Search Results

The LigaSure XP Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation and division of vessels, thick tissue (tissue bundles), and lymphatics is desired. The LigaSure XP Maryland Jaw Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as colorectal, bariatric, urologic, vascular, thoracic, and gynecologic. These may include, but are not limited to, such procedures as Nissen fundoplication, colectomy, cholecystectomy, adhesiolysis, hysterectomy, and so forth.

The LigaSure XP Maryland Jaw Sealer/Divider has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the LigaSure XP Maryland Jaw Sealer/Divider for these procedures.

The proposed LigaSure™ XP Maryland Jaw Sealer/Divider is a sterile, single-use bipolar vessel sealer. It is labeled as prescription use only. The device connects to the Valleylab™ FT10 Electrosurgical Platform generator for tissue ligation. Energy is applied to tissue interposed between the nano-coated Maryland-style jaws creating a ligation. The jaws contain an independent cutting blade for division of tissue. A distinctive characteristic is the new continuous rotation capability of the jaws and shaft. The shaft is a common 5 mm diameter available in three lengths (23 cm, 37 cm, 44 cm) for various general surgical procedures in both open and minimally invasive (laparoscopic) approaches. The instrument body is a pistol grip design which can be used by right or left-handed users to access the controls. The new device is offered with two handle body designs, One-Step Sealing (LXMJ23S, LXMJ37S, LXMJ44S) or Latching Handle (LXMJ23L, LXMJ37L, LXMJ44).

The provided text does not contain information about the acceptance criteria and study proving a digital health device's performance. Instead, it describes a substantial equivalence determination for a surgical instrument, the LigaSure™ XP Maryland Jaw Sealer/Divider.

Therefore, many of the requested categories in your prompt, such as "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "training set size," and "ground truth for the training set," are not applicable to this medical device submission, which focuses on hardware and electrosurgical performance rather than an AI-powered diagnostic or assistive tool.

However, I can extract the relevant performance testing and acceptance criteria information that is present in the document for the LigaSure™ XP Maryland Jaw Sealer/Divider.

Here's the information structured to the best of my ability given the provided document:

Acceptance Criteria and Study for LigaSure™ XP Maryland Jaw Sealer/Divider

This submission details the substantial equivalence of an electrosurgical cutting and coagulation device, the LigaSure™ XP Maryland Jaw Sealer/Divider. The performance testing described focuses on various engineering, biological, and functional aspects of the surgical instrument, not on the performance of a digital health or AI device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test set (e.g., number of vessels, lymphatic segments, or animals).

• Provenance: The tests described (bench, animal) are laboratory-based performance studies, likely conducted by the manufacturer Covidien, llc. The document does not mention data provenance in terms of country of origin or whether human data was retrospective or prospective, as clinical trials for efficacy/safety in humans were not the primary evaluation method shown (literature review was used for clinical support).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" for this device's performance would be objective measurements in engineering, biological models, and animal studies (e.g., burst pressure, hemostasis, thermal spread), not expert consensus on interpretations.

4. Adjudication method for the test set
This is not applicable and not provided. Performance outcomes are likely based on direct measurement against predefined physical/biological thresholds.

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. This device is a surgical instrument, not an AI or diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a surgical instrument, not an algorithm.

7. The type of ground truth used
The "ground truth" for this device's performance is based on:

• Engineering standards (e.g., ISO, ASTM, IEC for sterilization, packaging, electrical safety).
• Biocompatibility standards (ISO 10993-1).
• Predefined physical and biological thresholds/measurements from ex vivo (vessel/lymphatic sealing/burst) and in vivo (hemostasis, thermal spread) studies.
• "Clinical literature studies were evaluated to further support the safety and effectiveness use of the proposed LigaSure™ XP Maryland Jaw Sealer/Divider indications for use." This implies that existing clinical evidence for similar devices and principles contributes to the overall justification, but no new clinical study data from the sponsor is explicitly referenced.

8. The sample size for the training set
This is not applicable. This is a hardware device; there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established
This is not applicable.

Ask a specific question about this device

The Ritus™ tunneling tool kit is used to both create a tunnel tract through subcutaneous tissue and seal the end of the catheter. This allows the external portion of the Covidien™ peritoneal dialysis catheter to be temporarily buried in advance of dialysis for patients that are candidates for delayed peritoneal dialysis treatment.

The Ritus™ tunneling tool kit comes with a separate tunneling device and plug. This kit is designed to create a subcutaneous tunnel to temporarily bury the external portion of the peritoneal dialysis catheter within the abdominal, subcutaneous tissue in advance of needing dialysis.

The tunneling device is made of stainless steel with a rigid plastic handle on the proximal end. There is an angled tip with a removable plastic cap. Functioning as a dilator, the tunneling device separates the tissue to create a tunnel tract, then is used to pull the catheter through the tunnel to desired exit site.

The titanium catheter plug is designed to seal the end of the catheter for the length of time that the catheter is buried within the subcutaneous tissue.

This is not an AI/ML device, therefore, the requested information is not applicable.

Ask a specific question about this device

The INVOS™ Patient Monitor, model PM7100, is a noninvasive cerebral/somatic oximetry system intended for use as an adjunct monitor of regional hemoglobin oxygen saturation of blood in the brain or in other tissue beneath the sensor. It is intended for use on individuals > 2.5 kg at risk for reduced-flow or no-flow ischemic states. For patients ≤ 2.5kg, the INVOS™ Patient Monitor, model PM7100 is only intended for adjunct trend monitoring of regional hemoglobin oxygen saturation of blood tissue beneath the sensor.

