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PosiSep® X BAM Hemostat Dressing/Intranasal Splint is indicated for use in patients undergoing nasal/sinus surgery as a space occupying hemostat/splint to:

• Separate tissue or structures compromised by surgical trauma;
• Separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity;
• Help control minimal bleeding following surgery or trauma;
• Help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and
• Act as an adjunct to aid in the natural healing process

PosiSep® X BAM is indicated for use as a nasal hemostat to treat epistaxis. PosiSep® X BAM is intended for use under the direction of a licensed healthcare provider.

The Hemostasis PosiSep® X BAM is placed in the nasal cavity after sinus surgery to prevent adhesions, control mild bleeding, and provide a level of protection against bacteria and fungi. PosiSep X BAM is supplied as a compressed foam, and it quickly dehydrates blood, thereby causing rapid hemoconcentration of platelets, serum proteins and fibrinogen, leading to clotting that limits and controls bleeding and edema. Upon hydration, PosiSep® X BAM expands to contact and conform to the surrounding anatomy.

PosiSep X BAM is comprised of N, O-Carboxymethyl Chitosan derived from non-shell fish based Chitosan, modified Cellulose, and antimicrobial agents.

PosiSep® X BAM is fragmentable and eliminated from the site of application by natural excretion through the action of cilia.

The provided text is a 510(k) summary for a medical device called PosiSep® X BAM Hemostatic Dressing/Intranasal Splint. It describes the device, its intended use, and how its substantial equivalence to a predicate device (Hydrofera Bacteriostatic Nasal Dressing) was demonstrated. However, this is NOT a study that evaluates an AI/ML powered device, nor does it contain acceptance criteria or study results for such a device.

The information you requested (acceptance criteria table, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) are typically found in the clinical study report or performance evaluation section of an AI/ML device submission. This document does not contain any of that information.

The document describes performance bench testing for antimicrobial activity of the PosiSep® X BAM device, but this is a physical/chemical performance test of a traditional medical device, not an evaluation of an AI algorithm's diagnostic or predictive capabilities.

Therefore, I cannot provide the requested information from the given text because it is not relevant to an AI/ML device.

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NasalCEASE™ is intended to be inserted into the anterior nasal cavity to stop minor nosebleeds. It is intended to be marketed and sold as an Over-The-Counter device.

NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity.

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the format requested. The document is a 510(k) premarket notification for a medical device (NasalCEASE™), and it primarily focuses on establishing substantial equivalence to a predicate device.

Here's what can be extracted based on the provided text, and where the requested information is missing:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The overall "acceptance criteria" here is substantial equivalence to the predicate device, ENTaxis (K985069).
• Reported Device Performance:
  • "NasalCEASE™ is comprised of interwoven strands of calcium alginate and is manufactured as a sheet (2x4x0.5 cm) weighing approximately 20mg that can be rolled along its long or short axis and inserted into the anterior nasal cavity."
  • "Upon contact with blood or other physiological fluids in the nasal cavity it adsorbs those fluids and swells to apply a compressive force."
  • "Both physicians and patients were able to use the device correctly and effectively" (referring to the non-clinical testing).

Since the document is a 510(k) summary, detailed performance data against specific acceptance criteria (e.g., success rate, time to stop bleeding) is typically not included in this summary section but would have been part of the full submission.

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

• Sample Size (Test Set): Not specified. The non-clinical testing mentions "A panel of physicians used the device and provided it to patients for use at home," but no number is given for either physicians or patients.
• Data Provenance: Not explicitly stated (e.g., country of origin). It's implied to be from a clinical setting, but whether it was retrospective or prospective is not mentioned.

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. "A panel of physicians" is mentioned, but their number or specific qualifications (e.g., specialty, years of experience) are not provided.
• Qualifications of Experts: Only "physicians" is stated.

4. Adjudication method for the test set:

• Not specified. The text only says "A panel of physicians used the device and provided it to patients for use at home."

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 medical device (nasal packing), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance would not be relevant.

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

• Not applicable. This is not an algorithm-based device.

7. The type of ground truth used:

• Based on "Both physicians and patients were able to use the device correctly and effectively," the ground truth appears to be based on expert (physician) and user (patient) assessment of usability and effectiveness. This is closer to observational data or user feedback rather than a formal medical "ground truth" like pathology or clinical outcomes in a randomized controlled trial for therapeutic efficacy.

