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The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula (K241414) to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the CrossWise™ RF Transseptal Cannula to facilitate septal puncture. The CrossWise RF Transseptal Cannula is connected to a ValleyLabs Force2 ES Generator (K051644) via the CrossWise Multi-Use RF Adapter Cable (Model CW-1001) or CrossWise RF Adapter Cable (Model CW-1002 / K241414) and a commercially available 3/32" ES pencil. The CrossWise Multi-Use RF Adapter Cable has unique connectors on each end which cannot be connected to an improper device and/or accessory. The CrossWise Multi-Use RF Adapter Cable (Model CW-1001) and CrossWise RF Adapter Cable (Model CW-1002) are both compatible with all CrossWise RF Transseptal Access System models. The dimensions for the CrossWise Multi-Use RF Adapter Cable can be found on the package labels. Circa Scientific sterilized the CrossWise Multi-Use RF Adapter Cable via ethylene oxide (EO) for initial use and is intended for multiple patients use, following prescribed reprocessing instructions. The prescribed reprocessing includes cleaning and steam/autoclaye sterilization procedures that have been validated for up to10 uses when users follow the cleaning and sterilization methods described in the Cleaning and Sterilization Instructions sections of the CrossWise Multi-Use RF Adapter Cable IFU. The CrossWise Multi-Use RF Adapter Cable does not come into direct or indirect contact with the patient according to the definitions in Section 3.0 of ISO 10993-1, and Attachment G of the September 2023 FDA Guidance document.

The provided document is a 510(k) Pre-Market Notification for a medical device called the "CrossWise™ Multi-Use RF Adapter Cable." This document primarily focuses on demonstrating the substantial equivalence of the new device to a previously cleared predicate device, especially regarding its reusability and materials.

The request asks for information typically found in studies validating an AI/ML medical device, specifically regarding acceptance criteria and performance data for an algorithm. However, this 510(k) submission does not describe an AI/ML device or algorithm. Instead, it describes a physical medical device (an adapter cable) and the bench testing performed to ensure its safety and effectiveness, particularly its reprocessing capabilities.

Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish the ground truth," and "sample size for the training set," are not applicable to this type of device and submission.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, reinterpreting the request for a physical device rather than an AI/ML algorithm.

Device Description:
The CrossWise™ Multi-Use RF Adapter Cable (Model CW-1001) is used in Transseptal Puncture Procedures (TSP) to connect the CrossWise™ RF Transseptal Cannula to a 3/32" electrosurgical (ES) pencil. The cable delivers radiofrequency (RF) energy to the cannula to facilitate septal puncture. The primary difference from the predicate device is its ability to be reprocessed (cleaned and re-sterilized) for up to 10 uses, and minor material modification to the connector shroud to withstand autoclave temperatures.

1. Table of Acceptance Criteria and Reported Device Performance

For this multi-use physical device, the "acceptance criteria" revolve around its ability to maintain its functionality and safety after repeated reprocessing cycles, showing substantial equivalence to the predicate device.

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

• Test Set Sample Size: The document does not explicitly state the numerical sample size for individual tests (e.g., "n=X cables tested"). It mentions "Devices" were tested and "testing was conducted on devices at 2 aging points: after manufacturing (T=0) and after 6 months of accelerated aging (T=6M AA)." It also states that devices were "subsequently conditioned to reflect the intended reusability of the devices after reprocessing."
• Data Provenance: The data is from non-clinical bench testing performed by the manufacturer, Circa Scientific, Inc., to support the 510(k) submission. There is no indication of country of origin of the data beyond the manufacturer's location (Englewood, CO, USA). The testing is prospective as it's specifically designed to validate the new device's capabilities prior to market clearance.

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

• This concept is not applicable to this type of device validation. "Ground truth" established by experts (e.g., radiologists interpreting images) is relevant for AI/ML diagnostic tools. For this physical device, the "ground truth" is defined by established engineering and medical device standards for performance, sterilization, and material properties. The engineers and quality assurance personnel conducting and overseeing these tests are inherently acting as the "experts" whose work ensures compliance with these standards.

