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510(k) Data Aggregation
(136 days)
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(86 days)
Feather/numiere 05 06 07 (05) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the decolletage.
Feather/ numiere 05 06 07 (Models: 05) is an over-the-counter light-emitting diode (LED) device that emits energy for the treatment of wrinkles. The device works by simultaneously emitting 630nm±10nm, 830nm ±10nm wavelengths for the treatment of wrinkles on the neck and decolletage (upper chest). The device is designed in a flexible silicone panel that contains red (630nm±10nm) and near infrared (830nm±10nm) light-emitting diodes (LEDs). The device also contains a controller that controls the power on and off of the device, and regulates the intensity of the treatment by pressing buttons, and the controller
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(327 days)
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(194 days)
The Healgen® URS Test Strips are for the qualitative detection of leukocytes (white blood cells) and nitrite in urine as an aid in the screening of a urinary tract infection (UTI). It is intended for over-the-counter home use only.
The Healgen® URS Test Strips are in vitro diagnostic test devices for the qualitative detection of leukocytes and nitrites in urine. The device is composed of two color pads aligned on a strip. One pad is employed for testing leukocytes and the other for nitrites by visually reading the color change of the applicable pad and comparing with the corresponding blocks on a color chart.
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(29 days)
TENS:
The device is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, leg and feet, due to strain from exercise or normal household and work activities.
EMS:
The device is used to stimulate healthy muscles in order to improve and facilitate muscle performance.
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(36 days)
The Healgen Accurate Urine Drug Screen Dip Card is a rapid lateral flow immunoassays for the qualitative detection of 6-Monoacetylmorphine, d-Amphetamine, Benzoylecgonine, Buprenorphine, EDDP, d/l-Methadone, d-Methamphetamine, d/l-Methylenedioxymethamphetamine, Morphine, Nortriptyline, Oxazepam, Oxycodone, Phencyclidine, d-Propoxyphene, Secobarbital, THC-COOH, Norfentanyl and Tramadol in human urine. The test cut-off concentrations and the compounds the tests are calibrated to are as follows:
| Test | Calibrator | Cut-off (ng/mL) |
|---|---|---|
| 6-MAM | 6-Monoacetylmorphine | 10 |
| AMP | d-Amphetamine | 500 or 1000 |
| BAR | Secobarbital | 300 |
| BUP | Buprenorphine | 10 |
| BZO | Oxazepam | 300 |
| COC | Benzoylecgonine | 150 or 300 |
| EDDP | 2-ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine | 300 |
| MDMA | Methylenedioxymethamphetamine | 500 |
| MET | d-Methamphetamine | 500 or 1000 |
| MTD | Methadone | 300 |
| OPI | Morphine | 300 or 2000 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | d-Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | 11-nor-∆9-THC-COOH | 50 |
| NFYL | Norfentanyl | 5 |
| TML | Tramadol | 100 |
The single or multi-test panels can consist of up to eighteen (18) of the above listed analytes in any combination with or without on-board adulteration/specimen validity tests (SVT).
The tests provide only a preliminary result. A more specific alternative chemical method must be used to obtain a confirmed positive result. Gas Chromatography-Mass Spectrometry (GC-MS), Liquid Chromatography-Mass Spectrometry (LC-MS), and their tandem mass-spectrometer versions are the preferred confirmatory methods. Careful consideration and judgment should be applied to any drugs of abuse screen test result, particularly when evaluating preliminary positive results.
The Healgen Accurate Home Urine Drug Test Dip Card is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs in human urine at the cutoff concentrations of table below.
This is not a screening device to monitor prescription medication.
| CODE | SUBSTANCE | CUT-OFF (ng/mL) |
|---|---|---|
| AMP | Amphetamine | 1000 or 500 |
| BUP | Buprenorphine | 10 |
| BAR | Secobarbital | 300 |
| BZO | Oxazepam | 300 |
| COC | Cocaine | 300 or 150 |
| EDDP | EDDP | 300 |
| MET/mAMP | Methamphetamine | 1000 or 500 |
| MDMA | Ecstasy | 500 |
| OPI | Morphine | 2000 or 300 |
| MTD | Methadone | 300 |
| OXY | Oxycodone | 100 |
| PCP | Phencyclidine | 25 |
| PPX | Propoxyphene | 300 |
| TCA | Nortriptyline | 1000 |
| THC | Marijuana | 50 |
| 6-MAM | 6-Monoacetylmorphine | 10 |
| NFYL | Norfentanyl | 5 |
| TML | Tramadol | 100 |
This drug test dip card may contain any combination of the drug tests listed in the table above but only one cutoff concentration under same drug condition will be included per device.
