(570 days)
The Dillard Nasal Balloon (DNB) Catheter is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum.
The Dillard Nasal Balloon (DNB) Catheter is intended for use in ages 17 years or older.
The Dillard Nasal Balloon (DNB) Catheter has a total length of either 25cm or 100cm and is available in balloon diameters from 5mm to 12mm and balloon lengths of 20mm and 40mm. The balloon component of the catheter has radiopaque markers to assist with radiographic positioning (as applicable). The proximal end of the device is a common catheter design consisting of a plastic hub and strain relief. The hub is used to inflate the balloon and the luer connector integrated into the hub is compatible with standard inflation devices. A second lumen within the catheter, intended for guidewire use, extends through the central lumen back to the proximal hub and through the distal tip. All catheters and accessories are supplied sterile and intended for single use.
The Dillard Nasal Balloon Catheter (DNB) is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. It is intended for use in ages 17 years or older.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of acceptance criteria and the reported device performance:
The provided document does not explicitly present a table of "acceptance criteria" with numerical targets and the device's reported performance against those targets in the context of an algorithmic or AI-driven device. Instead, it lists various performance tests conducted to demonstrate substantial equivalence to a predicate device. The "reported device performance" is generally stated as the device performing "as intended" and being "as safe and as effective as the predicate device."
Here's an interpretation of relevant performance characteristics and implicitly met criteria:
| Characteristic/Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Dimensional specifications | Conformance to design specifications | Met (Implied by "performs as intended") |
| Joint separation strength | Adequate strength to prevent separation during use | Met (Implied by "performs as intended") |
| Compatibility with (standard) accessories | Functional integration with standard accessories | Met (Implied by "performs as intended") |
| Balloon burst pressure | Withstands intended internal pressures | Met (Implied by "performs as intended") |
| Inflation and deflation times | Within acceptable clinical ranges | Met (Implied by "performs as intended") |
| Balloon cycle fatigue in simulated use | Durability over intended usage cycles | Met (Implied by "performs as intended") |
| Biocompatibility | Non-toxic and biologically safe for human contact (ISO 10993) | Met (Compliance with ISO 10993) |
| Sterilization Validation | Effectively sterilized (ISO 11135) | Met (Compliance with ISO 11135) |
| Packaging Integrity and Transportation Validation | Maintains sterility and integrity during transport (ISO 11607, ISTA 2A) | Met (Compliance with ISO 11607 and ISTA Part 2A) |
| Shelf life | Stable and functional for stated shelf life | Met (3 years real-time equivalent, ASTM F1980 compliance) |
| Safety and Efficacy | No new questions of safety or effectiveness compared to predicate | Met (Conclusion from Clinical and Non-Clinical Testing) |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a separate "test set" in the context of an AI/algorithmic evaluation. The performance tests mentioned include:
- Simulated use in cadavers: The sample size for cadavers is not specified.
- Other performance tests (dimensional, strength, burst pressure, etc.): These typically involve a statistically relevant number of manufactured devices, but the specific quantity is not disclosed.
- Data Provenance: Not applicable in the context of typical AI data provenance (country of origin, retrospective/prospective). The data comes from direct physical testing of the device and its components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This device is a physical medical instrument, not an AI/algorithmic device requiring an expert-established "ground truth" in the way an image analysis algorithm would. The "ground truth" for its performance is established through engineering and biological testing standards and clinical observation (in cadavers). There is no mention of external experts establishing ground truth for the test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. This is not an AI/algorithmic device where adjudication of interpretations would be necessary. The performance tests yield objective physical measurements or observations.
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-assisted diagnostic or interpretative tool, so an MRMC study and effect size in improving human reader performance is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the Dillard Nasal Balloon Catheter's performance is established through:
- Engineering specifications and standards: For dimensional, strength, pressure, and fatigue tests.
- Biological testing standards (ISO 10993): For biocompatibility.
- Sterilization and packaging standards (ISO 11135, ISO 11607, ISTA 2A, ASTM F1980): For sterility, integrity, and shelf life.
- Simulated use in cadavers: Provides a realistic anatomical environment for evaluation, implicitly using the cadaver anatomy as "ground truth" for device interaction.
8. The sample size for the training set:
Not applicable. This is not an AI/algorithmic device that uses training data.
9. How the ground truth for the training set was established:
Not applicable. As above, this is not an AI/algorithmic device requiring a training set with established ground truth.
§ 874.4420 Ear, nose, and throat manual surgical instrument.
(a)
Identification. An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.(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 § 874.9.