Search Results

The devices are indicated for airway management in patients, during surgical procedures involving the head, neck, or mouth, to provide a clear surgical field by directing the circuit and connectors away from the operative area and reduce the risk of kink.

The subject device of this premarket 510(k) notification is referred to as Shiley™ Oral/Nasal RAE Tracheal Tube, Murphy Eye. The Shiley™ Oral/Nasal RAE Tracheal Tube, Murphy Eye has a translucent polyvinyl chloride (PVC) tube shaft with a radiopaque filament along its length. The subject device is offered as cuffless or cuffed in various sizes, for either oral or nasal use. All tubes are single use, sterilized by ethylene oxide, and supplied with a standard 15mm connector. The subject device and its packaging are not made with rubber latex or DEHP.

Five families of the subject devices share the same indications for use and intended use but differ in specific design features such as size, cuff presence, cuff shape, and number of murphy eyes.

a) Shiley™ Oral RAE Tracheal Tube Cuffless, Murphy Eye
b) Shiley™ Nasal RAE Tracheal Tube Cuffless Murphy Eye
c) Shiley™ Oral RAE Tracheal Tube Cuffed Murphy Eye
d) Shiley™ Oral RAE Tracheal Tube with TaperGuard™ Cuff Murphy Eye
e) Shiley™ Nasal RAE Tracheal Tube with TaperGuard™ Cuff Murphy Eye

N/A

Ask a specific question about this device

These devices are intended for oral or nasal intubation and are indicated for use in airway management, including those procedures requiring flexing of the neck or movement of the patient (e.g., to a lateral or prone position).

The subject devices are sterile, single-use tracheal tubes that incorporate a pre-formed Magill curve and have a continuous stainless-steel spiral wire incorporated into the wall to reduce the risk of collapse or kinking during patient positioning. All tracheal tubes feature standard depth marks, glottic depth marks and 15mm connector. The cuffed devices are provided with two different low-pressure cuff types, featuring a thin compliant wall that, when inflated, adapts and conforms to the irregular borders of the tracheal wall. The cuffed devices have an inflation system consisting of an inflation line, pilot balloon and self-sealing inflation valve, allowing for inflation and deflation of the cuff.

Five families of the subject devices share the same indications for use and intended use but differ in specific design features such as size, cuff presence, cuff shape, presence of murphy eye and stylet.

N/A

Ask a specific question about this device

VLFT10GEN: The Valleylab FT10 energy platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7mm thick tissue (tissue bundles), and lymphatics. When used with compatible ablation devices it is indicated for cardiac tissue ablation. The generator can also be used with compatible resectoscopes for endoscopically controlled removal or coagulation of tissue using 0.9% NaCl solution as the irrigation medium. The tissue fusion function has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.

Valleylab ™FT10 Electrosurgical Generator (VLFT10FXGEN): The VLFT10FXGEN is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab ™FT10 Vessel Sealing Generator (VLFT10LSGEN): The VLFT10LSGEN is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

Valleylab™ FT10 Energy Platform (VLFT10GEN): The Valleylab™ FT10 Energy Platform is a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. The generator provides radio frequency (RF) energy for monopolar and bipolar surgical applications, tissue-fusion, and vessel-sealing applications (LigaSure/vessel sealing function) and cardiac applications. It is a combination of a full-featured general surgery electrosurgical unit and a bipolar vessel sealing system. The monopolar and bipolar sections, including the LigaSure/Bipolar section of the system, are isolated outputs that provide the appropriate power for cutting, desiccating, and fulgurating tissue during monopolar and bipolar surgery.

Valleylab™ FT10 Electrosurgical Generator (VLFT10FXGEN): The Valleylab™ FT10 Electrosurgical Generator is a high frequency electrosurgical only version of the VLFT10GEN Energy Platform. It is intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Valleylab™ FT10 Vessel Sealing Generator (VLFT10LSGEN): The Valleylab™ FT10 Vessel Sealing Generator is the vessel sealing only version of the VLFT10GEN Energy Platform. It is a high frequency electrosurgical generator. When used with compatible sealing devices, it is indicated for sealing vessels up to and including 7 mm, tissue bundles, and lymphatics.

The provided text is a 510(k) summary for a medical device, the Valleylab™ FT10 Energy Platform Software Version 5.0. It describes the device, its intended use, a comparison to a predicate device, and performance data. However, this document does not contain details about a study evaluating a device based on AI/ML. Instead, it describes an electrosurgical generator and highlights performance data related to electrical safety, EMC, software verification/validation, and mechanical testing.

