(85 days)
HylaSine is indicated for use in patients undergoing nasal/sinus surgery as a space-occupying gel stent to separate and prevent adhesions between mucosal surfaces in the nasal cavity, to help control minimal bleeding following surgery or nasal trauma, and to prevent lateralization of the middle turbinate during the postoperative period.
HylaSine™, hylan B gel is a sterile, transparent, viscoelastic gel composed of cross-linked polymers of hyaluronan. This hyaluranon is a bioresorbable material that functions to fill nasal/sinus cavities following surgery or trauma and to keep mucosal surfaces separate during the healing process. During this time, the tamponade effect helps control minimal bleeding normally associated with routine sinus surgery. HylaSine leaves the site of placement by natural elimination, or it may be aspirated from the cavity earlier at the discretion of the physician.
The provided text describes a 510(k) summary for a medical device called Hylasine™ Hylan B Gel, an intranasal splint. However, it does not contain information about explicit acceptance criteria or a study proving the device meets those criteria, nor does it detail device performance metrics.
Instead, the document focuses on establishing substantial equivalence to legally marketed predicate devices. This is a common pathway for Class II and Class I medical devices in the US, where the focus is on showing that the new device is as safe and effective as a device already on the market, rather than requiring extensive clinical trials to prove efficacy against specific, predefined performance metrics.
Here's a breakdown of what is and is not present in the provided text, based on your requested categories:
1. A table of acceptance criteria and the reported device performance
- Not present. The document does not specify quantitative acceptance criteria (e.g., "device must reduce adhesions by X%"). It also does not report specific performance metrics from a study (e.g., "adhesion rate was Y%"). The closest it comes to a "performance" comparison is highlighting shared indications for use and material composition with predicate devices, implying similar performance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not present. There is no mention of a "test set" or any clinical study data involving human subjects to evaluate Hylasine™'s performance. The 510(k) submission is based on comparison to existing devices.
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)
- Not present. As no test set or clinical study is described, there's no mention of experts or ground truth establishment in this context.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not present. No clinical study or adjudication method is 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
- Not present. This device is a physical intranasal splint, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study or AI-related effectiveness study is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not present. This device is a physical product, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present. No clinical studies are described where a ground truth would be established. The "ground truth" for this 510(k) submission is the regulatory acceptance of its predicate devices.
8. The sample size for the training set
- Not present. There is no mention of a "training set" as this is not an AI/algorithm-based device.
9. How the ground truth for the training set was established
- Not present. No training set is mentioned.
Summary of the Document's Approach:
The provided 510(k) summary for Hylasine™ follows an approach of substantial equivalence to predicate devices. The "study" here is essentially a comparison of the new device's characteristics (intended use, material composition, bioresorbability, product code) to those of existing, legally marketed devices.
The acceptance criteria for a 510(k) submission like this are implicitly:
- The device has the same intended use as a predicate device.
- The device has the same technological characteristics as a predicate device, OR, if it has different technological characteristics, these differences do not raise new questions of safety and effectiveness.
The document demonstrates this by presenting a table comparing Hylasine™ to three predicate devices (Xomed MeroGel™, Boston Medical Custom Nasal Splint, LactoSorb Ethmoid Stent) across several attributes. The FDA's letter (K012532) confirms that based on this comparison, Hylasine™ was found to be substantially equivalent to the referenced predicate devices, allowing it to be marketed.
§ 874.4780 Intranasal splint.
(a)
Identification. An intranasal splint is intended to minimize bleeding and edema and to prevent adhesions between the septum and the nasal cavity. It is placed in the nasal cavity after surgery or trauma. The intranasal splint is constructed from plastic, silicone, or absorbent material.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.