AI diagnostic device would.

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)

• Number of Experts: Not applicable/Not specified. This device is a physical surgical instrument for dilation, not an AI device that requires expert ground truth for interpretation of medical images or data. Performance testing would likely involve engineering and clinical performance in a procedural context, not expert interpretation of outputs.
• Qualifications of Experts: Not applicable/Not specified.

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

• Adjudication Method: Not applicable/Not specified. This concept is relevant for AI image analysis where disagreements between readers need to be resolved to establish ground truth. For a physical device, performance is evaluated against engineering specifications and clinical outcomes in usability/safety studies.

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

• MRMC Study: No. This type of study is specifically designed for evaluating the impact of AI on human reader performance, which is not relevant for this physical balloon catheter device.
• Effect Size: Not applicable.

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

• Standalone Performance: Not applicable. This device is a physical instrument, not an algorithm.

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

• Type of Ground Truth: For a physical medical device like this, "ground truth" would relate to engineering specifications, material properties, and clinical outcomes (e.g., successful dilation, lack of tissue trauma, safety data) from usability/performance studies. The document does not specify the exact nature of the performance data (e.g., in-vitro bench testing, animal studies, or specific human clinical data beyond general statements of equivalence) or how "ground truth" for those outcomes was established, although it would inherently be based on direct measurement and observation rather than expert interpretation of a model's output.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not specified. This is a physical medical device, not an AI model that requires a training set.

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

• Ground Truth for Training Set: Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (balloon catheter) under Class I (Low Risk). It confirms that the device met all specified performance criteria, but the detail expected for an AI performance study (e.g., sample sizes for test/training, expert qualifications, adjudication, MRMC studies) is not present because those concepts are not relevant to this type of device submission. The submission is focused on demonstrating substantial equivalence to predicate physical devices.

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The Relieva Luma™ Sinus Illumination System is intended to provide a means to access the sinus space for diagnostic and therapeutic procedures in conjunction with other nasal and sinus products. It is also intended to illuminate within and transilluminate across nasal and sinus structures.

The Relieva Luma™ Sinus Illumination System is a flexible device that transmits light at the distal tip. The system also contains two accessories: a light cable and an adapter.

The provided text describes the Relieva Luma™ Sinus Illumination System and its 510(k) submission. However, it does not contain the detailed information necessary to answer all sections of your request regarding acceptance criteria and a definitive study proving the device meets them.

The document states: "The Relieva Luma™ Sinus Illumination System met all performance testing acceptance criteria." and "The Relieva Luma™ Sinus Illumination System is substantially equivalent to the predicate device as confirmed through relevant performance tests."

This indicates that some performance testing was conducted, and the device met its criteria, but the specifics of what those criteria were, how the tests were performed, and the results (beyond a statement of "met all criteria") are not included in the provided text.

Based on the available information, here is what can be extracted:

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

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

This information is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. This device is a manual surgical instrument, so "ground truth" would likely relate to its mechanical function, optical properties, or safety profile, rather than diagnostic accuracy established by experts.

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

This information is not provided in the document. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which isn't explicitly detailed for this device's performance testing.

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

An MRMC study is not mentioned in the document. This type of study focuses on diagnostic systems, often involving AI, which is not the primary function described for the Relieva Luma™ Sinus Illumination System. The device is a "manual surgical instrument for general use" that provides illumination and access.

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

A standalone performance evaluation (algorithm only) is not applicable as this is a physical medical device, not an AI algorithm.

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

This information is not provided in the document. For a physical device like this, "ground truth" would likely relate to objective measurements of its physical and optical characteristics (e.g., light output, flexibility, durability, biocompatibility), rather than diagnostic "ground truth" derived from expert consensus or pathology.

8. The sample size for the training set

This information is not applicable as this is a physical medical device, not an AI algorithm requiring a training set.

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

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

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The Ethmoid Sinus Spacer is indicated for use as a postoperative spacer to maintain an opening to the ethmoid sinus within the first 14 days following surgery. The Ethmoid Sinus Spacer also helps to prevent obstruction.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input. The document is solely a regulatory approval notice.

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The Sinus Guide Adapter and Calibration Device are intended to provide a means to access the sinus space for diagnostic and therapeutic procedures.

