(197 days)
EndSnorZ™ Sleep Appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. EndSnorZ™ Sleep Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.
The EndSnorZ Sleep Appliance is a mandibular advancement device. It holds the mandible in a protrusive position determined by the trained dentist. The device consists of upper and lower splints (trays), which are additive manufactured using a biocompatible light curable resin, and a connector, made of a biocompatible medical-grade synthetic polymer with injection molding technology. The connectors attach the upper and lower splints to maintain the forward position of the lower jaw. The device is adjustable in 0.5 mm increments. The device is customized to conform to the patient's upper and lower dentition, provided to Prismatik in patient scans. After loading the patient's scan, the splints are designed according to the scan and the clinician's prescription. Prismatik's computer aided design (CAD) software is used for the design phase. The connectors are applied after the splints are manufactured. This is a non-sterile device, to be used only by the single patient for whom it is custom-designed and is to be worn during sleep.
This document is a 510(k) premarket notification for a medical device called the EndSnorZ™ Sleep Appliance. It asserts substantial equivalence to a predicate device, the Silent Nite sl. The document describes laboratory testing and biocompatibility assessments to support this claim, rather than a clinical study evaluating the device's performance in humans against specific acceptance criteria.
Therefore, the requested information regarding "acceptance criteria" and "the study that proves the device meets the acceptance criteria" in the context of a clinical trial or performance evaluation with human subjects is not present in the provided text. The document focuses on demonstrating substantial equivalence through comparison to existing devices and laboratory testing of materials and mechanical properties.
However, I can extract information related to the device and the testing performed to support its substantial equivalence, which is a form of "proof" in the regulatory context.
Here's an interpretation based on the provided text, addressing the points where information is available and noting where it is not:
1. A table of acceptance criteria and the reported device performance:
The document does not present specific clinical acceptance criteria (e.g., a certain percentage reduction in AHI or snoring events) as it is not a clinical performance study with human outcomes. Instead, the "acceptance criteria" for this 510(k) submission are implied to be the demonstration of substantial equivalence to the predicate device through:
- Identical/Similar Indications for Use: The device aims to address the same clinical need as the predicate.
- Similar Technological Characteristics: The device functions similarly and is made of biocompatible materials with comparable mechanical properties.
- Fulfillment of Biocompatibility and Mechanical Testing Standards: Meeting established safety and performance standards for materials.
Here's a table summarizing the reported device performance in the context of substantial equivalence, based on the comparative testing and characteristics mentioned:
| Criterion (Implied for Substantial Equivalence) | Reported Device Performance (EndSnorZ™ Sleep Appliance) |
|---|---|
| Indications for Use Alignment | Indicated "to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older," worn "to support the lower jaw in a forward position," and "removable by the patient." Identical to predicate. |
| Mechanism of Action | "Designed so the lower jaw is in an advanced (forward protruding) state during sleep. This forward position improves the flow of air through the patient's pharyngeal space during sleep, repositioning the mandible and thus reducing snoring and mild to moderate OSA." Same as predicate. |
| Biocompatibility (per ISO 10993) | "All materials meet requirements of ISO 10993." Specifically, Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal Reactivity), Part 10 (Maximization for Delayed-Type Hypersensitivity). GLP Cytotoxicity testing (per ISO 10993, Part 5) performed on connectors. Test results showed materials and manufactured connectors are safe and biocompatible. |
| Tensile Strength of Connectors (against Predicate) | "compare the following mechanical properties of EndSnorZ Sleep Appliance to the Predicate: tensile strength of the connectors..." Results of all laboratory testing confirmed substantial equivalence. (Specific values not provided, only the conclusion of equivalence). |
| Dimensional Retention of Connectors (when exposed to artificial saliva, against Predicate) | "compare the following mechanical properties of EndSnorZ Sleep Appliance to the Predicate: ...the dimensional retention of connectors when exposed to artificial saliva." Results of all laboratory testing confirmed substantial equivalence. (Specific values not provided, only the conclusion of equivalence). |
| Design and Manufacturing Process Validation | Testing performed to "validate the design and process for manufacturing the EndSnorZ Sleep Appliance," "validate the position of the devices on the build platform of the SprintRay 3D printing machine for printing the devices with the Keysplint Soft Resin," and "validate that Prismatik's Wave CAD software accurately designs the sleep appliances and is 21 CFR Part 11 compliant." Implied successful validation as part of substantial equivalence. |
| Material Composition | Splints/Trays: Methacrylate-based light-cured polymer resin used to additively manufacture splints. (Different from predicate (Polyurethane or PETG) but identical to Reference #1 and similar to Reference #2). Advancement mechanism: Synthetic polymer nylon. (Same material type as predicate, but from different sources; both manufactured by injection molding). |
| Adjustable Range / Increments | Connector adjustment range: 20.5mm to 26mm (Predicate: 21mm to 26mm). Maximum adjustment: 5.5mm; increments of 0.5 mm (Predicate: 5.0 mm; increments of 1.0mm). Total achievable mandibular advancement: Approximately 10mm (Predicate: Approximately 10mm). Noted as "Similar." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of human data. The "test set" here refers to physical samples of the device and its components used for laboratory/bench testing. The number of samples for these tests (tensile strength, dimensional retention, biocompatibility) is not explicitly stated, but it would have been conducted under GLP (Good Laboratory Practice) guidelines.
- Data Provenance: The testing was performed by Prismatik (the manufacturer) and contracted labs for biocompatibility testing. The location of these labs is not specified, but the submission is to the U.S. FDA. The testing is prospective in the sense that it was conducted for this specific submission to demonstrate equivalence.
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. The ground truth for this submission is based on laboratory measurements and adherence to engineering/material standards (e.g., ISO 10993) and comparison to the predicate device's established characteristics. No expert clinical review of "ground truth" (e.g., diagnosis of OSA severity or snoring levels) from human patients was required or performed as part of this specific 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept pertains to multi-reader studies where disagreements among expert readers need to be resolved. This submission is based on laboratory testing and comparison to a predicate, not human image interpretation or clinical outcomes.
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. An MRMC study was not performed. This device is a physical intraoral appliance, not an AI or image analysis tool for diagnosis where human reader performance would be assessed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is derived from:
- Predicate Device Characteristics: The established safety and effectiveness profile of the legally marketed predicate device (Silent Nite sl).
- Laboratory/Bench Testing Standards: Defined metrics and acceptable ranges for material properties (e.g., tensile strength) and biocompatibility, as per ISO standards and engineering principles.
- Manufacturing Validation Data: Confirmation that the manufacturing process consistently produces the device according to design specifications.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of an AI/ML algorithm for which this information would be relevant.
9. How the ground truth for the training set was established
- Not applicable. There is no training set mentioned in this context.
§ 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.”