(472 days)
The Repose™ Bone Screw System is intended for anterior tongue base suspension by fixation of the soft tissue of the tongue base to the mandible bone using a bone screw with pre-threaded suture. It is also suitable for the performance of a hyoid procedure. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.
The Repose™ Bone Screw System consists of three main components: a bone screw attached to surgical suture material, a bone screw inserter, and a suture passer. The Repose™ Bone Screw is a sharp tipped, small diameter titanium screw with polypropylene monofilament no. I suture crimped into its base. The Repose™ Bone Screw Inserter is a disposable, battery operated, single use device. The Repose™ Suture Passer is designed to assist in passing the suture through the floor of the tongue in a tongue base advancement procedure or through the neck during a hyoid suspension procedure.
This document describes a medical device, the Repose™ Bone Screw System, and its substantial equivalence to predicate devices, rather than presenting a study focused on AI/algorithm performance. Therefore, many of the requested categories related to AI/algorithm performance and study design are not applicable.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" but rather focuses on meeting voluntary standards for materials and demonstrating substantial equivalence to predicate devices.
| Acceptance Criteria (Voluntary Standards/Equivalence) | Reported Device Performance/Meeting Criteria |
|---|---|
| Chemical and mechanical requirements for titanium alloy 6AL-4V Eli (ASTM F136-84) | The titanium alloy used "meets the chemical and mechanical requirements in voluntary standards established by ASTM (F136-84)." |
| Substantial equivalence to predicate devices (Sleep-In™ Bone Screw System, In-Fast™ Bone Screw System, Mitek GII Anchor) in intended use and technological characteristics. | The Repose™ Bone Screw System "has been tested and approved through a series of in vitro and in vivo studies, previously submitted under 510(k): K972023 for Influence Inc's Sleep-In™ Bone Screw System." It is stated to be "substantially equivalent to the Sleep In™ Bone Screw System with respect to the intended use for the treatment of OSA and/or snoring... and to the commonly accepted practice of Hyoid Bone Suspension." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
The document refers to "a series of in vitro and in vivo studies" previously submitted under K972023 for the Sleep-In™ Bone Screw System. However, it does not provide details on the sample size used for these studies, data provenance, or their retrospective/prospective nature.
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):
This information is not provided as the document is not describing a study with a ground truth established by experts in the context of an AI/algorithm. The "testing and approval" mentioned refers to traditional medical device testing, likely mechanical or biological, not diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided as it pertains to expert review for AI/algorithm ground truth, which is not applicable here.
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:
This document is for a physical medical device (bone screw system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a physical bone screw system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The concept of "ground truth" as typically applied to AI performance evaluation is not applicable here. The "proof" of the device's performance relies on its material properties (meeting ASTM standards) and its functional equivalence to predicate devices through in vitro and in vivo studies (details not provided in this document). For a physical implantable device, this would typically involve mechanical testing, biocompatibility studies, and potentially animal or human clinical trials assessing safety and efficacy outcomes, but not establishing a "ground truth" for diagnostic accuracy.
8. The sample size for the training set:
There is no training set as this is not an AI/algorithm study.
9. How the ground truth for the training set was established:
There is no training set and thus no ground truth to be established for it.
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”