4. Adjudication Method for the Test Set

• This concept is not applicable. Adjudication methods (e.g., 2+1, 3+1 consensus) are used for resolving disagreements in expert interpretations, typically in diagnostic or prognostic AI/ML studies. For bench testing of a physical device, results are typically objectively measured against pre-defined engineering specifications, not subject to subjective interpretation and 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

• This is not applicable. An MRMC study is designed to evaluate the impact of an AI diagnostic tool on human reader performance. The device here is a physical adapter cable, not an AI/ML algorithm.

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

• This is not applicable. A standalone performance evaluation is performed for AI/ML algorithms. The device submitted is a physical product. Its "standalone" performance is assessed via the bench tests (e.g., electrical resistance, tensile strength) without human interaction being part of the performance metric itself, but this is a fundamentally different type of evaluation from an AI algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this physical device is based on engineering specifications, material science properties, and established medical device performance standards (e.g., ISO 11135, ISO 17665, AAMI TIR12, ANSI/AAMI ST79, ANSI/AAMI ST98, IEC 60601-2-2). The physical and functional characteristics of the cable are objectively measured and compared against these pre-defined benchmarks to ensure safety and effectiveness for its intended use. There is no "pathology" or "outcomes data" in the sense of clinical study that establishes efficacy for this specific component; rather, component performance ensures the overall system works.

8. The Sample Size for the Training Set

• This is not applicable. There is no "training set" as this is not an AI/ML device that learns from data.

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

• This is not applicable as there is no "training set."

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The CrossWise™ RF Transseptal Cannula and accessories are used to create an atrial septal defect in the heart. Secondary indications include infusing solutions including heparinized saline and mixtures of 50% contrast media and 50% saline.

The CrossWise RF Transseptal Access System is used to puncture the Fossa Ovalis (FO) to establish transcatheter access from the right atrium to the left atrium. Monopolar radiofrequency (RF) energy is delivered between the CrossWise focal force electrode and a patient return electrode. The unique design of the focal force electrode minimizes trauma to cardiac tissue unless RF energy is applied. A colored sleeve is provided on the CrossWise RF Transseptal Cannula handle to indicate to the user when the tip of the catheter is still within the dilator.

The CrossWise RF Transseptal Cannula is supplied with a compatible dilator and a Super Stiff 0.032" PTFE-Coated Fixed Core J-Tip guidewire for vascular introduction using an over-thewire technique. The RF Transseptal Cannula is connected to a ValleyLabs Force2 Electrosurgical Generator (Medtronic, Inc) via the CrossWise RF Adapter Cable (packaged separately - Model CW-1002) and a commercially available Electrosurgical Pencil.

The CrossWise RF Transseptal Cannula is designed to facilitate injection of heparinized saline and/or contrast solution. The dimensions for the CrossWise RF Transseptal Cannula can be found on the device label. The CrossWise RF Transseptal Access System offers four configurations compatible with various commercially available guide sheaths (Table 5). All four configurations require use of a single model (CW-1002) CrossWise RF Adapter Cable Model which is packaged separately.

This document does not describe a study involving device performance metrics relevant to AI/ML, such as sensitivity, specificity, or F1 score, or any human reader studies using AI assistance. The provided text is a 510(k) summary for a medical device (CrossWise RF Transseptal Access System) to demonstrate substantial equivalence to predicate devices, focusing on non-clinical performance data like biocompatibility, sterilization, electrical safety, and bench testing.

Therefore, many of the requested categories related to acceptance criteria, device performance, ground truth, and human reader studies cannot be populated from the given text.

Here's a breakdown of the information that can be extracted:

1. A table of Acceptance Criteria and the Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria for performance metrics in a table format. Instead, it states that the device was tested to conform with various international standards and that "The nonclinical bench data support the safety of the device and demonstrate that the CrossWise RF Transseptal System performs as intended in the specified use conditions."

The types of tests performed and the general findings are:

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

• Test Set Sample Size: Not specified in terms of number of devices or number of tests for each type, other than "Devices were subjected to 2X sterilization and distribution simulation". The document states "Design verification testing was performed on the CrossWise RF Transseptal Access System with CrossWise RF Adapter Cable at two time points: immediately after manufacturing (T=0) and after six months of accelerated aging (T=6M AA)."
• Data Provenance: Not explicitly stated, however, the testing appears to be internal validation performed by the manufacturer, Circa Scientific, Inc., or a contract lab on their behalf. It is non-clinical (bench).

