Search Results

AIM is a bite block intended for use in patients 18 years and older who require supplemental oxygen and CO2 monitoring during procedures where the patient is expected to be minimally or moderately sedated. AIM is not indicated for use during procedures that are expected to require deep sedation.

AIM is a single-use, non-sterile bite block with integrated oxygen (O2) delivery and expired gas sampling tubing for patients undergoing procedures where supplemental oxygen and expired gas sampling is required expired. When paired with an oxygen supply and a capnography monitor, AIM can be left in place after the procedure to deliver oxygen and monitor CO2 levels.

AIM consists of a bite block, an attached oxygen delivery line and an attached CO2 sampling line. It delivers oxygen and samples exhaled CO2 in the oropharynx.

The provided text describes a 510(k) summary for a medical device named AIM, which is a bite block with integrated oxygen delivery and expired gas sampling tubing. The summary compares AIM to a predicate device, DualGuard™ (K140473), to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study proving the device meets these criteria, based on the provided document:

Acceptance Criteria and Device Performance Study for AIM

1. Table of Acceptance Criteria and the Reported Device Performance

The document describes performance tests by comparing the AIM device to its predicate, DualGuard™. The acceptance criteria appear to be equivalent or better performance than the predicate device.

Ask a specific question about this device

The HeartBeam AIMIGo™ System is a portable non-invasive recorder intended to record, store, and transfer a patient's 3-Lead (in three-directions) electrocardiogram (ECG) acquired from 5 electrodes. The device is intended to be used by adult patients in either a clinical setting or at home. The device does not conduct cardiac analysis and can be used with an ECG Viewer software system for manual interpretation of non-life-threatening arrhythmias by a physician or healthcare professional.

The HeartBeam AIMIGo™ System captures a 3-lead (in three-directions) electrocardiogram (ECG) recording of patients who have been prescribed a HeartBeam AIMIGo™ System for recording an ECG remotely. The HeartBeam AIMIGo™ System records and transmits the 3lead ECG signal which can be displayed as rhythm strips on a compatible ECG viewer. The HeartBeam AIMIGo™ System does not provide any analysis of the ECG data nor provide any recommendation toward a clinical diagnosis and is not intended to be used with automated ECG analysis systems. It reports a series of 3-lead ECG rhythm strips for manual interpretation. The hardware platform is designed to be functional and effective with any compatible software designed for the purpose of displaying ECG waveforms for clinical review. The HeartBeam AIMIGoTM System will be provided by prescription only.

The system allows the patient (or their caregiver or healthcare provider) the capability to perform the following:

• . Record a 3-lead (in three-directions) ECG with the recording device and accompanying mobile Patient Application
• Transmit the recorded 3-lead ECG signal to the cloud server, which can then be accessed ● by a clinician via the Clinician Portal for review and manual interpretation.

Filters applied may impact the ECG signal morphology, including significant attenuation of lowlevel atrial activity (P-waves / Flutter-waves), which may result in inability to discriminate certain types of arrhythmias (e.g., Atrial Fibrillation/Atrial Flutter).

The ECG report produced by HeartBeam AIMIGo is not intended for analysis of the T-wave or other morphological ECG evaluation.

The AIMIGo device is not intended for patients with tremors and/or those unable to place and maintain the device in the correct position for the duration of the recording.

The provided text addresses the clinical study, but lacks specific details on the acceptance criteria and the comprehensive study data. Based on the information available, here's a breakdown of what can be inferred and what is missing:

The HeartBeam AIMIGo™ System Clinical Study Summary

The HeartBeam AIMIGo™ System underwent two clinical studies to support its 510(k) submission, confirming its substantial equivalence to the predicate device (AliveCor KardiaMobile 6L) and a reference device (VectraCor Universal Smart ECG).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state a table of acceptance criteria with corresponding performance metrics. It indicates that "All study endpoints were met" for both clinical studies, implying that the device's performance reached the predefined success criteria. However, the specific metrics and targets are not detailed.

Inferred Performance Goals (based on study objectives):

• Pivotal Study: To demonstrate clinical equivalence of ECG waveforms between AIMIGo 3-L VECG and reference standard 12-L ECG for interpretation of non-life-threatening arrhythmias. This implies high level of agreement or correlation in ECG waveform morphology and characteristics relevant for arrhythmia detection.
• Device Positioning Validation Study: To validate that within a predetermined range of distance, direction, and orientation from the recommended position, the AIMIGo 3L VECG output signal characteristics remain unaffected when compared to a simultaneously recorded standard 12L ECG signal, for interpretation of non-life-threatening arrhythmias. This suggests performance robustness under varied positioning.

