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TurbAlign is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with sinus surgery (e.g., endoscopic sinus surgery, FESS). The implant provides short-term fixation of the middle turbinate to the nasal septum and thus minimizes the risk of adherence to the lateral nasal wall.

TurbAlign™ is a bioabsorbable, polydioxanone implant designed to hold the middle turbinate away from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. The implant includes self-anchoring features (e.g., one "distal anchor" and multiple "proximal anchors") which enable attachment to the middle turbinates for short-term fixation of the middle turbinate to the nasal septum.

TurbAlign includes an attached surgical needle which is inserted into the lateral aspect of the middle turbinate. It is then passed through the nasal septum and then through the contralateral middle turbinate. The implant is then pulled through all three structures until the distal anchor feature is embedded in the first middle turbinate at which time the turbinate is medialized to the septum. The contralateral turbinate is then medialized to the opposite side of the septum using a freer or equivalent and held into place via the proximal anchor. The excess portion of the implant is trimmed off.

The sterile, single-use implant is delivered using standard surgical instruments, such as needle drivers. The implant provides temporary fixation and is fully resorbed over 180 days.

This document is a 510(k) Pre-market Notification for a medical device called TurbAlign. It does not describe a study based on analyzing medical images or clinical data for AI/ML device approval. Instead, it describes hardware device attributes and physical performance tests.

Therefore, the requested information regarding acceptance criteria, reported performance for an AI/ML device, sample size for test/training sets, experts, adjudication methods, MRMC studies, or specific types of ground truth cannot be extracted from this document, as it pertains to a different type of medical device submission.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for an intranasal splint based on:

1. Biocompatibility Testing: Ensuring the materials are safe for human contact.
2. Distribution, Packaging, and Shelf-Life Testing: Verifying sterile barrier integrity and device performance over time.
3. Performance Testing – Bench: Evaluating mechanical integrity, anchoring features, and usability by ENT physicians in cadaver specimens.

The closest this document comes to "performance criteria" is the statement that "Mechanical integrity testing of the implant and needle properties was performed and demonstrated that the physical and functional requirements were met" and "Comparative testing... demonstrated equivalent performance of the device's anchoring features in the relevant tissue." For usability, it states that "the physicians graded the turbinate position post-TurbAlign placement and confirmed both turbinates were medialized and did not contact the lateral wall." However, these are not quantitative acceptance criteria in the format requested for an AI/ML study.

Summary of missing information for an AI/ML device:

• Table of acceptance criteria and reported device performance: Not applicable; no AI/ML performance metrics are mentioned.
• Sample size for test set and data provenance: No test set of data (images, etc.) is mentioned.
• Number of experts and qualifications: Experts (ENT physicians) were used for usability testing of the physical implant in cadavers, not for establishing ground truth on a data set.
• Adjudication method: Not applicable.
• Multi Read Multi Case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm-only) performance: Not applicable; this is a physical device.
• Type of ground truth used: Not applicable for an AI/ML context. The closest is the physical observation of turbinate medialization by physicians in cadavers.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

This 510(k) pertains to a traditional, non-AI medical device.

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SeptAlign is used to support and straighten minor deviations in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

The Spirair SeptAlign implant is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. SeptAlign is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. SeptAlign is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle to enable attachment to the tissue which is trimmed off affer use. SeptAlignis provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.

The SeptAlign implantis provided preloaded into a disposable delivery tool comprised of a non-patient contacting handle assembly and a medical grade stainless steel delivery cannula and trocar. The delivery tool enables placement of the distal portion of the implant in a minimally invasive manner. The SeptAlign implant and accessory delivery tool are provided sterile and are intended for single-use only.

I am sorry, but the provided text from the FDA 510(k) notification for the SeptAlign device does not specify acceptance criteria for device performance or describe a study that proves the device meets such criteria in terms of accuracy, sensitivity, or specificity for any diagnostic or prognostic task.

The document primarily focuses on the device's mechanical and material performance, biocompatibility, packaging, and shelf-life. It states that "No animal or clinical performance testing was required to support substantial equivalence." This indicates that the substantial equivalence determination for this device (SeptAlign) was not based on clinical performance studies measuring diagnostic accuracy or reader improvement.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance related to diagnostic/prognostic metrics.
2. Sample size, data provenance, expert ground truth establishment, adjudication, MRMC studies, standalone performance, or ground truth types. These are typically associated with studies evaluating AI/diagnostic device performance, which were not required or reported for this submission.

The "Performance Data" section (Pages 4-5) lists the following performance elements:

• Biocompatibility Testing: Confirms materials do not pose a risk of negative interaction. This is about safety, not diagnostic performance.
• Distribution, Packaging and Shelf-Life Testing: Demonstrates integrity of sterile barrier and preservation of performance, related to product stability and safety.
• Performance Testing – Bench: Focuses on the accessory delivery tool's functionality, mechanical integrity, and cannula joint strength. This is about the physical device and its delivery mechanism working as intended, not its ability to detect or diagnose anything.

The acceptance criteria implicitly met are related to these physical and material properties (e.g., passing biocompatibility tests, maintaining sterility, successful mechanical deployment).

In summary, the provided document does not contain the type of information needed to answer your questions regarding acceptance criteria for diagnostic performance or studies proving such performance, as the device is a physical implant (a bioabsorbable ribbon) rather than a diagnostic or AI-powered device.

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The Spirair Nasal Septal Strap is used to support and straighten in septal cartilage when sufficient healthy cartilage exists, and the cartilage is appropriately mobilized utilizing standard septoplasty techniques.

The Spirair Nasal Septal Strap is a bioabsorbable, polydioxanone ribbon that is intended to be used in nasal surgery. The Nasal Septal Strap is 190 mm long and 0.65 mm thick with barbed features ("anchors") which enable attachment to and support of nasal septal cartilage. The Nasal Septal Strap is trimmed to size by the physician to suit the anatomical conditions and clinical use case. The device includes a surgical needle attachment to the tissue which is trimmed off after use. The Nasal Septal Strap is provided sterile as a single use device and when permanently implanted, is resorbed within a 6-month period.

This document is a 510(k) summary for the Spirair Nasal Septal Strap, detailing its regulatory review and substantial equivalence to a predicate device. It primarily focuses on the device's technological characteristics, indications for use, and performance data required for regulatory clearance. It does not describe a study that proves a device meets specific acceptance criteria in the context of an AI/ML medical device, as the Spirair Nasal Septal Strap is a physical medical device.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance as it pertains to an AI/ML medical device, because the provided text is for a physical medical device and lacks any mention of AI, algorithms, or complex performance metrics typical of AI/ML systems.

The document discusses performance data related to:

• Biocompatibility Testing: According to ISO 10993-1 and FDA Guidance, assessing cytotoxicity, sensitization, irritation, implantation, and chemical characterization.
• Distribution, Packaging, and Shelf-Life Testing: Successful completion of accelerated aging and integrity of sterile barrier.
• Performance Testing - Bench: Demonstrating physical and functional requirements, including mechanical properties, material properties, migration of implant, and in vitro degradation.
• Performance Testing - Animal: A GLP animal study for safety, degradation, and biocompatibility.
• Performance Testing - Clinical: Interim safety data from a prospective, multi-center, multi-cohort, early feasibility clinical study in the US.

These tests are designed to demonstrate the safety and effectiveness of a physical implantable device, not an AI/ML algorithm.

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