Search Results

The D R Burton® OxyPAP™ device is indicated for the treatment and prevention of atelectasis. It also has the ability to provide supplemental oxygen when used with compressed oxygen. It includes the option of a pressure manometer. The device is for patients (ages 5 years and above) who are capable of following directions for positive airway pressure (PAP) therapy.

Normal use of the D R Burton OxyPAP™ should not be more than 24 hours total combined time.

The environment of use is for hospital and clinical setting.

The OxyPAP device is a handheld respiratory therapy device that creates a positive airway pressure. The OxyPAP device is intended to be used by pediatric (ages 5 years and above) and adult patients in the hospital environment, under the supervision of a healthcare professional. The OxyPAP device is a single patient use device.

The provided text describes the D R Burton OxyPAP device, its indications for use, and a comparison to predicate and reference devices for a 510(k) submission. However, this document does not contain any information about acceptance criteria, a specific study proving the device meets these criteria, or details regarding AI/algorithm performance and ground truth establishment.

The document is a US FDA 510(k) clearance letter and summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a dedicated standalone study. The "Performance" and "Non-clinical Comparative Performance" sections primarily describe comparative testing to show similarity to existing devices.

Therefore, I cannot fulfill all parts of your request based on the provided text. I will explain what information is present and what is missing.

Summary of what can be extracted from the document:

• Device Name: D R Burton OxyPAP
• Device Type: Incentive Spirometer, Positive Airway Pressure (PAP) Therapy Device
• Indications for Use: Treatment and prevention of atelectasis; ability to provide supplemental oxygen when used with compressed oxygen. For patients (ages 5 years and above) capable of following directions for PAP therapy. Normal use not more than 24 hours total combined time. Environment of use: hospital and clinical setting.
• Predicate Device: K991300 – DHD Healthcare Corp. – Boeing, Positive Airway Pressure (PAP) Therapy Device
• Reference Devices: K173819 – Trudell VersaPAP™ Device; K040991 – Ambu Disposable Pressure Manometer

Missing/Not Applicable Information based on the prompt's requirements:

The document focuses on substantial equivalence for a medical device that is not an AI/ML powered device. As such, information typically associated with AI/ML device validation studies (like distinct acceptance criteria for algorithm performance, expert review for ground truth, MRMC studies, training/test set details, etc.) is not present and not applicable to this type of device submission.

Specifically, the following sections of your request cannot be answered from the provided text:

• 1. A table of acceptance criteria and the reported device performance: The document presents comparative performance data (e.g., Mean PEEP, Mean Peak Expiratory Pressure), but these are comparisons to predicate/reference devices, not explicit acceptance criteria for a standalone study performance. There are no clear quantitative acceptance criteria stated for the D R Burton OxyPAP itself beyond being "substantially equivalent" to the predicate.
• 2. Sample size used for the test set and the data provenance: Not applicable as this is a physical device, not an algorithm being tested on a data set. The "bench testing" mentioned includes performance testing and drop testing, but no "sample size" in the context of data points.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like this is established through engineering and clinical performance testing, not expert review of AI outputs.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable. This is for an AI-assisted workflow, which is not the case here.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
• 7. The type of ground truth used: For a physical device, "ground truth" would refer to measured physical properties or clinical outcomes. The document discusses "Biocompatibility" (material certification to a legally marketed device) and "Bench Testing" (comparative performance, drop testing, effects of aging). These are the "truths" for this device.
• 8. The sample size for the training set: Not applicable. This is not an AI/ML device.
• 9. How the ground truth for the training set was established: Not applicable.

Information that is present (though not in the requested format for AI/ML devices):

• Device Performance Reported (Comparative, not against specific acceptance criteria):
  • Proposed OxyPAP:
    • Mean PEEP (cmH2O) @800 ml TV: 2.81 @ 5 Lpm, 12 @ 10 Lpm, 12.75 @ 15 Lpm
    • Mean Peak Expiratory Pressure (cmH2O) @800 ml TV: 15 Lpm / 15 cmH2O; 20 (400 TV) / 21 (800 TV)
    • Mean Inspiratory Pressure (cmH2O) @800 ml TV: -0.7 @ 5 Lpm, -4.7 @ 10 Lpm, -3.46 @ 15 Lpm
    • Mean Expiratory Pressure (cm H2O) @ 800 ml TV: 3.1 @ 5 Lpm, 12.1 @ 10 Lpm, 13 @ 15 Lpm
  • Predicate DHD EzPAP (for comparison):
    • Mean PEEP (cmH2O) @800 ml TV: 2 @ 5 Lpm, 8 @ 10 Lpm, 16 @ 15 Lpm
    • Mean Peak Expiratory Pressure (cmH2O) @800 ml TV: 15 Lpm / 15 cmH2O; 22 (400 TV) / 26 (800 TV)
    • Mean Expiratory Pressure (cm H2O) @ 800 ml TV: 5 @ 5 Lpm, 11 @ 10 Lpm, 20 @ 15 Lpm

The core conclusion of the document is that "Based upon the comparative performance testing we have demonstrated that the proposed device compared to the predicate and reference devices can be found to be substantially equivalent." This is the primary "acceptance criterion" for a 510(k) submission of this nature.

