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510(k) Data Aggregation
(444 days)
The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment choice.
The iNAP One Sleep Therapy System consists of six (6) main components. The components include a console (Model R07-A), a saliva container, a saliva absorbent (iNAP DryPad), a flexible polymer tubing (iNAP Tubing Set), soft polymer oral interfaces (iNAP Oral Interface), a Muffler (Optional) and a software application for mobile devices (iNAP Lab+). One additional accessory set (102C) is included, which is a combination of the iNAP Oral Interface and iNAP Tubing Set. The function of iNAP One Sleep Therapy System (Console Model: R07-A) is to develop a negative pressure gradient in user's oral cavity which can be adjusted between -20 to -90 mmHg (-27 to -122 cmH2O) via the App (iNAP Lab+) to achieve or maintain proper vacuum pressure for users.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the iNAP One Sleep Therapy System are primarily focused on its pressure setting range, accuracy, and clinical performance in treating Obstructive Sleep Apnea (OSA). The reported device performance is based on the clinical study described.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Adjustable Pressure Range | -20 to -90 mmHg (-27 to -122 cmH2O) |
| Pressure Accuracy | ±5 mmHg (±6.8 cmH2O) |
| Clinical Efficacy for OSA | In a subgroup of 18 subjects treated within the intended pressure range (-20mmHg to -90mmHg):- 72.2% (13 subjects) achieved a successful response (treated AHI < 5).- 22.2% (4 subjects) achieved a partial response (AHI reduction > 50% from baseline and treated AHI < 15).- Mean Baseline AHI: 36.01 ± 15.87- Mean Treated AHI: 5.53 ± 9.53 (P-value < 0.001 based on paired-t test). |
| Safety Profile | No adverse events reported in the clinical study. |
| Non-inferiority to Predicate Device (K193460) | Performance determined to be non-inferior. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: 30 OSA patients were initially enrolled in the clinical study. A subgroup analysis was performed on 18 subjects who received iNAP treatment within the intended pressure range of -20mmHg to -90mmHg.
- Data Provenance: Not explicitly stated, but the submission is from Somnics, Inc., located in Taiwan, and the regulatory consultant is in San Juan Capistrano, CA, USA. The study is described as a "clinical study," which implies it was a prospective study conducted for the purpose of evaluating the device. The specific country of origin for the patient data is not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text states that Polysomnogram (PSG) was used to evaluate inclusion criteria (AHI > 5), baseline AHI, and post-treatment AHI after 28 days of therapy. While PSG is the gold standard for diagnosing OSA and establishing AHI, the document does not specify the number of experts (e.g., sleep specialists, polysomnographic technologists) used to interpret these PSG studies or their specific qualifications.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for establishing the ground truth from the PSG results. It can be inferred that the PSG interpretations likely followed standard clinical protocols for sleep studies, which inherently involve expert interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any evaluation of human readers improving with AI assistance. The device is a "Sleep Therapy System" that generates negative pressure for OSA treatment, not an AI-assisted diagnostic tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The device itself is a physical therapy system, not an algorithm. Therefore, a "standalone algorithm only" performance evaluation, as might be done for an AI diagnostic tool, is not applicable in this context. The clinical study evaluates the performance of the device in use by patients.
7. The Type of Ground Truth Used
The ground truth for evaluating the device's efficacy was established using Polysomnogram (PSG), which is considered the gold standard for diagnosing and quantifying Obstructive Sleep Apnea (OSA). The key metric used was the Apnea-Hypopnea Index (AHI).
8. The Sample Size for the Training Set
The document does not mention the existence of a "training set" in the context of machine learning. The clinical study described is an evaluation of the device's performance after its development, not a study to train an algorithm.
9. How the Ground Truth for the Training Set was Established
As no training set (in the machine learning sense) is mentioned, this question is not applicable. The clinical study serves to demonstrate the safety and effectiveness of the device itself.
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(162 days)
The iNAP One Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults in whom positive airway pressure is not the preferred treatment choice.
The iNAP One Sleep Therapy System consists of six (6) main components. The components are a console, a saliva container, a saliva absorbent (iNAP DryPad), a flexible polymer tubing (iNAP Tubing Set), a soft polymer oral interface (iNAP Oral Interface) and a software application for mobile devices (iNAP Care). One additional accessory is Oral Interface with Tubing, which is a combination of the Oral Interface and Tubing Set. The function of iNAP One Sleep Therapy System is developing a negative pressure gradient in the user's oral cavity, which is set as -40 mmHg.
