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510(k) Data Aggregation
(120 days)
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(130 days)
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(318 days)
The Medline ReNewal Reprocessed Abbott Agilis NxT Steerable Introducer is indicated for the introduction of various cardiovascular catheters into the heart, including the left side of the heart, during the treatment of cardiac arrhythmias.
The Medline ReNewal Reprocessed Agilis NxT Steerable Introducer consists of a dilator, guidewire, and a bi-directional steerable introducer, which is designed to provide flexible catheter positioning in the cardiac anatomy. The steerable introducer is fitted with a hemostasis valve to minimize blood loss during catheter introduction and/or exchange. A sideport with three-way stopcock is provided for air or blood aspiration, fluid infusion, blood sampling and pressure monitoring. The device has either a small, medium, or large curl at the distal tip. The sheath handle is equipped with a rotating collar to deflect the tip clockwise ≥ 180° and counterclockwise ≥ 90°. The steerable introducer features distal vent holes to facilitate aspiration and minimize cavitation and a radiopaque tip marker to improve fluoroscopic visualization. The sheath material consists of braided stainless-steel wire covered with Pebax (polyether block amide) and Nylon. The sheath is filled with barium sulfate, and the distal tip has a platinum/iridium marker for visualization under fluoroscopy. A plastic dilator and stainless-steel guidewire are packaged with the introducer and are designed to facilitate the introduction and passage of the introducer through the vasculature.
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(266 days)
The MediAI-BA is designed to view and quantify bone age from 2D Posterior Anterior (PA) view of left-hand radiographs using deep learning techniques to aid in the analysis of bone age assessment of patients between 2 to 18 years old for pediatric radiologists. The results should not be relied upon alone by pediatric radiologists to make diagnostic decisions. The images shall be with left hand and wrist fully visible within the field of view, and shall be without any major bone destruction, deformity, fracture, excessive motion, or other major artifacts.
Limitations:
- This software is not intended for use in patients with growth disorders caused by congenital anomalies (e.g., Down syndrome, Noonan syndrome, congenital adrenal hyperplasia, methylmalonic acidemia, skeletal dysplasia, chronic renal disease, or prior long-term steroid exposure), as these conditions may cause complex skeletal changes beyond bone maturation.
- Images showing anatomical variations or notable abnormalities (e.g., bone tumors, sequelae of fractures, or congenital deformities) in the region required for interpretation are excluded from the intended use.
This AI-based software utilizes an internal algorithm that integrates global skeletal maturity features extracted from the whole hand radiograph with local skeletal maturity features derived from key Regions of Interest (ROIs). By synthesizing these skeletal maturity features, the software determines the accurate final bone age.
MediAI-BA provides an optional heatmap visualization that highlights regions contributing to the AI model output. The heatmap is intended only as supplementary, qualitative information to illustrate internal AI operations and is not intended for clinical interpretation, growth plate localization, or independent bone age assessment.
The confidence score graph is an internal model visualization intended only to illustrate the relative sharpness of the model's output distribution. It is not calibrated to clinical likelihood, has not been clinically validated, and is not intended to support diagnostic decisions or selection of a specific bone age.
Here's a breakdown of the acceptance criteria and study details for the MediAI-BA device, based on the provided FDA 510(k) clearance letter:
MediAI-BA Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Metric) | Target (Implicit from "no significant bias" and "high consistency") | Reported Device Performance and Confidence Intervals |
|---|---|---|
| Deming Regression - Slope | Close to 1 (indicating no proportional bias) | 1.000 (95% CI: 0.989–1.002) |
| Deming Regression - Intercept | Close to 0 (indicating no systematic bias) | 0.08 (95% CI: −0.004–0.158) |
| Bland-Altman Analysis - 95% Limits of Agreement | Narrow range (demonstrating high consistency and agreement) | −0.66 (−1.96 SD) to 0.71 (+1.96 SD) |
| Frequency Distribution of Differences - Mean | Close to 0 (indicating negligible average difference) | 0.026 years |
| Frequency Distribution of Differences - Standard Deviation | Low (indicating high precision) | 0.3505 years |
| Frequency Distribution of Differences - Cases within 0.5 years | High percentage (indicating strong agreement for a large majority of cases) | 89% of all cases |
| Heatmap Consistency (SSIM) | ≥ 0.85 (for most evaluation cases under normal conditions) | Most of 30 evaluation cases met criteria under brightness adjustment and Gaussian noise. All 5 cases met criteria under rotation. |
| Heatmap Accuracy | Bone age changes observed when highlighted region is masked (indicating region's contribution to output) | Bone age changes observed in 27 out of 30 cases when the highlighted region of the heatmap was masked. |
Study Details
2. Sample size used for the test set and the data provenance:
- Sample Size: 600 cases.