Observed Device Performance:

• "All study endpoints were met" for both the Pivotal Study and the Device Positioning Validation Study. This is the only reported device performance.

Table Structure (Hypothetical, as specific criteria are not provided):

Ask a specific question about this device

AiMIFY is an image processing software that can be used for image enhancement in MRI images. It can be used to increase contrast-to-noise ratio (CNR), contrast enhancement (CEP), and lesion-to-brain ratio (LBR) of enhancing tissue in brain MRI images acquired with a gadolinium-based contrast agent. It is intended to enhance MRI images acquired using standard approved dosage per the contrast agent's instructions for use.

The AiMIFY device is a software as a medical device consisting of a machine learning software algorithm that enhances images taken by MRI scanners. AiMIFY consists of a software algorithm that improves contrast-to-noise ratio (CNR), contrast enhancement (CEP), and lesion-to-brain ratio (LBR) of Gadolinium-Based Contrast Agent (GBCA) enhanced T1-weighted images while maintaining diagnostic performance, using deep learning technology. It is a post-processing software that does not directly interact with the MR scanner and does not have a graphical user interface. It is intended to be used by radiologists in an imaging center, clinic, or hospital. The AiMIFY software uses T1 pre and post-contrast MR images acquired as part of standard of care contrast-enhanced MRI exams as the software input. The outputs are the corresponding images with enhanced contrast presence. AiMIFY enhances DICOM images.

AiMIFY image processing software uses a convolutional network based algorithm to enhance the AiMIFY-contrast images from pre-contrast and standard-dose post-contrast images. The image processing can be performed on MRI images with predefined or specific acquisition protocol settings as follows: gradient echo (pre- and post-contrast), 3D BRAVO (pre- and post-contrast), 3D MPRAGE (preand post-contrast), 2D T1 spin echo (pre- and post-contrast), T1 FLAIR/ inversion recovery spin echo (pre- and post-contrast).

The AiMIFY image is created by AiMIFY and sent back to the picture archiving and communication system (PACS) or other DICOM node by the compatible MDDS for clinical review.

Because the software runs in the background, it has no user interface. It is intended to be used by radiologists in an imaging center, clinic, or hospital.

Note, depending on the functionality of the compatible MDDS, AiMIFY can be used within the facility's network or remotely. The AiMFY device itself is not networked and therefore does not increase the cybersecurity risk of its users. Users are provided cybersecurity recommendations in labeling.

Here's an analysis of the acceptance criteria and the study proving the device meets those criteria, based on the provided text.

Device: AiMIFY (1.x)
Indications for Use: Image processing software for enhancement of MRI images (increase CNR, CEP, LBR of enhancing tissue in brain MRI images acquired with gadolinium-based contrast agent).

1. Acceptance Criteria and Reported Device Performance

Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: 95 T1 brain cases.
  • Of these, 57 cases had identified lesions and were used for lesion-specific analyses (e.g., LBR, lesion-specific CNR).
• Data Provenance: Retrospective, acquired from clinical sites or hospitals.
  • Country of Origin: USA (California, New York, Nationwide), Beijing, China.
  • Acquisition details: Variety of T1 input protocols (BRAVO, MPRAGE+, FLAIR, FSE), orientations (axial, sagittal, coronal), acquisition types (2D, 3D), field strengths (0.3T, 1.5T, 3.0T), and MR scanner vendors (GE, Philips, Siemens, Hitachi).
  • Patient Demographics: Age (7 to 86, relatively even distribution), Sex (relatively even distribution of females and males), Pathologies (Cerebritis, Glioma, Meningioma, Metastases, Multiple Sclerosis, Neuritis, Inflammation, Other tumor related, other abnormalities).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Quantitative Assessment (ROI drawing): One board-certified radiologist.
• Qualitative Assessment (Reader Study): Three board-certified neuro-radiologists.
  • Specific years of experience are not mentioned, but "board-certified" implies a certain level of qualification and experience within their specialty.

