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The Sleep-In™ Bone Screw System is intended for anterior advancement and suspension of the tongue base by means of a bone screw threaded with suture. It is indicated for the treatment of obstructive sleep apnea ("OSA") and/or snoring.

The Sleep-In™ 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 Sleep-In™ Bone Screw is a sharp tipped, small diameter titanium screw with polypropylene monofilament no. 1 suture crimped into its base. The Sleep-In™ Bone Screw Inserter is a disposable, battery operated, single use device. The Sleep-In™ Suture Passer is designed to assist in passing the suture through the floor of the tongue during the Sleep-In™ procedure.

This document describes a medical device, the Sleep-In™ Bone Screw System, and its regulatory submission. It does not contain information about studies proving the device meets specific acceptance criteria in the manner a diagnostic or AI-powered device would. The information provided is for a traditional medical device (bone screw system), which typically relies on compliance with pre-established mechanical and material standards rather than performance metrics like sensitivity, specificity, or reader studies.

Therefore, many of the requested fields are not applicable to the provided text.

Here's a breakdown of what can be extracted and why other fields are not relevant:

Acceptance Criteria and Device Performance (Not Applicable - See Explanation Below)

This section is not applicable because the document describes a mechanical fixation device, not a diagnostic or AI system with performance metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" for such a device are primarily related to material properties and mechanical integrity, rather than a "reported device performance" in terms of diagnostic effectiveness.

The document states: "No performance standards applicable to the bone screw systems have been established by the FDA. However, the titanium alloy 6AL-4V Eli alloy used to manufacture the Sleep-In™ Bone Screw meets the chemical and mechanical requirements in voluntary standards established by ASTM (F136-84)." This indicates material compliance rather than performance criteria in the sense of a diagnostic device.

Study Information (Where Applicable):

• Sample size used for the test set and the data provenance: Not applicable. The document mentions "initial clinical experience" but does not detail a specific test set or its size for performance evaluation. The provenance of this clinical experience is not specified (e.g., country of origin, retrospective/prospective).
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth establishment with experts is typical for diagnostic or AI evaluation, not for a bone screw system.
• Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for a bone screw system.
• 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 type of study is for evaluating AI-assisted diagnostic tools, not mechanical devices.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined in terms of a "ground truth" for performance. For a mechanical device, successful implantation and clinical outcome (e.g., reduction in OSA/snoring symptoms) would be relevant, but specific methods for establishing a "ground truth" in this context are not detailed. The document mentions "initial clinical experience," which implies some form of outcomes data.
• The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
• How the ground truth for the training set was established: Not applicable.

Summary of Relevant Information from the Document:

While the document doesn't fit the typical structure for AI/diagnostic device evaluation, it does provide some critical information about the device's validation:

• Performance Standards Mentioned:
  • No FDA-established performance standards for bone screw systems.
  • The titanium alloy (6AL-4V Eli) used in the Sleep-In™ Bone Screw meets chemical and mechanical requirements of ASTM (F136-84). This acts as the material acceptance criterion.
• Studies Mentioned:
  • "The performance characteristics of the Sleep-In™ Bone Screw System has been tested and approved through a series of in vitro and in vivo studies." (Details of these studies, including sample sizes or specific acceptance criteria for these studies, are not provided in this excerpt.)
  • "Furthermore, initial clinical experience with the Sleep-In™ Bone Screw System has demonstrated its potential for treating patients suffering from OSA and/or snoring." (No specifics on size or results of this experience are given.)
• Substantial Equivalence Basis: The device's technological characteristics and intended use are deemed substantially equivalent to predicate devices based on:
  • Suspension of soft tissue to fixed bone by sutures attached to bone screws (similar to In-Fast™ Bone Screw System and Mitek GII Anchor).
  • Procedure based on accepted methods like Hyoid Bone Suspension, Chin Osteotomy, and Mandibular Advancement.
  • Repositioning of the tongue for OSA/snoring treatment (similar to PM Positioner™ and Snor-X Mouthguard).

In conclusion, this document primarily focuses on regulatory submission and substantial equivalence for a mechanical medical device, rather than providing detailed "acceptance criteria" and "study results" in the context of diagnostic performance or AI evaluation.

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