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The MediENT® Middle Turbinate Implant is intended to separate the middle turbinate from the lateral nasal wall during the clinically relevant healing phase associated with nasal/sinus surgery. 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.

The MediENT® Middle Turbinate Implant is a tack made of an absorbable copolymer that is designed to hold the middle turbinate away from the lateral nasal wall. The sterile, single-use implant is delivered using standard surqical instruments, such as Alligator grasper, Pediatric Blakesly, MediENT® Grasper or similar. The implant provides temporary fixation and can be expected to start degrading approximately 2 to 3 months post-implantation. The MediENT® Middle Turbinate Implant is packaged and provided sterile for single use only.

Acceptance Criteria and Device Performance for MediENT® Middle Turbinate Implant (K130354)

The MediENT® Middle Turbinate Implant is intended to provide temporary fixation of the middle turbinate to the nasal septum to separate it from the lateral nasal wall during the post-surgical healing phase, thereby minimizing the risk of adherence (synechia) and lateralization. The device's performance was evaluated through a clinical study against a predicate device, MeroPack™.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria (e.g., "Synechia rate must be less than X%"). Instead, the acceptance criterion for substantial equivalence was qualitative: to demonstrate that the MediENT® device is "as good as" the predicate device, MeroPack™, in preventing synechia and lateralization of the middle turbinate, and that its placement and implantation are safe.

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

• Sample Size: 60 patients.
• Data Provenance: Prospective, randomized, multi-center randomized trial conducted at five U.S. centers.

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

• The summary mentions that "synechia was evaluated by a blinded reviewer." It does not specify the exact number of experts (it implies one primary blinded reviewer) or their qualifications (e.g., radiologist, ENT surgeon, experience level).

4. Adjudication Method for the Test Set

• The summary states that "synechia was evaluated by a blinded reviewer." This suggests a single blinded reviewer for this particular outcome. There is no mention of an adjudication method like 2+1 or 3+1, which implies that a consensus process involving multiple reviewers was not explicitly used for the final determination of synechia in the clinical trial description. Other elements like edema and infection were "endoscopically examined to rate" by unspecified personnel.

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 done in the context of comparing human readers' performance with and without AI assistance. This device is an implantable medical device, not an AI-powered diagnostic or assistive tool for human interpretation.

6. If a Standalone Performance Study Was Done

• Yes, a standalone clinical performance study was done for the MediENT® device, but it was a comparative effectiveness study against a predicate device, not a "standalone" in the sense of an algorithm-only review for AI systems. The device itself (the implant) was evaluated directly in human subjects, functioning as intended without constant human intervention after placement.

7. The Type of Ground Truth Used

• The ground truth for the clinical study was based on clinical observation and assessment by a "blinded reviewer," specifically for synechia, and also included endoscopic examination for edema and infection, as well as turbinate position. This is a form of expert clinical assessment serving as the reference standard.

8. The Sample Size for the Training Set

• This question is not applicable in the context of this traditional medical device submission. The MediENT® Middle Turbinate Implant is a physical implant, not a software algorithm or AI model that requires a "training set" in the machine learning sense. The "training" for such a device would involve bench testing, cadaveric studies, and usability testing, all focused on its physical and mechanical properties and surgical delivery.

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

• As mentioned above, this question is not applicable. For a physical device, the "ground truth" during development (analogous to training) would be established through engineering specifications, biomechanical testing standards, and preclinical feedback from surgeons on usability and performance in cadaveric models. These activities are designed to optimize the device design to meet performance requirements rather than to train an algorithm.

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The ENTrigue® Sinus Dilation System is intended for use in surgical procedures to access, examine or treat the nasal and paranasal tissues leading to ostia.

The ENTrigue® Sinus Dilation System is indicated to access and treat the frontal recesses, sphenoid sinus ostia, and maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach.

The ENTrigue® Sinus Dilation System consists of a disposable balloon which is mounted on a reusable delivery instrument to allow for dilation of sinus ostia in the paranasal cavity under endoscopic quidance. The Sinus Balloon components include a balloon sleeve to slide over the tip of the delivery instrument, a connecting collar to latch the balloon sleeve to the delivery instrument, and an inflation line to connect to the balloon inflation device. The features of this device enable a physician to quide the device to the sinus ostium using endoscopic visualization.

The ENTrigue® Sinus Balloon Dilation Balloon and inflation device are individually packaged and provided sterile for single use only. The delivery instrument is a reusable instrument which must be sterilized prior to use following the recommended and validated cleaning and sterilizing procedures.

The provided text describes a 510(k) submission for the ENTrigue® Sinus Dilation System, focusing on its substantial equivalence to a predicate device. The information available pertains to the device's technical characteristics and the claim of equivalence, rather than a detailed clinical study with specific acceptance criteria and performance metrics typically found in efficacy trials.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not detail specific quantitative acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy) for the ENTrigue® Sinus Dilation System in a typical clinical study format. Instead, it focuses on demonstrating substantial equivalence to a predicate device, the Entellus Medical, Inc. XprESS™ Multi-Sinus Dilation Tool.