4. Adjudication Method for the Test Set

• Quantitative Assessment: ROIs were drawn by a single board-certified radiologist. No explicit mention of adjudication or multiple expert consensus for the initial ROI placement. The statistical analysis (Wilcoxon signed-rank test) focuses on the comparison of metrics derived from these ROIs.
• Qualitative Assessment (Reader Study): The readers individually rated images on Likert scales. The results are presented as aggregated statistics (e.g., "significantly better/not worse by p

Ask a specific question about this device

The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ endoscope/ arthroscope/ sinuscope is indicated for use. The 1788 4K Camera System with Advanced Imaging Modality is indicated for use in adults and pediatric patients.

A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repar, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the 1788 4K Camera System with Advanced Imaging Modality are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, orthopedic surgeons, ENT/heurosurgeons and urologists.

Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Additionally, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with Advanced Imaging Modality and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with Advanced Imaging Modality and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The L12 LED Light Source with Advanced Imaging Modality is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

Stryker's Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light, near-infrared illumination and transillumination, and cyan spectral imaging system. Near-infrared illumination is used for fluorescence imaging using SPY AGENT™ GREEN (indocyanine green for injection, USP) or CYTALUX™ (pafalocianine) injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. Cyan Spectral Imaging is intended as an alternative mode of visualization that uses narrow bands for illumination during endoscopic surgery to provide greater visualization of surface structures and fine capillary patterns of the mucosal membrane.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Stryker 1788 4K Camera System with Advanced Imaging Modality and L12 LED Light Source with AIM:

A table of acceptance criteria and the reported device performance cannot be fully constructed from the provided document. The document primarily lists regulatory standards and general performance categories, indicating that the device "passed" these tests. It does not provide specific quantitative acceptance criteria or detailed reported performance values for each criterion.

However, based on the Performance Data section (page 9), we can infer the types of tests conducted and their general outcome:

Inferred Acceptance Criteria and Reported Device Performance

Here's the requested information based on the provided document:

1. A table of acceptance criteria and the reported device performance

   • (See table above)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • The document states: "NOTE: The Advanced Imaging Modality (AIM) System does not require clinical studies to support the determination of substantial equivalence." This implies that no clinical test set (patient data) was used in the assessment for substantial equivalence. The testing described appears to be primarily bench and laboratory-based. Therefore, sample size and data provenance in the context of clinical data are not applicable based on this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

   • Since no clinical studies were performed, there's no mention of experts establishing ground truth for a clinical test set. The "Pass" results are based on compliance with engineering standards and comparisons to predicate devices in bench testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

   • Not applicable. No clinical test set demanding adjudication was used.

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 MRMC comparative effectiveness study was done. The document explicitly states: "The Advanced Imaging Modality (AIM) System does not require clinical studies to support the determination of substantial equivalence." There is also no mention of AI assistance in the context of human readers for this device. The "Advanced Imaging Modality" refers to specialized illumination and visualization techniques, not AI-powered image analysis for diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • Not applicable. This device is an imaging system (camera and light source) that provides visual information to a surgeon. It is not an AI algorithm that operates standalone without human interpretation or intervention for diagnostic or therapeutic decisions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • For the performance testing, the implied "ground truth" or reference was primarily device input specifications and the performance of currently legally marketed predicate devices. For regulatory compliance, the ground truth was adherence to FDA-recognized voluntary consensus standards (e.g., IEC standards for electrical safety, usability, software, etc.).

8. The sample size for the training set

   • Not applicable. This document describes a medical imaging hardware system, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

   • Not applicable. As there is no machine learning component requiring a training set, the establishment of ground truth for such a set is not mentioned.

Ask a specific question about this device

Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the L12 LED Light Source with AIM and SafeLight Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The L12 Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the L12 Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Additionally, the L12 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and pediatric patients and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

Upon interstitial administration of SPY AGENT GREEN, the L12 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the L12 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The L12 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The L12 LED Light Source with AIM is part of the Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The L12 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.

This document describes the Stryker L12 LED Light Source with AIM, which is an endoscopic imaging system used to provide real-time visible and near-infrared fluorescence imaging during various surgical procedures. The device received 510(k) clearance (K230754) based on substantial equivalence to predicate devices, primarily the 780 nm L11 LED Light Source with AIM (K221611).

The provided text does not contain details about acceptance criteria or a study proving the device meets those criteria, as typically seen for AI/ML-enabled devices involving diagnostic accuracy or similar performance metrics. This is because the L12 LED Light Source with AIM is a hardware component (a light source) that enables certain imaging modalities, rather than a diagnostic algorithm itself. As such, its performance evaluation focuses on functional aspects and safety rather than diagnostic accuracy or human reader improvement.