This test provides only preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. GC/MS or LC/MS is the preferred confirmatory method. Evaluate preliminary positive results carefully.
Healgen Accurate Home Urine Drug Test Dip Card and Healgen Accurate Urine Drug Screen Dip Card are immunochromatographic assays that use a lateral flow system for the qualitative detection of single or multiple drugs in human urine. The device is a dip card format. Each test device is sealed with two sachets of desiccant in an aluminum pouch. The device is in a ready-to-use format and no longer requires assembly before use.
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(137 days)
The NOVEOS Specific IgE Assay is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum. NOVEOS Specific IgE Assay is to be used with the NOVEOS Immunoassay Analyzer. It is intended for use as an in vitro diagnostic aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories.
The NOVEOS Specific IgE Assay is an immunometric, chemiluminescent procedure for the quantitative determination of IgE of known specificity in human serum samples. It employs fluorescent labelled magnetic, streptavidin coated microparticles which are incubated with a biotinylated allergenic capture reagent, patient sample and monoclonal anti-human IgE antibody: horseradish peroxidase conjugate. If present in the sample, IgE binds to the biotinylated allergen captured to the streptavidin-coated microparticles to form a complex. After a final wash, the resulting complex is incubated with the enzyme substrate and a chemiluminescent signal is generated, the magnitude of which is proportional to the concentration of IgE in the patient sample.
The concentration of allergen-specific IgE is determined from a standard curve, which is traceable to the World Health Organization (WHO) reference reagent serum Immunoglobulin E (IgE) 11/234.
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(172 days)
AI-CVD® is an opportunistic AI-powered quantitative imaging tool that provides automated CT-derived anatomical and density-based measurements for clinician review. The device does not provide diagnostic interpretation or risk prediction. It is solely intended to aid physicians and other healthcare providers in determining whether additional diagnostic tests are appropriate for implementing preventive healthcare plans. AI-CVD® has a modular structure where each module is intended to report quantitative imaging measurements for each specific component of the CT scan. AI-CVD® quantitative imaging measurement modules include coronary artery calcium (CAC) score, aortic wall calcium score, aortic valve calcium score, mitral valve calcium score, cardiac chambers volumetry, epicardial fat volumetry, aorta and pulmonary artery sizing, lung density, liver density, bone mineral density, and muscle & fat composition.
Using AI-CVD® quantitative imaging measurements and their clinical evaluation, healthcare providers can investigate patients who are unaware of their risk of coronary heart disease, heart failure, atrial fibrillation, stroke, osteoporosis, liver steatosis, diabetes, and other adverse health conditions that may warrant additional risk assessment, monitoring or follow-up. AI-CVD® quantitative imaging measurements are to be reviewed by radiologists or other medical professionals and should only be used by healthcare providers in conjunction with clinical evaluation.
AI-CVD® is not intended to rule out the risk of cardiovascular diseases. AI-CVD® opportunistic screening software can be applied to non-contrast thoracic CT scans such as those obtained for CAC scans, lung cancer screening scans, and other chest diagnostic CT scans. Similarly, AI-CVD® opportunistic screening software can be applied to contrast-enhanced CT scans such as coronary CT angiography (CCTA) and CT pulmonary angiography (CTPA) scans. AI-CVD® opportunistic bone density module and liver density module can be applied to CT scans of the abdomen and pelvis. All volumetric quantitative imaging measurements from the AI-CVD® opportunistic screening software are adjusted by body surface area (BSA) and reported both in cubic centimeter volume (cc) and percentiles by gender reference data from people who participated in the Multi-Ethnic Study of Atherosclerosis (MESA) and Framingham Heart Study (FHS). Except for coronary artery calcium scoring, other AI-CVD® modules should not be ordered as a standalone CT scan but instead should be used as an opportunistic add-on to existing and new CT scans.