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

• Not applicable. This is a non-AI/ML medical device submission based on physical and electrical performance. Ground truth would be based on instrument readings, standardized methods, and expert evaluation of physical properties, not clinical expert consensus.

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

• Not applicable for this type of device and 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:

• No. This is not an AI/ML device.

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

• No. This is not an AI/ML device.

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

• For the non-clinical performance data, the "ground truth" is based on:
  • Validated test methods outlined in international standards (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety, ISO 11135 for sterilization).
  • Objective measurements from laboratory equipment and physical inspection.
  • Functional verification against design specifications.

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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The LIFEPAK Invasive Pressure Adapter Cable is intended to connect invasive pressure transducers from the patient to the LIFEPAK monitor/defibrillator for invasive pressure monitoring purposes and/or aid in diagnostic evaluation by a health care professional. The LIFEPAK Invasive Pressure Adapter Cable is intended for use in outdoor and indoor emergency care settings.

The LIFEPAK Invasive Pressure Adapter Cable is a reusable, insulated, shielded, electrical cord (trunk cable) with a proximal connector (to connect with the LIFEPAK 35 device) and a main yoke that houses three distal leans with connectors (to connect with invasive pressure transducers). The LIFEPAK Invasive Pressure Adapter Cable is designed to transmit an electrical signal (data) between devices (i.e., to connect invasive pressure transducers from the patient to the LIFEPAK 35 monitor/defibrillator). The invasive pressure cable is designed to connect up to three pressure transducers to the front panel of the LIFEPAK 35 monitor/defibrillator for invasive pressure monitoring. Three channels are available for invasive pressure (IP) monitoring, with labels P1, P2, and P3. Each channel also has a user-selectable label for the line type through the LIFEPAK 35 monitor/defibrillator.

Invasive Pressure monitoring involves the conversion of fluid pressure into an electrical signal. The conversion is accomplished with a pressure transducer (i.e., IP Probe). The invasive pressure cable passes the electrical signal from the transducers to the LIFEPAK 35 monitor/defibrillator.

The LIFEPAK Invasive Pressure Adapter Cable is available in two different models that are compatible with either ICU Medical Transpac® IV Disposable Pressure Transducers or Edwards Lifesciences TruWave® Disposable Pressure Transducers. These pressure transducers provide industry standard sensitivity and defibrillation protection of at least 360 joules.

The LIFEPAK Invasive Pressure Adapter Cable is not intended for use with other manufacturers' defibrillators and/or monitors. The LIFEPAK Invasive Pressure Adapter Cable is intended only for use with LIFEPAK 35 monitor/defibrillator.

The provided document describes a 510(k) premarket notification for the "LIFEPAK® Invasive Pressure Adapter Cable." It does not contain information about acceptance criteria for a device's performance, nor does it detail a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device through general performance testing.

Therefore, most of the requested information cannot be extracted from this document. However, I can provide the available details:

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

This information is not provided in the document. The document states "Performance testing has been completed to demonstrate that the proposed LIFEPAK Invasive Pressure Adapter Cable meets the safety and performance requirements established in the design specifications." However, the specific acceptance criteria and the numerical results of these tests are not detailed.

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

This information is not provided in the document. The document only mentions "Biocompatibility Evaluation" and "Design Verification Testing" were completed.

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. The document does not describe a study involving expert-established ground truth.

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

Not applicable. The document does not describe a study with 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 device is an adapter cable, not an AI-powered diagnostic tool, and no MRMC study is mentioned.

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

Not applicable. The device is a physical cable, not an algorithm.

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

Not applicable. The document does not describe a study that uses ground truth in this context. The "performance data" refers to engineering and biocompatibility testing.

8. The sample size for the training set:

Not applicable. The device is a physical cable, not a machine learning algorithm that requires a training set.

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

Not applicable. The device is a physical cable, not a machine learning algorithm.

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Intubation with Ambu VivaSight 2 DLT is indicated for pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation of one lung from the other, e.g. for thoracic surgery.