8. The sample size for the training set:

• Not applicable/Not specified. There is no mention of a "training set" in the context of this physical device. If "training set" refers to pre-market testing, it's covered by the "panel of physicians" and "patients" mentioned above, for which no sample size is given.

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

• Not applicable/Not specified. As above, no "training set" or explicit ground truth establishment method in this context. The "ground truth" for the non-clinical testing would be the real-world observation by physicians and patients regarding the device's functionality and effectiveness in stopping minor nosebleeds at home.

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The intended use of Hylasine™ is for use in nasal/sinus cavity as a space-occupying gel stent, to separate mucosal surface and to help control minimal bleeding following surgery or nasal trauma.

Hylasine™ is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. Due to its physical properties, Hylasine may be used to reduce synechiae and middle meatal stenosis. Its tamponade effect may also contribute to controlling bleeding. Hylasine leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.

Here's an analysis of the provided text regarding the Hylasine™ device's acceptance criteria and studies:

Acceptance Criteria and Device Performance (Based on Clinical Safety and Efficacy Study Summary):

Study Details:

1. Sample Size used for the test set and the data provenance:

   • Sample Size: 30 patients.
   • Data Provenance: The study was a clinical evaluation conducted at three centers. It involved comparing treatment in one sinus with no treatment in the contralateral sinus of the same patient. This indicates prospective, multi-center clinical data. The country of origin is not explicitly stated, but the submission is to the US FDA, implying data may be from the US or internationally recognized clinical trials.

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

   • The document does not explicitly state the number or qualifications of experts used to establish ground truth for the clinical study's endpoints (synechiae/adhesions, middle meatal stenosis, mucosal status, bleeding control). It only mentions that the product was judged as effective for bleeding, implying clinical assessment by the physicians involved in the study.

3. Adjudication method for the test set:

   • The document does not specify an adjudication method like 2+1 or 3+1. The results are presented as direct comparisons within each patient (treated vs. untreated contralateral sinus).

4. 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, an MRMC study was NOT done. This device is a medical product (gel stent), not an AI diagnostic or assistance system that would involve human readers interpreting images.

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

   • Not applicable. This is a medical device (gel) and not an algorithm or AI system.

6. The type of ground truth used:

   • Clinical observation and assessment. The ground truth for the clinical study outcomes (synechiae, stenosis, mucosal status, bleeding) would have been established through direct clinical examination and assessment by the treating surgeons/clinicians during the follow-up period.

7. The sample size for the training set:

   • Not applicable. This device is a physical product (gel), not a machine learning model, so there is no concept of a "training set" in the context of data used for algorithm development. The safety and performance data came from preclinical animal studies and a human clinical trial.

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

   • Not applicable. As a physical device, there is no "training set" or "ground truth" established for algorithm training. The preclinical and clinical studies provided evidence for safety and effectiveness. For the preclinical studies, ground truth for endpoints like irritation, toxicity, and implantation was established through standard laboratory and histological analyses. For the clinical study, it was clinical observation.

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POST OPERATIVE PACKING AFTER SEPTAL RHINOPLASTIC, OR TURBINATE SURGERY.

BACTERISTATIC NASAL DRESSING

I'm sorry, but this document does not contain the information requested. The document is a 510(k) clearance letter from the FDA for a device called "Hydrofera Bacteristatic Nasal Dressing." It states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

However, the letter does not include any details about acceptance criteria, device performance studies, sample sizes, data provenance, expert qualifications, ground truth establishment, or any information related to multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

This document is purely a regulatory clearance notice and does not delve into the specific technical or clinical study data that would inform such a description.

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Xomed MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.

Xomed MeroGel™ Nasal Dressing and Sinus Stent is a biomaterial composed of HYAFF®, an ester of hyaluronic acid, a natural occurring constituent of the extracellular matrix. Due to its absorption properties, MeroGel™ may be used to help control minimal bleeding. In contact with body fluids, it changes into viscous and transparent gel, conforming to mucosal surfaces and eventually dissolves or may be irrigated from the cavity.

The provided text is a 510(k) summary for the Xomed MeroGel™ Nasal Dressing and Sinus Stent. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report that quantitatively proves device performance against those criteria.