Therefore, I cannot extract information pertaining to:

1. A table of acceptance criteria and the reported device performance regarding AI/ML performance metrics (e.g., sensitivity, specificity, AUC). The document refers to "acceptance criteria" for engineering and safety tests, not for AI performance.
2. Sample sizes used for the test set and the data provenance for AI/ML evaluation.
3. Number of experts used to establish the ground truth for an AI/ML test set and their qualifications.
4. Adjudication method for an AI/ML test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done for AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done for an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for AI/ML.
8. The sample size for the training set for an AI/ML algorithm.
9. How the ground truth for the training set was established for an AI/ML algorithm.

The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence." This means that no clinical studies (which would typically involve human readers for an MRMC study or large datasets for standalone AI performance) were conducted or included in this 510(k) submission. The "Software verification and validation testing" mentioned is general software quality assurance, not specific to AI/ML model performance.

In summary, the provided text does not contain the information requested about AI/ML device performance and testing.

Ask a specific question about this device

The Valleylab™ SM Smoke Management Pencil and accessories are designed for general electrosurqical applications, including cutting and coagulation, and for removing surgical smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect.

The Valleylab™ SM Smoke Management Pencils are monopolar electrosurgical smoke evacuation pencils intended for cutting and coagulation of tissue while simultaneously removing surgical smoke. The pencils are designed to capture surgical smoke and improve visibility to target tissues, while reducing staff and patient exposure to the hazards of surgical plume. The Valleylab™ SM Smoke Management Extended Nozzle accessories are for use with longer electrodes for deeper access procedures. The predicate device is the Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772.

The proposed devices are compatible with Covidien electrosurgical generators at a maximum peak voltage 4500 Vpk having a 3-prong connector and smoke evacuators having a 3/8" port. Electrode compatibility includes use with standard 3/32" diameter hex and non-hex electrodes. The pencils are available in 10' and 15' tubing/cable lengths models.

This document pertains to the 510(k) premarket notification for the Valleylab™ SM Smoke Management Pencil and accessories. It's important to note that this device is a physical electrosurgical tool and does not contain an AI component. Therefore, much of the requested information regarding acceptance criteria and studies for AI-driven devices (like sample sizes for test sets, ground truth establishment for AI, MRMC studies, standalone algorithm performance, and training set details) is not applicable here.

However, I can extract and present the acceptance criteria and performance testing conducted for this device, which are relevant to its substantial equivalence determination.

Acceptance Criteria and Reported Device Performance

The substantial equivalence determination for the Valleylab™ SM Smoke Management Pencil and accessories is based on meeting various performance standards and demonstrating safety and efficacy comparable to its predicate device (Valleylab™ Smoke Evacuation Rocker Switch Pencil cleared under K182772).

Here's a summary of the performance testing and their acceptance criteria, as reported in the 510(k) summary:

Study Details Regarding Acceptance Criteria (as applicable to a non-AI medical device)

Given that this is a 510(k) submission for an electrosurgical pencil and accessories, and not an AI-driven device, the detailed questions regarding AI study methodology are largely not applicable. However, I will address what is known from the provided text for each point:

1. A table of acceptance criteria and the reported device performance: See the table above.
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   • The document does not specify exact sample sizes for each test (e.g., number of units tested for sterilization, biocompatibility, electrical safety, or bench performance).
   • The data provenance is not explicitly stated in terms of country of origin but is from Covidien LLC, a Medtronic company. The tests would be prospective in nature, as they involve testing the actual device prototypes or production samples against established standards.
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 for this type of device testing. Ground truth (e.g., sterility, electrical safety, mechanical integrity) is established by adherence to recognized international and national standards, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Device performance against technical standards is typically assessed through objective measurements, not human 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, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this device, "ground truth" refers to the objective, measurable parameters defined by recognized international and national standards (e.g., ISO for sterilization and biocompatibility, IEC for electrical safety and EMC, ASTM for packaging and shelf-life).
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In conclusion, the Valleylab™ SM Smoke Management Pencil and accessories have undergone rigorous non-clinical performance evaluations against established medical device standards to demonstrate substantial equivalence to a predicate device. The nature of this product as a physical electrosurgical tool means that many of the AI-specific questions are not relevant.

Ask a specific question about this device

Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP is intended for oral or nasal intubation of the trachea.
The Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non DEHP is intended for use in oral or nasal intubation of the trachea for anesthesia and is indicated for airway management.

The subject device is an oral/nasal endotracheal tube intermediate cuff. The translucent tube incorporates a Magill curve and features a radiopaque line. The tube features a thin wall, polyvinyl chloride (PVC) high pressure, low volume cuff with two different cuff shapes. An inflation system consisting of an inflation line, pilot balloon, and inflation valve allows inflation and deflation of the cuff. The subject device is manufactured from materials without latex or DEHP.

