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510(k) Data Aggregation
(239 days)
The AKITA JET is a nebulizer system that will be used with patients for whom doctors have prescribed medication (except pentamidine) for nebulization in the home care, nursing home, subacute institution, or hospital environment.
The AKITA JET nebulizer and the AKITA JET nebulizer handset together constitute a multi-use, electronic nebulizer system designed to aerosolize liquid medications. The system includes and features:
- An electrically powered compressor which provides an air flow to the AKITA JET ● nebulizer handset.
- . A nebulizer handset based upon the PARI LC Sprint, K060399
- Single patient, multi-use in the home setting .
- . Multiple patient, multi-use in the hospital and clinical settings
- .
- . Nebulization only during inhalation phase
- Smart Card series for defined patient breathing patterns .
The provided document is a 510(k) summary for the AKITA JET nebulizer system, demonstrating substantial equivalence to predicate devices. It outlines the device description, indications for use, and a high-level overview of performance tests conducted. However, it does not contain detailed information about specific acceptance criteria or the study data that would allow for a comprehensive answer to your request regarding detailed performance metrics, sample sizes, ground truth establishment, or multi-reader studies.
The document focuses on comparing the AKITA JET to predicate devices across several categories to prove substantial equivalence rather than presenting a de novo performance study against pre-defined acceptance criteria.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details on sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance, based solely on the information given in the provided text.
Here's what can be extracted and what is missing:
Acceptance Criteria and Study Information for AKITA JET Nebulizer System
The provided 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo acceptance criteria with specific quantitative thresholds that are then met by a new study. The performance tests mentioned are generally for comparison with existing similar devices or to ensure basic safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implied by comparison to predicates) | Reported Device Performance (Implied from comparison) |
|---|---|
| General Attributes | |
| - Indications for Use (Similar to predicates) | Meets (Substantially equivalent) |
| - Patient Population (Similar to predicates) | Meets (Substantially equivalent) |
| - Environments of Use (Similar to predicates) | Meets (Substantially equivalent) |
| Nebulizer Performance | |
| - Particle Characterization (Compared to PARI LC Sprint K060399) | "performance tests were done" (Implied: comparable) |
| - Delivery during inhalation (Compared to AKITA2 K072019, AutoNeb K935693) | "performance tests were done" (Implied: comparable) |
| - Delivery based on breathing patterns (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| - Algorithm to program breathing patterns (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| - Controlled inhalation flow (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| - Use of programmable Smart Cards (Compared to AKITA2 K072019) | "performance tests were done" (Implied: comparable) |
| Safety and Effectiveness Testing | |
| - Cascade Impactor testing | "Included" (Implied: Met safety/effectiveness benchmarks) |
| - VOC, PM2 |
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(409 days)
A jet nebulizer system designed to aerosolize commonly prescribed liquid medication (except pentamidine) for inhalation by the patient in the home care, nursing home, sub-acute institutions or hospital environment.
The Prodose AAD system is a single patient reusable portable pneumatic jet nebulizer, designed to deliver a precise and reproducible dose of aerosolized liquid medication. The device consists of a base unit containing a dedicated air compressor and a hand-piece containing a pressure or a base ann versant control system, a medication chamber, a baffle, and a mouthpiece. The pre-set dose volume is stored on a disc, which has a bi-directional inductively coupled transponder with data storage capacity in a non-volatile memory (EEPROM) embedded in the disc.
The Prodose AAD system analyses the patient's breathing pattern to determine the acrosol pulse time. The system then pulses aerosol during patient inspiration only. The length of each pulse of acrosol is calculated according to the measured inspiratory time. Prodose continues to monitor the breathing pattern throughout treatment in order to adapt to changes in the breathing pattern. When the pre-set dose of medication has been delivered, the system indicates that the treatment is complete.
The provided text describes the Prodose AAD System, a jet nebulizer. However, it does not contain a study section that outlines acceptance criteria, device performance, sample sizes, ground truth establishment, or any comparative effectiveness studies.
The document is a premarket notification (510(k)) that focuses on establishing substantial equivalence to predicate devices. It describes the device, its intended use, and compares its attributes and differences to a legally marketed predicate device (HaloLite AAD System).
Therefore, I cannot provide the requested information from the given text as the detailed study data is absent.
What the document does provide:
- Device Description: The Prodose AAD system is a single-patient reusable portable pneumatic jet nebulizer designed to deliver a precise and reproducible dose of aerosolized liquid medication. It analyzes the patient's breathing pattern to pulse aerosol only during inspiration.
- Intended Use: Aerosolize commonly prescribed liquid medication (except Pentamidine) for inhalation by patients in home care, nursing homes, sub-acute institutions, or hospitals.
- Differences from Predicate Device (HaloLite AAD System):
- LCD graphic display vs. flashing LED lights for visual feedback.
