(28 days)
To maintain a nasal airway while providing septal support following surgery.
The Doyle Combo Nasal Airway Splint is designed to provide septal support and allow nasal breathing post-operatively through the integral airway. The patented design features an expandable PVA sponge layer for added comfort and stabilization. For additional security, the splints can be sutured through the pre-formed holes in the anterior tips. The Doyle Combo Nasal Airway Splints are packaged as a pair (left side and right side) and are supplied sterile, ready to use.
The provided text is a 510(k) summary for the Doyle Combo Nasal Airway Splint. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving that a device meets specific acceptance criteria through a detailed clinical study demonstrating performance metrics like sensitivity or specificity.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Here's why and what information is available:
- Acceptance Criteria and Reported Device Performance: This information is not present. The 510(k) summary focuses on the device description, indications for use, contraindications, and identification of predicate devices. There are no performance metrics (e.g., accuracy, sensitivity, specificity, or specific measurements) reported, nor are there acceptance criteria defined.
- Sample size and data provenance: No clinical study data is presented, so no sample size information is available.
- Number of experts and qualifications: Not applicable as no expert-derived ground truth or performance study is detailed.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: No such study is mentioned or summarized.
- Standalone (algorithm only) performance: Not applicable as this is a physical medical device, not an algorithm.
- Type of ground truth used: Not applicable as no clinical performance study is detailed.
- Sample size for the training set: Not applicable as no machine learning algorithm development or training set information is relevant to this submission.
- How the ground truth for the training set was established: Not applicable.
What the document does state regarding "Testing":
The document mentions: "Testing: Device is constructed using well-established medical grade silicone and PVA sponge." This refers to material verification rather than clinical performance testing against specific criteria for effectiveness. The FDA's 510(k) clearance in {1} confirms substantial equivalence based on this and the comparison to predicate devices, not on a detailed study proving performance against acceptance criteria.
§ 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.