AI-CVD® is an opportunistic AI-powered modular tool that provides automated quantitative imaging reports on CT scans and outputs the following measurements:
- Coronary Artery Calcium Score
- Aortic Wall and Valves Calcium Scores
- Mitral Valve Calcium Score
- Cardiac Chambers Volume
- Epicardial Fat Volume
- Aorta and Main Pulmonary Artery Volume and Diameters
- Liver Attenuation Index
- Lung Attenuation Index
- Muscle and Visceral Fat
- Bone Mineral Density
The above quantitative imaging measurements enable care providers to take necessary actions to prevent adverse health outcomes.
AI-CVD® modules are installed by trained personnel only. AI-CVD® is executed via parent software which provides the necessary inputs and receives the outputs. The software itself does not offer user controls or access.
AI-CVD® reads a CT scan (in DICOM format) and extracts scan specific information like acquisition time, pixel size, scanner type, etc. AI-CVD® uses trained AI models that automatically segment and report quantitative imaging measurements specific to each AI-CVD® module. The output of each AI-CVD® module is inputted into the parent software which exports the results for review and confirmation by a human expert.
AI-CVD® is a post-processing tool that works on existing and new CT scans.
AI-CVD® passes if the human expert approves the segmentation highlighted by the AI-CVD® module is correctly placed on the target anatomical region. For example, Software passes if the human expert sees the AI-CVD® cardiac chamber volumetry module highlighted the heart anatomy.
AI-CVD® fails if the human expert sees the segmentation highlighted by the AI-CVD® module is not correctly placed on the target anatomical region. For example, Software fails if the human expert sees the AI-CVD® cardiac chamber volumetry module highlighted the lungs anatomy or a portion of the sternum or any adjacent organs. Furthermore, Software fails if the human expert sees that the quality of the CT scan is compromised by image artifacts, severe motion, or excessive noise.
The user cannot change or edit the segmentation or results of the device. The user must accept or reject the segmentation where the AI-CVD® quantitative imaging measurements are performed.
AI-CVD® is an AI-powered post-processing tool that works on non-contrast and contrast-enhanced CT scans of chest and abdomen.
AI-CVD® is a multi-module deep learning-based software platform developed to automatically segment and quantify a broad range of cardiovascular, pulmonary, musculoskeletal, and metabolic biomarkers from standard chest or whole-body CT scans. AI-CVD® system builds upon the open-source TotalSegmentator as its foundational segmentation framework, incorporating additional supervised learning and model training layers specific to each module's clinical task.
The provided FDA 510(k) Clearance Letter for AI-CVD® outlines several modules, each with its own evaluation. However, the document does not provide a single, comprehensive table of acceptance criteria with reported device performance for all modules. Instead, it describes clinical validation studies and agreement analyses, generally stating "acceptable bias and reproducibility" or "acceptable agreement and reproducibility" without specific numerical thresholds or metrics. Similarly, detailed information on sample sizes, ground truth establishment methods (beyond general "manual reference standards" or "human expert knowledge"), and expert qualifications is quite limited for most modules.
Here's an attempt to extract and synthesize the information based on the provided text, recognizing the gaps:
Acceptance Criteria and Study Details for AI-CVD®
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for each module. Instead, it describes performance in terms of agreement with manual measurements or gold standard references, generally stating "acceptable bias and reproducibility" or "comparable performance." The table below summarizes what is reported.