- Microprocessor disc stores pre-set dose information vs. colored buttons.
- Internal DC supply from mains power vs. internal replaceable 9-volt battery.
- Able to supply longer aerosol pulses into long inhalation cycles, shortening treatment times.
- Utilizes a larger number of data points to compensate for inhalation airflows.
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(168 days)
A Nebulizer system designed to aerosolize commonly prescribed liquid medication ( except Pentamidine) for inhalation by the patient in the home care, nursing home or hospital environment.
The Medic-Aid HaloLite AAD system is a single patient use, prescribed portable nebulizer designed to deliver a precise and reproducible dose of aerosolized liquid medication. The device consists of a hand-piece containing a pressure transducer, a microprocessor control system, and a medication chamber, based on the Medic-Aid -Ventstream Nebulizer, K933535, and mouthpiece.
The HaloLite system analyses the patient's breathing pattern to determine the aerosol pulse time. The system then pulses aerosol during inspiration only. Each pulse of aerosol is matched according to the inspiratory time. HaloLite continues to monitor the breathing pattern in order to adapt to changes in breathing throughout the treatment. When the preset dose has been delivered, the system indicates that the treatment is complete.
The provided text is a 510(k) summary for the Medic-Aid HaloLite AAD system, a nebulizer. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and performance data in the format requested. Therefore, much of the requested information is not available in the provided document.
Here's an attempt to answer based on the available information, with clear indications where the information is "Not Provided":
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (HaloLite AAD) |
|---|---|---|
| Intended Use | Nebulize commonly prescribed liquid drugs (except Pentamidine) for inhalation by patient. | Meets; designed to "aerosolize commonly prescribed liquid drug (except Pentamidine) for inhalation by the patient." |
| Environment of Use | Home, Hospitals, and Nursing Homes. | Meets; "Single patient / multi-use for Home, Hospitals and Nursing Homes." |
| Patient Population | Patients requiring nebulized drug delivery via a mouthpiece. | Meets; "Patients requiring nebulized drug delivery via a mouthpiece." |
| Sidestream Jet System | Yes (based on predicate comparisons). | Yes |
| Synchronized Delivery of Nebulized Drug | Yes (based on Vortran AutoNeb). | Yes; "pulses aerosol during inspiration only. Each pulse of aerosol is matched according to the inspiratory time." |
| Drug Delivery on Demand | Yes (based on Vortran AutoNeb). | Yes; "pulses aerosol during inspiration only." |
| Flow Rates | Consistent with predicate devices (e.g., 6-8 LPM for Vortran, 1.5-16 LPM for Medic-Aid Ventstream). | 6 LPM |
| Gas Source - Compressed Air | Yes | Yes |
| Software Driven | Microprocessor (differentiator from predicates). | Microprocessor |
| Mode of Operation | Turn on during patient inhalation. | Turn on during patient inhalation |
| Drug Delivery Triggered by | Patient Inhalation Airway Pressure Signal. | Patient Inhalation Airway Pressure Signal |
| Used with Mouthpiece | Yes | Yes |
| Materials in Contact with Patient | Polypropylene Mouthpiece | Polypropylene Mouthpiece |
| Provided Clean, Non-sterile | Yes | Yes |
| Dose Measurement Accuracy | Not explicitly stated an acceptance criterion, but the text mentions "summed to provide an accurate method of dose measurement so that a pre-set dose can be delivered." | "summed to provide an accurate method of dose measurement so that a pre-set dose can be delivered." |
| Pulse Range | Not explicitly stated as an acceptance criterion, but compared to AutoNeb. | 0.15 to 2.0 seconds |
2. Sample size used for the test set and the data provenance
- Sample Size: Not Provided.
- Data Provenance: Not Provided. The document describes the device and compares it to predicate devices, but does not detail a specific test study with a described sample set. It's likely that performance data was generated internally for technical verification, but the specifics are not included in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not Provided.
- Qualifications of Experts: Not Provided.
4. Adjudication method for the test set
- Adjudication Method: Not Provided.
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 device is a nebulizer, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is Not Applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a hardware nebulizer with a microprocessor, not a standalone algorithm. Therefore, a standalone algorithm-only performance study is Not Applicable and was not performed. The device's "standalone" performance would relate to its ability to accurately deliver aerosolized medication. While the document mentions "accurate method of dose measurement," specific study details are not provided here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not Provided in terms of a formal study assessing device performance. The "ground truth" for substantial equivalence is based on the features and performance of legally marketed predicate devices. The device's own performance would be verified against engineering specifications, likely through bench testing, but the methodology and "ground truth" for those tests are not detailed here.
8. The sample size for the training set
- Sample Size: Not Applicable. This is a hardware medical device (nebulizer), not an AI/machine learning model that would require a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not Applicable. As this is not an AI/machine learning model, no training set or ground truth for a training set was established.
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