It is also intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation of blood tissue beneath the sensor in any individual.

The INVOS™ Pediatric rSO2 sensor is indicated for single patient use when cerebral/somatic monitoring of site-specific regional oxygen saturation (rSO2) is required in patients weighing greater than 4 kg and less than 40 kilograms. This sensor is only intended to be used with INVOS™ PM7100 system with INVOS™ Near Infrared Spectroscopy (NIRS) technology. For additional information regarding setup and use of the INVOS™ PM7100 System including indications for use, contraindications, warnings and cautions, consult the Monitoring System Operator's Manual.

The INVOS™ OxyAlert NIRSensor disposable sensor Model IS is indicated for single patient use when cerebrallsomatic monitoring of site-specific regional oxygen saturation (rSO2) is required in patients weighing > 2.5 kilograms and < 40 kilograms or for trend monitoring of rSO2 of blood tissue beneath the sensor in any individual < 40kg. This sensor is only intended to be used with INVOS™ Near Infrared Spectroscopy (NIRS) technology including monitoring systems and devices integrated with INVOS™ NIRS technology. For additional information regarding setup and use of the INVOS™ System including indications for use, contraindications, warnings and cautions, consult the Monitoring System Operator's Manual.

The INVOS™ PM7100 Patient Monitor is a cerebral/somatic tissue oximeter intended for use as an adjunct trend monitor of regional hemoglobin and oxygen saturation monitoring. The monitor utilizes a near infrared diffuse reflectance spectroscopy system employing near infrared light at four wavelengths for the adult and pediatric system configurations. One pair of wavelengths is used to estimate the percentage of hemoqlobin saturated with oxygen in tissue beneath the sensor; another pair of wavelengths is used for the sensor on/off detection algorithm. The infant system configuration currently only employs the two wavelengths needed to estimate regional oxygenated hemoglobin.

The subject device is non-sterile and consists of a multi-channel touch screen display, preamplifier, cables, and three single use sensor types for use in the adult (PMSENS71-A; cleared in K182868), pediatric (PMSENS71-P; new to subject device), and infant (IS; new to subject device) populations.

The subject device utilizes up to four detachable sensors to collect signals, and up to two preamplifiers receive signals from the sensors, digitize the signals, process the data and then periodically estimate the rSQ2 at each sensor site. The preamplifiers then transmit the measured and calculated parameter data to the monitor where the information is displayed. The oximeter is powered primarily by AC power at 100 VAC to 240 VAC ±10% and is equipped with an internal rechargeable lithium-ion battery for intra hospital transport and back-up purposes. The INVOS™ PM7100 Patient Monitor is intended for use in hospitals, and is not intended for home use or out-of-hospital transport.

The PM7100 Monitor configures the PMPAMP71 preamplifier modules for monitoring and allows the user to configure sensor placements on a patient's body as well as establish baseline rSQ2 values. Device features include a user configurable rSO2 baseline, alarms, signal strength indicator and area under the curve thresholds. The monitor measures and displays an rSO2 trend line in a graph for the estimated regional oxygen saturation value unique to the specific area under each sensor. the baseline rSQ2 value, the current estimated rSQztrend accuracy value and percent change from patient rSO2 baseline. The PM7100 Monitor also displays alarm information and indicates connected sensor type. The Monitor is equipped with technical (system status) and physiological (patient status) alarms. Alarm conditions are detected via the sensor, the physiological and technical information are then processed in the preamplifier/processor, which then communicates this information to the monitor then provides a visual and audio alarm notification. The device permits the user to silence alarms, mark events, and manage case history data.

The PMPAMP71 preamplifier interfaces with the PM7100 monitor via a cable for communications and power, and with one or two sensors via reusable sensor cables to receive optical signals. The optical signal flows from the sensor into the PMPAMP71 which in turn generates saturation (rSO2) for tissue under the sensor that is communicated to the PM7100 monitor.

The INVOS™ Adult SpO2Sensor, PMSENS71-A, is a non-sterile, non-invasive, disposable sensor intended for application on cerebral and somatic sites. The PMSENS71-A was designed for use with the INVOS™ PM7100 and 5100C cerebral/somatic monitoring systems for monitoring of site-specific regional oxygen saturation (rSO2) in adult patients weighing >40 kilograms. There have been no significant changes to this sensor since clearance under K182868.

The INVOS™ Pediatric rSO2 Sensor, PMSENS71-P, is a new non-sterile, non-invasive, disposable sensor intended for application on cerebral and somatic sites in pediatric patients greater than 4 kg and less than 40 kilograms. The PMSENS71-P was designed to support the existing two wavelength rSO2algorithm along with a new two wavelength sensor on/off detection algorithm. Accordingly, the PMSENS71-P sensor is designed to emit and collect sensor data with a total of four wavelengths.

The INVOS™ Infant Regional Saturation Sensor, model IS, is a non-sterile, non-invasive, disposable sensor intended for application on cerebral and somatic sites in the infant and neonate patient population. The IS sensor configuration currently only employs the two wavelength m. Accordingly, the IS sensor is designed to emit and collect sensor data with a total of two wavelengths. The INVOS™ Reusable Infant Sensor Adapter Cable (PMAC71RIC) is a new non-sterile, non-invasive reusable cable intended for adapting the infant sensor connection to the PM7100 preamplifier.

The INVOS™ Docking Station connects to the INVOS™ PM7100 Patient Monitor and is designed with a mounting surface on the back of the docking station which can connect to the Patient Monitor Stand or any other compatible mounting service. The docking station is equipped with inputs for AC power, USB, serial port and VGA port. The docking station also facilitates recharging of the back-up battery. There have been no significant changes to the docking station since clearance in K182868.