This document is a 510(k) Summary for the Shiley™ Oral/Nasal Endotracheal Tube Intermediate Cuff, Non-DEHP, and it details the device's substantial equivalence to predicate devices, supported by performance data.

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

1. Table of Acceptance Criteria and the 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)

• Sample Size: The document does not specify the exact sample sizes for each bench test conducted. It states that "terminally sterilized samples" were tested. For biocompatibility, it mentions "testing was performed on final finished subject device" for sizes 8.5mm to 10.0mm, and testing from the predicate device was leveraged for sizes 3.0mm to 8.0mm.
• Data Provenance: The document does not provide details on data provenance such as country of origin or whether the studies were retrospective or prospective. It describes laboratory bench testing and biocompatibility testing.

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 section is not applicable as the document describes bench testing and biocompatibility assessments, which do not typically involve human experts establishing a "ground truth" in the way clinical studies or diagnostic AI studies do. The "ground truth" for these tests is defined by the objective pass/fail criteria of the specified international standards.

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

Not applicable. As stated above, this pertains to objective bench and biocompatibility testing following established international standards, not clinical adjudication by experts.

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. A MRMC comparative effectiveness study was not performed. This document describes the clearance of a physical medical device (an endotracheal tube), not an AI-powered diagnostic tool.

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

Not applicable. This device is an endotracheal tube; it does not involve an algorithm or AI.

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

The "ground truth" for the performance data in this submission consists of the acceptance criteria defined by international consensus standards (ISO 5361, ISO 5356, ISO 18190, ISO 10993-1) and specific test protocols for mechanical properties, biocompatibility, and sterilization, along with human factors standards (EN 62366-1).

8. The sample size for the training set

Not applicable. This document describes the clearance of a physical medical device (an endotracheal tube), not a machine learning model that requires a training set.

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

Not applicable. See point 8.

Ask a specific question about this device

The BISTM Advance Monitoring System is intended for monitoring the state of the brain by data acquisition of EEG signals under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The BISTM Advance Monitoring System, and all its associated parameters, is intended for use on adults and pediatric patients (4 years old and above) within a hospital or medical facility.

For Adult patients, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of desflurane, propofol and sevoflurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.

The use of the BIS™ Index for monitoring may be associated with the following when used with propofol anesthesia: reduction in primary anesthetic use; reduction in emergence and recovery time; and reduction in incidence of awareness with recall.

For pediatric patients, ages 4 and above, the BIS™ Index, one of the BIS™ Advance Monitoring System's output parameters, may be used to guide anesthetic administration of sevoffurane with balanced anesthetic techniques in order to monitor the anesthetic effects on the brain.

The use of the BIS™ Index in pediatric patients, when used with sevothurane anesthesia, has demonstrated a reduction in primary anesthetic use.

The BIS™ Advance Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on acquisition and processing of EEG signals. It processes raw EEG signals to produce a single number, called the Bispectral Index, or BIS value, which correlates with the patient's level of hypnosis.

The BIS™ Advance Monitoring system is comprised of the following components: BIS™ Advance Monitor, BIS™ Advance Docking Station, BIS™ Advance Adapter Cable, GCX Mounting Accessory, BISx/BISx4 Module, Patient Interface Cable (PIC) and Monitor Interface Cable (MIC).

The BIS™ Advance Monitor displays:

• The current BIS™ number .
• . Raw EEG waveforms in real time
• . Various signal quality indicators (EMG. SQI)
• 트 Trend graphs of processed EEG parameters (including various options)
• I Processed EEG variables:
  • . Electromyography (EMG)
  • Signal Quality Index (SQI)
  • . Suppression Ratio (SR)
  • . Burst Count (BURST) (for Extend Sensor and four-channel monitoring only)
  • . Suppression Time (ST)
  • I Spectral Edge Frequency (SEF)
  • Median Frequency (MF)
  • EEG Power Asymmetry Index (ASYM) (for four-channel monitoring only)
• I Alarm Indicator and Messages

The BIS™ Advance Monitor displays 2 channels of EEG when connected to the BISx module and a unilateral BIS sensor (BIS™ Extend Sensor, BIS™ Pediatric Sensor and BIS™ Quatro Sensor) and displays 4 channels of EEG, two from each side of the brain, when connected to the BISx4 module and BIS™ Bilateral Sensor.

For both the 2-channel and the 4-channel systems, BIS monitoring is implemented as follows:

A sensor placed on the patient's head transmits EEG signals to the BISx module. The BISx module filters the data, analyzes it for artifacts and processes it using digital signal processing techniques, then sends the data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal in order to provide easier pattern recognition of changes over time during the recording.

The acceptance criteria for the BIS™ Advance Monitoring System are primarily related to its proposed changes: a narrowed indication for use and a new monitor design. The submission aims to demonstrate substantial equivalence to the predicate device (BIS EEG Vista Monitor System and BISX, K072286).

