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510(k) Data Aggregation
(280 days)
For patients aged 18 and older, the Relieva Seeker Balloon Sinuplasty System is intended to provide a means to access the frontal sinus space and to dilate the frontal recess, frontal sinus ostia and spaces within the frontal sinus cavity for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.
The Relieva Seeker Balloon Sinuplasty System (Seeker) is an integrated device with a low-profile rail, balloon catheter, sinus illumination system with an illuminated ball tip, and a handle. The sinus balloon may be inflated to dilate the frontal recess, frontal sinus ostia, and spaces within the frontal sinus cavity.
Here's a summary of the acceptance criteria and study information for the Relieva Seeker Balloon Sinuplasty System based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Dimensional attributes (e.g., precise measurements, fits as intended) | Met all acceptance criteria for dimensional attributes. |
| Cycle fatigue (e.g., withstands repeated stress without failure) | Met all acceptance criteria for cycle fatigue. | |
| Balloon burst (e.g., ability of balloon to withstand specified pressure without bursting prematurely) | Met all acceptance criteria for balloon burst. | |
| Bond separation (e.g., strength of connections between components) | Met all acceptance criteria for bond separation. | |
| Biocompatibility | Compatibility with biological systems (e.g., non-toxic, non-irritating) | Testing showed that the Seeker Balloon Sinuplasty System is biocompatible. |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 (e.g., less than 1 in a million chance of non-sterile product) | Achieved by ethylene oxide, validated according to AAMI/ANSI/ISO 11135-1: 2007 (overkill/half-cycle approach). Demonstrated a sterility assurance level of 10^-6. Ethylene oxide residuals met ISO 10993-7:2008 requirements. (Note: Device not tested or labeled as "non-pyrogenic"). |
| Packaging & Shelf Life | Maintenance of sterility and device integrity over time and during transport (e.g., protection from damage, degradation) | Established per ASTM F1980-07, ISTA 2A:2011, ASTM F88-09, ASTM F2096-11, F1886, and F1929-98 requirements. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only details bench testing for performance data. It does not elaborate on a specific "test set" in the context of clinical or image-based diagnostic studies. The performance data is derived from:
- Bench testing: In vitro laboratory tests on the device materials and components.
- Biocompatibility testing: Laboratory tests on the materials.
- Sterilization validation: Laboratory tests to confirm a sterility assurance level.
- Packaging shelf life tests: Laboratory tests to simulate transport and storage conditions.
Therefore, there isn't a "sample size for the test set" or "data provenance" (country of origin, retrospective/prospective) in the sense of patient data because clinical data were not found necessary for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As clinical data was not required, there was no need for experts to establish ground truth for a clinical or diagnostic test set.
4. Adjudication Method for the Test Set
Not applicable. No clinical or diagnostic test set requiring adjudication was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "Clinical data were not necessary for the Seeker Balloon Sinuplasty System."
6. Standalone Performance Study
Yes, in a way. The "performance data" described (bench testing, biocompatibility, sterilization, packaging) represents the "standalone" performance of the device itself, separate from human interaction in a diagnostic or interpretive context. However, it's not a standalone algorithm performance in the context of AI, as this is a physical medical device.
7. Type of Ground Truth Used
The "ground truth" for the performance data (as opposed to a diagnostic ground truth) was established by:
- Engineering specifications and industry standards: For dimensional attributes, cycle fatigue, balloon burst, bond separation.
- Biomedical testing standards: For biocompatibility.
- Standardized sterilization protocols and verification methods: For sterilization efficacy and residuals.
- Industry packaging and aging standards: For packaging shelf life.
8. Sample Size for the Training Set
Not applicable. This device is a physical medical instrument, not an AI/machine learning algorithm requiring a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI algorithm, there is no ground truth to establish for it.
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(139 days)
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 adults 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 prior to each use. The PathAssist Light Seeker comes with two standard light post adapters, which allow the device to be compatible with commonly used 2.5mm light guides (cables).