Therefore, the following information is not present in the provided text:

• A table of acceptance criteria and reported device performance.
• Sample size used for a test set and data provenance.
• Number of experts used to establish ground truth.
• Adjudication method for a test set.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study, or effect size.
• Results from a standalone (algorithm only) performance study.
• Type of ground truth used for performance validation.
• Sample size for the training set.
• How the ground truth for the training set was established.

Summary of available information related to acceptance criteria and study:

The device's "acceptance criteria" in this context are primarily defined by its intended use and demonstrating substantial equivalence to predicate devices, rather than specific performance metrics (like accuracy, sensitivity, specificity) against a clinical endpoint.

Intended Use:

• MeroGel™ Nasal Dressing and Sinus Stent is intended for use in the nasal/sinus cavities as a space-occupying dressing and/or stent, to separate mucosal surfaces and to help control minimal bleeding following surgery.

Study (Demonstration of Substantial Equivalence):

The device's acceptance is based on a comparative analysis to existing predicate devices, the Merocel® Sinus-Pak™ and Merocel® Standard Nasal Dressing. The study is a reasoned argument for substantial equivalence, not a clinical trial with specific performance metrics.

1. Acceptance Criteria & Reported Device Performance: This information is not explicitly stated in a table with performance metrics in the provided document. The "acceptance" is the FDA's marketing clearance based on substantial equivalence. The "performance" is described qualitatively:

   • Predicate Device Performance (Implied): Controls bleeding, aids in prevention of adhesions, absorbant for postop fluids.
   • MeroGel™ Performance: Similar intended use and indications; changes into a viscous and transparent gel, conforming to mucosal surfaces; eventually dissolves or may be irrigated; helps control minimal bleeding; highly absorbent.
   • Difference and Justification: The key difference is that MeroGel™ dissolves/forms a gelatinous mass and can be removed by irrigation, unlike the predicate devices which require manual removal. This difference is presented as not raising new safety or effectiveness concerns, supported by the material (HYAFF®) being biocompatible.

2. Sample size used for the test set and the data provenance: Not applicable for this type of submission. There is no "test set" in the sense of a dataset for a performance study. The comparison is conceptual, based on intended use and material properties.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in a clinical performance sense, is not established or discussed for a test set.

4. Adjudication method for the test set: Not applicable.

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 not an AI/imaging device requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: Not applicable. The "truth" in this submission is the established safety and effectiveness of the predicate devices and the biocompatibility of the new material, which infer similar performance.

8. The sample size for the training set: Not applicable. There is no "training set" for an algorithm.

9. How the ground truth for the training set was established: Not applicable.

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ENTaxis™ Nasal Packings are intended for nasal epistaxis and as post operative nasal packings. ENTaxis™ Nasal Packing is intended for - Epistaxis - · Post operative nasal packing

ENTaxis™ Nasal Packings are highly conformable, sterile, hemostatic packings designed for managing bleeding in the nasal cavity and as post operative packings. ENTaxis™ nasal packings are 12" (30cm, 2g) "ropes" that are 100% composed of pure calcium alginate fibers.

The provided text describes the 510(k) summary for the ENTaxis™ Nasal Packing device, which includes information regarding its clinical safety and efficacy study. Based on this information, here’s a summary conforming to your request:

Acceptance Criteria and Device Performance

The clinical study evaluated the ENTaxis™ Nasal Packing against conventional Merocel™ packing for post-operative use in sinus surgery, focusing on specific clinical endpoints. While specific numeric acceptance criteria (e.g., "bleeding must be reduced by X%") are not explicitly stated in a table format, the study's conclusions demonstrate superior performance of ENTaxis™ for the tested endpoints.

Table 1: Acceptance Criteria (Implied) and Reported Device Performance

Study Details

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

   • Test Set Sample Size: 50 patients (100 nasal cavities).
   • Data Provenance: The study was a multi-center, randomized, and controlled clinical study. The specific country of origin is not explicitly stated, but the submitter is Laboratoires Brothier S.A. from France, suggesting European origin for the clinical trial, or at least a multi-national one. It was a prospective clinical study comparing two different types of packings.

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

   • The document refers to the study by R. Peynegre, P. Bonfils, L. Castillo, et al. from 1998, conducted in "five ENT surgery departments." This implies multiple clinicians were involved in the assessments. However, the exact number of experts establishing ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience") are not detailed in the provided text. Assessments were made by clinical personnel within the ENT surgery departments.

