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The Dorsal Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

Device Description

The Dorsal Appliance is comprised of upper and lower customized acrylic splints for the treatment of mild to moderate sleep apnea. The upper splint comprises bilateral turnbuckle adjustment mechanisms. The device aims to improve the patient's air exchange thereby reducing snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.

AI/ML Overview

This document is a 510(k) premarket notification for the Dorsal Appliance, an intraoral device intended for the reduction of nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The submission argues for substantial equivalence to a predicate device, the Acrylic Herbst Appliance.

Here's an analysis of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, there are no explicit "acceptance criteria" defined in terms of specific performance metrics or thresholds for the target device (Dorsal Appliance). Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Acrylic Herbst Appliance) through a comparison of technological characteristics, materials, and intended use. The performance "reported" is primarily a statement that the materials and fabrication processes are identical to the predicate device, implying similar performance.

Acceptance Criteria (Implied)	Reported Device Performance
Intended Use Equivalence:	The Dorsal Appliance has the "same intended use" as the predicate: "The reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA)."
Technological Characteristics Equivalence (no new safety/effectiveness questions):	The "fundamental scientific technology... is the same" as the predicate. "Each of the design features is common to the predicate."
Material Equivalence:	"The materials and fabrication processes used in the manufacture of the subject device are identical to the materials and fabrication processes used in the manufacture of the predicate device." Materials: medical grade polymethylmethacrylate (acrylic splints) and stainless steel (adjustment screw mechanism).
Biocompatibility:	"Because material biocompatibility was accepted for the predicate and because there are no differences in manufacturing which could affect biocompatibility, additional biocompatibility testing was not supplied in support of this clearance."
Physical Properties:	"Data regarding performance testing of the device material was provided." "Because the identical material is used for both the subject and predicate devices, these performance results support the finding of substantial equivalence. The results included general properties (water solubility and absorption) and physical properties (tensile and flexural strength, and elastic modulus)." (Specific numerical values for these properties are not provided in the excerpt.)
Risk Mitigation:	"A risk analysis was performed... The risks identified in the guidance (e.g., intraoral gingival, palatal, or dental soreness; TMJ Dysfunction Syndrome; obstruction of oral breathing and loosening or flaring of lower anterior teeth or general tooth movement) and those detected by the risk analysis were mitigated though the use of biocompatible materials identical to those used in the predicate and the use of appropriate labeling."
Differences addressed:	The only differences noted are the "type of advancement mechanism used" (turnbuckle for the subject device vs. telescopic for the primary predicate) and the "adjustable range" (5mm for the subject device vs. 5.5mm for the primary predicate). These differences are argued not to raise new safety and effectiveness questions, as the turnbuckle mechanism is used in other similar intra-oral devices (reference predicate Dorsal Appliance, K103076) and the adjustable range falls within limits of other similar predicate devices.

2. Sample size used for the test set and the data provenance:

Sample size for the test set: Not applicable. The document explicitly states: "Clinical testing of the subject device was not used in support of clearance." This was a substantial equivalence submission based on non-clinical data (material properties, design comparison, risk analysis) relative to a predicate device.
Data provenance: Not applicable, as there was no clinical test set. The data presented relates to material properties and comparative design analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. There was no clinical test set requiring ground truth establishment by experts for performance evaluation.

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

Not applicable. No clinical test set was used.

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. This device is a mechanical intraoral appliance, not an AI-powered diagnostic or assistive technology.

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 consensus, pathology, outcomes data, etc.):

Not applicable for a clinical test set. The "ground truth" for the substantial equivalence argument relies on the established safety and effectiveness of the predicate device (Acrylic Herbst Appliance, K113126) and the materials used, as well as regulatory guidance for this device class.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning system that requires a "training set."

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

Not applicable. This device is not an AI/machine learning system.