Here's an analysis of the acceptance criteria and the studies presented:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it relies on demonstrating that the new device's performance is equivalent or better than the predicate, especially for the new monitor design, and that the narrowed indications for use are clinically supported.

However, based on the comparative effectiveness study for the Indications for Use, we can infer some performance aspects:

2. Sample Size for the Test Set and Data Provenance

• OLIVER Study (Adults):
  • Sample Size: 143 subjects
  • Data Provenance: Multicenter, prospective study conducted across 3 sites in the United States.
• BTIGER Study (Pediatrics):
  • Sample Size: 170 subjects
  • Data Provenance: Multicenter, prospective, randomized control study conducted across 8 sites in the United States.

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

The document does not detail the number or qualifications of experts used to establish ground truth for the clinical studies. However, for studies involving "level of consciousness" and "unresponsiveness to verbal command" in the OLIVER study, and "anesthetic administration" in the BTIGER study, licensed healthcare practitioners would have been involved in assessing these clinical endpoints. The studies were conducted under the "direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use," as stated in the Indications for Use.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1) for establishing ground truth in the clinical studies.

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

• Was an MRMC study done? The document describes two clinical studies (OLIVER and BTIGER) that compare BIS™ guidance to standard practice or assess the correlation of BIS™ with clinical endpoints. While these are comparative studies, they are not framed as "multi-reader multi-case" studies in the typical sense of AI-assisted image interpretation. The comparison is between a device-guided approach and non-device-guided approaches or correlation with physiological states, rather than human readers interpreting cases with and without AI assistance.
• Effect size of human reader improvement with AI vs. without AI assistance: Not applicable in the traditional MRMC context, as the studies are not designed to measure improved human reader performance with AI assistance for interpretation. Instead, the BTIGER study showed that the BIS™ guided treatment group achieved statistically significantly lower end-tidal sevoflurane administration compared to the standard practice group, indicating a direct effect on patient management rather than an improvement in human interpretation.

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

The core of the BIS™ Advance Monitoring System is mentioned as processing raw EEG signals to produce a single number, the Bispectral Index (BIS value), which correlates with the patient's level of hypnosis. The device also displays raw EEG waveforms, signal quality indicators, and processed EEG parameters. The clinical studies (OLIVER and BTIGER) inherently evaluate the performance of this algorithm output (BIS Index) in a clinical setting, effectively testing its "standalone" diagnostic utility in influencing anesthetic administration and correlating with consciousness levels. The output (BIS index) as a predictor of consciousness or a guide for anesthetic use is evaluated.

7. Type of Ground Truth Used

• OLIVER Study: The ground truth for correlating BIS™ with the level of sedation appears to be based on clinical assessment of patient responsiveness, specifically "response to a verbal command."
• BTIGER Study: The ground truth for evaluating the impact of BIS™ guidance was the clinical outcome of "mean end-tidal sevoflurane (ETSevo) administration" during the maintenance phase of anesthesia, and the clinical decision-making by practitioners.

8. Sample Size for the Training Set

The document focuses on the performance of the current BIS™ algorithm and its new monitor. It states that "no software changes were performed to the BISx/BISx4 module (the unit that performs the computation for EEG acquisition), the BIS algorithm nor to the algorithm database structure." This suggests the core BIS algorithm was developed and trained prior to this submission. The document does not provide information on the sample size for the training set of the BIS algorithm itself. It only provides information for the clinical validation studies (test sets).

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

As with the training set sample size, the document does not provide information on how the ground truth was established for the training set of the BIS algorithm, as the algorithm itself was not modified in this submission. The core algorithm's development and training would have occurred during the development of earlier versions of the BIS monitoring system (e.g., the predicate device K072286).

Ask a specific question about this device

The Endoflip™ 300 System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esoplagus, in patients from five years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The subject Endoflip™ 300 System is equivalent to the predicate Endoflip™ 300 System (K223705) except for an update to the Endoflip™ 300 System software to remove the analysis episode feature of the predicate device. Other software updates include minor feature enhancements and bug fixes. Changes to device labeling rrom the software updates and other minor changes for clarification purposes were also addressed.

The Endoflip™ 300 System software is supplied pre-installed in the Endoflip™ 300 Display System. It is also the software used for the Endoflip™ 300 Reader in reader mode only. There is no change to the display system hardware or to how the reader is supplied (USB stick).

No changes were made to any of the other components that comprise the Endoflip™ 300 System when compared to the predicate.

The provided text describes a 510(k) premarket notification for the Endoflip™ 300 System, which involves software updates to an existing device. This entire document is a 510(k) submission meant to demonstrate substantial equivalence to a predicate device, not a study specifically designed to establish acceptance criteria for a new device.

