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510(k) Data Aggregation
(87 days)
The Invacare Twilight Full Face Mask is intended to be used with positive airway pressure (PAP) devices, such as CPAP and Bi-Level, which provide 4-20 cmH2O for the treatment of adult obstructive sleep apnea. There is a port on the mask to allow for pressure measurement. The mask is to be used on adult patients (>30 kg) for whom positive airway pressure therapy has been prescribed. The mask is intended for single or multiple patient re-use.
The Twilight full Face Mask consists of a mask that fits over the nose and mouth of a patient and a headgear to hold the mask in place. The mask has a removable molded silicone cushion that seals around the patient's nose and mouth. The cushion mounts to a rigid clear plastic frame. The frame has built in exhalation ports, a full swivel for locating the pressure device hose, a tubing swivel to allow for twisting of the hose, and a built in anti-asphyxia valve to allow the inner volume of the mask to be open to the outer atmosphere when there is no pressure being supplied by the flow generator device. Mounted to the frame is an adjustable forehead support for resting against the patient's forehead. The headgear has quick release clips and loop adjustment on the straps.
The provided document describes a 510(k) Pre-market Notification for the Invacare Twilight Full Face Mask, which aims to demonstrate substantial equivalence to legally marketed predicate devices rather than necessarily proving the device meets specific acceptance criteria in a quantitative performance study. The document focuses on comparing the proposed device's specifications and intended use to those of existing devices.
Therefore, the requested information elements related to detailed study methodologies (sample size, ground truth, expert adjudication, MRMC studies, training sets) are largely not applicable in the context of this 510(k) submission, as it relies on a comparison of device characteristics and adherence to general performance standards rather than a clinical efficacy trial.
However, I can extract the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The "Acceptance Criteria" here are implicitly defined by the specifications of the predicate devices. The "Reported Device Performance" is the Invacare Twilight Full Face Mask's own specifications. Substantial equivalence is demonstrated by showing that these specifications are comparable.
| Specification | Invacare Twilight Full Face Mask (Reported Performance) | ResMed Mirage Full Face Mask Series 2 (Predicate) | Respironics Spectrum 2 Reusable Full Face Mask (Predicate) | Acceptance Criteria (Implied by Predicates) |
|---|---|---|---|---|
| Intended Use | With PAP devices (CPAP/Bi-Level, 4-20 cmH2O) for adult (>30kg) obstructive sleep apnea. Single/multiple patient re-use. | Multi-patient use for adult (>30kg) CPAP/bi-level therapy. | Adults with Respironics CPAP/bi-level devices. Covers nose/mouth. Built-in exhalation. Single/multiple patient re-use. | Comparable intended use for adult obstructive sleep apnea with PAP devices in the 4-20 cmH2O range, suitable for single or multiple patient re-use. |
| Patient Use | Adults >30Kg | Adults >30Kg | Adults | For adult patients, generally >30kg. |
| Single/Multiple Patient Use | Multiple-patient | Multiple-patient | Multiple-patient | Multiple-patient re-use. |
| Input Device Range | 4-20 cmH2O | 4-20 cmH2O | 3-40 cmH2O | Within a clinically acceptable range for PAP therapy, generally including 4-20 cmH2O. |
| Mask Frame Material | Polycarbonate | Polycarbonate | Polycarbonate | Biocompatible and durable material, such as polycarbonate. |
| Nasal Cushion Material | Silicone | Silicone | Silicone | Biocompatible and comfortable material, such as silicone. |
| Anti-asphyxia Valve | Yes - silicone | Yes - silicone | Yes - silicone | Presence of an anti-asphyxia valve, typically silicone. |
| Hose Connection Input | For Ø22mm hose | For Ø22mm hose | For Ø22mm hose | Standard Ø22mm hose connection. |
| Exhalation Ports | 5 | 6 | 44 | Sufficient exhalation ports to prevent re-breathing (specific number may vary but must be effective). |
| Swivel Connections | 360° Rotation | 360° Rotation | 360° Rotation | 360° rotation for hose flexibility. |
| Ports | 1 port (for pressure measurement) | 2 ports | 1 port (for pressure measurement) | At least one port for pressure measurement. |
| Exhaust Flow | 23 LPM @ 4 cmH2O53 LPM @ 20 cmH2O | 22 LPM @ 4 cmH2O54 LPM @ 20 cmH2O | Below 5 cmH2O, unknown~ 43 LPM @ 20 cmH2O | Comparable exhaust flow rates to ensure proper CO2 washout, particularly at common therapy pressures. |
