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The CONMED ALTRUS® Thermal Tissue Fusion System is indicated for open and laparoscopic techniques in general surgical and gynecological procedures for ligating (sealing) and dividing (cutting) of tissue when hemostasis is desired.

The CONMED Altrus Thermal Tissue Fusion system consists of the following:

• CONMED Altrus Thermal Tissue Fusion Energy Source .
• CONMED Altrus Thermal Tissue Fusion Handpiece. .
  The CONMED Altrus Thermal Tissue Fusion system employs focused thermal energy and pressure to simultaneously seal and/or seal and divide tissue. By applying direct heat instead of electrical, radio frequency or ultrasonic energy, the ConMed Altrus products can reduce the potential of unintended thermal injury.
  The energy source uses an LCD display, a power supply, amplifiers and associated electronic components coupled with several microprocessors and associated software to provide the energy to the accompanying handpiece. The energy source works in harmony with the handpiece in a closed loop communication process. This process allows for the handpiece to provide information to the energy source regarding the tissue and adjust the predetermined electrical parameters in response to the effect on the tissue. As energy is delivered to the heaters in the distal portion of the handpiece, these heaters increase in temperature, by means of simple resistive heating. This thermal effect coupled with mechanical pressure on the vessel provides the means for the fusion of the tissue between the jaws to form the ligation (seal) The cutting effect is accomplished in a similar manner, with a different set of parameters controlled by the software.
  The CONMED Altrus Thermal Tissue Fusion handpiece is a single use device which is provided sterile. The device uses a scissors to parallel jaw closure mechanism with one flat jaw and one crowned jaw in which the vessels/tissues are grasped and through which pressure and heat are applied. It is a multi-functional device capable of vessel sealing, grasping and dissecting during open general surgical procedures. The two jaw sizes allow for applications in a variety of clinical environments for access in confined areas as well as large open areas.
  Energy is delivered to the heaters by a cable which provides power to the handpiece as well as allows for communication to and from the handpiece.

The CONMED Altrus Thermal Tissue Fusion System is a medical device that uses focused thermal energy and pressure to seal and/or divide tissue, aiming to reduce the potential for unintended thermal injury compared to traditional electrosurgical methods.

Here's an analysis of the provided information regarding its acceptance criteria and the study that proves it meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document, a 510(k) premarket notification summary, does not explicitly list quantitative acceptance criteria in a table format. Instead, it focuses on demonstrating substantial equivalence to predicate devices. Substantial equivalence implies that the new device is as safe and effective as a legally marketed device.

Therefore, the "acceptance criteria" here are implicitly linked to the performance characteristics of the predicate devices. The document states:

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

The summary states that "Preclinical laboratory and performance testing were performed." However, it does not provide specific details about the sample sizes used for these tests, nor does it mention the data provenance (e.g., country of origin, retrospective or prospective nature of the data). This level of detail is typically found in the full testing reports that accompany a 510(k) submission, but is not included in this summary.

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

The document does not specify the number of experts used or their qualifications for establishing ground truth for any testing. Given that the testing mentioned is "preclinical laboratory and performance testing," it is likely that engineering and clinical experts were involved in designing and evaluating the tests, but this is not explicitly stated.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Since the testing mentioned is "preclinical laboratory and performance testing" rather than human clinical trials involving subjective interpretation, a formal adjudication process (like 2+1 or 3+1 for image reviews) would not typically be applicable or described in this type of submission summary.

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

No MRMC comparative effectiveness study was done or is mentioned. The CONMED Altrus system is a surgical device, not an AI-powered diagnostic or assistive tool for human readers. Therefore, the concept of improving human reader performance with AI assistance is not relevant to this device.

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

The CONMED Altrus Thermal Tissue Fusion System is a physical medical device (energy source and handpiece) used directly by a surgeon. It is not an algorithm that operates standalone. Therefore, a standalone algorithm-only performance test is not applicable and was not performed. The performance is inherently "human-in-the-loop" as a surgeon manipulates the device.

