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The BluePro® is a mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.

The BluePro® oral appliance design concept is based upon the use of a standard set of upper and lower trays, referred also as splints in documentation, that are then customized for fit by a dentist. The design is commonly referred to as a Mandibular Repositioning Device (MRD).

The provided text describes the regulatory clearance of a medical device, the BluePro®, by the FDA. However, it does not include detailed information about specific acceptance criteria or a dedicated study proving the device meets those criteria in the typical sense of a clinical trial with performance metrics like sensitivity, specificity, accuracy, or reduction in AHI.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (ApneaRx - K113569), which is a common pathway for FDA clearance for Class II devices. This means the device is being cleared because it is similar enough to an already legally marketed device, not necessarily because it has met specific, pre-defined performance thresholds in a clinical study presented in this document.

Here's an attempt to answer your questions based only on the provided text, acknowledging that many details you requested are not present:

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

The document does not explicitly state "acceptance criteria" in the format of performance metrics (e.g., "device must achieve X accuracy"). Instead, the acceptance criteria for regulatory clearance appear to be based on demonstrating substantial equivalence to the predicate device in terms of indications for use, technology/principle of operation, environment of use, patient population, and safety (biocompatibility).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states "No clinical testing" was performed for the 510(k) submission. Therefore, there is no "test set" in the sense of a clinical study cohort with a defined sample size for performance evaluation.

The closest substitute mentioned is "Commercial experience" ("The BluePro® has been marketed outside the US since October 2014. The results of this experience support the substantial equivalence of the BluePro® for the intended use..."). This is a form of real-world data, retrospective in nature, but no specific sample size, country of origin data breakdown, or detailed analysis is provided in this document.

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, as no clinical test set with ground truth established by experts is mentioned.

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

Not applicable, as no clinical test set or adjudication process is mentioned.

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. The device is a physical intraoral appliance, not an AI/software device that assists human readers.

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

Not applicable. The device is a physical intraoral appliance, not an algorithm.

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

Not applicable, as no clinical test set with ground truth is mentioned. The "evidence" primarily relies on demonstrating similarity to a predicate device and existing commercial experience (outcomes data in a very general sense, without specific metrics).

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm requiring a training set.

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

Not applicable. This is a physical medical device, not an AI/machine learning algorithm.

Summary of Device Safety and Performance Evidence for Substantial Equivalence:

The primary "study" or evidence presented in this 510(k) submission is a comparison to a legally marketed predicate device (ApneaRx - K113569). Bluesom argues that the BluePro® is substantially equivalent based on:

• Indications for Use: Identical to the predicate.
• Technology / Principle of Operation: Similar (both use pre-formed trays to advance the mandible, both employ boil and bite design).
• Environment of Use: Similar.
• Patient Population: Similar.
• Contraindications: Similar.
• Non-clinical Performance Testing:
  • Commercial experience: The device has been marketed outside the US since October 2014, and this general "real-time clinical experience" is cited to support its substantial equivalence. No specific outcomes data or sample size from this experience is provided.
  • Biocompatibility: Testing was performed on finished devices for Cytotoxicity, Sensitization, and Irritation according to ISO 10993-1, consistent with FDA guidance for intraoral devices with prolonged mucosal contact.
  • Mechanical and Durability: Supported by real-time use and simulated 1-year use via "Braem testing."
  • Cleaning: Demonstrated effectiveness via rinsing and toothbrushing.

In essence, the submission relies on the established safety and effectiveness of the predicate device and demonstrates that the BluePro® shares sufficient similarities and appropriate non-clinical testing (biocompatibility, durability) to warrant the same regulatory classification and market access. No new clinical trials proving specific performance metrics were required or conducted for this 510(k) clearance.

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