The INVOS™ Patient Monitor Stand is an accessory that connects to the INVOS™ Docking Station. The monitor stand has not changed since clearance in K 182868.

The document provided describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the INVOS™ PM7100 Patient Monitor, INVOS™ Pediatric rSO2 Sensor, and INVOS™ Infant Regional Saturation Sensor.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

Device: INVOS™ PM7100 System (with Infant/Neonatal IS sensor)

Device: INVOS™ PM7100 System (with Pediatric rSO2 sensor, PMSENS71-P)

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

Infant/Neonatal Sensor Study (Hypoxia Study):

• Sample Size: 24 subjects
• Data Provenance: Not explicitly stated regarding country of origin, but described as a non-invasive hypoxia study conducted on healthy, non-smoking adults and adolescent volunteers. Given the FDA submission context, it's highly likely to be conducted in the US. This was a prospective clinical study.

Pediatric Sensor Feasibility Study (Room Air Study):

• Sample Size: 28 subjects
• Data Provenance: Not explicitly stated regarding country of origin. This was a prospective clinical feasibility study.

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

The document does not explicitly mention the use of experts to establish a "ground truth" in the traditional sense of image annotation or disease diagnosis for the clinical studies.

• For the Infant/Neonatal sensor study, the "ground truth" or reference for the rSO2 trend precision appears to be the cleared INVOS™ 5100C system in conjunction with the Infant/Neonatal Sensor (predicate system).
• For the Pediatric sensor feasibility study, the "ground truth" or reference for rSO2 performance was the predicate INVOS™ 5100C system in conjunction with the Pediatric sensor, SPFB. Sensor on/off detection accuracy was evaluated against observed physical states.

Therefore, this aspect of ground truth establishment by human experts, as typically seen in AI/ML performance studies, is not applicable in the context of this device's testing.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used for establishing ground truth in studies involving human interpretation (e.g., radiology reads). As the studies described here involve direct physiological measurements and comparisons to a predicate device, or assessment of a sensor's physical state detection, an adjudication method in this sense is not applicable. The "ground truth" was established by the measurements from the predicate device or the direct observation of sensor states.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improving with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The device is an oximeter, and the studies focused on its measurement accuracy and trend precision compared to a predicate device, and the functionality of new features like sensor on/off detection. It is not an AI/ML-based diagnostic device that assists human readers.

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

Yes, in essence, the "Performance Data Summary" describes standalone performance for the specific algorithms and hardware of the device.

• Non-clinical Performance Testing: This section details bench-top optical phantom testing to verify static rSO2 calculation, confirming the subject device's rSO2 algorithm performs within acceptable limits compared to the predicate system. This is a standalone performance test.
• Clinical Studies: The clinical studies evaluated the direct output of the device (rSO2 measurements, trend precision, sensor on/off detection) against a reference (predicate device or physical observation), without direct human-in-the-loop interpretation impacting the device's output. While a human uses the device, the performance metrics are about the device's intrinsic measurement capabilities.

7. The Type of Ground Truth Used

• Infant/Neonatal Sensor Study: Comparative "ground truth" was established based on measurements from the cleared INVOS™ 5100C system in conjunction with the Infant/Neonatal Sensor (predicate system) during induced hypoxia. This is a form of comparative reference device data.
• Pediatric Sensor Feasibility Study (rSO2 performance): Comparative "ground truth" was established based on measurements from the cleared INVOS™ 5100C system in conjunction with the Pediatric sensor, SPFB (predicate system) at room air. This is also a form of comparative reference device data.
• Pediatric Sensor Feasibility Study (sensor on/off detection): The ground truth was based on direct observation of the sensor's physical state (on subject, off subject, face up/down on sheet, hanging).

8. The Sample Size for the Training Set

The document does not describe the use of a "training set" in the context of machine learning. The studies described are verification and validation studies (test sets) for the device's performance, not for training a model. The algorithms are based on Near Infrared Spectroscopy (NIRS) technology, not on machine learning that requires a specific training phase with a dedicated dataset.

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

Not applicable, as no machine learning training set is described or utilized in the regulatory submission for this device. The device's operation is based on established NIRS principles and algorithms, rather than data-driven machine learning models requiring large labeled training sets.

Ask a specific question about this device

The Sonicision™ 7 curved jaw cordless ultrasonic dissection device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, and other open and endoscopic procedures. The device can be used to coagulate isolated vessels up to and including 7 mm in diameter, using the minimum mode. The device can be used to coagulate isolated vessels up to and including 5 mm in diameter, using the maximum mode.

The Sonicision™ 7 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

The Sonicision™ reusable battery pack is a non-sterile, rechargeable, lithium-ion battery that provides power to compatible surgical devices. For full device indications for use, reference the indications for use statements of the compatible devices.

A functional Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device is assembled by the user within the operating room. The functional device is assembled from the following three components: (1) a sterile, single-use dissector, (2) a user cleaned and sterilized reusable generator, and (3) a user cleaned and disinfected reusable battery. There are four different lengths of sterile single-use dissectors to allow surgeons a range of options to meet the needs of each specific surgical case.

The assembled functional device is a hand-held, battery-powered device used to dissect through tissue and to coagulate vessels up to and including 7 mm in diameter. The clinical intended use is achieved by the surgeon when pressure is applied to tissue placed between the clamping jaw and the exposed portion of the probe while activating ultrasonic energy by pressing a button on the handpiece.