Please find below the requested information about the acceptance criteria and study proving the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria | Reported Device Performance (iNAP One Sleep Therapy System) |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 series for patient contact materials. | All biocompatibility tests (Cytotoxicity, Skin Sensitization, Oral Mucosa Irritation, Pyrogenicity, Leechable & Extractables) passed for all relevant components (Oral Interface, Tubing Set, Oral Interface with Tubing Set). |
| Bench Testing | Substantial equivalence to predicate device (Winx) in negative pressure application and maintenance. | Substantially equivalent to Winx device in negative pressure application and maintenance. |
| Acoustics | Acoustic power < 30 dB per ISO 7779. | Acoustic power < 30 dB per ISO 7779:2010. |
| Software | Software verification and validation (FDA Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"). Level of concern: "major". | Software verification and validation conducted; documentation provided as recommended by FDA guidance. |
| Clinical Performance | Non-inferiority to predicate device (Winx mouthpiece) regarding clinical performance; lower incidence of adverse events; durable beneficial effect over 28-30 days. | Clinical performance non-inferior to Winx mouthpiece. Incidence of adverse events and serious adverse events was lower compared to Winx/Winx+ mouthpieces. Beneficial effect durable over 28-30 days. |
| Negative Pressure Setting & Accuracy | 40 mmHg (±10%) | 40 mmHg (±10%) |
| Electrical Safety | Compliance with IEC 60601-1: Class II Equipment, Type BF, IP22, Continuous Operation. | Compliance with IEC 60601-1: Class II Equipment, Type BF, IP22, Continuous Operation. (Note: Predicate device was IPX0, but no additional risks induced). |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Compliance with IEC 60601-1-2. |
| Safety for Home Environment | Compliance with IEC 60601-1-11. | Compliance with IEC 60601-1-11. |
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 mentions two randomized studies for clinical testing:
- One performed in Taiwan.
- The other, a multicenter international study with sites in Germany, Taiwan, and the United States.
The specific sample size (number of participants) for these clinical studies, nor whether they were retrospective or prospective, is not explicitly stated in the provided text. However, randomized studies are generally prospective.
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)
The provided text does not explicitly state the number of experts used or their specific qualifications for establishing ground truth in the clinical studies. The clinical studies likely used objective measures (e.g., polysomnography data for OSA severity, adverse event reports) rather than expert consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for the clinical test set data. Given the nature of OSA treatment effectiveness and adverse event reporting, it's more likely that predefined clinical endpoints and safety criteria were used rather than a consensus-based adjudication for subjective interpretations.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device (iNAP One Sleep Therapy System) is a treatment device for Obstructive Sleep Apnea, not a diagnostic imaging device involving human readers or AI assistance in image interpretation. The study focused on the effectiveness of the physical device compared to a predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the iNAP One Sleep Therapy System is a physical medical device for treating OSA, not an algorithm, and it operates with a human user (the patient). The software component (iNAP Care mobile app) is for tracking usage records and sealing-leakage time ratio, not for standalone diagnostic or therapeutic action.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the clinical studies, the ground truth would have been established through outcomes data, including:
- Measures of Obstructive Sleep Apnea severity (though specific metrics like AHI are not detailed in this summary, they are standard for OSA studies).
- Adverse event data for safety comparison.
- Patient compliance and usage data.
8. The sample size for the training set
The document does not mention a training set in the context of device performance evaluation. The clinical studies were randomized trials comparing the subject device to a predicate, not machine learning model training.
9. How the ground truth for the training set was established
This question is not applicable as there is no mention of a training set for machine learning or AI algorithm development in the provided text.
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(347 days)
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
The Winx Sleep Therapy System consists of four (4) main components and two (2) sizing methods. The components are: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports. The sizing methods include: a sizing template and an iPhone sizing application (Winx Mouthpiece Sizing Application). The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Winx Sleep Therapy System (Winx+ Mouthpiece)
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary focuses on demonstrating substantial equivalence of the Winx+ mouthpiece to the predicate Winx mouthpiece, rather than setting entirely new, independent acceptance criteria for the Winx+ system. However, specific performance targets and safety metrics were evaluated.