7. The Type of Ground Truth Used

Based on the description of "preclinical laboratory and performance testing," the ground truth would likely be established through:

• Direct observation and measurement of physical outcomes: e.g., tensile strength of sealed vessels, burst pressure, time to seal, charring, tissue division efficacy, and temperature profiles.
• Engineering specifications and standards: Confirming the device operates within defined parameters (e.g., power output, temperature control, mechanical force).
• Comparative results against predicate devices: Demonstrating similar or superior performance to existing, legally marketed devices.

Pathology or outcomes data are not explicitly mentioned in this summary but could be part of comprehensive preclinical testing to assess tissue effects.

8. The Sample Size for the Training Set

The concept of a "training set" is typically associated with machine learning or AI algorithms. Since the CONMED Altrus Thermal Tissue Fusion System is a hardware device with associated software controlling its operation, but not an AI/ML device in the modern sense, the term "training set" for algorithm development is not applicable or mentioned in this summary. The software parameters are likely determined through engineering design, testing, and optimization rather than an iterative machine learning training process.

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

As "training set" for an AI/ML algorithm is not applicable, the question of how its ground truth was established is also not relevant to this device. The "ground truth" for the device's design and operating parameters would be established through engineering principles, benchtop testing, and preclinical studies to ensure safety and effectiveness.

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For percutaneous placement of a long-term initial-placement feeding and/or decompression device.

The EnTake PEG Standard and Safety System contains a gastrostomy feeding tube, external retention bolster, two-port feeding adapter, feeding tube clamp packaged sterile in a kit containing procedural aides. The EnTake PEG System consist of both standard and safety kits in both push and pull versions. Standard kits contain the components that are typically used in the procedure. Safety kits contain alternative safety versions of the scalpel, the needle introducer and the 5 cc syringe.

The EnTake PEG System will be offered in a variety of sizes and variations that allow for installation via guidewire (push) or pull wire, placement in a new gastrostomy.

The provided text describes a 510(k) submission for the "EnTake™ PEG Standard and Safety System." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than independent performance studies with detailed acceptance criteria and expert reviews often seen for AI/ML devices.

Therefore, much of the requested information regarding acceptance criteria derived from a study, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth establishment will not be present in this document.

However, I can extract the information that is available and clarify what is missing based on the nature of this submission.

1. A 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)

• Not applicable/Not provided in the document. This document describes a 510(k) submission based on substantial equivalence, which primarily relies on comparison to existing legally marketed devices, biocompatibility, and bench testing, rather than clinical efficacy studies requiring large test sets of patient data.

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/Not provided in the document. Ground truth establishment by experts for a test set is not part of this 510(k) summary, as it does not involve the evaluation of an algorithm's performance on medical images or diagnostic data.

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

• Not applicable/Not provided in the document. Adjudication methods are not relevant to this type of device submission.

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, an MRMC comparative effectiveness study was not done. This is not an AI/ML device, and such a study is not required for a PEG tube system.

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

• Not applicable/No. This device is a medical instrument (PEG tube system), not an algorithm, so standalone performance testing in this context is irrelevant.

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

• The "ground truth" for this device's performance is established through biocompatibility and bench testing standards, and the characteristics of the predicate devices. The device passed predetermined performance specifications based on these tests and demonstrated substantial equivalence to the predicate devices in terms of intended use, technological characteristics, and materials.

8. The sample size for the training set

• Not applicable/Not provided in the document. This is not an AI/ML device that requires a training set.

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

• Not applicable/Not provided in the document. As above, this is not an AI/ML device and does not utilize a training set in the conventional sense.

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The ConMed Irrigation Nozzle is intended for colon cleansing when medically indicated, such as before radiological or endoscopic examinations.

The device is sterile, for single-use and is intended for use as an accessory with The device is stome, for clingie nomercial distribution and acts as a nozzle when inserted into a patient's recturn to direct water into and cleanse the lower colon when medically indicated, such as before radiological or endoscopic examination. The nozzle is designed as a one-piece, injection molded plastic handpiece having a slight curvature at the end intended for insertion into the rectum. At the opposite end the device has a barbed fitting for attachment to the tubing from the colonic irrigation system. Several tip configurations are made available to provide options for the clinician.

The provided text is a 510(k) Premarket Notification for a non-AI medical device (ConMed Irrigation Nozzle). As such, it does not contain information typically found in submissions for AI/ML-powered medical devices regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

Therefore, I cannot extract the requested information.