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K Number

K113126

Device Name

ACRYLIC HERBST APPLIANCE

Manufacturer

GERGENS ORTHODONTIC LAB

Date Cleared

2013-07-17

(632 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K070327,K083209,K103076,K111009

Intended Use

The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.

Device Description

The Acrylic Herbst Appliance is comprised of upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism for the treatment of mild to moderate sleep apnea. The device aims to improve the patient's air exchange thereby reduce snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible.

AI/ML Overview

The provided 510(k) summary for the GERGEN'S ORTHODONTIC LAB INC. Acrylic Herbst Appliance (K113126) does not include specific acceptance criteria or a dedicated study demonstrating the device meets quantitative performance metrics.

Instead, the submission relies on demonstrating substantial equivalence to previously cleared predicate devices based on technological characteristics and intended use. The document explicitly states: "Clinical testing of the subject device was not used in support of clearance."

Therefore, based on the provided text, I cannot complete the requested tables and sections with quantitative acceptance criteria or a study proving those criteria are met for performance of the device in its intended clinical use. However, I can extract information related to the device's technical characteristics and the comparison to predicate devices, which forms the basis of its clearance.

Here's a breakdown of what can be inferred from the provided text regarding the closest equivalent to "acceptance criteria" and "study":

1. Table of Acceptance Criteria and Reported Device Performance

As noted, there are no quantitative clinical acceptance criteria or reported clinical performance metrics for the subject device in this document. The "performance data" mentioned refers only to material properties.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance (as presented in the 510(k) summary)
Device has the same intended use as predicate devices.	Intended Use: The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years of age or older.
(This matches the intended use of predicate devices).
Device has the same technological characteristics as predicate devices (design, function, materials, adjustability, manufacturing method, sterility).	Technological Characteristics: The Acrylic Herbst Appliance shares the same basic design (upper and lower trays with bilateral Herbst mechanisms), function (increase pharyngeal space by anterior mandibular repositioning), materials (medical grade acrylic and stainless steel), adjustability, method of manufacture (customized), and sterility (non-sterile) as its predicate devices.
Device material properties are suitable.	Material Properties: Data supporting general properties (water solubility and absorption) and physical properties (tensile and flexural strength, and elastic modulus) were provided. (Specific values are not detailed in the summary).
Device poses no new safety concerns.	Risk Analysis: A risk analysis found no new safety concerns specific to the Gergen's Orthodontic Acrylic Herbst Appliance.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. No clinical test set was used for the subject device's clearance. The clearance is based on substantial equivalence to predicate devices, not on a direct clinical study of the subject device.
Data Provenance: Not applicable for a clinical test set. The data provenance for material properties is not specified beyond "provided in support of clearance."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical test set was used for this device's clearance.

4. Adjudication method for the test set

Not applicable. No clinical test set was used for this device's clearance.

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. This device is an anti-snoring appliance, not an AI-powered diagnostic tool, and no MRMC study was performed.

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

Not applicable for clinical performance. The "ground truth" for the device's clearance is its demonstrated similarity in intended use and technological characteristics to legally marketed predicate devices, which are presumed safe and effective.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" that proves the device meets "acceptance criteria" (in the context of this 510(k) submission) is a comparison to predicate devices (Allesee Orthodontic Appliances, Inc. (K070327), Specialty Appliances Works, Inc. (K083209), Dynaflex Inc. (K103076), and Embassy Dental (K111009)). The submission states:

"Clinical testing of the subject device was not used in support of clearance."

"The fundamental scientific technology of the Gergen's Orthodontic Acrylic Herbst Appliance is the same as previously cleared devices... i.e., each of the design features is common to one or more of the predicate devices."

"In comparison to the predicate devices, the Acrylic Herbst Appliance has

the same intended use (as described above),
the same technological characteristics (as described above)
and so does not raise new questions of safety and effectiveness."

Therefore, the "proof" is the argument for substantial equivalence based on shared fundamental technology, intended use, and material properties, rather than direct clinical performance data for the subject device itself.

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