The provided FDA 510(k) summary for the Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device does not contain information about acceptance criteria for AI/ML performance, nor does it describe a study specifically proving the device meets AI/ML acceptance criteria. This document describes a medical device, not an AI/ML algorithm.

However, I can extract the performance data and comparisons that were provided for this medical device to demonstrate its substantial equivalence to predicate devices. This will address the general request for acceptance criteria and the study that proves the device meets them, but it will be in the context of a medical device, not an AI/ML algorithm.

Acceptance Criteria and Device Performance for Sonicision™ 7 Curved Jaw Cordless Ultrasonic Dissection Device

The submission demonstrates substantial equivalence to predicate devices through various performance tests. The "acceptance criteria" here are implied by achieving comparable performance to the predicate devices or meeting recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

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 does not explicitly state the numerical sample sizes for each of the performance tests (e.g., how many vessels were tested in ex-vivo burst testing, how many animals in acute/chronic in-vivo studies). It only mentions "several bench and animal tests."

The data provenance (country of origin, retrospective/prospective) is not specified in this summary. These types of tests are typically prospective studies conducted by the device manufacturer or contracted labs.

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)

This device is a surgical instrument, not an AI/ML diagnostic tool requiring expert interpretation of images for ground truth. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI sense does not apply here. The "ground truth" or reference standards are established through direct measurements (e.g., burst pressure), histological analysis, and observed clinical outcomes in animal models. The experts involved would be qualified biomedical engineers, veterinarians, and possibly surgeons overseeing the animal studies, but their specific number and qualifications are not detailed.

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

Not applicable. This is a medical device performance study, not an AI/ML algorithm evaluation with human readers.

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 is a medical device performance study, not an AI/ML algorithm evaluation with human readers.

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

Not applicable. This is a medical device performance study, not an AI/ML algorithm evaluation. While the device has "control software," its performance is evaluated in conjunction with the mechanical and ultrasonic components, as a complete system operated by a human surgeon.

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

The "ground truth" for the device's performance is established through:

• Direct physical measurements: Ex-vivo burst pressure, temperature measurements.
• Biological observations: Visual assessment of hemostasis, measurement of lateral thermal spread.
• Pathology/Histology: Although not explicitly stated, chronic in-vivo studies often involve histological examination of tissue to confirm vessel sealing and assess tissue damage.
• Outcomes data: For the chronic in-vivo study, "maintaining hemostasis for at least 21 days" refers to an outcome measurement.

8. The sample size for the training set

Not applicable. This is a medical device and not an AI/ML algorithm. There is no "training set" in the context of machine learning. The device development involved engineering design, prototyping, and iterative testing, but not machine learning training.

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

Not applicable. As there is no AI/ML training set, there is no ground truth established for it.

Ask a specific question about this device

The Emprint™ SX Ablation Platform with Thermosphere™ Technology is intended for use in percutaneous, laparoscopic, and intraoperative coagulation) of soft tissue, including partial or complete ablation of nonresectable liver tumors.

The Emprint™ SX Ablation Platform is not intended for use in cardiac procedures.

The system's optional 3D navigation feature assists in the placement of the Emprint™ SX Navigation Antenna with Thermosphere™ Technology using real-time image guidance during intraoperative and laparoscopic ablation procedures. The navigation feature enhances the output of a compatible medical ultrasound imaging system and displays an image of the antenna and its predicted trajectory on a computer monitor. The size and shape of the predicted zone relative to the position of the antenna are displayed on the enhanced ultrasound image.

The Emprint™ SX Ablation Platform with Thermosphere™ Technology is microwave-based system intended to deliver energy through an antenna inserted into soft tissue for the purpose of coagulating (ablation) a defined tissue volume. The Emprint™ SX Ablation Platform utilizes a 2450 MHz 100W generator to deliver power to a single microwave ablation antenna. The platform is software-controlled and a touchscreen Graphical User Interface is used to select the desired ablation time (up to 10 minutes) and power (5 to 100W) settings. Using an optional temperature probe, the ablation platform can be set to monitor the temperature of a desired target and to automatically turn the generator off, when the target reaches a pre-set temperature. The ablation platform uses circulating, room-temperature, normal saline to cool the non-radiating portion of the antenna shaft and to provide a consistent ablation zone. The normal saline is pumped from an IV bag through the antenna shaft and back to the IV bag in a closed system.

Using an optional/selectable navigation feature, the Emprint™ SX Ablation Platform assists physicians in the accurate placement of the trackable Emprint™ SX Navigation Antenna into a target anatomical structure by overlaying the image of the antenna and its trajectory onto an ultrasound image in real time.

Sensors are attached to platform-compatible, open and laparoscopic ultrasound probes and to the platform's trackable antenna. These sensors detect fluctuations in an electromagnetic field emitted from the system's Table Top Field Generator (TTFG). The TTFG is placed underneath the patient and transmits positional information that is processed by the system's navigation hardware and interpreted by its software. The platform's software allows the surgeon to see a representation of the ablation zone on an auxiliary display and the system's operator to control the ablation system via the touchscreen interface.

This document is a 510(k) summary for a software update (Emprint™ SX 1.1.1 Software Update) to an existing device, the Emprint™ SX Ablation Platform with Thermosphere™ Technology. It focuses on demonstrating substantial equivalence to the predicate device, which is the previous version of the same system. Therefore, the document primarily addresses the software change and its impact rather than the original device's full acceptance criteria and clinical efficacy.

