(28 days)
This device is intended to clean the external ear canal and tympanum. The need to clear and clean the external ear canal.
Comprehensive, single use, sterile procedure pack comprising: 18 swg fine end 14 swg suction tube Cotton wool mop Wax curette
The provided document primarily consists of a 510(k) submission summary for the Exmoor Suction Clearance Kit and the FDA's clearance letter. It describes the device, its intended use, and its equivalence to predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or the detailed aspects of a performance study.
Therefore, I cannot provide detailed answers to most of your questions based only on the provided text. The document focuses on regulatory clearance based on substantial equivalence, rather than a clinical performance study with defined acceptance criteria and statistical analysis.
Here's what can be inferred or stated about the information requested, with clear indication of what is not present:
1. A table of acceptance criteria and the reported device performance
- Not provided. The document describes the device and its intended use but does not present a table of acceptance criteria (e.g., specific metrics for efficacy or safety) or reported performance against such criteria. The basis for clearance is substantial equivalence to legally marketed predicate devices, implying that their performance is considered acceptable.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. This document does not detail any clinical test sets or studies with sample sizes.
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 provided. No information on experts or ground truth establishment for a test set is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. No test set 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 provided. This device is an instrument kit (Ear Suction Clearance Kit), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not provided. Since no specific performance study with a test set is detailed, the type of ground truth is not mentioned. The regulatory clearance is based on substantial equivalence to predicate devices, not on a new clinical ground truth establishment.
8. The sample size for the training set
- Not applicable/Not provided. This is a physical medical device. The concept of a "training set" is not relevant to its regulatory filing based on substantial equivalence.
9. How the ground truth for the training set was established
- Not applicable/Not provided. See point 8.
§ 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.