(123 days)
This device is intended to collect middle ear fluid within the viscosity range of sae 30-50 for laboratory analysis.
Requirement for aspiration and analysis of middle ear fluid from behind an intact tympanic membrane (ear drum)
This single use device is designed to collect specimens of middle ear fluid from behind an intact tympanic membrane and comprises the following: polythene disposal bag, glove (examination), 'Disposafe' (for sharps), fenestrated surgical ear drape, mop, label, vial assembly, suction tube (hand-piece), myringotome (aspirating), specimen bag (laboratory), aural speculum, 2.5mm. It has been sterilized by gamma irradiation and is ready for use.
The document does not detail specific acceptance criteria or a study that proves the device meets those criteria. Instead, it is a 510(k) submission for regulatory clearance, focusing on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance metrics against pre-defined acceptance criteria through a clinical or performance study.
Here's what can be extracted based on the provided text, and what information is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
The document primarily focuses on the device's design, intended use, and comparison to predicate devices for regulatory clearance. It claims the device is "ready for use" after sterilization by gamma irradiation and states its intended use is to "collect middle ear fluid within the viscosity range of sae 30-50 for laboratory analysis." However, it does not present specific performance metrics or acceptance criteria that would typically be found in a performance study (e.g., fluid collection efficiency, viscosity handling capability, sterility validation results beyond the statement of gamma irradiation).
2. Sample size used for the test set and the data provenance
- Sample size: Not specified.
- Data provenance: Not specified.
The submission does not refer to a test set in the context of a performance study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of experts: Not applicable, as no performance study is described with a test set requiring expert ground truth.
- Qualifications of experts: Not applicable.
4. Adjudication method for the test set
- Not applicable, as no performance study is described with a test set.
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. This device is a physical medical kit for fluid collection, not an AI or imaging device that would typically involve human readers or MRMC studies.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. This device is a physical medical kit, not an algorithm.
7. The type of ground truth used
- Not applicable, as no performance study is described for which ground truth would be established. The "ground truth" for this 510(k) submission relates to the device's design, manufacturing, and intended use as compared to legally marketed predicate devices, for the purpose of demonstrating substantial equivalence. The FDA's decision is based on this regulatory review, not on a clinical performance study with established "ground truth" in the manner of diagnostic devices.
8. The sample size for the training set
- Not applicable, as no training set for an algorithm is mentioned or relevant to this physical device.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.