| Pressure Drop at patient connection | < 0.3 cmH2O @ 50 LPM< 1.0 cmH2O @ 100 LPM | Unknown (for predicate devices) | Unknown (for predicate devices) | Low pressure drop across the mask to ensure effective therapy delivery, likely conforming to relevant standards (e.g., ISO 17510-2 requirements). |
| Internal volume (Dead space) | < 303ml (varies by size) | < 258mL (varies by size) | 274ml - 428ml (varies by size) | Internal volume (dead space) within a clinically acceptable range to minimize re-breathing of exhaled gases, varying by cushion size. |
The study proving the device meets these "acceptance criteria" is the 510(k) submission itself, which argues for substantial equivalence. The document states: "The performance data found in this submission shows that the Invacare Full Face Mask performs as intended and in a manner that is substantially equivalent to the predicate devices." This substantial equivalence argument is supported by the detailed comparison table and performance testing against recognized standards.
Specifically, the device performance was evaluated against the following standards:
- ISO 17510-2:2003: Sleep apnoea breathing therapy - Part 2: Masks and application accessories
- ISO 5356-1:2004: Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets
- ISO 13485:2003: Medical devices - Quality management systems -- Requirements for regulatory purposes
- ISO 14971:2000 (Amendment 2003): Medical devices -- Application of risk management to Medical Devices
- EN 980:2003: Graphical symbols for use in the labeling of medical devices
- EN 1041:1998: Information supplied by the manufacturer with medical devices
These standards represent the "acceptance criteria" for the performance and safety aspects of the mask, and conformance to them is asserted by the manufacturer.
Information Not Applicable or Not Provided in the Document:
Due to the nature of a 510(k) submission predominantly focused on substantial equivalence to predicate devices and adherence to recognized standards, the following detailed study methodologies are not described or are not relevant to this type of regulatory filing.
- Sample size used for the test set and the data provenance: Not applicable. Performance testing typically involves engineering tests on prototypes/production samples, not a clinical "test set" in the sense of patient data for a diagnostic algorithm. No country of origin for such data is specified beyond the device being from Invacare Corporation in Elyria, Ohio, USA. The testing is laboratory-based, not retrospective/prospective patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth in this context refers to engineering specifications and performance benchmarks from international standards, not expert clinical assessment of a diagnostic outcome.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 is a medical device (face mask), not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device (face mask), not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for the device's performance is adherence to the specified technical parameters (e.g., exhaust flow, pressure drop, internal volume) and compliance with relevant international standards (ISO, EN). This is established through engineering testing and quality management systems.
- The sample size for the training set: Not applicable. This is a medical device, not an AI/machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
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(88 days)
Incision, excision, vaporization, ablation and coagulation of oral soft tissues including: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Laser Assisted Uvulopaletoplasty (LAUP) This laser is effective for cutting, ablating, coagulating and removing oropharangeal soft tissue that has been diagnosed as anatomically abnormal or naturally occurring hypertrophic which has been identified and confirmed as being associated with chroninc palatal snoring. Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Reduction of bacterial level (decontamination) and inflammation Soft tissue crown lengthening Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Treatment of aphthous ulcers Vestibuloplasty
Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Examples: Removal of beningn lesions from ear, nose and throat. Excision and vaporization of vocal cord nodules and polyps. Incision and excision of carcinoma in-situ. Ablation and vaporization of kyperkeratosis. Excision of carcinoma of the larynx. Laryngeal papillomectomy. Excision and vaporization of herpes simplex I and II.
