(3 days)
The Diamond Digital Sleep Orthotic (DDSO) is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The Diamond Digital Sleep Orthotic (DDSO) is a removable intraoral device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The device functions as a mandibular repositioner, maintaining the lower jaw in a forward, (protrusive) position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space and decrease air turbulence, therefore improving their ability to exchange air during sleep.
The DDSO is a patient-matched prescription medical device, indicated for use during sleep to treat patients who snore and/or have mild to moderate obstructive sleep apnea. The design consists of two splints that fit independently over the upper and lower teeth and engage by means of an adjustable mechanism. This mechanism enables the practitioner to set the amount of mandibularadvancement at the time of fitting the device.
The amount of titration (mandibular protrusion) ranges from in 1.0 mm increments.
The provided text is a 510(k) summary for the Diamond Digital Sleep Orthotic (DDSO). This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study.
Therefore, many of the requested elements for describing acceptance criteria and a study that proves the device meets them (such as acceptance criteria table, sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details, and ground truth establishment) are not explicitly present in this document.
The document states that:
- "Internal verification and validation testing demonstrate that product specifications are met and equivalent in design, performance, and technological characteristics." (Page 7)
- "Bench testing was conducted to determine the critical process parameters for Selective Laser Sintering... Results demonstrate that design outputs meet the design inputs and specifications for Diamond's additive manufacturing processes and control." (Page 7)
- "human clinical studies are not needed" (Page 7-8) because the device's design, technology, and indications for use are similar to previously cleared devices.
- "no new risks are introduced with the new device that are not present in the predicate device" (Page 9).
The document primarily relies on non-clinical performance testing (bench testing) and comparison to predicates to show substantial equivalence. It does not describe a clinical study designed to demonstrate quantitative performance metrics against pre-defined acceptance criteria for efficacy in reducing snoring or OSA. Instead, the "performance" discussed is related to mechanical properties, biocompatibility, and manufacturing process validation.
Given this, I will address the questions based on the information available in the document, and explicitly state when the requested information is not present.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Summary: The Diamond Digital Sleep Orthotic (DDSO) received 510(k) clearance based on demonstrating substantial equivalence to a predicate device (The Panthera Anti-Snoring Device, K143244) and a reference device (The Panthera Anti-Snoring X3 Device, K171576). The "study" proving the device meets acceptance criteria was primarily a series of non-clinical performance verification and validation tests (bench testing), along with biocompatibility testing and a risk analysis, rather than a clinical trial with pre-defined efficacy endpoints for snoring or OSA reduction. The acceptance criteria were therefore focused on demonstrating mechanical integrity, material safety, and comparable design/technology to the predicates, ensuring no new questions of safety or effectiveness.
1. A table of acceptance criteria and the reported device performance
The document does not provide a quantitative table of acceptance criteria or performance metrics for clinical efficacy (e.g., AHI reduction, snoring severity reduction). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence through:
| Acceptance Criterion (Implicit) | Reported Device Performance (as stated in sections 5.4, 5.5, 5.8) |
|---|---|
| Mechanical Strength & Durability (for intended use) | "Bench testing was conducted to determine the critical process parameters for Selective Laser Sintering... Results demonstrate that design outputs meet the design inputs and specifications for Diamond's additive manufacturing processes and control." (Page 7) |
| "Fatigue testing was conducted on the new device to assess the assembly and critical functioning components. A final custom load test was performed on the new device and the predicate and assessed in parallel." (Page 7) | |
| "demonstrate that the subject device is as safe, as effective, and has sufficient mechanical strength for its intended clinical use and therefore can be considered substantially equivalent to the predicate" (Page 7) | |
| Material Biocompatibility (non-toxic, non-irritating) | "A biological evaluation plan to assess the biocompatibility of materials and the material composition used for manufacturing the device... referencing the following [ISO] standards: ISO 14971, ISO 10993-1, 10993-10, 10993-12, 10993-17, and 10993-18." (Page 7) |
| "Comparative chemistry consisted of extractables and leachable extract and a toxicological risk assessment of the compounds identified." (Page 7) | |
| "The toxicology report demonstrates that the Diamond Digital Sleep Orthotic is toxicologically equivalent to the predicate device and therefore as safe and as effective for its intended use." (Page 7) | |
| Design & Technological Equivalence to Predicate | Refer to Table 2: 510(K) Summary Table (Pages 4-5) which details numerous similarities between DDSO and the predicate (Panthera Anti-Snoring Device) including intended use, regulation, classification, patient population, environment of use, reusability, cleaning, prescription status, custom fit, adjustability, materials, design process, principle of operation, and means of mandibular advancement. Minor differences (e.g., advancement mechanism, advancement range) are addressed by stating they "do not raise new questions of safety or effectiveness" and are supported by the reference device (Panthera Anti-Snoring X3 Device). |
| Risk Mitigation & Safety | "Diamond Orthotic Laboratory performed a risk analysis and evaluated the materials of construction and the design process for all hazards in accordance with ISO 14971... All testing methods and results support that all software specifications have met the acceptance criteria of each module and interaction of processes." (Page 8) |
| "no new risks are introduced with the new device that are not present in the predicate device" (Page 9) | |
| Clinical Efficacy (implicit, by equivalence to predicate) | Not directly measured in this submission through a clinical study. Reliance on the predicate device's established efficacy. The document explicitly states: "human clinical studies are not needed" (Page 7-8) as the device is similar to previously cleared devices in design, technology, and indications for use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of a clinical test set for efficacy. The "test set" for performance was actual devices for bench testing (e.g., "fatigue testing was conducted on the new device," "a final custom load test was performed on the new device and the predicate"). The exact number of devices tested is not specified.
- Data Provenance: The testing was "Internal verification and validation testing" (Page 7) conducted by Diamond Orthotic Laboratory. No specific country of origin for data is stated beyond the company's US base. It was non-clinical bench testing, not human subject data, and thus neither retrospective nor prospective in the clinical sense.
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. This was bench testing and comparison to a predicate, not a study requiring expert readers or ground truth derived from clinical data labeled by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process was described or required for this type of submission.
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
- No. This device is an intraoral medical device, not an AI system or an imaging diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI was not performed or relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical performance and biocompatibility testing, the "ground truth" was established by engineering specifications, material science standards (e.g., ISO, ASTM), and comparative analysis against the predicate device's known characteristics. For example, biocompatibility was assessed against ISO standards, and mechanical performance was compared to the predicate.
8. The sample size for the training set
- Not applicable. This is a physical medical device, not an AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as no training set was used.
§ 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.”