Since this submission is a software update to an already cleared device and not an initial clearance for a new device type, there is no detailed acceptance criteria table, clinical study data, or ground truth establishment presented in sections 1-7 of your request. The submission argues that the software update does not affect the device's fundamental performance, indications for use, or underlying principles of operation.

Here's a breakdown based on the provided text, addressing as many of your points as possible:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in terms of quantitative clinical performance metrics for the device as a whole in this software update submission. The acceptance criteria for this specific submission relate to the successful implementation and verification of the software change without introducing new safety or effectiveness concerns.
• Reported Device Performance: The document states that "Comprehensive SW Verification testing was performed by Medtronic in support of the proposed change." The conclusion is that "The results of comprehensive verification testing raised no new questions of safety or effectiveness." This implies the software update met internal verification criteria to ensure it did not negatively impact the previously established performance.

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

• Test Set: Not specified for this software update. "Comprehensive SW Verification testing" was performed, but details on the number of test cases or scenarios are not provided in this summary.
• Data Provenance: The testing was performed by Medtronic, the manufacturer. The document doesn't specify if external data was used for this software update's verification. It's internal testing.

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

• Not applicable for this software update submission. The "ground truth" for a software verification typically involves predefined expected software behaviors and outputs, which are assessed by software engineers and quality assurance personnel. It doesn't involve clinical experts in the same way a diagnostic device's clinical performance study would.

4. Adjudication method for the test set:

• Not applicable/Not specified in the provided summary. Software verification typically follows defined test protocols and review processes by the development and quality assurance teams, rather than a clinical adjudication method.

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 document describes a software update to a microwave ablation platform, not an AI-assisted diagnostic or interpretative device that would typically involve MRMC studies. The device's navigation feature does assist in antenna placement, but the current submission is about a software bug fix related to error handling, not an enhancement to the navigation's clinical efficacy or human reader performance.

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

• Yes, in essence. The "software verification testing" would assess the algorithm's (software's) performance in isolation, ensuring it functions as intended (e.g., clearing errors, processing messages correctly) without human intervention in the execution of the software's core logic. However, since this is a system that always involves human-in-the-loop operation (a surgeon using it for ablation), the "standalone" here refers to the software component's functional correctness.

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

• For this software update, the ground truth would be the expected and correct behavior of the software based on its design specifications. This is established during the software development lifecycle through requirements definition, design documents, and coding standards, and is then verified through testing. It's not clinical "ground truth" like pathology for a diagnostic device.

8. The sample size for the training set:

• Not applicable. This submission is not for a machine learning or AI algorithm that requires a training set. It's for a traditional software update that fixes an error handling behavior.

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

• Not applicable, as there is no training set for this type of software update.

Ask a specific question about this device

The Puritan Bennett 980 Series Ventilator System is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3kg (0.66lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively to patients who require the following types of ventilator support

• Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trachectorny tube) or non-invasively (via mask or nasal prongs)

• Assist/Control, SIMV, or Spontaneous modes of ventilation

The Puritan Bennett 980 Series Ventilator System is a dual-microprocessor-based, touch-screen controlled; critical care ventilator intended to provide continuous ventilation for neonate to adult patients who require either invasive ventilation or non-invasive ventilation. It can be used in hospitals and institutions and for intra -hospital transport applications with access to the appropriate services.

The ventilator system offers features for patient comfort while delivering sensitive, precise breaths to critically ill patients. The product ventilates Neonatal, Pediatric, and Adult patients with predicted body weights from 0.3 kg, and with tidal volumes for mandatory volume-controlled breaths from 2 mL to 2500 mL.

The following options are being made to the Subject Device:

• Initial release -
  • Integrated Nebulizer option ●
  • High Flow Oxygen Therapy (HFO2T) option ●
  • NIV+ Software option ●
  • New Monitored Parameter Porive ●
• Modification to previously cleared feature -
  • Updated IE Sync Algorithm

This document is an FDA 510(k) Premarket Notification for the Puritan Bennett 980 Series Ventilator System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/ML medical device.

Therefore, none of the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, or training set details can be extracted from the provided text. The document states that "Clinical evidence was not necessary to show substantial equivalence," and the non-clinical evidence focuses on verification and validation against standards and software/system tests, not a performance study as would be expected for a new or modified algorithm with performance metrics.

Ask a specific question about this device

The Sonicision™ cordless ultrasonic dissection device is indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The device can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision™ cordless ultrasonic dissection device can be used to coagulate isolated vessels up to 5 mm in diameter.

The Sonicision™ 13 cm device is also indicated for use in otorhinolaryngologic (ENT) procedures.

The Sonicision™ Cordless Ultrasonic Dissector is a component of the Sonicision™ Cordless Ultrasonic Dissection Device, which is a hand-held surgical device consisting of three interdependent components that. when assembled, enable ultra-high-frequency mechanical motion (ultrasonic energy) to transect, dissect, and coagulate tissue.

The dissector is a sterile, single-use component to which the Sonicision reusable generators and battery packs attach. This component contains features essential to the control and performance of the assembled device; such as the clamping jaw, active blade, speaker, two-stage energy button, rotation wheel, and jaw lever.

Four configurations are available, differing principally by shaft lengths are 13 cm, 26 cm, 39 cm, and 48 cm; corresponding with catalog numbers SCD13, SCD26, SCD396, and SCD48, respectively. The only difference between SCD391 and SCD396 is the packaging configuration. There is no difference in the design of the device.

The provided text describes a 510(k) premarket notification for the Sonicision™ Cordless Ultrasonic Dissector, a surgical device. While it details performance testing, it does not explicitly state specific "acceptance criteria" numerical values that the device had to meet. Instead, the performance studies aim to demonstrate comparability or non-inferiority to the predicate device.