Therefore, many of the requested details regarding a standalone study, multi-reader multi-case study, and detailed ground truth methodologies for a specific study proving acceptance criteria are not present in this type of regulatory document.

However, based on the information provided, here's what can be extracted:

Acceptance Criteria and Device Performance:

The document's primary objective is to demonstrate substantial equivalence to the predicate device (Endoflip™ 300 System K223705) after software updates. Therefore, the "acceptance criteria" are implicitly that the updated device performs equivalently to the predicate device and does not introduce new safety or effectiveness concerns.

Specific numerical acceptance criteria and reported device performance from a clinical trial or performance study are not explicitly provided in terms of metrics like sensitivity, specificity, or error rates. Instead, the performance is evaluated through software verification.

Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria for a new device's performance are not given (as this is a 510(k) for an updated software version of an existing device), we can infer the acceptance criteria for the software updates.

Study Details:

The document describes software verification testing as the primary study type to establish substantial equivalence for the software updates.

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

   • Test Set Sample Size: Not specified. Software verification typically involves testing against a range of inputs and scenarios, but a "sample size" in the context of clinical data for performance metrics is not applicable here as no clinical performance data is presented.
   • Data Provenance: Not specified, as it's software verification, not a clinical data study.

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

   • Not applicable. This was software verification, not a study requiring expert-established ground truth on clinical data. The "ground truth" for software testing would be the expected behavior of the software according to its design specifications.

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

   • Not applicable. This was software verification.

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, a multi-reader multi-case comparative effectiveness study was not done. The device (Endoflip™ 300 System) is a "Gastrointestinal Motility Monitoring System" that measures pressure and dimensions; it's not described as an AI-powered diagnostic tool for interpretation, but rather a direct measurement device with software for processing and displaying those measurements. The updates were minor software enhancements and bug fixes.

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

   • Yes, in a sense. The "study" was software verification, which inherently evaluates the algorithm's performance on its own against specifications, without human interpretation in the loop for diagnostic accuracy. The device itself is standalone in its measurement function, providing data to clinicians for their interpretation.

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

   • For software verification, the "ground truth" would be the software's design specifications and requirements. Each test case has an expected output or behavior based on these specifications, and the software's actual output is compared against this expected behavior. This is not clinical ground truth like pathology or expert consensus.

7. The sample size for the training set:

   • Not applicable. This was software verification testing for an updated version of an existing medical device, not a machine learning model involving a training set.

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

   • Not applicable for the same reason as above.

Ask a specific question about this device

The Endoflip™ 300 System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from 5 years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The Endoflip™ 300 System is the next generation of the predicate Endoflip™ System consisting of design changes to the device hardware and software components. The design changes improve device usability when compared to the predicate. Changes were made to the platform components only; no design changes were made to the system catheters (Endoflip™ or Esoflip™) except for labeling changes (not related to indications for use). The system is comprised of a pump, display, cart and accessories, including pre-use tube and balloon catheters.

The provided text is an FDA 510(k) clearance letter and summary for the Endoflip™ 300 System. It describes the device, its intended use, and the types of testing performed to demonstrate substantial equivalence to a predicate device.

However, the document does not contain information on acceptance criteria for a performance study evaluating the device's diagnostic accuracy or effectiveness against a ground truth, nor does it describe a study specifically designed to prove the device meets such criteria in terms of clinical performance.

The performance data summarized in section VII focuses on engineering, safety, and usability aspects of the device's hardware and software components, rather than its clinical diagnostic or treatment efficacy. Specifically, the document states:

• "Clinical studies were not required to demonstrate the safety and performance of the Endoflip TM 300 System."

Therefore, I cannot provide the requested information about acceptance criteria for clinical performance and a study proving those criteria are met. The document indicates that for this particular 510(k) submission, clinical studies to demonstrate safety and performance (in the sense of diagnostic or treatment efficacy) were not deemed necessary, likely due to the device being a "next generation" of an already cleared predicate with no change to the indications for use and improvements primarily in usability and platform components.

To answer your specific points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes engineering, safety, and usability testing, not clinical performance against specific diagnostic or treatment acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable for clinical performance. For engineering, safety, and usability tests, the sample sizes and data provenance are not specified in this summary, but would be part of the underlying test reports.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established for the performance studies presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 a gastrointestinal motility monitoring system, not an AI-assisted diagnostic tool for image interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of diagnostic performance. The device itself is a measurement system; its "standalone" performance relates to its ability to accurately measure pressure and dimensions, which would be verified through mechanical and software testing.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical performance evaluation. The "ground truth" for the tested engineering aspects would be established against calibrated standards or specifications.
8. The sample size for the training set: Not applicable. The document does not describe a machine learning or AI algorithm that would require a training set for diagnostic purposes.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on the engineering and design controls demonstrating the safety and effectiveness for a device that is essentially an updated version of a previously cleared system, rather than a novel diagnostic or therapeutic device requiring extensive clinical performance studies to establish efficacy against a clinical ground truth.