Here's an analysis based on the information provided, specifically highlighting why certain requested sections are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are fundamental engineering and safety standards, and the reported performance is a simple "PASS" for these tests. There are no specific quantitative performance metrics (e.g., sensitivity, specificity, accuracy) provided as would be expected for an AI/ML-driven diagnostic device.

2. Sample size used for the test set and the data provenance

Not applicable. The device is a hardware component (light source). Performance testing was conducted in a bench setting on the device itself, not on a dataset of patient images or patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This information is relevant for studies evaluating human perceptual or cognitive performance, typically in conjunction with AI/ML algorithms. The provided document describes safety and functional testing for a light source.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are used to establish ground truth in image datasets, often by resolving discrepancies among expert readers. This device underwent bench and software functional testing.

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

Not applicable. This device is not an AI/ML algorithm designed to assist human readers in image interpretation. It is a light source that enables certain imaging modalities. The document explicitly states: "The L12 LED Light Source does not require clinical studies to support the determination of substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware component, not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the conventional sense for AI/ML evaluation. The "ground truth" for the tests performed was defined by engineering specifications and expected functional outputs of the light source (e.g., specific light output, proper communication, correct timing).

8. The sample size for the training set

Not applicable. This device does not use a training set as it's not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this device.

Ask a specific question about this device

Aimanfun Lumea Comfort is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Aimanfun Lumea Comfort, Model: A-2788, A-2789 and A-3588 is an over-the-counter use device for the reduction of hair growth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the Intense Pulsed Light (IPL) technology with lower energy level, including 5 Levels of output energy. Intense Pulsed light technology is able to achieve hair removal results at a fraction of the energy level used in other light-based hair removal equipment.

The hand-held device package includes main unit, adaptor and user manual and it uses a Xenon Lamp to emit specified wavelength pulsed light to heat the root where the hair grows, and a skin proximity sensor to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.

The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria in the format requested. The document is an FDA 510(k) summary for a hair removal device, focusing on demonstrating substantial equivalence to predicate devices rather than detailing specific performance studies with acceptance criteria, sample sizes, expert involvement, or ground truth methodologies.

The "Performance Testing" section states: "As the modification of subject device as above, results in no technological characteristics changes, the tests and data utilized to demonstrate safety and efficacy of the predicate device (legally existing device) are suitable for use in the assessment of the subject devices except for usability study verification. In usability study, the testing result demonstrates that the intended users can understand the package labeling, correctly choose the device and use it for the indicated OTC use, based on reading the lableling materials."

This indicates that clinical performance data was not deemed necessary for this specific submission because the device's technical characteristics were not changed from the predicate device, only its intended use (from prescription to Over-The-Counter). The only new testing mentioned is a usability study to confirm layperson understanding of instructions for OTC use. However, details of this usability study (sample size, criteria, etc.) are not provided.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

Ask a specific question about this device

The CPS Aim™ Universal II slittable inner catheter (subselector/cannulator) is designed for intracardiac access of the coronary sinus and subselection of the venous system of the heart, and to serve as a conduit during implantation for delivery of contrast medium and Abbott Medical devices (such as guidewires and implantable left heart leads). In addition, the CPS Aim™ Universal II slittable inner catheter (subselector/cannulator) can work with outer guide catheters as a system.

The CPS Aim™ Universal II Slittable Inner Catheter (subselector/cannulator) is used to facilitate left heart lead delivery procedures. It is an introducer that is used to cannulate the coronary venous system and act as a conduit for contrast medium, implantable coronary leads, or other devices.

The CPS Aim™ Universal II Slittable Inner Catheter design is based on the currently marketed CPS Aim™ Universal Slittable Inner Catheter design and components. Three modifications were made:

1. Modified hydrophilic coating: the subject device uses a different hydrophilic coating material as compared to the currently marketed CPS Aim Universal catheters.
2. Use of a modified braid design pattern to provide improved kink resistance: the predicate device braid is a single braided wire, and the subject braid contains paired braided wires.
3. Reduction in shelf-life from three (3) years to two (2) years.

The CPS Aim™ Universal II Slittable Inner Catheter will be added as a line extension to the currently marketed family of CPS catheters. New. unique model numbers will distinguish the CPS Aim™ Universal II inner catheter models from existing CPS catheter models.