Ask a specific question about this device

The D R Burton iPEP Therapy System or vPEP is intended for use as a Positive Expiratory Pressure (PEP) by patients capable of generating an exhalation flow of 10 lpm for 3-4 seconds and an Incentive Spirometer as an inspiratory, deep breathing positive exerciser.

Intended for single-patient, multi-use.

iPEP System for hospital and clinical settings vPEP for hospital, clinical, and home care setting

D R Burton Healthcare as indicated above proposes to offer 2 devices which we will refer to as the:

• iPEP (integrated Incentive spirometer with PEP) system and ●
• . vPEP which is a standalone PEP therapy device

iPEP system

• Volumetric Incentive Spirometer up to 4000 cc
• Oscillatory PEP module (cartridge) ●

The design of the iPEP system permits the PEP cartridge to be removed and used as an independent PEP device, which we refer to as the Pocket PEP.

In order to use the Pocket PEP the iPEP system includes a separate mouthpiece, carrying / storage case and dust cover which are needed when one wants to use the PEP cartridge independent of the iPEP systems (Pocket PEP).

When the PEP cartridge is removed from the iPEP system, one can insert a cover where the PEP cartridge has been removed to allow the incentive spirometer to be used one its own.

vPEP

• The vPEP is the standalone device that is pre-assembled and is not intended to be used in the iPEP ● System. The vPEP incorporates the identical internal components of the PEP cartridge of the iPEP system.

The provided document is a 510(k) Summary for the D R Burton iPEP System and vPEP, which are devices intended for Positive Expiratory Pressure (PEP) therapy and as Incentive Spirometers. The study described is a non-clinical bench testing and usability study, focused on demonstrating substantial equivalence to predicate devices. There is no clinical study described.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents two comparison tables (Table 1 for PEP function, Table 2 for Incentive Spirometer function) comparing the proposed device against its predicates. The acceptance criteria for the proposed device are implicitly set by its performance falling within a certain range (e.g., 15%) of the predicate devices' performance.

Note on "Criteria within 15%": This phrase appears in Table 1 for Frequency and Amplitude/Pressure, suggesting that the proposed device's performance metrics were expected to be within 15% of the predicate device's values. The reported values for the iPEP and vPEP appear to meet this implicit criterion.

Additional Bench Testing:

• Aging, Simulated Life (cleaning), Drop Testing, Cleaning: Performed with pre- and post-exposure evaluation.
• Biocompatibility Materials: Cytotoxicity, sensitization, and irritation testing for materials with limited duration (<24 hours) patient contact.
• Usability Studies: Confirmed appropriate design and instructions for use for intended user groups.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Description: The "test set" for the non-clinical, comparative bench testing is not explicitly defined in terms of a specific number of units or data points beyond the flow rates (5 lpm and 25 lpm) at which measurements were taken. However, for "Usability Studies," there were at least 15 users per identified group (lay users and Healthcare Providers).
• Data Provenance: The data is generated from bench testing and usability studies conducted by D R Burton Healthcare LLC. This is prospective data from internal testing. There is no mention of country of origin for the data beyond the company's location in Farmville, North Carolina, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is largely not applicable as the described studies are non-clinical bench tests and usability tests.

• For the bench testing, the "ground truth" is established by direct measurement against engineering specifications and comparison to the performance of predicate devices per existing literature or internal testing of those devices. No independent clinical experts are mentioned for establishing ground truth in this context.
• For the usability studies, the "ground truth" (i.e., whether the device is usable and instructions are clear) is assessed by the performance and feedback of the users themselves. The document states "2 user groups, lay users and Healthcare Providers," but does not specify their individual qualifications beyond being "Healthcare Providers."

4. Adjudication Method for the Test Set

Not applicable as there is no mention of a formal adjudication process for establishing a "ground truth" from expert opinions for the non-clinical bench testing or usability studies. The bench tests rely on objective measurements, and usability studies on user feedback and performance.

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 medical instrument (incentive spirometer, PEP device), not an AI-powered diagnostic or interpretive tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not have an "algorithm" in the sense of AI or image analysis. Its performance is mechanical and measured directly in the bench tests described. The device's function is standalone in its mechanical operation, but it requires human interaction for its intended therapeutic purpose (patient breathing into it).