- Data Provenance:
- Country of Origin: United States.
- Collection Sites: Five sites across multiple states and multiple clinical organizations.
- Retrospective/Prospective: Not explicitly stated, but the description of "collected from five sites" suggests a retrospective collection of existing images for this study. The phrase "None of the cases used in this study were utilized for training or development of the MediAI-BA model" reinforces that these were untouched test cases.
- Demographics: 50.0% males and 50.0% females. Racial/ethnic composition included White, Hispanic, Black, Asian & Pacific Islander, among others.
- Image Sources: X-ray scanner manufacturers included Samsung Electronics, Carestream Health, Kodak, Siemens, and Konica Minolta.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Four evaluators.
- Qualifications of Experts: Not explicitly stated, but the context of "pediatric radiologists" in the Indications for Use and the assertion that the device "demonstrated performance comparable to bone age readings obtained by human evaluators using the GP atlas method" strongly imply that these evaluators were pediatric radiologists experienced in bone age assessment using the GP (Greulich and Pyle) atlas method.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document states that ground truth was "established by four evaluators." It does not specify the exact adjudication method (e.g., whether it was consensus, average, or majority rule among the four).
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, an MRMC comparative effectiveness study was not explicitly described. The study compared the device's standalone performance against the ground truth established by human evaluators. It did not evaluate how human readers' performance might improve when assisted by the AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, a standalone performance study was done. The performance metrics (Deming regression, Bland-Altman, frequency distribution of differences) directly compare the "software's bone age analysis results" and "MediAI-BA outputs" against the "ground truth." This is a direct measurement of the algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The ground truth was established by "four evaluators" using the "GP atlas method." This indicates expert consensus/interpretation using a recognized standard (GP atlas).
8. The sample size for the training set:
- Not specified in the provided text. The document explicitly states that "None of the cases used in this study were utilized for training or development of the MediAI-BA model," but does not give details about the training set itself.
9. How the ground truth for the training set was established:
- Not specified in the provided text.
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(394 days)
The MEMO Patch M is intended to record, transfer and store single-channel electrocardiogram via USB transmission to PC. The monitor is intended for use by healthcare professionals, patients with known or suspected heart conditions and health-conscious individuals. The ECG data is intended to supplement other patient data and is not intended for automated analysis. The device has not been tested and it is not intended for pediatric use.
The MEMO Patch M is a continuous electrocardiogram (ECG) recording device to record, store, and transfer single channel ECGs and is designed for a fully retrospective review of data that was recorded over the specified wear period. The MEMO Patch M has Bluetooth module to verify ECG signals with mobile device and to authenticate the activation of MEMO Patch M. The device is in the form of an ECG patch that records ECG signals. As well the patch connects with a cradle and transmits ECG data via USB communication to PC. Healthcare professional actives the ECG patch, connects the patch with the cradle to the PC, and accesses raw ECG data on the ECG dataloader viewer. The MEMO Patch M includes a battery powered electronic unit that is used with off-the-shelf (OTS) disposable medical grade gel electrodes for long term monitoring. The adhesive electrodes should be replaced by the user every 24 hours or when it no longer adheres to skin. The device is only intended for manual interpretation, and does not provide any automated ECG analysis. The intended clinical use of the ECG is to display the waveforms of the P, QRS, and T waves of the measured electrocardiogram. The intended clinical use of the ECG waveform to be limited to the discrimination of normal sinus rhythm from easily identifiable, non-lethal arrhythmias. The device is not intended for additional analysis or the detection of specific cardiac conditions, such as ischemia, myocardial infarction, and ldft ventricular hypertrophy, etc. The Ambulatory ECG Monitor is intended to capture and continuous electrocardiogram information for long-term monitoring. The device records continuously for the entire wear period, up to 8 days. The MEMO Patch M is a prescription use device and the recorded ECG data is intended to be used with patient-triggered events. When a patient presses the event marking button during a symptom, this event is recorded and displayed on the PDF report of raw ECG data. However, there is no ability to detect specific cardiac events on the PDF report.
