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510(k) Data Aggregation
(29 days)
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(118 days)
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(231 days)
The RIB LINK™ Fixation System is indicated for use in the stabilization, fixation, and reconstruction of rib fractures, fusions, osteotomies, resections, including spanning gaps and/or defects, and chest wall deformities including rib hump deformity. These implants are indicated for use in skeletally mature patients with normal or osteoporotic bone for chest wall fixation.
The RIB LINK™ Fixation System includes a variety of plates, rods, and screws intended for use in rib fixation and stabilization applications. The implants are available in various sizes and styles and can be assembled in multiple construct configurations to accommodate varying patient anatomy. The constructs can be surgically positioned across the external surface of the ribs. RIB LINK™ implants are manufactured from titanium alloy as specified in ASTM F136.
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(266 days)
The Remi Impression Material is intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums to fabricate patient matched nightguards/mouthguards.
The Remi Impression Material is an addition-cure silicone impression material (Type 0 putty consistency) composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry.
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(251 days)
The BD Rubber Utility Catheter is indicated for intermittent catheterization of the urethra to drain urine from the bladder by patients who are not capable of voluntary urination.
The BD Rubber Utility Catheter is an uncoated, latex, intermittent urethral catheter that is provided sterile and intended for single use. It is intended for the drainage of urine from the bladder via intermittent urethral catheterization. The device is intended for use in adult and pediatric patients 2 years of age or older. Selection of the appropriate catheter size should be determined by the patient's healthcare provider based on clinical judgement.
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(146 days)
These cannulae are indicated for CPB procedures requiring delivery of cardioplegia in a retrograde direction through the coronary sinus for up to 6 hours in duration.
The Retrograde Coronary Sinus Perfusion Cannulae models in scope of this 510(k) consist of a wire-wound silicone cannula body with a beveled tip (6-Fr models have a non-wire wound cannula body). Two side holes are present near the tip. The back of the cannula body terminates in a locking female luer. A pressure monitoring line is an integral part of the cannula body, beginning at the tip and terminating in a locking female luer fitting or 3-way stopcock with a locking female luer fitting. An inflatable balloon is located at the distal beveled tip. The inflation assembly is located at the back of the cannula body and contains a female slip luer and a one-way valve assembly. Cannulae have a guidewire or solid stylet with a male luer handle or a TruTouch handle.
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(142 days)
This device is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid, which is intended to be used in a hospital or medical clinic.
Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal, Intra-operative (abdominal, thoracic, and vascular), pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), GYN/Pelvic, urology, adult and pediatric cardiac, and peripheral vessel exams.
Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for Pediatric application in Cardiac, Liver and Urinary Tract).
The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System is a general purpose, mobile, software controlled, ultrasonic diagnostic system. Its function is to acquire and display ultrasound images in Modes of operation include: B, M, PWD, CWD, Color Doppler, Power Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, iScape View, Color M, TDI, V Flow, Smart 3D, 4D(Real-time 3D), Strain Elastography, STE, STQ, Contrast imaging (Contrast agent for LVO), Contrast imaging (Contrast agent for Liver), Contrast imaging (Contrast agent for Pediatric application in Cardiac, Liver and Urinary Tract).
The Resona A10S, Resona A20 Pro, Resona A20T, Resona A20S, Resona A20W, Resona A20, Resona A20 Exp, Resona A20 Premium, Resona A20 Elite, Resona A20 Plus, Resona A Elite, Resona A MV, Eagus A20W, Eagus A20 Diagnostic Ultrasound System can also measure anatomical structures and offer analysis packages to provide information based on which the competent health care professionals can make the diagnosis.
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(220 days)
ROSA Knee System with USIP for use with ROSA RECON platform, is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon in providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components. The robotic arm placement is performed relative to the position and orientation of the femur and tibia as tracked by the ultrasound and optical systems. It is also based on the surgical plan specified by the surgeon intra-operatively on the robot user interface. To be able to perform this tracking, a virtual 3D bone model of the patient's femur and tibia are generated pre-operatively from a CT-scan of their leg.
The ROSA Knee System with USIP is designed for use on skeletally mature patient population. It includes an ultrasound imaging system, a robotic arm, an optical sensor navigation system and accessories, surgical instruments, and a software system. It does not include a pre-operative planning feature.
The ROSA Knee System is to be used with the following fixed bearing knee replacement systems in accordance with their indications and contraindications: Persona® CR, Persona PS, Persona Ti-Nidium® CR, Persona Ti-Nidium PS and Persona IQ® The Smart Knee™.
The ROSA® Knee System with USIP (Ultrasound Imaging Platform) is used to assist surgeons in performing Total Knee Arthroplasty (TKA) with features to assist with the bone resections. The USIP device is to be used with the Zimmer Biomet ROSA Knee System to perform TKA. The USIP device provides an ultrasound-based location solution for tibia and femur replacing the use of fluted pins placed in the femur and tibia. The USIP is composed of the ultrasound acquisition box, which connects to the ROSA Knee System and two belts; femur and tibia, which contain the ultrasound transducers. NavitrackERs are mounted on the femur and tibia belts and calibrated to locate the bone relative to the robot. The belts wrap or partially wrap the thigh (femur belt) and the calf (tibia belt) of the patient. The belts image the patient's bone via the ultrasound transducers contained in the belts.