The CPS Aim™ Universal II Slittable Inner Catheters will be available in the same working lengths, 59 cm and 65 cm, as the predicate device, and will be available with the same shape of curves as the predicate device. The key design features of the CPS Aim™ Universal II Slittable Inner Catheters have only undergone a minimal change to support the coating and braid change. There is no change to the accessories, including the slitter and valve bypass tool (VBT).

The key design features CPS Aim Universal and CPS Aim Universal II Slittable Inner Catheters and their accessory, the CPS Valve Bypass Tools include:

• Braid reinforced, varying durometer PEBAX catheter shaft with molded proximal hub.
• Inner diameter of the catheter is PTFE lined.
• Atraumatic distal soft tip.
• Embedded marker band on soft tip for fluoroscopic visibility.
• Outside surface of the catheter shaft is coated with a hydrophilic coating to provide lubricity during use.
• Hub of the catheter is fitted with a retention cap and an integrated valve that provides hemostasis and facilitates contrast injection. The hub also includes a sideport assembly with 3-way stopcock.
• The catheters are available in cannulator and sub-selector models.
• Accessories such as valve bypass tool (VBT) used to assist the insertion of Abbott Medical devices (leads, guidewires, inner catheters, etc.).

Similar to the existing CPS catheters, the CPS Aim™ Universal II Slittable Inner Catheters are supplied sterile (via ethylene oxide) in one package and are intended for single procedure.

There is no change in accessory product or process for the different models as a result of this line extension. The proposed indications for use is consistent with the cleared indications.

Based on the provided text, the device in question is a medical catheter, the CPS Aim™ Universal II Slittable Inner Catheter. The document describes a 510(k) premarket notification for this device, claiming substantial equivalence to a predicate device (CPS Aim™ Universal Slittable Inner Catheter, K130252). This type of submission generally focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving novel clinical efficacy. Therefore, the information provided primarily pertains to design verification and biocompatibility testing against established standards and the predicate device.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantified acceptance criteria for each test and then present the specific performance numbers. Instead, it states that "performance testing demonstrated that the CPS Aim™ Universal II Slittable Inner Catheter performs in a substantially equivalent manner to the currently marketed predicate device" and that the device "meets its design specifications and is as safe and effective as the predicate devices."

However, it does list the types of tests conducted, which imply the areas where performance was assessed:

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify the sample sizes (number of units or batches) used for each individual test (biocompatibility, design verification, shelf-life). It also does not mention the country of origin of the data or whether it was retrospective or prospective, as these types of studies typically involve laboratory bench testing and animal model testing (where applicable for biocompatibility).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information, relating to expert consensus or clinical adjudication for establishing ground truth, is not applicable or provided in this 510(k) summary. The studies described are bench tests and biocompatibility tests, not clinical performance evaluations that would require human expert interpretation of device output.

4. Adjudication Method for the Test Set

Not applicable for the types of tests described (bench and biocompatibility testing).

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through bench and biocompatibility testing, not on comparative clinical effectiveness with human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This device is a physical medical catheter, not an AI algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable.

7. The Type of Ground Truth Used

For biocompatibility testing, the "ground truth" is adherence to established biological safety standards (ISO 10993-1, FDA GLP 21 CFR 58), and for specific tests, it would be the absence of toxic reactions, irritation, etc., as measured by standardized assays. For design verification, the "ground truth" is adherence to predefined engineering specifications and functional requirements. For shelf-life, it's the maintenance of performance characteristics over the specified period.

8. The Sample Size for the Training Set

This device is not an AI algorithm, and therefore there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

Ask a specific question about this device

Upon intravenous administration of SPY AGENTTMGREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLightTM Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

Upon interstitial administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved label, the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The 780 nm L11 LED Light Source with AIM is part of the 780 nm Advanced Imaging Modality (AIM) System. The system is an endoscopic real-time 4K visible white light and near-infrared illumination and transillumination imaging system. Near-infrared illumination is used for fluorescence imaging using indocyanine green and pafolacianine injection. Near-infrared illumination is also intended for use during transillumination of the ureters using the IRIS Ureteral Kit during minimally invasive and open surgical procedures. The 780 nm L11 LED Light Source is a light-generating until designed to illuminate surgical sites in the following applications: visible light, near-infrared fluorescence, and near-infrared transillumination.