Ask a specific question about this device

The Microstream™ CO2 NanoPod, when connected to the host monitor, is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, EtCO2, FiCO2, and CO2-based respiration rate for adult, pediatric and neonatal patients, utilizing Microstream™ Advance CO2 sampling lines.

The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/ hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up.

IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SPO2 data to the NanoPod in order to calculate these parameters.

The Microstream™ CO2 NanoPod is intended for use in hospitals, hospital-type facilities, during intra-hospital transport between and within areas of care.

The Microstream™ CO2 NanoPod is a finished medical device that when connected to a host monitor is intended to provide continuous, non-invasive measurement and monitoring of carbon dioxide (CO2) during the respiration cycle, including End-tidal CO2 (EtCO2), Fractional Concentration of Inspired CO2 (FiCO2), and CO2 based respiration rate, for adult, pediatric, and neonatal patients utilizing Microstream™CO2 or Microstream™ Advance CO2 sampling lines.

The Microstream™ CO2 NanoPod also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr), and oxygen desaturation index (ODI) values. The IPI measurement is intended for use in pediatric and adult patients only, and A/hr and ODI measurements are intended for age 22 and up. Both IPI and ODI values can be calculated and displayed only if the host monitor collects SpO2 data and provides this SpO2 data to the NanoPod to calculate these parameters.

The Microstream™ CO2 NanoPod encloses a NanoMediCO2 capnography module, which measures inspired/expired carbon dioxide and respiration rate. The NanoPod is powered by the host monitor on a DC supply.

The Microstream™ CO2 NanoPod system includes the following sub-systems:

• . NanoPod is the medical device enclosure that encloses the NanoMediCO2 module. The NanoPod has a connected active cable that has a LEMO connector end, which connects to a host monitoring system.
• . NanoMediCO2 capnography module is enclosed in the NanoPod. The NanoMediCO2 module measures inspired and expired carbon dioxide and respiration rate. The active cable is what provides bidirectional communication between the Host monitor and the NanoMediCO2 module enclosed inside the NanoPod.
• . Interface Board is enclosed inside NanoPod which consists of an LED exposed on the outside of the NanoPod to provide the functional status of the subject device to the user.
• l Cradle is a plastic holder used to connect the NanoPod with a GCX clamp or other mounting solution, which can then be used to mount the NanoPod on a pole or bedrail. There are no sharp edges on the Microstream™ CO2 NanoPod, which enables the medical device to be held in the hand at times when it is removed from its mounting cradle.

The Microstream™ and or Microstream™ Advance CO2 sampling lines can attach to the NanoPod CO2 port on the NanoPod enclosure. Microstream™ Capnography parameters are displayed the Microstream™ and or Microstream™ Advance CO2 sampling line is connected to the NanoPod CO2 Port and the Microstream™ CO2 NanoPod is connected via LEMO connector to a host monitoring system. Please note that the Microstream™ and Microstream™ Advance sampling lines have been cleared in their own respective 510K submissions.

Due to the nature of the provided document (a 510(k) summary for a medical device), the information typically presented as "acceptance criteria" and "study proving it meets criteria" from the perspective of an AI/software device is not directly applicable. This document describes a hardware medical device (CO2 monitor) and its regulatory clearance process, which relies on demonstrating substantial equivalence to a predicate device rather than meeting specific performance metrics against a clinical ground truth via a study.

Therefore, many of the requested fields (sample size, expert qualifications, adjudication, MRMC, standalone performance, etc.) are not available in this document because they pertain to clinical studies or AI/software validation, which were explicitly stated as not required for this device's clearance.

However, I can extract the information relevant to this medical device's clearance process as best as possible, interpreting "acceptance criteria" as the performance and safety requirements it needed to meet for its 510(k) clearance, and "study" as the testing performed.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not applicable. This was a hardware device undergoing bench and software testing, not a clinical study with patient data.
• Data Provenance: Not applicable. The testing was laboratory-based, focused on device performance according to engineering and regulatory standards.

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

• Not applicable. "Ground truth" in the clinical sense (e.g., diagnosis by experts) was not established. The "ground truth" for the device's performance would be the reference measurements from calibrated equipment against which the device was tested.

4. Adjudication method for the test set:

• Not applicable. There was no clinical test set requiring adjudication of findings.

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 a measurement tool (CO2 monitor), not an AI-assisted diagnostic device, and no MRMC study was performed or required.