Ambu VivaSight 2 DLT is a sterile, single-use, double-lumen endobronchial tube intended to be used for isolation of the left or right lung of a patient for one lung ventilation.

The VivaSight 2 DLT system is intended to be used for verifying tube placement and repositioning.

Intubation with VivaSight 2 DLT is indicated for patients with pathological lung conditions or other medical conditions that require endobronchial intubation, mechanical ventilation and isolation of one lung from the other, e.g. for thoracic surgery.

Ambu VivaSight 2 DLT is a sterile, single-use, left-sided, double-lumen endobronchial tube with an embedded video camera and light source at the distal end of the tracheal lumen and integrated video cable with video connector.

The embedded video camera is used for visualization during the intubation procedure and to verify the tube placement. The picture is shown on an Ambu displaying unit, which Ambu VivaSight 2 DLT is connected to via Ambu VivaSight 2 Adapter Cable. Ambu VivaSight 2 Adapter Cable is a non-sterile, single patient use accessory to Ambu VivaSight 2 DLT. Ambu VivaSight 2 DLT is connected to and powered by an Ambu displaying unit via Ambu VivaSight 2 Adapter Cable; the whole system is referred to as the VivaSight 2 DLT system.

Ambu VivaSight 2 DLT is indicated for left or right lung isolation and use as a temporary artificial airway in adults requiring mechanical one-lung ventilation and is fitted with a stylet to enable shaping of the tube for navigation during intubation.

A colorless tracheal cuff provides sealing against tracheal wall and the corresponding pilot balloon indicates state of cuff inflation/deflation. Similarly, a blue bronchial cuff provides sealing against bronchial wall and the corresponding pilot balloon indicates state of cuff inflation/deflation.

A flush line with flush exits next to the camera lens ensures possibility for cleaning of the camera lens.

Ambu VivaSight 2 DLT can be connected to ventilation equipment via a Y-connector, which is included with the product. The Y-connector is sterile, single-use. The Y-connector caps enable lung deflation and use of accessories such as bronchoscopes and suction catheters in Ambu VivaSight 2 DLT. Furthermore, valves on the Y-connector enables opening and closing of the ventilation flow to each of the tracheal and bronchial lumens. The Y-connector airway tubes are colour coded to indicate tracheal and bronchial connection.
Ambu VivaSight 2 DLT will be available in four sizes: 35 Fr, 37 Fr, 39 Fr, and 41 Fr.

The provided text is a 510(k) summary for the Ambu VivaSight 2 DLT. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study with human-in-the-loop or standalone AI performance.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be found in this document because the submission relies primarily on bench testing and compliance with recognized consensus standards to show substantial equivalence.

The document explicitly states: "The following data have been submitted in the premarket notification to support safety and effectiveness of the device: Testing - Bench Declaration of conformity to the following applicable recognized consensus standards..."

It then lists various bench tests and standards with "Result: All tests passed." and concludes: "Performance testing has demonstrated that the device is as safe and effective as the predicate device."

The acceptance criteria and study detailed in your request (focused on AI performance, human reader improvement, and specified ground truth methodologies) are not applicable to the information provided in this 510(k) summary for the Ambu VivaSight 2 DLT.

This device is a medical instrument (double-lumen endobronchial tube with an embedded camera), not an AI-driven diagnostic or assistive technology in the context of the detailed questions. The "visualization during the intubation procedure" refers to a live video feed for direct human observation, not an image analysis AI that would require the kind of performance studies you've outlined.

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The Assurance™ Alar Sensor is indicated for single patient use for continuous noninvasive monitoring of functional arterial oxygen saturation and pulse rate from the nasal alar of adult and pediatric patients, (weighing >30kg). The sensor can be used in a variety of healthcare environments where compatible pulse oximetry monitors are indicated for use, under professional supervision.