The provided text describes a 510(k) submission for the "780 nm L11 LED Light Source with AIM" device and mentions that the device passed several performance bench tests. However, it explicitly states:

"NOTE: The 780 nm L11 LED Light Source does not require clinical studies to support the determination of substantial equivalence."

This means that while the device underwent technical and performance testing, there wasn't a clinical study to prove the device meets clinical acceptance criteria. Therefore, most of the requested information regarding clinical acceptance criteria, sample sizes for test sets, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth for clinical performance is not available in the provided text.

Here's a breakdown of what can be extracted based on the input:

1. A table of acceptance criteria and the reported device performance

The provided document lists performance tests and indicates a "PASS" for each, suggesting these tests represent the acceptance criteria for those specific aspects. Clinical acceptance criteria are not mentioned as clinical studies were not required.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as no clinical test set was used for a study proving clinical acceptance criteria. The performance tests were bench tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as no clinical test set was used requiring expert ground truth for clinical acceptance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used requiring adjudication.

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

Not applicable. The document explicitly states that clinical studies were not required. The device is a light source, not an AI-assisted diagnostic tool for "human readers."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This refers to an algorithm's performance. The "780 nm L11 LED Light Source with AIM" is a medical device providing illumination and imaging, not a standalone AI algorithm. While it has an "AIM" (Advanced Imaging Modality) system, the document focuses on the light source itself and its functionality for fluorescence and transillumination, not an independent algorithm for diagnostic output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical study requiring a ground truth for diagnostic or clinical performance was conducted. The "PASS" for the bench tests indicates adherence to engineering or performance specifications.

8. The sample size for the training set

Not applicable, as no clinical training set was used for an AI algorithm.

9. How the ground truth for the training set was established

Not applicable, as no clinical training set was used.

Ask a specific question about this device

780 nm 1688 4K Camera System :

The 1688 4K Camera System is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, neurosurgery and plastic surgery whenever a laparoscope/ arthroscope/ sinuscope/ sinuscope is indicated for use. The 1688 4K Camera System is indicated for adults and pediatric patients.

A few examples of the more common endoscope surgeries are Laparoscopic cholecystectomy, Laparoscopic hernia repar, Laparoscopic appendectomy, Laparoscopic pelvic lymph node detection, Laparoscopically assisted hysterectomy, Laparoscopic and thorascopic anterior spinal fusion, Anterior cruciate ligament reconstruction, Knee arthroscopy, Small joint arthroscopy, Decompression fixation, Wedge resection, Lung biopsy, Dorsal sympathectomy, Pleurodesis, Internal mammary artery dissection for coronary artery bypass, Coronary artery bypass grafting where endoscopic visualization is indicated and Examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the 1688 Video Camera are general and pediatric surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons, neurosurgeons and urologists.

780 nm L11 LED Light Source with AIM and Safelight Cable:

Upon intravenous administration of SPY AGENT GREEN (indocyanine green for injection, USP), the 780 nm L11 LED Light Source with AIM and SafeLight™ Cable are used with SPY AGENT GREEN to provide real-time endoscopic visible and near infrared fluorescence imaging. The 780 mm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion in adults and pediatric patients aged one month and older, and visualization of at least one of the major extra-hepatic bile ducts (cystic duct, common bile duct and common hepatic duct) in adults and pediatric patients 12 to 17 years of age, using near-infrared imaging.

Fluorescence imaging of biliary ducts with the 780 nm L11 LED Light Source with AIM and SafeLight Cable is intended for use with standard-of-care white light and, when indicated, intraoperative cholangiography. The devices are not intended for standalone use for biliary duct visualization.

Additionally, the 780 nm L11 LED Light Source with AIM and SafeLight Cable enable surgeons to perform minimally invasive cranial neurosurgery in adults and endonasal skull base surgery in adults and pediatric patients > 6 years of age using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion using near infrared imaging.

Upon interstitial administration of SPY AGENT GREEN, the 780 nm L11 LED Light Source with AIM and SafeLight Cable is used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

The 780 nm L11 LED Light Source with AIM is also intended to transilluminate the ureter during open or laparoscopic surgical procedures.