The Sinus Guide Adapter is used to hold the Sinus Guide Catheter and the InstaTrak Receiver. The Sinus Guide Adapter is used in conjunction with a Calibration Device that is compatible with the InstaTrak Navigation system. The Calibration Device is used to calibrate the tip position and the trajectory line of the Sinus Guide Catheter. Once calibrated, the Calibration Device is removed.

The Acclarent ReliENT™ Navigation Device is an accessory to the Sinus Guide Catheter, enabling navigation capability for diagnostic and therapeutic procedures in the sinus space.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "The Sinus Guide Catheter when accessorized with the Sinus Guide Adapter and Calibration Device met all performance testing acceptance criteria." However, specific quantitative acceptance criteria (e.g., accuracy thresholds, precision targets) and their corresponding reported device performance values are not detailed in the provided text. The submission focuses on substantial equivalence based on meeting all general performance criteria.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It broadly refers to "performance testing" being conducted.

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

The document does not provide information about the number of experts, their qualifications, or how ground truth was established for the specific performance tests.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. No effect size of human readers improving with AI vs. without AI assistance is provided, as this device does not appear to involve AI.

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

This device is not an AI algorithm but a physical accessory for a navigation system. Therefore, a standalone algorithm-only performance study would not be applicable. The performance testing would relate to the physical and functional aspects of the adapter and calibration device.

7. The Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for performance testing. Given the nature of a navigation device accessory, the ground truth would likely involve physical measurements and system accuracy assessments against known standards or reference points. It would not typically involve expert consensus, pathology, or outcomes data in the same way an image analysis algorithm would.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable as this is a physical medical device (an accessory for a navigation system), not an AI/ML algorithm.

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

As this is not an AI/ML algorithm, there is no training set or ground truth establishment relevant to AI model training.

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Intended for use as a postoperative stent to maintain an opening to the sphenoid sinus, during the first 14 days following surgery and helps prevent obstruction by adhesions.

Sphenoid Sinus Stent

This document is a 510(k) clearance letter from the FDA for the Micromedics Sphenoid Sinus Stent. It primarily establishes substantial equivalence to a predicate device and outlines regulatory compliance requirements. It does not contain the acceptance criteria, study details, or performance data asked for in the prompt.

Therefore, an answer fulfilling all requirements of the prompt cannot be generated from the provided text. The document acts as a regulatory approval, not a scientific study report.

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The Frontal Sinus Trephination Cannula is indicated for patients with sinus disease that require frontal sinus irrigation or repeated frontal sinus irrigation for up to thirty days.

The device consists of a cannula and an occlusion plug.

This medical device submission for the "Frontal Sinus Trephination Cannula" is a 510(k) premarket notification, which establishes substantial equivalence to existing predicate devices rather than proving safety and effectiveness through clinical trials with acceptance criteria. As such, the provided text does not contain any information about:

• Acceptance criteria or reported device performance
• Sample sizes or data provenance for test sets
• Number or qualifications of experts for ground truth
• Adjudication methods
• MRMC comparative effectiveness studies
• Standalone algorithm performance
• Type of ground truth used
• Sample size or ground truth establishment for training sets

The document focuses on:

1. Device Description: It details the device (cannula and occlusion plug).
2. Intended Use: Specifies its indication for frontal sinus irrigation for up to thirty days.
3. Substantial Equivalence (Predicate Devices): It identifies two predicate devices:
   • Medtronic Xomed Frontal Sinus Mini-Trephine Set irrigation cannula (for the trephination aspect).
   • Vansonnenberg Chest Drainage Tubes (K925176) and common peritoneal catheters (for the short-term indwelling aspect as an introduction/drainage catheter).
   • Bard Medical's Catheter Plug (for the occlusion plug).
4. Regulatory Classification: States the device's classification as Class I with specific product codes (77KBF, 79GBX).
5. FDA Clearance Letter: The letter from the FDA confirms substantial equivalence to legally marketed predicate devices and permits the device to be marketed, subject to general controls.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria, study details, and performance metrics because this type of information is not typically part of a 510(k) submission focused on substantial equivalence for a Class I device.

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