Clinical Performance Acceptance Criteria (derived implicitly from non-inferiority claims):
| Performance Metric | Acceptance Criteria (for Winx+ to be non-inferior to Winx) | Reported Device Performance (Winx+ Mouthpiece) |
|---|---|---|
| Effectiveness (Primary Endpoint): | ||
| Clinical Success Rate (First Night) | Non-inferiority to Winx mouthpiece, defined as AHI reduction of >50% compared to control PSG AND treatment AHI < 20 events per hour, with a delta (margin) set at -0.20 (i.e., Winx+ success rate should not be more than 20% lower than Winx, with statistical significance) | 63.3% (19 of 30 subjects met clinical success criteria) against Winx's 40.0%. P<0.0001 for non-inferiority vs. Winx (with delta = -0.20). |
| Clinical Success Rate (Last Treatment Night - Long-term) | Non-inferiority to a proportion of 40% (likely the predicate's established performance based on previous studies), with a delta (margin) of -0.20. (This implies that for extended use, the Winx+ should maintain a success rate not more than 20% lower than the predicate's established long-term performance). | 78.3% (18 of 23 subjects met clinical success criteria). P<0.001 for non-inferiority against a proportion of 40% (with delta = -0.20). |
| Safety: | No new safety issues identified. No serious or severe adverse events (AEs) related to the device. Minimal, self-resolving adverse events with no need for medical intervention or prescription medication. | No serious or severe AEs reported. 75% of AEs were mild, 25% moderate. All AEs resolved without medical intervention or prescription medication. Mean duration of AEs: 8.4 ± 9.3 days. |
Non-Clinical Performance Criteria (for Winx Sleep Therapy System using Winx+ Mouthpiece):
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Design Verification | Meet engineering specifications (performance, strength, reliability, life, component compatibility) | Pass |
| Electrical Safety | Pass IEC 60601-1 and 60601-1-2 | Pass |
| Biocompatibility | Pass ISO 10993-1 (cytotoxicity, sensitization, oral irritation) | Pass |
| Environmental | Pass environmental testing | Pass |
| Shipping | Pass D4169-09 | Pass |
| Acoustics | Pass ISO 7779 | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" refers to the subjects enrolled in the clinical studies evaluating the Winx+ mouthpiece.
-
Randomization Study (comparing Winx+ vs. Winx):
- Sample Size: 30 subjects for each mouthpiece type (implied, as 12 of 30 for Winx and 19 of 30 for Winx+ are reported).
- Data Provenance: Not explicitly stated, but clinical studies for FDA submissions typically involve data from within the US or compliant international sites. The lack of specific country information points to a standard clinical trial setting. The study design (randomized, crossover) indicates a prospective collection of data.
-
Extension Study (long-term Winx+ follow-up):
- Sample Size: 23 subjects (18 of 23 achieved success). This study was a 30-day extension of subjects who likely participated in the initial phase or were new enrollees for long-term evaluation. 24 of 29 subjects completed the 30-day home-use period.
- Data Provenance: Not explicitly stated regarding country, but likely the same as the Randomization Study. This was also a prospective collection of data, following subjects over time.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The primary endpoint (Clinical Success) was based on objective physiological measurements: Apnea-Hypopnea Index (AHI) determined by Polysomnography (PSG).
- Number of Experts: Not explicitly stated how many experts reviewed each PSG. However, PSG studies are typically scored by trained and certified sleep technologists, often overseen or interpreted by a Board-Certified Sleep Physician. The document does not specify if multiple independent scorers were used for adjudication.
- Qualifications of Experts: Assumed to be qualified sleep technologists and/or sleep physicians who are experts in interpreting PSG data according to established clinical guidelines for OSA diagnosis and severity. Specific years of experience are not mentioned.
4. Adjudication Method for the Test Set
The ground truth was established by Polysomnography (PSG) readings, with the primary endpoint being "Clinical Success" defined by specific AHI criteria (AHI reduction > 50% and treatment AHI < 20 events per hour).
The document does not explicitly describe an adjudication method for disagreements in PSG scoring if multiple scorers were used. It is standard practice for PSG labs to have quality control and review processes in place, but a formal (e.g., 2+1 or 3+1) adjudication method for the study's ground truth derivation is not detailed. The AHI is an objective metric derived from PSG parameters, generally reducing the need for subjective adjudication found in image-based diagnoses.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done.
This type of study is more common for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Winx Sleep Therapy System is a treatment device, and its effectiveness was measured by objective physiological outcomes (AHI from PSG) rather than human interpretation of data. The "comparison" was between two device configurations (Winx vs. Winx+ mouthpiece) in treating patients, not a comparison of human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
The Winx Sleep Therapy System is a medical device, not an AI algorithm. Therefore, the concept of a "standalone" study for an algorithm does not directly apply here.
The device itself operates autonomously, generating negative pressure. The "study" evaluated the device's performance when used by patients, with outcomes measured by clinicians using standard diagnostic tools (PSG). The comparison was between two versions of the device's mouthpiece (Winx vs. Winx+), effectively testing one device (Winx+) in a "standalone" therapeutic capacity against its predicate (Winx).
