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Separate tissue or structures compromised by surgical trauma
Separate and prevent adhesions between mucosal surfaces in the nasal cavity and minimize ostial stenosis following endoscopic sinus surgery
Control minimal bleeding following surgery or trauma by tamponade effect, blood absorption and platelet aggregation
Act as an adjunct to aid in the natural healing process
The Chitogel Endoscopic Sinus Surgery Kit is indicated for use as a nasal packing to treat epistaxis.

Device Description

The Chitogel Endoscopic Sinus Surgery Kit consists of the following components:

Sealed vial containing 300mg Dextran Aldehyde Powder
Sealed vial containing 10ml Sodium Phosphate Buffer Solution
Sealed vial containing 10ml Chitosan Succinaamide Solution
12cc control syringe
Fluid dispensing connector
Two (2) mixing cannulae
Malleable cannula
The Chitogel Endoscopic Sinus Surgery Kit is used during nasal surgery. The components in the Chitogel Kit are mixed by the physician using the syringe and cannulae provided. The pre- measured components mix to form the biodegradable gel. Once the components are mixed and create the gel, the physician applies the gel to the target area using the malleable cannula and thereby creating a nasal packing.
All components are provide sterile and are for single use only.

AI/ML Overview

The provided text describes a medical device (Chitogel Endoscopic Sinus Surgery Kit) and its comparison to a predicate device (Novashield Injectable Nasal Packing and Stent) for FDA 510(k) clearance. This document is a Summary of Substantial Equivalence, not a detailed study report with all the specific information requested.

Therefore, much of the requested information regarding acceptance criteria, study methodologies, sample sizes, and ground truth establishment, particularly for a device with an AI/algorithm component, is not present in this document because this device is a physical medical product, not an AI/software device.

However, I can extract and infer some relevant information based on the typical content of such documents for medical devices:

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

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics typical of an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, it focuses on qualitative equivalency to a predicate device and safety testing for a physical product.

The "acceptance criteria" here refer to meeting standards for biological safety, physical properties, and functional performance as demonstrated through various tests. The "reported device performance" is essentially that the device passed all these tests and met their respective acceptance criteria.

Acceptance Criteria Category (Implied)	Reported Device Performance
Biological Safety Testing	All samples passed testing and met acceptance criteria for: Cytotoxicity, Sensitization, Acute Systemic Toxicity.
Simulated Clinical Performance (Animal Model)	Successfully combined into a gel, introduced into sinus cavities, maintained position after introduction, degraded over time using saline irrigation. No adverse events observed.
Physical/Chemical Properties (Non-Clinical Testing)	All samples passed testing and met acceptance criteria for: Viscosity, Gel time, Delivery of gel, Biodegradation, Packaging.
Clinical Performance (Human Studies - via published articles)	Demonstrated performance consistent with indications for use: separated tissue/structures, prevented adhesions, minimized ostial stenosis, controlled minimal bleeding, aided natural healing process. Confirmed in studies/peer-reviewed journals.
Sterilization	Passed testing for sterility (ETO & Gamma).
Single Use Confirmation	Confirmed as single use.

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

Test Set Sample Size: Not explicitly stated for specific tests.
- For biological testing (cytotoxicity, etc.), it would typically involve an adequate number of samples as per ISO standards, but no specific count is given.
- For non-clinical physical testing (viscosity, gel time, etc.), "All samples" passed, but the quantity of "samples" is not provided.
- For animal testing, it mentions "an animal model" (singular imply a single type of animal study, not necessarily a single animal), but no specific number of animals is provided.
- For "Clinical Experience", it refers to "Several clinical studies" and "randomized controlled studies," but the specific number of participants in these studies (i.e., the sample size of the test set) is not provided in this summary.
Data Provenance:
- Clinical Experience: References multiple published journal articles involving "randomized controlled studies." While specific countries are not mentioned, one of the authors, "Wormald, PJ," is associated with the University of Adelaide, Australia, suggesting at least some data might originate from Australia. The company itself is based in New Zealand.
- Retrospective/Prospective: The description "randomized controlled studies" indicates these were prospective clinical trials.

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 as the device is a physical product, not an AI system requiring expert labeling for ground truth. Clinical "observations were documented" and confirmed in studies, likely by the treating physicians and study investigators, but their specific qualifications or number for "ground truth establishment" in an AI context are not relevant here and thus not stated.

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

This information is not provided and is generally not applicable for a physical medical device submission like this. Adjudication methods are typically relevant for complex subjective assessments in AI studies or clinical trials where multiple readers/assessors need to reach a consensus on ground truth or outcomes. For this device, the outcomes are observed clinical effects (e.g., bleeding control, adhesion prevention).

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, an MRMC comparative effectiveness study was not done or mentioned. This type of study is specifically designed for evaluating diagnostic AI systems where human readers' performance (e.g., radiologists, pathologists) is compared with and without AI assistance across multiple cases. This device is a physical surgical implant, not a diagnostic AI tool.

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

Not applicable. This question pertains to AI algorithms. The Chitogel device is a physical kit that forms a gel used by a surgeon. There is no "algorithm" to perform in a standalone capacity.

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

For the clinical effectiveness discussed, the "ground truth" was based on clinical observations and outcomes data from prospective randomized controlled trials. These include:

Direct observation of tissue separation.
Assessment of adhesion prevention.
Measurement/assessment of bleeding control.
Observation of the natural healing process.
Histopathological analysis (implied by "wound healing" studies, potentially at a microscopic level in animal or human biopsies, but not explicitly stated as the primary ground truth source here).

8. The sample size for the training set

Not applicable. This device is a physical product and does not involve AI/machine learning, thus there is no "training set."

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

Not applicable. See point 8.

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