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

   • The text states, "Every patient served as their own control by being treated with both test products." This indicates a paired-comparison or within-subject design where individual patient outcomes for ENTaxis™ were compared against their own outcomes for Merocel™. Different assessments were made by clinicians during surgery, on Day 2 (epistaxis and pain on removal), and on Day 9 (quality-of-healing). There is no explicit mention of an adjudication panel or method like 2+1/3+1 consensus for resolving discrepancies in assessments.

4. 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, this was not an MRMC comparative effectiveness study involving AI or human readers. This study evaluated two medical devices (nasal packings) directly through patient outcomes after surgical procedures, not the diagnostic performance of human readers with or without AI assistance.

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

   • No. This study is a clinical trial evaluating the performance of a physical medical device (nasal packing) in human patients, not an algorithm, and thus standalone performance in an AI context is not applicable.

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

   • The ground truth was based on clinical outcomes data directly observed and assessed by medical professionals during and after sinus surgery. This includes objective measures (degree of bleeding) and subjective patient experiences (pain on removal), as well as clinical inspection of healing by ENT specialists.

7. The sample size for the training set:

   • There is no mention of a "training set" in the context of this device study, as this is a physical medical device and not an AI or machine learning algorithm.

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

   • Not applicable, as there was no training set for an algorithm.

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The treatment of simple anterior (front) nosebleeds by application of a noseclip to the external nose in adults and children. Not for use on infants.

Existing respiratory noseclip is to be used to treat simple anterior (front) nosebleeds.

I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) submission and FDA clearance letter for a nosebleed noseclip. It discusses the device's intended use, classification, and substantial equivalence to predicate devices, but it does not detail specific performance metrics, study designs, or data to demonstrate "acceptance criteria" other than regulatory compliance.

Therefore, I cannot provide the requested table or answer the questions regarding sample size, ground truth, expert qualifications, adjudication methods, or comparative effectiveness studies based on the input text.

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The catheter is designed to aid in controlling nasal hemorrhage due to trauma from injury. The device may r he baneler is a postoperative nasal packing following various intranasal surgical procedures, including septoplasty and rhinoplasty procedures.

Disposable Sillicone Epistaxis Catheter

I am sorry, but without further information about the device and its performance, I cannot provide a detailed answer to your request. The provided text is a letter from the FDA regarding a 510(k) premarket notification for a "Disposable Silicone Epistaxis Catheter." It confirms the device's substantial equivalence to a predicate device and its regulatory classification. However, it does not contain any information about:

• Acceptance criteria for performance.
• Reported device performance data.
• Study details (sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth type, training set details).

To answer your request, I would need a different document, such as a summary of safety and effectiveness, a clinical study report, or a 510(k) summary that includes performance data and study design.

If you can provide a document that contains this information, I would be happy to help you extract and present it according to your requested format.

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The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions.

Not Found

Based on the provided documents, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria with the requested level of detail.

The documents are a 510(k) clearance letter and an "Indications For Use" statement for the "Ultracell Packing with Sleeve (Nasal Pack)". This type of submission (510(k)) is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through detailed performance studies with ground truth establishment, expert adjudication, or MRMC studies.

The provided information indicates:

1. Device: Ultracell Packing with Sleeve (Nasal Pack)
2. Regulatory Class: I (21 CFR 874.4100/Procode: EMX) - Devices in this class generally have lower risk and often do not require extensive clinical or performance studies for 510(k) clearance if their technological characteristics and indications for use are similar to predicate devices.
3. Indications For Use: "The device is used during surgery to protect tissue from trauma, absorb fluids and to act as a barrier against adhesions."
4. Nature of Clearance: Substantial Equivalence to a predicate device marketed prior to May 28, 1976. This means the FDA determined the device is as safe and effective as a legally marketed device, not that it met specific quantitative performance metrics from a formal study as would be required for higher-risk devices or novel technologies.

Therefore, I cannot provide the requested information in the format of a table with acceptance criteria, study details, sample sizes, expert qualifications, or adjudication methods because these are typically not part of a Class I 510(k) submission for a device like a nasal pack. Such details would be expected for AI/ML-driven devices, diagnostic devices, or higher-risk therapeutic devices.

The documents only address the regulatory clearance through the 510(k) pathway based on substantial equivalence, not the detailed performance evaluation against specific, measurable acceptance criteria that would be relevant for an AI/ML device as implied by your questions.

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