7. The Type of Ground Truth Used
The ground truth for evaluating effectiveness was based on objective physiological data from Polysomnography (PSG).
- Specifics: The primary endpoint, "Clinical Success," was defined by an Apnea-Hypopnea Index (AHI) reduction of >50% (comparing treatment PSG to control PSG) and a treatment AHI of <20 events per hour. This is a widely accepted clinical metric for Obstructive Sleep Apnea (OSA) severity and treatment success.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of an AI algorithm development. The Winx Sleep Therapy System is a physical device.
If we interpret "training set" broadly as the data used to initially develop or refine the device design before the pivotal clinical studies, that information is not provided. The provided text focuses on the clinical studies (Randomization and Extension) used for regulatory submission and demonstrating substantial equivalence.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a "training set" for an AI algorithm, or detailed information about the early development data for the physical device, this information is not available in the provided text. The non-clinical performance data (design verification, electrical, biocompatibility, etc.) were conducted to evaluate the device against engineering specifications and regulatory standards, which serve as foundational "ground truths" for safe and effective device design.
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(82 days)
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
The Winx Sleep Therapy System consists of four (4) main components and two (2) sizing methods. The components are: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports. The sizing methods include: a sizing template and an iPhone sizing application (Winx Mouthpiece Sizing Application). The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
The provided text is a 510(k) summary for the Winx Sleep Therapy System, which is an intraoral device for obstructive sleep apnea. It describes the device, its intended use, and states that it is substantially equivalent to a predicate device based on performance data from bench testing.
However, the document does not contain the following information:
- A table of acceptance criteria and reported device performance. The document only states that "Results of bench testing demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate." It does not provide specific performance metrics or acceptance thresholds.
- Details about any clinical study, including sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies. The approval explicitly states it's based on "bench testing" and not clinical trial data.
- Sample sizes for training sets. As there's no mention of a clinical study or an AI/algorithm-only performance evaluation, this information is not applicable and not present.
Therefore, many of your specific questions cannot be answered from the provided text. The document refers to "Performance Data" but then immediately states that "Results of bench testing demonstrate..." This indicates that the evaluation for substantial equivalence was primarily based on non-clinical (bench) testing, not on human clinical trials that would involve the collection of efficacy data against specific acceptance criteria.
Summary of available information vs. requested information:
- A table of acceptance criteria and the reported device performance: Not provided. The document states "Results of bench testing demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate" but does not quantify performance or acceptance criteria.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable/Not provided. The evaluation was based on bench testing, not a clinical test set.
- 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. No clinical test set.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided. No clinical test set.
- 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/Not provided. This device is for sleep therapy, not an AI diagnostic imaging tool; therefore, MRMC studies are not relevant in this context and not mentioned.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable/Not provided. No mention of an AI algorithm being evaluated.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided. The evaluation was based on a comparison to a predicate device via bench testing, not clinical outcomes or expert ground truth.
- The sample size for the training set: Not applicable/Not provided. No AI algorithm is mentioned, and therefore no training set.
- How the ground truth for the training set was established: Not applicable/Not provided. No AI algorithm and no training set.
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(105 days)
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
The Winx Sleep Therapy System consists of four (4) main components: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports. The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
The provided text does not contain detailed acceptance criteria, device performance data in a quantitative format, or descriptions of studies that prove the device meets specific acceptance criteria. The document is primarily a 510(k) summary for regulatory clearance, focusing on substantial equivalence to a predicate device.
However, based on the information provided, here's what can be extracted and what is explicitly not available:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific, quantitative acceptance criteria or corresponding device performance values are reported in the provided text. The document broadly states: "Performance testing demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate." This is a general statement, not a table of specific metrics.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided in the text. There is no mention of a specific "test set" or its size, nor is there any information about the country of origin of data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not provided in the text. There is no mention of experts, ground truth establishment methods, or their qualifications.
4. Adjudication Method for the Test Set:
This information is not provided in the text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided in the text. There is no mention of a comparative effectiveness study involving human readers or the effect size of AI assistance. The device in question is a physical device (intraoral pressure device), not an AI algorithm for interpretation.
6. Standalone (Algorithm Only) Performance Study:
This information is not provided in the text. The device is a physical system, not an algorithm, so a "standalone" algorithmic performance study is not applicable in the way it would be for AI software.
7. Type of Ground Truth Used:
This information is not provided in the text. Given the nature of a physical device for OSA treatment, "ground truth" would typically refer to clinical outcomes (e.g., AHI reduction) measured by polysomnography, but this is not mentioned.