The Assurance™ Alar Sensor is a disposable, single patient use Pulse Oximetry sensor designed to attach to the patient's nasal alar region - the fleshy region at the side of the nose. Skin contact and adhesive free sensor retention is via soft silicone rubber cushions encapsulating the optical components. The Assurance™ Alar Sensor with its associated patient cable, terminates in a DB-9 connector compatible with monitors employing Nellcor OxiSensor II SpO2 technology such as the Nellcor N-395. The sensor utilizes red and IR LED light sources of 660 nm and 890 nm respectively along with a silicon photodiode detector to detect changes in oxygen saturation in the blood. Since oxygen saturated blood absorbs different amounts of light at each wavelength (red and infrared) as compared with unsaturated blood, the amount of light absorbed at each wavelength by the blood in each pulse can be used to calculate oxygen saturation.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Clinical Testing (Hypoxia Performance): 12 healthy volunteer subjects.
• Data Provenance: The study was a "Controlled desaturation testing," which implies a prospective, controlled clinical study. The country of origin of the data is not explicitly stated, but the context of an FDA submission suggests it was likely performed in the US or under standards accepted by the FDA.

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

• The document mentions "Reference blood samples were drawn from an indwelling arterial catheter and analyzed on a Co-oximeter." This indicates that the ground truth for SpO2 was established through laboratory analysis by a Co-oximeter, which is a highly accurate method for blood gas analysis, rather than expert interpretation of images or other subjective assessments. Therefore, the concept of a "number of experts" for ground truth as might apply to image-based diagnostics is not directly applicable here.

4. Adjudication Method for the Test Set

• Not applicable as the ground truth was established by direct measurement with a Co-oximeter on blood samples, not through expert consensus or interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated. This type of study is more common for diagnostic imaging AI, where human readers interpret cases with and without AI assistance. This submission focuses on a sensor's accuracy compared to a gold standard.

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

• Yes, the hypoxia performance testing describes a standalone evaluation of the device. The sensor was connected to monitors, and the SpO2 values were recorded. The statistical analysis of the data pairs yielded the device's accuracy (Arms) independently, without human interpretation influencing the primary SpO2 measurement recorded by the device.

7. The Type of Ground Truth Used

• The type of ground truth used for SpO2 accuracy was outcomes data/reference standard measurement obtained from Co-oximeter analysis of arterial blood samples (SaO2).

8. The Sample Size for the Training Set

• The document does not report a separate training set size for the Assurance™ Alar Sensor. This device is a pulse oximeter sensor, which typically relies on established biophysical principles and calibration during manufacturing rather than machine learning algorithms that require extensive training data in the same way an AI diagnostic tool would. The accuracy is likely inherent to its design and calibration, not learned from a dataset.

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

• Not applicable, as no training set for a machine learning algorithm is mentioned. The device's operation is based on spectrophotometric principles, not a learned model from a training set.

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The Smith & Nephew Adaptor Cable is intended for connecting a Smith & Nephew Radiofrequency Denervation Probe to Smith & Nephew RF Lesion Generators.

The Smith & Nephew Adaptor Cable has been designed as an accessory device to the Smith & Nephew Electrothermal Spine System and will provide the option of bipolar energy distribution. The subject device is designed to be used with Smith & Nephew Electrothermal generators, Radiofrequency (RF) denervation probes, and cannulae to create RF heat lesions for the treatment of pain. This configuration eliminates the need of a grounding pad, allowing for return of the delivered energy via a secondary non-active RF probe.

This is a 510(k) summary for a medical device that is an adaptor cable, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on design features and intended use, rather than clinical performance or AI/ML model metrics.

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These devices are intended to be used as replacement accessories to Original Equipment Manufacturer monitors used in the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. These systems are used to monitor patients who are either well or poorly perfused, in hospitals, hospital type facilities, intra-hospital transport and home environments.

AIV's Pulse Oximeter Adapter Cables are direct replacements for similar cables manufactured by the Original Equipment Manufacturers (OEM) for their respective monitors. They use the same type of construction and have the same technological characteristics as the predicate devices (OEM). The adapter cable connects the OEM pulse oximeter sensor with the OEM monitor.

This document describes the 510(k) summary for Pulse Oximeter Adapter Cables from American IV Products, Inc. The submission aims to demonstrate substantial equivalence to existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

For this device, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices, focusing on key characteristics like intended use, construction, and performance. The "reported device performance" reflects that these criteria have been met through testing and comparison.