Therefore, I cannot populate a table with explicit acceptance criteria and corresponding reported performance numerical values as they are not presented in that format in the document. The document describes the type of performance tests conducted and the finding of comparability.

However, I can extract and present the information related to the studies in the requested format, interpreting "acceptance criteria" as the goal of the test (e.g., comparable burst strength) and "reported device performance" as the outcome in relation to the predicate.

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

Acceptance Criteria and Device Performance

As explicit numerical acceptance criteria are not provided, the "acceptance criteria" are inferred as demonstrating comparability or non-inferiority to the predicate device for various performance aspects.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Ex-vivo Burst Testing: Specific sample size not provided, but performed on "blood vessels."
   • Ex-vivo Tissue Testing: Specific sample size not provided, but performed on "mesentery."
   • Acute In-vivo Testing: Specific sample size not provided.
   • Chronic In-vivo Testing: Specific sample size not provided.
   • Human Factors Validation: Performed in a "porcine model and a human cadaver model." Specific number of participants/cadavers not provided.
   • Data Provenance: The studies are described as "bench and animal tests" and human cadaver models, implying controlled laboratory or clinical simulation environments. The country of origin is not specified but is presumably where Covidien (Boulder, Colorado) conducts its R&D or contracted research. The studies are prospective in nature, designed specifically to test the device.

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

   • The document does not specify the number or qualifications of experts involved in establishing ground truth for any of these performance tests. For animal and cadaver studies, typically veterinarians, pathologists, and surgeons/anatomists would be involved, but this information is not provided.

3. Adjudication method for the test set:

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the outcomes of these performance tests. The results seem to be presented as direct measurements or observations.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study involving human "readers" or AI assistance was not done. This device is a surgical instrument, not an imaging diagnostic device that would typically involve human "readers" or AI for image interpretation. The human factors validation is about user interaction with the device, not diagnostic interpretation.

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

   • This is not applicable as the device is a physical surgical instrument and does not involve an AI algorithm with standalone performance. Its performance is always integrated with human use.

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

   • Burst Strength: Likely measured mechanically (physics-based ground truth).
   • Temperatures/Cool Down Times: Measured using temperature sensors (physics-based ground truth).
   • Hemostasis/Lateral Thermal Spread: Likely assessed visually, histologically (pathology-based), or through direct measurement during animal studies (outcomes/observational ground truth).
   • Hemostasis Retention: Assessed through long-term observation in chronic animal studies (outcomes data).
   • Human Factors Validation: Established by objective task completion metrics (e.g., successful dissection, coagulation, no user errors) and subjective user feedback, compared against pre-defined user needs and FDA expectations for usability.

7. The sample size for the training set:

   • This concept (training set) is not applicable as the device is a physical surgical instrument, not a machine learning/AI model. Therefore, there is no "training set" in the conventional sense. The development of the device would involve engineering, design, and iterative testing, but not data-driven "training" like an AI.

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

   • As there is no "training set" for an AI model, this question is not applicable to this device submission.

Ask a specific question about this device

The HET Bipolar System is intended to be used for the treatment of symptomatic grade I and grade II internal hemorrhoids.

The HET™ Bipolar Forceps is a sterile, single-use bipolar forceps having a tapered tubular configuration. The device is connected via an integrated bipolar cable to the bipolar output of an electrosurgical generator. The accessory monitor displays the temperature at the forceps-tissue interface and provides power for a temperature sensor and an LED light source mounted on the disposable forceps. The HET™ Bipolar Electrocautery Forceps and Monitor do not generate RF energy themselves and may be used with any Bipolar Electrosurgical generator in the coagulation power setting with an output power set at 10 W and a maximum voltage of 1250V.

This document is a 510(k) Pre-Market Notification for the HET™ Bipolar Electrocautery Forceps and Monitor. The submission states that the device is identical to its predicate device (K140422) in terms of design, materials, software, and treatment mechanism. The purpose of this 510(k) is to limit the indications for use to symptomatic grade I and grade II internal hemorrhoids and clarify that the action is tissue ligation. Therefore, the performance data presented refers to the predicate device.

Here's an analysis based on the provided document:

Acceptance Criteria and Device Performance

Since the subject device is identical to the predicate device and the 510(k) is primarily for clarifying indications and the mechanism of action (tissue ligation), there are no new acceptance criteria or device performance results reported for the subject device in this document. The performance data refers to the predicate device (K140422).

Based on the information for the predicate device (K140422) as referenced in this submission:

Study Details for Predicate Device (K140422) as referenced:

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

   • Sample size: Not explicitly stated in this document. The document mentions "Performance testing was conducted" to characterize the device's performance when used with "eight FDA cleared, commercially available, bipolar electrosurgical generators." The specific number of cases, tissue samples, or treatments is not provided.
   • Data provenance: Not specified in this document. It's likely from laboratory or bench testing given the nature of evaluating thermal injury and treatment time. It's not stated whether it's retrospective or prospective.

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

   • Not applicable as the reported performance testing (zone of thermal injury, treatment time) appears to be objective, measurable parameters typically assessed through engineering and scientific methods rather than expert interpretation of images or clinical outcomes in the context of ground truth establishment.

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

   • Not applicable. The performance tests described (thermal injury, treatment time, electrical safety, biocompatibility, sterilization) are objective measurements and engineering assessments, not requiring adjudication in the context of expert case review.

4. 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 or AI-assisted study was performed or is relevant to this device. This is a medical device for electrosurgical treatment, not an AI diagnostic tool.