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(255 days)
Redermax Antibacterial Wound Matrix is intended for the management of wounds. Redermax Antibacterial Wound Matrix is indicated for the management of:
- Partial and full thickness wounds
- Pressure ulcers
- Venous ulcers
- Diabetic ulcers
- Chronic vascular ulcers
- Tunneled/undermined wounds
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence)
- Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears)
- Draining wounds.
Redermax Antibacterial Wound Matrix is a sterile, single-use device intended for use in the management of wounds. Redermax is a soft, white, conformable, non-friable, absorbable, three-dimensional matrix that provides an environment for the body's healing process to occur. Redermax is supplied dry in sheet form. The device consists of composite fibers made from biocompatible and biodegradable materials. With the defined rate of absorption, the matrix provides a structural structure for wound healing before complete degradation through hydrolysis. Redermax is a porous matrix composed of poly(lactic-glycolic acid) (PLGA), polydioxanone (PDO), Poloxamer 188, and poly (hexamethylene biguanide) hydrochloride (PHMB), and based on in vitro testing, the PHMB effectively reduces the growth of bacteria within the Redermax Wound Matrix for a period of up to 7 days. The device does not contain any human or animal materials or tissue.
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(234 days)
RevealAI-Lung Software is a computer aided diagnostic (CADx) software application intended for the characterization of incidentally-detected lung nodules on computed tomography (CT) scans. When a nodule is identified, the Software automatically compares the nodule characteristics with a clinically established database of lung nodules and provides a similarity score to assist clinicians' assessment of patients' cancer risk.
The mSI score is indicated for the evaluation of incidentally-detected pulmonary nodules of diameter 6-15mm in patients aged 18 years or above. In cases where multiple abnormalities are present, the mSI score can be used to assess each abnormality independently. Risk should be interpreted on an individual patient level and mSI is a relative risk score, not a percentage cancer risk.
Note that mSI is not indicated for lung cancer screening. The validation data excluded CT images with missing slices.
The RevealAI-Lung device is a post-processing software program that analyzes patient lung computed tomography (CT) images and is designed to provide computer-aided diagnostic (CADx) information about lung nodules to radiologists.
The user opens the patient's lung CT image from a third-party acquisition device in an existing medical device viewing system and scrolls through the image slices as in their normal workflow. The user identifies a lung nodule on the CT image, and evaluates that nodule for cancer risk and the potential need for follow-up using existing known risk factors, clinical management guidelines and the Reveal-AI-Lung provided mSI score. In cases where multiple nodules are present, RevealAI-Lung can be used to assess each nodule independently.
Here's a breakdown of the acceptance criteria and the study proving RevealAI-Lung meets them, based on the provided FDA 510(k) Clearance Letter:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Primary Endpoint (Multi-Reader Multi-Case (MRMC) Study): Improvement in radiologists' ability to discriminate between malignant and benign pulmonary nodules from CT images with and without the aid of the mSI. Measured as the difference in Area Under the Receiver Operating Characteristic Curve (AUC). | Average AUC improvement: 0.181 (from 0.538 unassisted to 0.719 with RevealAI-Lung assistance). This difference was statistically significant (p < 0.0001). |
| Consistency of Performance Across Readers: Every radiologist must improve their performance when using RevealAI-Lung. | Achieved: Every radiologist (10/10) improved their performance when using RevealAI-Lung. Individual AUC improvements ranged from 0.106 to 0.258. |
| Sensitivity Improvement (at 5% malignancy likelihood threshold): Increase in sensitivity when using RevealAI-Lung. | Increased sensitivity by 14 points (from 0.68 ± 0.039 to 0.82 ± 0.036). |
| Specificity Improvement (at 5% malignancy likelihood threshold): Increase in specificity when using RevealAI-Lung. | Increased specificity by 12 points (from 0.344 ± 0.041 to 0.467 ± 0.043). |
| Standalone Performance: Ability of RevealAI-Lung to discriminate between benign and malignant nodules. | Achieved: Standalone testing of RevealAI-Lung demonstrated it performed as expected in discriminating between benign and malignant nodules. (Specific quantitative metrics for standalone AUC are not explicitly provided, but "performed as expected" is stated.) |
| Validation on External Populations: Consistent device performance across additional incidental nodule populations. | Achieved: Tested on three additional populations (US, Canada, UK). Each study produced performance with an AUC > 0.8, and demonstrated follow-up decisions would be improved compared to clinical guidelines. |
| Consistency Across Subgroups: Performance improvements consistent across patient, nodule, and technical parameters. | Achieved: Results were independent of radiologist experience, patient demographics (age, sex, race/ethnicity), scan characteristics (contrast, scan date, manufacturer), and nodule parameters (size, lobe, opacity). Range of improvement in subgroups: 0.12 - 0.30. |
| Software Quality System Compliance: Adherence to FDA guidance for software in medical devices, 21 CFR §892.2060 special controls, human factors, usability, and cybersecurity. | Achieved: Design, validation, and verification were planned, executed, and documented according to FDA guidance. Assessed as Moderate Level of Concern. Usability evaluations confirmed safety and effectiveness. Cybersecurity activities and risk management were performed. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Performance Testing (MRMC Study): 108 cases (patients) with incidental lung nodules. The cases included size-matched benign and malignant nodules.