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(98 days)
The Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for: Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.
The Medical Diode Laser Systems generate a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coagulation of the target tissue.
The Medical Diode Laser Systems generate a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
The Medical Laser Family has following characteristics:
- Dual wavelengths
- Temperature monitoring system
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(426 days)
The Medical Wire Fecal Transwab Liquid Cary Blair Medium Collection and Transport Device is intended to preserve the viability and infectivity of fecal specimens after their collection and during transport from the collection site to the testing laboratory. The product can be used to collect stool specimen directly from the patient, using the swab as a rectal swab. Alternatively, the swab can be used to take material from a previously collected stool specimen. Fecal Transwab® specimens are processed using standard clinical laboratory operating procedures for microbiological specimens.
Each Fecal Transwab® Liquid Cary Blair Medium Collection and Transport Device comprises a sterile peel pouch containing a plastic screw-cap self standing tube with conical shaped bottom filled with 2 ml of Liquid Cary Blair transport medium and a specimen collection swab with a polyurethane foam coated tip. After sampling the swab applicator is placed in the tube where the bud is bathed in the liquid medium. The swab shaft is broken to allow the swab to fit in the tube, with the screw-cap being replaced.
Fecal Transwab can also be supplied as a medium only device without a swab, in which case the specimen can be inoculated into the medium using a sterile swab, or scoop, or inoculating loop.
The Liquid Cary Blair transport medium is a maintenance medium comprising inorganic phosphate buffer, calcium chloride and sodium chloride with a reduced environment due to the presence of sodium thioglycollate. The medium is designed to maintain the viability without overgrowth of enteric bacteria during transit to the testing laboratory.
The foam-tipped collection swab provided with the Medical Wire Fecal Transwab® Collection and Transport System has a plastic shaft with a defined breakpoint site. A bold red marker line indicates the limit of insertion if the swab is used to take a rectal specimen.
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(118 days)
Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheters are indicated for use to diagnose cardiac arrhythmia.
The steerable diagnostic electrode catheters are radiopaque, flexible, insulated catheters with a polymer shaft, each having a mechanical operating mechanism. In each catheter the polymer shaft connects to the catheter handle whereby the curve or loop is actuated by a single pull cable. The Dynamic Tip Catheters have a plunger mechanism, which, when moved forward or back, results in curvature of the distal tip.
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(104 days)
The Medusa Orthopedics Boa External Fixation System and its components are indicated for open and closed fracture fixation, pseudoarthrosis or nonunions of long bones, limb lengthening by epiphyseal or metaphyseal distraction, correction of bony or soft tissue deformities, and correction of segmental or nonsegmental bony or soft tissue defects.
The Medusa Orthopedics Boa External Fixation System is for use on all long bones including: tibia, fibula, femur, humerus, radius and ulna.
The Medusa Orthopedics Boa External Fixation System is a ring fixator device used to stabilize and maintain alignment of complicated bone fractures, soft tissue and/or congenital deformity repairs of an extremity. The fixator consists of two rings connected by four (4) struts that are lengthened and shortened independently. It is a modular system and facilitates a multitude of frame configurations to provide a wide variety of patient needs. The independent motion of the struts allows the surgeon to adjust the position of the proximal and distal rings. By utilizing the body's natural ability of osteogenesis to grow new bone tissue, the system guides the orientation and position of the new bone to the desired corrected location in a steady controlled manner.
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(168 days)
The Mesh Nebulizer designed to aerosolized liquid medications for inhalation by patient, the device may be used with pediatric (> 4 years of age) and adult patients in the home, hospital and sub-acute care settings.
It is not intended for use with Pentamidine.
The Mesh Nebulizer H6 is a portable handheld device that uses micromesh vibration technology to generate aerosols for inhalation by patients. The H6 consists of a main unit, a nebulizer cup and optional accessories, including inhalation masks (available in child and adult sizes), a mouthpiece and a power cord. The main unit housing is made of ABS material, the nebulizer cup is made of PC material, the inhalation mask is made of PP&TPE&silicone material, and the mouthpiece is made of PP&silicone material. It can be powered by an internal lithium battery or by an adapter that complies with the IEC 60601-1 standard.
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