Arthroscopy: Hemostasis, incision, excision, vaporization and ablation of joint tissues during arthroscopic surgery. Examples: Menisectomy Synovectomy Chondromalacia
Gastroenterology: Hemostasis, incision, excision and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Examples: Hemostasis of upper and lower GI bleeding Excision and vaporization of colorectal carcinoma Excision of polyps
General Surgery, Dermatology & Plastic Surgery, and Podiatry: Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue and dermabrasion. Examples: Matrixectomy Excision of neuromas Excision of periungual and subungual warts Excision of plantar warts Excision of Keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillary hemangioma Excision, vaporization & hemostasis of abdominal tumors Excision, vaporization & hemostasis of rectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs
GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Examples: Hemorrhoidectomy Excision, vaporization, and hemostasis of rectal pathology Excision, vaporization, and hemostasis of abdominal tumors
Gynecology: Ablation, excision, hemostasis and vaporization of tissue. Examples: Endometrial ablation Excision or vaporization of condylomata acuminata Vaporization of CIN (cervical intraepithelial neoplasia) Cervical conization Menorrhagia
Neurosurgery: Hemostasis of tissue. Example: Hemostasis in conjunction with meningiomas
Ophthalmology: Retinal photocoagulation Diabetic retinopathy
Pulmonary Surgery: Hemostasis, vaporization, and excision of tissue. Examples: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction
Urology: Hemostasis, vaporization and excision of tissues. Examples: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia.
The Twilight™ dental diode laser system may be used to perform several dental applications. Twilight™ uses advanced laser technology to incise, excise and ablate intraoral soft tissues safely and effectively. A Gallium Aluminum Arsenide (GaAIAs) solid state laser diode provides optical energy to oral soft tissues. A flexible fiberoptic handpiece delivers the Twilight™ laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and pulse may be adjusted to specific user requirements.
The provided document is a 510(k) premarket notification for a medical device called "Twilight™," a dental diode laser system. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a de novo study with specific acceptance criteria and performance data.
Therefore, many of the requested sections (acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and detailed ground truth for test and training sets) are not explicitly available in this type of submission.
The core of this 510(k) is to establish that the Twilight™ laser is "substantially equivalent" to predicate devices already on the market. This often means demonstrating similar technological characteristics, intended uses, and safety profiles, rather than conducting new clinical trials to prove efficacy against specific, new acceptance criteria.
However, based on the information provided, here's what can be inferred and stated regarding your request:
1. A table of acceptance criteria and the reported device performance
This document does not specify quantitative acceptance criteria or report specific device performance metrics (e.g., success rates, precision, accuracy) from a dedicated study. The "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating substantial equivalence to predicate devices, meaning it performs similarly and is as safe and effective for its indicated uses.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (Implicit from Substantial Equivalence Claim) |
|---|---|
| Safe and effective operation for indications for use. | The device "incise, excise and ablate intraoral soft tissues safely and effectively." "Twilight™ performs through the same mechanism as other diode laser technologies." |
| Equivalent performance specifications to predicate devices. | Stated as "Equivalent performance specifications." |
| Equivalent intended uses to predicate devices. | Stated as "Equivalent intended uses." |
| Equivalent mechanism of action to predicate devices. | Stated as "performs through the same mechanism as other diode laser technologies." |
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 for Test Set: Not applicable/Not provided. This submission does not describe a clinical study with a "test set" in the context of evaluating novel performance. Instead, it relies on the known performance and safety of predicate devices.
- Data Provenance: Not applicable/Not provided. No specific study data is presented. The "evidence of equivalence" is based on comparing the Twilight™ device's specifications and intended uses to those of existing, FDA-cleared predicate devices.
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)
- Number of Experts: Not applicable/Not provided. No clinical study requiring expert-established ground truth is described.
- Qualifications of Experts: Not applicable/Not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/Not provided. No clinical study requiring adjudication is described.
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
- MRMC Study: Not applicable. This document pertains to a medical device (laser system) and not an AI/imaging diagnostic device that would typically involve human readers or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Not applicable. This document is for a physical medical device (laser system), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable/Not provided. No new ground truth was established for this submission. The "ground truth" for demonstrating substantial equivalence rests on the established safety and effectiveness of the predicate devices for their approved indications.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/Not provided. No training set for an algorithm is relevant to this device submission.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable/Not provided.
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