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

• Not applicable. This is a hardware device; the concept of a "standalone algorithm" is not relevant here. The device itself performs the measurements.

7. The type of ground truth used:

• The "ground truth" for the device's performance would be the established reference standards and calibrated instrumentation used in the bench performance testing to verify the accuracy of CO2 measurements, respiration rate, etc. This is typical for the validation of medical measurement devices.

8. The sample size for the training set:

• Not applicable. This device does not use a "training set" in the machine learning sense. Its operation is based on established physical principles (Non-dispersive infrared spectroscopy) and predefined algorithms.

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

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

Ask a specific question about this device

ProdiGI Traction Wire: The Medtronic ProdiGI Traction Wire is indicated to grasp tissue within the esophagus, stomach, and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.

ProdiGI Traction Magnet: The Medtronic ProdiGI Traction Magnet is indicated to grasp tissue within the stomach and colon of adults during an Endoscopic Submucosal Dissection (ESD) procedure.

The ProdiGI Traction System includes the Traction Wire and Traction Magnet devices. The Traction Wire and Traction Magnet are not intended to be used together. Both devices are used in adults only and are used to provide improved visualization of the submucosal space during an endoscopic submucosal dissection (ESD) procedure.

ProdiGI Traction Wire Device: The Traction Wire consists of two graspers: a primary tissue grasper with traction wire attached (ERD-TW20 and ERD-TW35), and a secondary tissue grasper (ERD-TWSG) without a wire. The secondary tissue grasper is used to secure the distal end of the traction wire. The traction wire is a nitinol shape-memory loop (2.0 cm or 3.5 cm in length) that provides tension to the attached tissue after deployment. The nitinol wire is attached to the grasper with a stainless-steel crimp.

ProdiGI Traction Magnet Device: The traction magnet (ERD-TMST and ERD-TMLG) consists of two identical tissue graspers with a permanent neodymium magnet attached to the grasper via a suture. The sutured magnet provides tension to the attached tissue after deployment.

Here's an analysis of the provided text to describe the acceptance criteria and the study proving the device meets them, based on your requested format:

Acceptance Criteria and Device Performance for ProdiGI

The ProdiGI device underwent non-clinical/bench studies and usability testing to demonstrate its safety and effectiveness. Importantly, no clinical data was provided. The primary studies proving the device meets acceptance criteria are summarized in the "Performance Testing - Bench", "Usability Testing", and "Performance Testing - Animal" sections of the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document presents acceptance criteria and reported performance in a narrative and tabular format for both bench and usability testing. I will consolidate the key performance criteria for each device type into a single table. Note that specific numerical results (e.g., 'b)(4)') were often redacted in the original text, so I will indicate where this occurs.

Table 1: Consolidated Acceptance Criteria and Reported Device Performance (Bench and Usability)

2. Sample Sizes and Data Provenance

• Bench Testing: The document states that the longest nitinol wire device (ERD-TW35) was used as a representative model for Traction Wire testing. For the Traction Magnet, both models (ERD-TMLG and ERD-TMSM) were used. The sample sizes for each mechanical test are not explicitly stated as numerical values (e.g., "n=X") but are implied by the performance claims that "The device passed all the tests." The provenance is internal bench testing, likely conducted prospectively by the sponsor.
• Usability Testing:
  • Traction Wire: A total of (b)(4) procedures were performed (mixture of different organs and with/without traction). Specifically, (b)(4) procedures with Traction Wire and (b)(4) procedures without Traction (control) for Visualization (N1.1) and Perforation (N1.4). (b)(4) procedures with Traction and (b)(4) without for Procedure Time (N1.2). (b)(4) procedures each in esophagus, stomach, and colorectal for anatomical locations (N1.3). (b)(4) procedures with (b)(4) cm lesions for lesion size (N1.5). (b)(4) procedures for trauma (N1.6) and complications (N1.7). The data provenance is described as "Ex-vivo porcine and bovine tissue from the esophagus, stomach and colon."
  • Traction Magnet: Sample sizes are largely redacted (indicated as (b)(4)). Two procedures each in the stomach and colon were used for testing. (b)(4) procedures with Traction Magnet and (b)(4) without Traction for Visualization (NL1), Procedure Time (NL2), and Perforation (NL4). Minimum (b)(4) successful dissections each in stomach and colorectal for anatomical locations (NL3). Minimum (b)(4) with (b)(4) lesions and minimum (b)(4) with (b)(4) lesions for lesion size (NL5). The data provenance is also "Ex-vivo porcine and bovine tissue from the esophagus, stomach and colon."
• Animal Testing (In Vivo):
  • Animals: (b)(4) animals for traction wire testing and (b)(4) animals for traction magnet testing. Each animal was the subject of device procedures and control procedures.
  • Procedures: Table 5 (redacted) outlines the number of procedures for each device and tissue type. Specifically, N=8 procedures for control and N=8 procedures for test for both Traction Wire and Traction Magnet endpoints in Tables 6 and 7, respectively. Lesions of (b)(4) to (b)(4) cm were created.
  • Provenance: This was a GLP-compliant study using live porcine models, described as in vivo testing.