The primary "acceptance criterion" in this context is that the ENTrigue® Sinus Dilation System is "as safe and effective" as the predicate device. The performance data presented are qualitative and based on comparing technological characteristics and intended use.

Acceptance Criteria (Implicit for Substantial Equivalence):

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

• Sample Size: The document mentions "Bench and cadaveric testing, featuring multiple users." It does not specify the exact number of cadavers or the number of components tested for bench testing. It also doesn't specify the number of "users" (presumably surgeons) involved.
• Data Provenance: The provenance (e.g., country of origin, retrospective/prospective) is not specified. It is likely prospective testing specifically conducted for this 510(k) submission, given the nature of bench and cadaveric studies.

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

• The document refers to "multiple users" for the cadaveric testing. It does not specify the number or qualifications of these users/experts. It can be inferred that these would be medical professionals (e.g., ENT surgeons) experienced in sinus dilation procedures, as the testing was to validate "user requirements."

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method. The testing appears to be functional validation and comparison, rather than a scenario requiring multiple expert opinions for ground truth establishment. The focus is on the device's operational performance.

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

• No, an MRMC comparative effectiveness study was not done as described in the provided text. The submission focuses on substantial equivalence through bench and cadaveric testing, not a clinical trial comparing human reader performance with and without AI assistance. This device is a surgical instrument, not an AI diagnostic tool.

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

• This question is not applicable as the ENTrigue® Sinus Dilation System is a physical surgical instrument, not an algorithm or AI system. Its performance is inherently "standalone" in the sense that it is the device itself being evaluated for its physical function, guided by a human surgeon.

7. The Type of Ground Truth Used:

• For the bench testing, the "ground truth" would be engineering specifications and expected functional performance.
• For the cadaveric testing, the "ground truth" would be the successful and safe execution of the intended surgical procedures (e.g., successful dilation of ostia as observed by the "multiple users" for meeting "user requirements"), demonstrating physical interaction with anatomical structures. This is essentially expert observation and assessment of procedural success and device functionality in a simulated environment.

8. The Sample Size for the Training Set:

• This question is not applicable. The ENTrigue® Sinus Dilation System is a physical surgical instrument and does not involve a "training set" in the context of machine learning or AI models. This type of device is developed and validated through engineering design, material science, and functional testing, not through data-driven training.

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

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

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The ENTact™ Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissues during nasal septal surgery.

The ENTact™ Septal Stapler consists of resorbable fixation devices, which are delivered via an manual surgical stapler delivery system. The ENTact™ implantable septal staples, composed of an absorbable copolymer, may be used during nasal surgery to approximate the mucoperichondrial flaps of the nasal septum and at the completion of surgery. The staples are provided preloaded in a single-use, disposable stapler.

I am sorry, but the provided text does not contain specific information about acceptance criteria or a study proving that the device meets such criteria. The document is a 510(k) summary for the ENTact™ Septal Stapler, detailing its classification, predicate devices, description, and indications for use. It also includes the FDA's letter of substantial equivalence determination.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information based on the given text.

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BioElast™ 5-0 absorbable sutures are indicated for use in general soft tissue approximation and/or ligation, but not for use in cardiovascular or neurological tissues, microsurgery or ophthalmic surgery.

BioElast™ 5-0 Suture is a sterile, monofilament, absorbable surgical suture composed of poly-4-hydroxybutyrate. The BioElast™ 5-0 Sutures will be provided undyed at a 5-0 size.

The provided text describes a 510(k) summary for the BioElast™ 5-0 Suture. It details the device, its indications for use, and a general statement about safety and performance, but it does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in a quantitative sense.

Specifically, the document states: "Results of bench and in-vivo testing demonstrate that the BioElast™ 5-0 Suture is biocompatible and substantially equivalent in function to the predicate devices."

This statement indicates that testing was performed and that the device was found substantially equivalent to predicate devices (Tepha, Inc., TephaFLEX® Absorbable Suture and Ethicon, Inc., PDS*II). However, it does not provide:

1. A specific table of acceptance criteria and reported device performance. The document only gives a general statement of meeting certain benchmarks through substantial equivalence.
2. Details about sample sizes for test sets or data provenance.
3. Information on experts used to establish ground truth.
4. Adjudication methods.
5. Information about Multi-Reader Multi-Case (MRMC) comparative effectiveness studies. This is typically for AI-powered diagnostic devices, not sutures.
6. Information about standalone algorithm performance. Again, this is for AI-powered diagnostic devices.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

Given the nature of the device (a surgical suture) and the context of a 510(k) summary for a Class II medical device, the "acceptance criteria" here are generally implied by the regulatory standard of substantial equivalence to existing legally marketed predicate devices. This means that the new device performs as intended and is as safe and effective as the predicate devices, based on comparative bench and in-vivo testing.

Therefore, I cannot populate the requested table and detailed information as the provided text does not contain that level of detail for a medical device study typical of AI/diagnostic tools.

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