The 780nm Advanced Imaging Modality (AIM) System is an endoscopic real-time 4K visible white light and near-infrared light illumination and imaging system. Near-infrared illumination is used for both fluorescence imaging using SPY AGENT TM GREEN (indocyanine green for injection, USP) and transillumination of the ureters during minimally invasive and open surgical procedures, respectively. The 780nm AIM System includes the following components: (1) A Camera System for processing nearinfrared and visible light images; (2) A Light Source and SafeLight Cable for emitting light within the visible light as well as near-infrared light spectrum; (3) An Endoscope for visible light and near-infrared light illumination and imaging; (4) The IRIS Ureteral Kit for transillumination of the ureters; and. (5) SPY AGENT "M GREEN (indocyanine green for injection, USP) used for fluorescence imaging.

This document describes the 780 nm Advanced Imaging Modality (AIM) System (K214046) and its substantial equivalence to a predicate device (K211202). The provided text mentions various performance tests but does not detail any specific clinical study that establishes acceptance criteria for device performance related to diagnostic accuracy or clinical outcomes.

Instead, the performance data section focuses on engineering and safety standards, as well as bench and animal studies (referencing the predicate AIM system) to demonstrate the device's technical specifications and safety.

Therefore, I cannot fulfill the request for information regarding clinical acceptance criteria, sample sizes for test sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth for clinical evaluation, or training set sample sizes from the given text.

However, I can extract the information that is present regarding technical performance testing:

1. Table of Acceptance Criteria and Reported Device Performance (Technical/Safety):

The document lists various tests and their results, indicating compliance with established standards or device input specifications. These are not clinical performance metrics in the traditional sense (e.g., sensitivity, specificity) but rather technical and safety assessments.

Missing Information (Not present in the provided text):

Since the document focuses on demonstrating substantial equivalence based on technical and safety testing rather than a clinical performance study measuring specific diagnostic accuracy or clinical outcomes, the following information cannot be extracted:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of human reader improvement with AI vs without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical performance.
8. The sample size for the training set (as this is not an AI/ML device in the context of clinical decision support, but rather an imaging system).
9. How the ground truth for the training set was established.

Ask a specific question about this device

The Zone Specific AIM™ Device is an implantable suture retention device which facilitates percutaneous or endoscopic soft tissue repairs, including repair of meniscal tears.

The Zone Specific AIM™ is an all-inside meniscal repair device that sequentially deploys implants and suture. The device is composed of peek implants and ultra-high molecular weight polyethylene (UHMWPE) suture (Hi-Fi). The handheld, disposable device, provided sterile for single use, is removed at the end of the repair leaving behind a suture/implant construct. The anchor, suture, and disposable handheld device are EO Sterilized.

This is a 510(k) premarket notification for the Zone Specific AIM™ Device, a meniscal repair device. The document primarily focuses on establishing substantial equivalence to a predicate device (ConMed Linvatec Sequent™ Meniscal Repair Device).

Since this is a 510(k) submission for a medical device that performs a mechanical repair, the acceptance criteria and performance data are primarily focused on physical and mechanical properties, not on a diagnostic algorithm. There is no AI component described in this document. Therefore, many of the requested fields related to AI algorithm performance (like sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract the general acceptance criteria and the types of studies performed to demonstrate the device's performance relative to its intended use and substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" and "reported device performance" in a direct numerical comparison for each test. Instead, it states that "Testing has been completed to demonstrate that the Zone Specific AIM™ performs as intended and is substantially equivalent to the predicate device" and "met the endotoxin limits." This implies that the device met the acceptance criteria for each test, but the specific numerical targets and results are not detailed in this summary.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for mechanical device testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This is a mechanical device, not an AI diagnostic algorithm. "Ground truth" in this context would refer to established engineering standards or validated test methods, not expert consensus on anatomical findings.

4. Adjudication Method for the Test Set

Not applicable. This is a mechanical device. Adjudication methods like 2+1, 3+1 are used for human review of data, typically in diagnostic studies.

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

Not applicable. This document does not describe an AI-powered device or an MRMC study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This document does not describe an AI algorithm.

7. The Type of Ground Truth Used

For mechanical and material tests, the "ground truth" implicitly refers to:

• Established engineering standards (e.g., ASTM, ISO standards for strength, cyclic loading, sterilization effectiveness, biocompatibility).
• Predicate device performance data, used as a benchmark for substantial equivalence.
• Regulatory limits (e.g., for endotoxin levels).

8. The Sample Size for the Training Set

Not applicable. There is no AI training set described.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no AI training set described.

Ask a specific question about this device