The Entellus Medical PathAssist Light Seeker is a manual surgical instrument intended to locate, illuminate within, and transilluminate across nasal and sinus structures in adults. The device demonstrated substantial equivalence to predicate devices through various performance tests.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The submission primarily focuses on establishing "substantial equivalence" to predicate devices, rather than defining specific numerical acceptance criteria for performance metrics that would be applicable to a diagnostic or AI-driven device. The "performance data" section details the types of testing performed to confirm the device's design specifications and intended function.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Technological Equivalence (Principle of Operation, Design, Function, Materials, Biocompatibility, Reusability, Reprocessing) to predicate devices [Sinus Seekers, 510(k) exempt] and/or [Relieva Luma Sinus Illumination System, K071845]. | Met: The subject device and predicate device [Sinus Seekers, 510(k) exempt] are both shaped like a sinus seeker, advanced under endoscopic visualization, made of stainless steel, non-sterile, reusable, and require cleaning/sterilization. Both are biocompatible per ISO 10993-1. The subject device and predicate device [Relieva Luma Sinus Illumination System, K071845] both transmit light from proximal to distal tip via light fibers, can be connected to a standard light source via a light cable and adapter, and are biocompatible per ISO 10993-1. Performance testing validated that the device meets design specifications and performs as intended. |
| Biocompatibility | Met: Biocompatibility testing was performed, and the device is biocompatible per ISO 10993-1. |
| Design Verification (Dimensional and Functional Testing) | Met: Design verification testing, including dimensional and functional testing, was performed to support the useful life of the device. |
| Simulated Use Design Validation | Met: Simulated use design validation testing was performed in a cadaver model. |
| Sterilization Efficacy | Met: Steam sterilization testing was conducted. The device is labeled non-sterile and must be cleaned and sterilized prior to each use. Cleaning validation testing performed on device [K102366] was referenced. |
| Compatibility with Light Guides | Met: Compatibility testing confirmed the device's ability to connect to commonly used 2.5mm light guides (cables) via two standard light post adapters. |
| Storage and Transportation Stability | Met: Storage and transportation testing was performed. |
2. Sample size used for the test set and the data provenance
The submission refers to "simulated use design validation testing in a cadaver model." However, it does not specify the sample size (number of cadavers) used for this test set.
The data provenance is from simulated use testing in a cadaver model, which would be considered prospective in the context of device validation. The country of origin of the data is not specified, but given the submitter's location (Maple Grove, MN, USA), it's likely from the US.
It's important to note that no animal or clinical data were submitted. This is typical for Class I devices seeking substantial equivalence where non-clinical testing is deemed sufficient.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide details on the number of experts used or their specific qualifications for evaluating the cadaver model testing. Given the nature of this type of testing (design validation for a manual surgical instrument), it would typically involve experienced surgical professionals or engineers assessing the device's function and performance within the cadaveric anatomy. However, this information is not explicitly stated.
4. Adjudication method for the test set
The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for the cadaver model testing. For this type of design validation, observations and assessments are usually made by the testing personnel, and consensus would be implied if multiple individuals were involved, but a formal adjudication process is not 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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a manual surgical instrument for illumination and transillumination, not an AI-driven or diagnostic imaging tool. Therefore, the concept of human readers improving with or without AI assistance is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone (algorithm only) performance study was not done. The PathAssist Light Seeker is a physical, manually operated device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "simulated use design validation testing in a cadaver model," the "ground truth" would implicitly be the anatomical structures within the cadaver and the observed functionality of the device (its ability to locate, illuminate, and transilluminate as intended) as assessed by the testing personnel. This is a form of direct observation and functional assessment rather than a diagnostic 'ground truth' like pathology or expert consensus on image interpretation.
8. The sample size for the training set
Not applicable. This device is a manual surgical instrument and does not involve machine learning or an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As a manual surgical instrument, there is no training set or machine learning algorithm for which ground truth would be established.
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