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510(k) Data Aggregation
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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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The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures
The Soniquence 3-Button Fingerswitch Wand is an accessory intended for use with the Soniquence SmoothWave RF Generator. The device connects to a high-frequency generator via a male connector, and the distal female connector interfaces with a compatible Soniquence monopolar electrode. The device is supplied non-sterile and is intended for use with Soniquence monopolar electrodes.
The 3-Button Fingerswitch Wand provides user access to three monopolar waveforms without the need for generator front-panel manipulation. The handpiece enables activation of CUT, BLEND, and HEMO modes via integrated finger-actuated switches. When a button is depressed, the corresponding mode is activated regardless of the generator display settings. Visual indicators illuminate to confirm activation of the selected mode.
a) The CUT button will activate CUT mode. When depressed, the yellow indicator (CUT) illuminates.
b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates.
c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates.
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2 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.
3 Way SoftSimplastic Catheters:
Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.
The RÜSCH SoftSimplastic balloon catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity in ml and shaft size in French gauge (Fr.), Charrière (Ch.) or millimeters (mm) are indicated on the funnel of each individual catheter. They have a radiopaque contrast stripe along the shaft and are supplied sterile.
The following tip types are available: Couvelaire and Coudé/Mercier. Sizes range from 14 to 24 Ch./Fr. The catheters have a length of approximately 42 cm.
The RÜSCH SoftSimplastic balloon catheters are made of PVC uncoated. These catheters are only for short term usage. Maximum duration of use: Up to 30 days.
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Rx use: revyve® Antimicrobial Skin and Wound Cleanser for prescription use is intended for use under the supervision of healthcare professionals for mechanical cleansing, moistening, debriding, and removal of foreign material including microorganisms and debris from wounds, including acute and chronic dermal lesions, such as Stage I - IV pressure ulcers, venous ulcers, leg ulcers, diabetic foot ulcers, post-surgical wounds, first and superficial second degree burns, grafted and donor sites. It is also intended for moistening absorbent wound dressings and cleaning minor cuts, minor burns, superficial abrasions.
OTC use: revyve® Antimicrobial Skin and Wound Cleanser for OTC use is intended for mechanical cleansing wounds and moistening absorbent wound dressings for the management of minor cuts, abrasions, lacerations, and minor burns.
revyve® Antimicrobial Skin and Wound Cleanser is a clear, colorless liquid containing poloxamer 407, EDTA, sodium citrate/citric acid, polyhexanide (PHMB) and glycerol. PHMB at a concentration of 0.1% w/w is added as preservative to prevent microbial growth, within the product during shelf-storage. This skin and wound cleanser will be packaged in 4 fluid oz (118.3 mL) polyethylene squeeze bottle. revyve® Antimicrobial Skin and Wound and Cleanser will be used for mechanically cleaning wounds and for moistening and lubricating absorbent wound dressings for ulcers, first and superficial second-degree burns, post- surgical wounds and abrasions. The mechanical action of moving across the wound provides for the mechanism of action and aids in the removal of foreign material such as dirt, debris, and microorganisms. It will be provided in non-sterile form, labeled for single patient, single use only.
The device will be available as both a Rx and OTC product.
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The Reprocessed 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 Reprocessed Agilis NxT Steerable Introducer consists of a dilator, guidewire, and 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 a 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.
Note: Only the steerable sheath and dilator are the subject (reprocessed devices) of this submission. The guidewire is purchased off-the shelf (K935170) and packaged with the reprocessed devices.
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The Ready-to-Use Hydrophilic Catheter is indicated for intermittent catheterization of the urethra for individuals (men, women, pediatrics) who are unable to promote natural urine flow or have a significant volume of residual urine following a natural bladder-voiding episode.
The catheter is inserted into the urethra to reach the bladder, allowing urine to drain and ensuring bladder emptying.
Ready to use Nelaton Catheter is a sterile, single use catheter, intended to be inserted through the urethra to the bladder for intermittent urine drainage. The catheters are available in a variety of lengths and French sizes to accommodate individual anatomy of adult and pediatric patients (including males and females).
The catheter is made of polyurethane, and is not made with PVC. It is prelubricated with a hydrophilic coating. The distal end is either a smooth closed straight or coude tip with two eyelets for efficient drainage. The color-coded funnel at the proximal end can be connected to a urine collection container. There is a gripper on the catheters for adult males (length of 40cm), which serves as protection from the user's touch and aids the user during insertion.
The catheter is sealed in a foil pouch with the hydration liquid (distilled water) in one compartment, so the coated catheter is lubricated by direct contact with the hydration liquid and can be ready to use. Ready to use Nelaton Catheter is sterilized by E-beam irradiation, and the shelf life is 3 years.
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