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

• Sample Size for the Test Set: Not explicitly stated as a separate "test set" in the context of an AI/algorithm-driven device. For these types of accessories, the testing primarily involves bench testing and comparison to the physical and electrical characteristics of multiple predicate devices. The number of specific AIV part numbers tested is 13, each corresponding to a different OEM part number for various monitor systems.
• Data Provenance: The testing is primarily retrospective, comparing the AIV cables to existing OEM devices and standards. The data is generated from bench testing within the manufacturer's environment to ensure conformity and equivalence. The country of origin of the data is not specified but is inferred to be the manufacturer's location in the USA (Hanover, MD).

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

This type of device (adapter cables) does not typically involve "experts" establishing a "ground truth" for a test set in the way an AI diagnostic algorithm would. Instead, engineering and quality assurance personnel perform instrumental measurements and comparisons. The submission mentions "Director of Regulatory Affairs and Quality Assurance" (Gregory Falk), suggesting that qualified personnel within the company are responsible for overseeing the testing and ensuring compliance. Specific numbers or detailed qualifications of technical experts involved in the bench testing are not provided in this summary.

4. Adjudication Method for the Test Set

Not applicable in the context of this device. Adjudication methods (e.g., 2+1) are typically used for interpreting ambiguous cases in diagnostic imaging or similar scenarios where human interpretation is a variable. For adapter cables, compliance is determined by meeting physical, electrical, and performance specifications through direct measurement and comparison, not by consensus among interpreters.

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 an adapter cable, not an AI or diagnostic algorithm, so no MRMC study or AI assistance comparison would be performed.

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

Not applicable. This device is an adapter cable, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Predicate Device Specifications: The technical and performance specifications of the legally marketed OEM pulse oximeter adapter cables.
• Consensus Standards: International (e.g., IEC 60601-1, IEC 60601-1-2) and national consensus standards for medical electrical equipment safety and electromagnetic compatibility.
• Functional Intent: The confirmed ability of the AIV cables to perform the intended function of connecting the sensor to the monitor to allow continuous SpO2 and pulse rate monitoring, without degrading the performance of the overall system.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is a hardware accessory, not an AI or machine learning algorithm.

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

Not applicable. There is no training set or ground truth in the AI/ML sense for this device.

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The Model 6149 Pacing Vector Selector Cable Switch is a manually operated unit used during lead implants for PSA measurements and provides the capability to switch RV and LV tip and ring signals to five possible electrode combinations.

The Model 6149 Pacing Vector Selector Cable Switch was designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It is manually operated and has no active circuits or power sources. It is a 3-channel Patient Adapter Cable, easily switchable between PSA vector measurements on implanted leads without relocating alligator clips on the lead terminal. A 2-pole, 5 position switch is integrated into the 3-channel molded connector housing on the distal end of the cable. The pacing vectors options provided are: Left Ventricle Tip to Right Ventricle Coil, Left Ventricle Ring to Right Ventricle Coil, Left Ventricle Ring to Left Ventricle Tip, Left Ventricle Tip to Left Ventricle Ring, Right Ventricle Tip to Right Ventricle Coil.

The provided text is a 510(k) summary for the Remington Medical Inc. Model 6149 Pacing Vector Selector Patient Adapter Cable. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement, as these are typically part of a detailed study report or testing documentation, not a 510(k) summary.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided input. The document focuses on regulatory approval based on substantial equivalence, not on a detailed clinical or performance study report.

I can only extract the following relevant information from the provided text:

• Device Name: Guidant Model 6149 Pacing Vector Selector Patient Adapter Cable
• Device Description: A manually operated 3-channel Patient Adapter Cable designed to interface between the Guidant Model 3105 or 3106 Pacing System Analyzer and Guidant 6697 Patient Cables. It has no active circuits or power sources. It features a 2-pole, 5-position switch to select between five pacing vector options.
• Intended Use: Used during chronic implantation of a pacing or defibrillation lead system for PSA measurements, providing the capability to switch RV and LV tip and ring signals to five possible electrode combinations.
• Technological Characteristics Summary: The Model 6149 is an accessory to the ERA 300, and its addition is considered minor, raising no safety or effectiveness concerns.