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

   • Not applicable. This is not an AI algorithm.

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

   • For performance testing related to thermal injury and treatment time, the "ground truth" would be objective measurements (e.g., histological analysis of tissue for thermal damage depth, precise timing measurements).
   • For biocompatibility, the ground truth is established by standardized biological assays (e.g., cell viability for cytotoxicity, skin reaction for irritation/sensitization).
   • For sterilization, the ground truth is the measured Sterility Assurance Level (SAL).
   • For electrical safety, the ground truth is conformance to the specified standard (IEC 60601-1-2:2014).

7. The sample size for the training set:

   • Not applicable. This is not an AI or machine learning device requiring a training set.

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

   • Not applicable.

Ask a specific question about this device

The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation of vessels, tissue bundles and lymphatics is desired. The tissue fusion of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.

It's also indicated for adult, children and adolescent ENT procedures (3 years of age and above), including tonsillectorny, for the ligation and division of vessels, tissue bundles 2-3 mm away from unintended thermally sensitive structures.

The BiZact device has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use for these procedures.

The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider is a sterile, single use, hand-held electrosurgical device that incorporates radio frequency (RF) tissue fusion technology for a desired tissue effect when used with the ForceTriad™ Energy Platform (Force Triad), the Valleylab™ LS10 Generator (VLLS10GEN), or the Valleylab™ FT10 Energy Platform (VLFT10GEN) for ligation and division of vessels, tissue bundles, and lymphatics during open general surgical procedures.

The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider attaches to a compatible electrosurgical generator with a 10-foot cord containing a proprietary connector. The generator can identify the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider via the radiofrequency identification (RFID) tag embedded in the connector (VLLS10GEN and VLFT10GEN) or with a barcode on the connector (ForceTriad). The generator delivers energy to the device using a defined algorithm that adjusts the generator output as a function of the electrical resistance of the tissue.

This document describes the FDA's decision to clear the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356) for an expanded indication to include children aged 3 to less than 12 years. The key basis for this clearance is the demonstration of substantial equivalence to a previously cleared device (K182451).

The provided text details a clinical study to support the expanded indication but does not provide specific acceptance criteria in a quantitative table format that directly correlates to a device's performance in terms of metrics like sensitivity, specificity, or accuracy, which are typical for AI/diagnostic devices. This is because the BiZact device is a surgical instrument, not an AI or diagnostic device. Its performance is assessed through safety and effectiveness in a surgical context, primarily focusing on clinical outcomes.

Therefore, I will interpret "acceptance criteria" here as the clinical safety and effectiveness benchmarks that the device needed to meet for the expanded indication, and "device performance" as the clinical outcomes observed in the study.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356)

Given that this is a surgical device, not an AI or diagnostic tool, the "acceptance criteria" are based on clinical safety and effectiveness endpoints for the surgical procedure it facilitates. The study primarily aimed to demonstrate that expanding the indication to include children (3 to <12 years) does not introduce new safety or effectiveness concerns compared to its existing use in adults and adolescents.

1. Table of Acceptance Criteria (Clinical Endpoints for Expanded Indication) and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set (Clinical Study)

• Sample Size: Sixty (60) pediatric subjects.
• Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "multi-center" study, suggesting multiple sites potentially within one or more countries. It was a prospective clinical study.

3. Number of Experts and Qualifications for Ground Truth Establishment (Clinical Study)

• Number of Experts: Investigators (referring to the operating surgeons/clinicians at each site) and an Independent External Medical Monitor. The exact number of investigators is not specified (since it was multi-center). Only one Independent External Medical Monitor is mentioned.
• Qualifications: "Investigators" are physicians performing the tonsillectomy and assessing patients. The "Independent External Medical Monitor" typically holds medical qualifications (e.g., MD) and experience in clinical trial oversight, often specializing in the relevant medical field (ENT/pediatrics in this case), to ensure patient safety and data integrity. Specific years of experience are not provided.

4. Adjudication Method for the Test Set (Clinical Study)

• Adjudication of adverse events was performed by the "Investigators and an Independent External Medical Monitor." This suggests a process where initial assessment is made by the site investigator, and then reviewed/confirmed by an independent monitor. The specific "2+1" or "3+1" type of formal consensus is not explicitly detailed, but there was an independent review process for AE assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Not applicable. This device is a surgical instrument, not an AI or diagnostic imaging system. Therefore, an MRMC study designed to assess human reader performance with or without AI assistance is not relevant to its evaluation. The study focused on clinical outcomes of using the device during surgery.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)

• Not applicable. This is a surgical device, always used with human-in-the-loop (i.e., by a surgeon). There is no "algorithm only" performance to evaluate. Its function is directly tied to the surgeon's use during a procedure.

7. Type of Ground Truth Used (Clinical Study)

• Clinical Outcomes and Expert Assessment: The ground truth for safety and effectiveness was established through direct clinical observation of intra-operative blood loss, patient follow-up for adverse events, and assessment by clinical investigators and an independent medical monitor. This combines objective clinical measurements (blood loss) with subjective clinical evaluations of patient well-being and adverse event causality.

8. Sample Size for the Training Set

• Not applicable. This is a hardware surgical device, not a machine learning model. There is no concept of a "training set" for the device itself.
• However, if we consider "training" in a broader sense as prior experience or data that informed the device's design and previous clearances, then the predicate device (K182451) and its associated studies (likely including animal studies, bench testing, and potentially clinical data on adults/adolescents) could be seen as foundational.