- Sample Size for Validation Testing on External Populations: 675 patients with incidental lung nodules (276 with cancer).
- Data Provenance:
- MRMC Study: Sourced from 3 US sites and 1 in Canada.
- External Validation Studies: One each from the US, Canada, and the UK.
- Retrospective or Prospective: Both the MRMC study and the external validation studies appear to be based on retrospective data, as they used "CT series... from patients in routine practice where lung nodules had been noted incidentally on the original radiology report" and involved "following the patients for at least 5 years" for ground truth (where pathology was not available).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document specifies the ground truth for the test sets (both MRMC and external validation) was established with "strict requirement for diagnostic certainty (either pathologic confirmation or two-years radiologic monitoring to confirm benign nodules)."
While it doesn't explicitly state the number of experts who established the ground truth, the involvement of "pathologic confirmation" or "two-years radiologic monitoring" implies the standard clinical practice involving pathologists and/or radiologists in the diagnostic process. The MRMC study itself involved 10 radiologists reading the cases, and while they were assessing malignancy likelihood, the ground truth for those cases was pre-established based on the methods described.
4. Adjudication Method for the Test Set
The adjudication method for establishing the ground truth (pathologic confirmation or two-year radiological monitoring) is not explicitly detailed in terms of expert consensus (e.g., 2+1, 3+1). However, the "strict requirement for diagnostic certainty" implies a high standard of clinical diagnosis.
For the MRMC study's reader evaluations, there was no direct adjudication of reader disagreement against each other. Instead, each reader's interpretation (with and without AI) was compared against the pre-established ground truth for each case. Each case was read twice by each reader, separated by a 28-day washout period, with AI use randomized for the second read.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Yes, an MRMC comparative effectiveness study was done.
- Reader Improvement: Radiologists improved their accuracy for the diagnosis of pulmonary nodules by an average of 18 points (0.181 AUC).
- Average AUC without the device: 0.538
- Average AUC with the device: 0.719
- Statistical Significance: This difference was statistically significant (p < 0.0001; Dorfman-Berbaum-Metz ANOVA random-reader random-case (RRRC) with jackknife (Wilcoxon)).
- Consistent Improvement: Every radiologist (10 out of 10) improved their performance when using RevealAI-Lung, with individual improvements ranging from 0.11 to 0.26 AUC points.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, standalone testing was done.
- Performance: "Standalone testing of RevealAI-Lung demonstrated that it performed as expected in discriminating between benign and malignant nodules."
- Additional Validation: "Validation of RevealAI-Lung was performed to determine device performance against the ground truth using pre-established acceptance criteria. The device was subsequently tested on incidental nodules from three additional populations (one each US, Canada, and the UK). Each of these studies produced performance with an AUC > 0.8, and demonstrated follow-up decisions would be improved compared to clinical guidelines." This indicates strong standalone performance on external datasets.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for both training and validation sets was established with "strict requirement for diagnostic certainty":
- Pathologic Confirmation: For malignant nodules, this would typically involve biopsy results.
- Two-Years Radiologic Monitoring: For benign nodules, this means stable appearance over two years of follow-up CT scans, indicating a non-cancerous nature.
- Outcome Data: The phrase "following the patients for at least 5 years" for confidently matched diagnoses used in training, and implied in validation, points to long-term outcomes data to confirm the definitive diagnosis.
8. The Sample Size for the Training Set
- Training Dataset: RevealAI-Lung was trained on "radiologist-identified lung nodules from 4-30mm in diameter."
- Specific Sample Size: The exact number of cases or nodules in the training set is not explicitly stated in the provided document, beyond the characteristics of the subjects (median age 63, 43% female).
9. How the Ground Truth for the Training Set Was Established
- Method: "Only nodules that were confidently matched to a definitive diagnosis were used for training, including following the patients for at least 5 years."
- This implies a combination of pathology (for malignant cases) and long-term radiologic stability/outcomes (for benign cases) to ensure diagnostic certainty, similar to the method described for the test sets. The mention of "radiologist-identified lung nodules" for the training set likely refers to how the nodules were initially marked or selected, while the "confidently matched to a definitive diagnosis" over 5 years is how their ground truth was ultimately confirmed.
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