7. The Type of Ground Truth Used

• For PEP and Incentive Spirometer performance (frequency, amplitude, pressure, volume accuracy): The ground truth is based on direct physical measurements using calibrated equipment, compared to the established performance characteristics and specifications of the predicate devices.
• For Biocompatibility: Ground truth is established by standardized laboratory testing against accepted biological safety norms (cytotoxicity, sensitization, irritation).
• For Usability: Ground truth is established by observations of user interactions and user feedback against predefined usability metrics and risk analysis requirements.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical medical product. There is no mention or implication of a machine learning or AI model that would require a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set, there is no ground truth to establish for it.

Ask a specific question about this device

Temporary anchorage point for the attachment of Orthodontic appliances

Not Found

This document is a 510(k) clearance letter from the FDA for a dental implant, not a study evaluating a device's performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not present in the provided text.

The document states that the Infinitas Mini-Implant is substantially equivalent to legally marketed predicate devices. This equivalence determination is based on the device's indications for use: "Temporary anchorage point for the attachment of Orthodontic appliances."

Here's a breakdown of what can be extracted or inferred from the provided text, and what is missing:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in the document. The FDA determined the device is "substantially equivalent" to predicate devices, which implies that it meets certain safety and effectiveness standards, likely based on material properties, design, and intended use as compared to existing devices.
• Reported Device Performance: Not explicitly reported in terms of specific performance metrics within this document. The substantial equivalence determination is the primary "performance" reported by the FDA in this letter.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not provided. This document is an FDA clearance letter, not the submission itself. The data supporting the substantial equivalence would have been part of the K100633 submission, which is not included here.

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/Not provided. This type of information would be relevant for a clinical performance study using expert evaluation, which is not detailed in this clearance letter.

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

• Not applicable/Not provided. Similar to point 3, this is relevant for clinical studies not detailed here.

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 indication. This document refers to a physical device (mini-implant), not an AI algorithm. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• No indication. This document refers to a physical device (mini-implant), not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

• Not provided with explicit detail regarding a 'test set'. For a physical device like this, ground truth would relate to its physical properties (e.g., material strength, biocompatibility, dimensions) and potentially clinical outcomes in comparison to predicate devices, but the specific methodology for establishing this is not in the clearance letter.

8. The sample size for the training set:

• Not applicable/Not provided. This term typically refers to machine learning models, which is not the subject of this document. For a physical device, testing would involve samples of the device itself.

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

• Not applicable/Not provided.

Ask a specific question about this device

Temporary anchorage point for the attachment of orthodontic appliances

Not Found

The provided document is an FDA 510(k) clearance letter for the Infinitas Mini-Implant System. It does not contain information about acceptance criteria for a device's performance, nor does it describe any study that proves a device meets such criteria.

The document primarily focuses on:

• Stating that the device is substantially equivalent to legally marketed predicate devices.
• Listing the regulation number, name, and product code.
• Outlining the general controls and additional controls that may apply.
• Providing contact information for regulatory guidance.
• Stating the intended use of the device ("Temporary anchorage point for the attachment of orthodontic appliances").

Therefore, I cannot answer your request as the information regarding acceptance criteria, study details, sample sizes, ground truth, expert qualifications, or MRMC studies is not present in the provided text.

Ask a specific question about this device

"CUTICOVER™ SKIN is a skin barrier for protection against the detrimental effects of moisture, urine, or feces."

CUTICOVER™ SKIN is a barrier film of identical formulation to the predicate NUVO Barrier Film device.

The provided text is a 510(k) summary for the CUTICOVER™ SKIN Barrier Device (K042955). This document primarily establishes substantial equivalence to a predicate device (NUVO Barrier Film, K980117) and does not contain detailed information about a comprehensive study with specific acceptance criteria and performance metrics as typically expected for novel devices or those requiring clinical studies. The basis for clearance is that the device is identical in formulation, design, composition, indications, and packaging to a previously cleared device.

Therefore, many of the requested categories will be marked as "Not applicable" or "Not provided" because the nature of this submission does not involve a de novo study to prove device performance against acceptance criteria in the way a clinical trial or algorithm validation study would.

Here is the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Details of the Study (or lack thereof)

This 510(k) summary primarily relies on demonstrating substantial equivalence to a predicate device, rather than providing data from a new study designed to meet specific performance acceptance criteria for the CUTICOVER™ SKIN device itself. Therefore, many of the following points are not applicable as no such detailed study is presented in the provided text.

1. Sample size used for the test set and the data provenance: Not applicable. No test set data is presented for CUTICOVER™ SKIN. The submission relies on the established safety and effectiveness of the predicate device.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new test set requiring expert ground truth establishment is described.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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 skin barrier, not an AI-assisted diagnostic tool, so an MRMC study is irrelevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a new study for this device. The "ground truth" for clearance is the established performance and safety of the predicate device.
7. The sample size for the training set: Not applicable. No training set is mentioned as this is not an algorithm or a device requiring a training phase in this context.
8. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device