8. Sample Size for the Training Set:
This information is not provided in the text. There is no mention of a "training set" as this device is not an AI/ML algorithm that requires training data in the conventional sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided in the text. As there's no training set mentioned, the establishment of ground truth for it is also not discussed.
Summary of what is present:
- Indications for Use: The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
- Substantial Equivalence: The device claims substantial equivalence to the 'Attune Sleep Apnea System' (K111549).
- Performance Claim: "Performance testing demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate." This is a general statement required for regulatory submission.
To reiterate, the provided text is a regulatory filing summary for a physical medical device, not a scientific publication detailing comprehensive performance studies with acceptance criteria, sample sizes, and ground truth methodologies often associated with AI/ML device evaluations.
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(301 days)
The Attune Sleep Apnea System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
The Attune Sleep Apnea System consists of three (3) main components: a small electronic bedside console, a soft polymer mouthpiece, and a flexible polymer tube that connects the mouthpiece to the console. A mouthpiece holder is provided for mouthpiece storage and use during weekly system cleaning.
The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
Console: The console generates a gentle negative pressure, collects excess saliva, records patient use time, and monitors pressure. The console is provided with a power cord, which connects to a standard electrical outlet. An optional laboratory console is available for use in a sleep laboratory. The laboratory console includes wires that extend from the console. The wires connect to the sleep laboratory's polysomnography (PSG) system, allowing the sleep technicians to view the console's pressure on the same monitor as the other PSG channels.
Mouthpiece: The mouthpiece is provided in ten (10) discrete sizes. Sleep technicians use a bite wax to obtain an impression of each patient's teeth and a sizing template to determine the best mouthpiece size.
Tubing: The tubing connects to the console by screwing into the console base and to the mouthpiece with luer connectors.
Use: The patient connects the system and places the mouthpiece in his or her mouth. The mouthpiece is worn during sleep. The console generates a gentle, negative pressure, which is delivered through the mouthpiece into the oral cavity and holds the tongue and soft palate out of the airway.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Prospectively Defined) | Reported Device Performance |
|---|---|
| AHI reduction of > 50% | Clinical Success observed in 41.3% of the Primary Endpoint Cohort (based on AHI reduction and treated AHI) |
| Treated AHI < 20 | Included in the definition of Clinical Success |
Note: The document explicitly states "Clinical Success was prospectively defined as AHI reduction of > 50% and treated AHI < 20." The reported device performance for these criteria is intertwined within the "Clinical Success" rate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 63 subjects in the Primary Endpoint Cohort.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the study was described as a "multi-center" trial, suggesting it likely took place across several locations, possibly within the United States given the FDA submission.
- Retrospective or Prospective: Prospective. The study is described as "a four-week, multi-center, prospective, open label, randomized first-night order of control vs. treatment, single-arm trial."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text does not detail how the AHI (Apnea-Hypopnea Index) measurements were established or adjudicated for the clinical trial, nor does it mention the involvement or qualifications of experts for this purpose.
4. Adjudication Method for the Test Set
This information is not provided in the document. The text does not describe any specific adjudication method (e.g., 2+1, 3+1) used for the clinical trial results.
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
This information is not applicable/not provided. The device described is the "Attune Sleep Apnea System," which is an intraoral device for treating sleep apnea, not an AI or imaging diagnostic tool that would typically involve human readers or MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable/not provided. The device is a physical intraoral system, not an algorithm. Therefore, a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
The ground truth used for assessing the device's effectiveness was based on physiological measurements of sleep apnea, specifically:
- AHI reduction of > 50%
- Treated AHI < 20
These measurements are standard metrics derived from polysomnography (PSG) studies, which are considered the gold standard for diagnosing and assessing the severity of sleep apnea. The document mentions "polysomnography (PSG) system" in relation to the laboratory console, implying PSG was the method for collecting relevant data.
8. The Sample Size for the Training Set
This information is not explicitly provided as this type of device (physical medical device) typically undergoes traditional clinical trials, not machine learning model training. The concept of a "training set" in the context of AI/ML is not directly relevant here. However, the document does mention "two feasibility studies" that preceded the pivotal trial.
9. How the Ground Truth for the Training Set Was Established
As with point 8, the concept of a "training set" and its ground truth establishment in an AI/ML context is not directly applicable. For the clinical trials, the "ground truth" (i.e., the actual AHI values) would have been established through standard clinical diagnostic procedures, likely polysomnography, as accepted in sleep medicine.
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