3. Number of Experts and Qualifications for Ground Truth

• Usability Testing: The document states "All clinicians participating in the study were trained in therapeutic endoscopy, including training in submucosal dissection." It specifically stratified physicians by experience:
  • Novice: < 3 years and/or < 20 ESD cases to date.
  • Moderate: 3-5 years of experience and/or 1-2 ESD cases per month.
  • Skilled: > 5 years of experience and three or more ESD cases per month.
  • For the Traction Wire, "skilled by moderate and provice physicians participated."
  • For the Traction Magnet, "two skilled, two moderate and two novice physicians participated."
  • The observations and ratings from these physicians formed the basis of the usability ground truth.
• Animal Testing: Bleeding, perforation, mucosal laceration, visualization, ease of removal, and ease of procedure were assessed by "study physicians intraoperatively via endoscopic visualization." No specific number of physicians is given for the animal studies, but they are implied to be experts in therapeutic endoscopy and ESD.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1) for the usability or animal studies. It appears that the expert physicians directly provided the ratings and assessments which were then used to calculate means and comparisons. For perforation in the animal study, it notes a singular assessment that was then reviewed for causality ("unrelated to the device use or design or the control procedure").

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

While not explicitly termed an "MRMC study," the usability testing and animal (in vivo) testing were designed as comparative effectiveness studies where human readers (physicians/experts) performed procedures with and without AI (device) assistance. The "AI" here refers to the device itself as providing assistance, not an AI algorithm in the traditional sense of image analysis.

• Effect Size of Human Readers (with device vs. without):
  • Visualization: For both Traction Wire and Traction Magnet, the device showed PASS for visualization, meaning the average visualization score with the device was equal to or better than without. This indicates a positive effect on visualization compared to unassisted procedures. For the animal study, Visualization (Start, Mid, End) was consistently rated as Traction better than Control for both devices.
  • Procedure Time: For the Traction Wire, procedure time was PASS (device time <= control time). For the Traction Magnet, procedure time was PASS but the result was "Control better than Traction," meaning the control group completed faster, but this was deemed acceptable due to expected deployment time.
  • Perforation: For both usability and animal studies, "Perforation rate with traction device <= perforation rate without traction device" was generally met, indicating no increase in perforation risk. In the animal study, the Traction Magnet even showed "Perforation: Traction better than Control."
  • Ease of Procedure: In the animal study, "Ease of Procedure (Easiness, Temporal, Effect)" was consistently rated as Traction better than Control for both devices, suggesting an improvement in user experience with the device assistance.

These results indicate that the device (as an assistive tool) leads to improved or similar performance across several key metrics for human operators, with specific advantages in visualization and ease of procedure.

6. Standalone (Algorithm Only) Performance

This question appears to be primarily applicable to AI/ML algorithms. The ProdiGI device is a physical endoscopic traction device, not a software algorithm. Therefore, no standalone (algorithm only) performance was conducted or is applicable. The "performance" of this device is inherently tied to its use by a human operator.

7. Type of Ground Truth Used

• Bench Testing: Engineered specifications, mechanical measurements, and direct observation of device function against predetermined thresholds.
• Usability Testing: Expert consensus/subjective rating scales (e.g., 3-point or 5-point visualization scales) provided by trained clinicians performing procedures on ex-vivo tissue, combined with objective measures like procedure time and observed adverse events.
• Animal Testing (In Vivo): Direct intraoperative observation by study physicians (using Likert scales for bleeding, binary for perforation, and subjective scales for visualization and ease of use) and necropsy findings (for perforation and mucosal laceration), performed on live porcine models. This represents a form of outcomes data (physiological effects, procedural outcomes) directly observed by experts.

8. Sample Size for the Training Set

This question is typically relevant for AI/ML models where a distinct "training set" and "test set" are used. For a physical medical device undergoing traditional non-clinical and usability testing, there isn't a "training set" in the AI sense. The development of the device itself would involve iterative design and testing, but not a formally defined "training set" for an algorithm.

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

As noted above, a "training set" for a physical device is not typically defined in the same way as for an AI/ML model. The "ground truth" for the device's design and functionality would be established through engineering specifications, clinical needs assessments, and iterative testing/refinement during its development lifecycle, prior to formal validation studies described here.

Ask a specific question about this device