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

• Not applicable. As above, there is no "training set" for the device. The device's design and performance claims are based on engineering principles, bench testing (e.g., burst pressure), biocompatibility testing, a previously cleared predicate device, and prior animal/clinical studies described in previous 510(k) submissions. These prior studies would have established their ground truth through standard preclinical and clinical methods relevant to surgical devices.

Ask a specific question about this device

The Mahurkar(TM) Acute Single Lumen Catheters provides temporary access for acute hemodialysis. The flexible tubing permits percutaneous insertion into subclavian, jugular, and femoral veins.

The Mahurkar(TM) Acute Dual Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion.

The Mahurkar(TM) Acute Triple Lumen Catheters are intended for short-term central venous access for hemodialysis. apheresis, and infusion.

The Mahurkar(TM) Acute High Pressure Triple Lumen Catheters are intended for short term central venous access for hemodialysis, apheresis, infusion, central venous pressure injection of contrast media. The maximum recommended infusion rate is 5 mL/sec for power injection of contrast media.

The Mahurkar™ Acute Single Lumen Catheter is a radiopaque, polyurethane tube that features a single-lumen design on the proximal end. A rotatable suture wing, for securing the catheter to the patient, is attached to the hub and five outflow holes are arranged in a spiral near the tapered tip. The single lumen catheter is available in 8.0 Fr outer diameter and in implant lengths 15 cm and 19.5 cm. An optional, disposable Y-adapter can be used to convert the single extension to a dual.

The Mahurkan™ Acute Dual Lumen Catheter is a radiopaque, polyurethane tube that features a two-lumen design on the proximal end. The color-coded adapters on each lumen indicate arterial and venous flow. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected, by a hub, to a dual lumen shaft that is available in pre-curved and straight configurations. The shaft extends to side slots near the distal tip. The dual lumen catheter is available in 8.0 Fr. 10.0 Fr. 11.5 Fr. or 13.5 Fr outer diameters and a variety of implant lengths ranging from 9 cm to 24 cm. It is offered as a single device or as convenience kits.

The Mahurkar™ Acute Triple Lumen Catheter and the Mahurkar™M Acute High Pressure Triple Lumen Catheter are radiopaque, polyurethane tubes that features a three-lumen design on the proximal end. The color-coded adapters on each lumen indicate arterial flow, venous flow, and medial infusion. The adapters are connected to extension tubes which are available in curved or straight configurations. The extension tubes are connected, by a hub, to a triple lumen shaft that extends to side slots near the distal tip. The triple lumen catheter is available in 12 Fr outer diameter and a variety of implant lengths ranging from 13 cm to 24 cm. They are offered as a single device or as convenience kits.

The FDA 510(k) summary for the Mahurkar™ Acute Single, Dual and Triple Lumen Catheters does not describe acceptance criteria or a study proving the device meets those criteria in the traditional sense of a clinical trial for diagnostic performance.

This submission is for modifications to an already cleared device, primarily regarding changes to priming volumes on labels and instructions for use, and an update to static flow rate tables for the triple lumen catheter to align with ISO 10555-1. Therefore, the "acceptance criteria" and "device performance" are focused on demonstrating that these changes do not negatively impact the device's substantial equivalence to its predicate and that the updated information is accurate and compliant with relevant standards.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of "acceptance criteria" and "reported device performance" as one might expect for a new diagnostic or AI device. Instead, the performance data provided is focused on demonstrating that the modified aspects of the existing device are substantially equivalent to the predicate device and meet relevant regulatory standards.

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

• Test Set Sample Size: Not explicitly stated with specific numbers for each test. The document mentions "the Mahurkar™ Acute Catheters" as the subject of biocompatibility tests and "the devices" for engineering tests. Given this is an engineering and labeling change, the "sample" would likely refer to a certain number of manufactured catheters used for physical testing, rather than patient data.
• Data Provenance: The biocompatibility testing was conducted previously and references "Good Laboratory Practice (GLP)." The engineering tests were likely conducted in-house by Covidien, LLC. There is no mention of country of origin for any data or whether it was retrospective or prospective, as these are not relevant for this type of submission focused on engineering changes to an existing device.

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

This information is not applicable to this 510(k) submission. "Ground truth" established by experts, as typically seen in AI/diagnostic device submissions, would involve clinical interpretations or medical diagnoses. This submission pertains to physical device characteristics (priming volumes, flow rates, material compatibility) and regulatory compliance.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1 consensus) are used for clinical interpretive tasks, especially with ambiguous cases, to establish a definitive "ground truth." This is not relevant for the engineering and biocompatibility testing described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

No. This is not an AI device, nor is it a diagnostic device that would typically undergo MRMC studies. This submission concerns physical catheters.

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

No. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

For the biocompatibility tests, the "ground truth" would be established by validated laboratory assays and adherence to international standards (ISO 10993). For the priming volumes and flow rates, the "ground truth" would be the physically measured values according to established and validated engineering test methods, with the alignment of flow rates to ISO 10555-1 serving as a standard for accuracy.

8. The Sample Size for the Training Set

Not applicable. This isn't an AI/machine learning device that requires a training set.

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

Not applicable. As above, no training set is involved.

In summary: This 510(k) is for minor modifications (labeling and a standard alignment) to an already cleared medical device (catheters). The "study" described focuses on demonstrating that these changes do not alter the substantial equivalence of the device, primarily through engineering performance testing (priming volumes, flow rates, cleaning agent compatibility) and by referencing prior biocompatibility testing. It is not an AI/diagnostic device submission, so many of the requested categories are not relevant.

Ask a specific question about this device