To answer your specific questions, information not present in the provided text includes:

1. A table of acceptance criteria and the reported device performance: Not present.
2. Sample sizes used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not present. The device is a passive adapter cable, not an AI or imaging device that would typically undergo such a study.
6. If a standalone study (algorithm only without human-in-the-loop performance) was done: Not present. The device is an adapter, not an algorithm.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not present.
9. How the ground truth for the training set was established: Not present.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence rather than a detailed performance study report. It indicates the device is a simple, manually operated adapter cable with no active components, making many of your questions about AI study methodologies (like training sets, ground truth establishment, and expert adjudication) not applicable to this particular device.

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The AC-1 Adapter Cable, 8 pin and 12 pin Philips is indicated for the continuous noninvasive monitoring of flunctic oxygen saturation of arterial hemoglobin (SpQ2) and pulse rate (measured by an SpO3 sensor) for use will, adult, pediatric, infant, and neonatal patients in hospital-type facilities, mobile, and home environments.

The AC-1 Adapter Cable, 8 pin and 12 pin Philips is fully compatible oximetry cable that allows the MacDon The AC-1 Adapter Cable, o pur and 12 pm Introl of the cable represents a design change to the Masimo AC-1.

The AC-1 Adapter Cable, 8 pin and 12 pin Philips is similar in construction to the predicate device enabling the Masimo LNOP The AC-T Adapter Cubter Cable, o pin and compatible pulse oximeter monitors from Philips.

Here's an analysis of the provided 510(k) summary, specifically focusing on the acceptance criteria and the study used to demonstrate it:

First, it's important to note that this 510(k) summary is for an adapter cable, not a complete medical device (like an oximeter with a sensor). Therefore, the performance criteria and studies are geared towards demonstrating the cable's compatibility and equivalence, rather than establishing the primary efficacy of an oximetry system from scratch.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Clinical Testing: Not explicitly stated. The summary mentions "Clinical studies were performed using the AC-1 Adapter Cables... on patients who were subjected to progressive induced hypoxia." However, it does not provide the number of patients or individual measurements.
• Data Provenance: Not explicitly stated regarding country of origin or retrospective/prospective. However, the description of "progressive induced hypoxia" implies a controlled, prospective clinical study.

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

• Ground Truth Establishment: The ground truth for SpO2 was established by CO-Oximetry of arterial blood samples. This is an objective, laboratory-based method, not reliant on expert interpretation of images or clinical findings.
• Number of Experts/Qualifications: Not applicable, as CO-Oximetry is a direct measurement, not an expert-based assessment.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by direct measurement (CO-Oximetry), which does not require adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No. This is not applicable to an adapter cable and its primary function of connecting an oximeter sensor to a monitor, where the output is a numerical SpO2 value. There are no "readers" in the context of interpretation that would benefit from AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Standalone Study: Yes, in essence. The clinical performance testing described is a standalone evaluation of the device system (cable + sensor + oximeter) against a "gold standard" (CO-Oximetry). There is no human intervention or interpretation of the raw signal being assessed; the device provides a direct numerical output.

7. The Type of Ground Truth Used

• Type of Ground Truth: Pathology (specifically, laboratory analysis of arterial blood samples via CO-Oximetry).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is an adapter cable, which is a hardware component. There is no mention or indication of any machine learning algorithms or a "training set" in the context of its function as described.

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for this type of device.

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The NC Adapter Cable with Nellcor sensors are indicated for the continuous noninvasive monitoring of functional I its readiner of arterial hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor) for use with adult, pediation informator of Liveral In hospitals, hospitals, hospital-type facilities, mobile, and home environments.

The NC Adapter Cable is fully compatible oximetry cable that allows the use of Nellcor Sensors with Masimo SET Radical pulse oximeter monitors. The cable represents a design change to the Masimo patient cables and the MS board. The NC Adapter Cable is similar in construction to the predicate device enabling the Nellcor Sensors to be connected to Masimo SET Radical pulse oximeters. The NC Adapter Cable is designed, and manufactured for full compatibility with Masimo SET Radical pulse oximeters using Nellcor Sensors. The NC Adapter Cable is constructed of similar materials and components of equivalent specifications as used in the predicate devices.

Here's a summary of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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