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The SNORE-CURE Anti-snoring Appliance is intended as an aid in the alleviation of snoring by repositioning the lower jaw slightly forward and open together with the tongue to expand the patient's airway, thereby decreasing air turbulence.

The SNORE-CURE Anti-snoring Appliance is intended as an aid in the alleviation of snoring by repositioning the lower jaw slightly forward and open together with the tongue to expand the patient's airway, thereby decreasing air turbulence.

The provided text describes a 510(k) submission for the SNORE-CURE Anti-snoring Appliance, which is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

The 510(k) process does not typically involve a formal study with acceptance criteria and device performance evaluation in the same way a clinical trial for a new drug or novel medical device would. Instead, the primary focus is on establishing substantial equivalence to a predicate device. Therefore, a table of acceptance criteria and reported device performance, and details about associated studies as requested in the prompt, are not explicitly present in the provided document.

However, based on the information provided, we can infer some details related to "device testing" and "equivalence."

Here's an analysis of the provided text with respect to your questions, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance

• Not explicitly provided. The document states that the SNORE-CURE appliance is "substantially similar in design, materials and function" to the predicate device (Snore-Guard). The "performance" is described in terms of its mechanism and physical advancement characteristics, not as a quantified outcome against specific acceptance criteria for snoring alleviation.

  • Inferred Performance Description (from "DEVICE TESTING" section):
    • SNORE-CURE: Advances the mandible 6-7mm anteriorly with an average overjet of 4mm and opens the mandible 8mm.
    • Predicate Device (Snore-Guard): Advances the mandible about 6-8mm anteriorly and opens the mandible 7-8mm.

  These are presented to show mechanical similarity, not clinical efficacy metrics against pre-defined acceptance criteria.

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. The 510(k) summary does not detail any clinical study or test set with a specific sample size. The "DEVICE TESTING" section focuses on mechanical characteristics comparison rather than patient data.

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 applicable/Not provided. This type of detail is relevant to studies with expert adjudicated ground truth, which is not described in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. No adjudication method is mentioned as no specific test set or clinical study requiring adjudication is detailed.

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. MRMC studies are typically for evaluating diagnostic imaging or AI-assisted interpretation, which is not the nature of this device. This is a physical anti-snoring appliance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This refers to an AI algorithm's performance, which is not relevant to this physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Not applicable/Not provided. No ground truth (in the context of clinical outcomes or diagnostic accuracy) is mentioned because no clinical efficacy study is detailed. The "ground truth" for the 510(k) is the established performance and characteristics of the predicate device.

8. The sample size for the training set

• Not applicable/Not provided. No training set is mentioned as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

• Not applicable/Not provided.

Summary of Device Acceptance (510(k) Context):

The acceptance criteria for a 510(k) submission revolve around demonstrating substantial equivalence to a predicate device. For the SNORE-CURE, this was achieved by showing:

• Similar Intended Use: Both SNORE-CURE and Snore-Guard are intended as aids in the alleviation of snoring by repositioning the lower jaw.
• Similar Design and Materials: The SNORE-CURE is stated to be "substantially similar in design, materials and function" to the Snore-Guard.
• Similar Mechanism of Action and Mechanical Characteristics:
  • Both devices advance the mandible anteriorly and open it vertically.
  • SNORE-CURE: mandible advancement 6-7mm anteriorly, average overjet 4mm, mandible opening 8mm.
  • Snore-Guard: mandible advancement 6-8mm anteriorly, mandible opening 7-8mm.

The "study" that proves the device meets "acceptance criteria" (of substantial equivalence) is the comparison presented in the "DEVICE TESTING" section. No formal clinical trial data is presented in this summary to demonstrate the device's efficacy in alleviating snoring against specific metrics, but rather its mechanical similarity to a previously cleared device. The FDA's clearance letter (K980952, June 1, 1998) confirms that they found the device "substantially equivalent" for the stated indications for use.

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