| AI-CVD® Module | Acceptance Criteria (Implicit/General) | Reported Device Performance |
|---|---|---|
| Coronary Artery Calcium Score | Comparative safety and effectiveness with expert manual measurements. | Demonstrated comparative safety and effectiveness between expert manual measurements and both automated Agatston CAC scores and AI-derived relative density-based calcium scores. |
| Aortic Wall & Aortic Valve Calcium Scores | Acceptable bias and reproducibility compared to manual reference standards. | Bland-Altman agreement analyses demonstrated acceptable bias and reproducibility across imaging protocols. |
| Mitral Valve Calcium Score | Reproducible quantification compared to manual measurements. | Agreement analyses demonstrated reproducible mitral valve calcium quantification across imaging protocols. |
| Cardiac Chambers Volume | Based on previously FDA-cleared technology (AutoChamber™ K240786). | (No new performance data presented for this specific module as it leverages a cleared predicate). |
| Epicardial Fat Volume | Acceptable agreement and reproducibility with manual measurements. | Agreement studies comparing AI-derived epicardial fat volumes with manual measurements and across non-contrast and contrast-enhanced CT acquisitions demonstrated acceptable agreement and reproducibility. |
| Aorta & Main Pulmonary Artery Volume & Diameters | Low bias and comparable performance with manual reference measurements. | Agreement studies comparing AI-derived measurements with manual reference measurements demonstrated low bias and comparable performance across gated and non-gated CT acquisitions. Findings support reliability. |
| Liver Attenuation Index | Acceptable reproducibility across imaging protocols. | Agreement analysis comparing AI-derived liver attenuation measurements across imaging protocols demonstrated acceptable reproducibility. |
| Lung Attenuation Index | Reproducible measurements across CT acquisitions. | Agreement studies demonstrated reproducible lung density measurements across gated and non-gated CT acquisitions. |
| Muscle & Visceral Fat | Acceptable reproducibility across imaging protocols. | Agreement analyses between AI-derived fat and muscle measurements demonstrated acceptable reproducibility across imaging protocols. |
| Bone Mineral Density | Based on previously FDA-cleared technology (AutoBMD K213760). | (No new performance data presented for this specific module as it leverages a cleared predicate). |
2. Sample Size and Data Provenance for the Test Set
- Coronary Artery Calcium (CAC) Score:
- Sample Size: 913 consecutive coronary calcium screening CT scans.
- Data Provenance: "Real-world" data acquired across three community imaging centers. This suggests a retrospective collection from a U.S. or similar healthcare system, though the specific country of origin is not explicitly stated. The term "consecutive" implies that selection bias was minimized.
- Other Modules (Aortic Wall/Valve, Mitral Valve, Epicardial Fat, Aorta/Pulmonary Artery, Liver, Lung, Muscle/Visceral Fat):
- The document refers to "agreement analyses" and "agreement studies" but does not specify the sample size for the test sets used for these individual modules.
- Data Provenance: The document generally states that "clinical validation studies were performed based upon retrospective analyses of AI-CVD® measurements performed on large population cohorts such as the Multi-Ethnic Study of Atherosclerosis (MESA) and Framingham Heart Study (FHS)." It is unclear if these cohorts were solely used for retrospective analysis, or if the "real-world" data mentioned for CAC was also included for other modules. MESA and FHS are prospective, longitudinal studies conducted primarily in the U.S.
3. Number of Experts and Qualifications for Ground Truth
- Coronary Artery Calcium (CAC) Score:
- Number of Experts: Unspecified, referred to as "expert manual measurements."
- Qualifications: Unspecified, but implied to be human experts capable of performing manual Agatston scoring.
- Other Modules:
- Number of Experts: Unspecified, generally referred to as "manual reference standards" or "manual measurements."
- Qualifications: Unspecified.
4. Adjudication Method for the Test Set
The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for establishing ground truth on the test set. It mentions "expert manual measurements" or "manual reference standards," suggesting that the ground truth was established by human experts, but the process of resolving discrepancies among multiple experts (if any were used) is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
-
Was an MRMC study done? No, the document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The performance data presented focuses on the standalone AI performance compared to human expert measurements.
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Effect Size of Human Reader Improvement: Not applicable, as an MRMC study was not described.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? Yes, the described performance evaluations for all modules (where new performance data was presented) are standalone performance studies. The studies compare the AI-CVD® algorithm's output directly against manual measurements or established reference standards.
7. Type of Ground Truth Used
- Coronary Artery Calcium Score: Expert manual measurements (Agatston scores).
- Aortic Wall and Aortic Valve Calcium Scores: Manual reference standards.
- Mitral Valve Calcium Score: Manual measurements.
- Epicardial Fat Volume: Manual measurements.
- Aorta and Main Pulmonary Artery Volume and Diameters: Manual reference measurements.
- Liver Attenuation Index: (Implicitly) Manual reference measurements or established methods for hepatic attenuation.
