(108 days)
MeroPack™ Bioresorbable Nasal Dressing and Sinus Stent is indicated for use in patients undergoing nasal/sinus surgery as a space occupying stent to separate and prevent adhesions between mucosal surfaces during mesothelial cell regeneration in the nasal cavity; to help control minimal bleeding following surgery or nasal trauma by tamponade effect, blood absorption and platelet aggregation; and to prevent lateralization of the middle turbinate during the postoperative period.
MeroPack™ is a sterile bioresorbable nasal dressing and sinus stent composed of lyophilized and compressed HYAFF® and Collagen. When placed appropriately, MeroPack™ absorbs fluid and swells, conforming to the nasal cavity and creating a tamponade effect that helps to control the minimal bleeding normally associated with routine sinus surgery. The stent gradually degrades over time and is slowly absorbed within 14 days, or it may be aspirated from the cavity earlier at the discretion of the physician.
The provided text describes a 510(k) submission for the Medtronic XOMED MeroPack™ Nasal Packing and Sinus Stent, which is a medical device and not an AI/ML algorithm. Therefore, many of the requested fields for an AI/ML device study (like sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable to this document.
However, I can extract information related to the device's performance based on the provided text, primarily by comparing it to predicate devices to establish substantial equivalence.
Here's the relevant information:
1. Table of acceptance criteria and the reported device performance
Since this is a 510(k) for a medical device and not an AI/ML algorithm, the "acceptance criteria" are implied by the comparison to a legally marketed predicate device. The device is deemed substantially equivalent if it performs similarly across key characteristics.
| Characteristic / Acceptance Criteria (Implied) | Predicate Device (MeroGel™) Performance | Proposed Device (MeroPack™) Performance | Assessment |
|---|---|---|---|
| Intended Use | Post-op, help control minimal bleeding and separate mucosal surfaces / adhesion prevention | Post-op, help control minimal bleeding and separate mucosal surfaces / adhesion prevention | Meets |
| Indications | nasal/sinus surgery | nasal/sinus surgery | Meets |
| Material/Construction | esterified hyaluronic acid | esterified hyaluronic acid and collagen | Similar (addition of collagen) |
| Absorbent Qualities | in excess of 10 times weight of the device | in excess of 10 times weight of the device | Meets |
| Sterility | gamma irradiation | gamma irradiation | Meets |
| Resorption time | approx. 14 days | Within 14 days | Meets |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 and FDA Guidance G95-1 | Meets (additional compliance) |
| Method of Action | hygroscopic, forms gelatinous mass in contact with fluids | hygroscopic, forms gelatinous mass in contact with fluids | Meets |
| Method of Removal | gentle irrigation of residues | gentle irrigation of residues | Meets |
Studies that prove the device meets acceptance criteria:
The submission states: "Studies were conducted both by a contract laboratory and by in-house laboratories; all followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7." However, the specific details or results of these studies are not provided in the summary. The "acceptance criteria" here are essentially being "substantially equivalent" to the predicate devices.
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided summary.
- Data provenance: Not specified, but likely from laboratory testing (in-house and contract) rather than human subject data for "test sets" in the AI/ML sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device, not an AI/ML algorithm. The "ground truth" for a physical device is its material properties, performance characteristics (e.g., absorbency, resorption rate), and biocompatibility, typically established through laboratory testing and material science standards (like ISO 10993-1).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a medical device.
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 is a medical device, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a physical medical device.
7. The type of ground truth used:
The ground truth relies on established scientific and engineering principles for medical devices, including:
- Material composition analysis: To confirm the presence of esterified hyaluronic acid and collagen.
- Physical property testing: To measure absorbency (e.g., "in excess of 10 times weight of the device").
- Sterility testing: To confirm gamma irradiation effectiveness.
- Biocompatibility testing: Conducted according to ISO 10993-1 and FDA Guidance G95-1 standards.
- Degradation/resorption studies: To determine the "Within 14 days" resorption time.
8. The sample size for the training set:
Not applicable. This is a medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable. This is a medical device, not an AI/ML algorithm.
§ 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.