- Lung Attenuation Index: (Implicitly) Manual reference measurements or established methods for lung density.
- Muscle and Visceral Fat: (Implicitly) Manual reference measurements.
- Cardiac Chambers Volume & Bone Mineral Density: Leveraged previously cleared predicate devices, suggesting the ground truth for their original clearance would apply.
8. Sample Size for the Training Set
The document provides information on the foundational segmentation framework (TotalSegmentator) and hints at customization for AI-CVD® modules:
- TotalSegmentator (Foundational Framework):
- General anatomical segmentation: 1,139 total body CT cases.
- High-resolution cardiac structure segmentation: 447 coronary CT angiography (CCTA) scans.
- AI-CVD® Custom Datasets: The document states that "Custom datasets were constructed for coronary artery calcium scoring, aortic and valvular calcifications, cardiac chamber volumetry, epicardial and visceral fat quantification, bone mineral density assessment, liver fat estimation, muscle mass and quality, and lung attenuation analysis." However, it does not provide the specific sample sizes for these custom training datasets for each AI-CVD® module.
9. How Ground Truth for the Training Set Was Established
- TotalSegmentator (Foundational Framework): The architecture utilizes nnU-Net, which was trained on the described CT cases. Implicitly, these cases would have had expert-derived ground truth segmentations for training the neural network.
- AI-CVD® Custom Datasets: "For each module, iterative model enhancement was applied: human reviewers evaluated model-generated segmentations and corrected any inaccuracies, and these corrections were looped back into the training process to improve performance and generalizability." This indicates that human experts established and refined the ground truth by reviewing and correcting model-generated segmentations, which were then used for retraining. The qualifications of these "human reviewers" are not specified.
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(85 days)
The Vital Spinal Fixation System implants are non-cervical spinal fixation devices intended for posterior pedicle screw fixation (T1‑S2/ilium), posterior hook fixation (T1‑L5), or anterolateral fixation (T8‑L5). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients.
These devices are indicated as an adjunct to fusion for all of the following indications: degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), deformities or curvatures (i.e. scoliosis, kyphosis, and/or lordosis, Scheuermann's Disease), tumor, stenosis, pseudoarthrosis and/or failed previous fusion. When used as an adjunct to fusion, the Vital Spinal Fixation System is intended to be used with autograft and/or allograft.
In addition, the Vital Spinal Fixation System is intended for treatment of severe spondylolisthesis (Grade 3 and 4) of the L5‑S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, having implants attached to the lumbosacral spine and or ilium with removal of the implant after attainment of a solid fusion. Levels of pedicle screw fixation for these patients are L3-sacrum/ilium.
When used for posterior non-cervical pedicle screw fixation in pediatric patients, the Vital System implants are indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The Vital System is intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach.
The Vital™ (Vitality) Spinal Fixation System is a thoracolumbar and sacroiliac fixation system designed to aid in the surgical correction of several types of spinal conditions. The system consists of a variety of spinal rods, pedicle screws, hooks, and connectors intended only to provide temporary stabilization during the development of a solid fusion of the spine with bone graft. The system can be rigidly locked into a variety of configurations, with each construct being customized to the patient's anatomy. All implants are single use only and should not be reused under any circumstances. The implant system is intended to be removed after solid fusion has occurred.
The system also includes instrumentation for insertion, securing and removal of the implants. All implants are made from medical grade titanium alloy; select rods are also available in medical grade cobalt chromium alloy. Implants made from medical grade titanium, medical grade titanium alloy, and/or medical grade cobalt chromium may be used together. Never use titanium, titanium alloy, and/or cobalt chromium with stainless steel in the same implant construct.
The Vital™ MIS System is a percutaneous screw delivery system that is an extension of the Vital™ System. The Vital MIS System implants consist of a variety of spinals rods and pedicle screws that are modified under the MIS line extension to feature cannulated screws (extended and non-extended tab) and modified spinal rods (bullet nose, connection, curvature). The system includes a variety of instrumentation which are also compatible with Vital and Vital MIS implant offerings in the Vital™ System and allow for a minimalized, percutaneous, or mini-open surgical approach, extending MIS capabilities to the cannulated implants of the wider Vital™ System.
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