The document discusses the device's substantial equivalence to predicate devices (Jimmy John III Rectal Nozzle and GC Irrigator) for its intended use in colon cleansing. It mentions that all devices are for similar use, made of similar materials, and have a similar design. This is a common approach for non-AI devices to demonstrate safety and effectiveness without needing extensive clinical trials in the same way an AI-powered device would.

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Cannulation of the Papilla of Vater to deliver contrast medium for fluoroscopic visualization of the biliary/pancreatic system.

The ProFormaTM HF 4.5 Cannula is used for endoscopic cannulation of the biliary ductal system. With a tapered, atraumatic tip, and high flow injection port, this device provides cannulation of the papilla and access into the biliary system. The 4.5 French tip accepts a 0.035" (0.889 mm) guidewire. The unique multi-lumen port design at the proximal end, allows for injection of contrast medium through two lumens with a separate port for guidewire passage.

Colored visual markers located on the distal tip endoscopically aid in the assessment of cannulation and insertion into the biliary system. A distal radiopaque maker band aids in fluoroscopic visualization. A proximal marker band indicates when the catheter exists the duodenoscope.

The provided K050777 document does not contain information about a study proving device performance against acceptance criteria for an AI/ML powered device.

This document describes a 510(k) submission for a medical device called the "ProForma™ HF 4.5 Cannula," which is used for endoscopic cannulation of the biliary ductal system. The submission is from 2005, significantly predating the widespread use and regulatory framework for AI/ML in medical devices.

Therefore, I cannot fulfill your request for information related to acceptance criteria and a study proving an AI/ML device meets them based on this document. The document focuses on establishing substantial equivalence for a physical medical device based on its technological characteristics, biocompatibility, and functionality testing, not on the performance of a software algorithm.

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To be used to guide and exchange endoscopic accessories and electrosurgical devices for biliary procedures. The guidewire is indicated for selective cannulation of the biliary ducts, including but not limited to the common bile, cystic, pancreatic, and right and left hepatic ducts.

The FXWire™ Advanced Measurement Guidewire is a kink resistant metal alloy cored guidewire, which is encapsulated in a PTFE jacket. The guidewire has a flexible radiopaque tip, with a hydrophilic coating for enhanced lubricity. At the distal end of the guidewire, there are painted marker bands beginning at 6cm and extending to 30cm from the distal tip of the guidewire, as well as two radiopaque marker bands placed at 10cm and 15 cm from the distal tip of the guidewire. Additionally, at the proximal end of the guidewire, endoscopic marker bands have been placed beginning at 210cm and extending to 270cm from the distal tip of the guidewire. These marker bands enable endoscopic and fluoroscopic visualization of movement, as well as estimation of stricture length. This guidewire meets the recognized standard for high frequency current leakage (Reference ANSI/AAMI Standard HF 18-1993) when used with a sphinctertome and may be left in place during electrosurgical cutting.

The provided text is a 510(k) summary for the FXWire™ Advanced Measurement Guidewire. It describes the device, its intended use, and its technological characteristics. However, it does not contain specific acceptance criteria, a detailed study design, or reported device performance metrics in a way that allows for the completion of the requested table and information points.

The summary states: "Design verification data demonstrated that the FXWire™ Advanced Measurement [Guidewire] met the performance requirements and is as safe and effective as the predicate device." But it does not provide the "performance requirements" (acceptance criteria) themselves, nor does it quantify the "performance."

Therefore, I cannot fulfill your request for the acceptance criteria table and the detailed study information as the necessary data is not present in the provided document.

Missing Information:

• Specific Acceptance Criteria: The document mentions "performance requirements" but does not list them (e.g., specific thresholds for tensile strength, lubrication, marker band accuracy, etc.).
• Reported Device Performance: No quantitative results from any tests are presented.
• Study Design Details: No information regarding sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment is included for any performance testing.

Without the actual "design verification data" or at least a summary of its results against defined criteria, I am unable to create the requested table and provide the detailed study information.

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For TENS and Neuromuscular Stimulation

Not Found

I am sorry, but the provided text from the FDA letter and attachment does not contain information regarding the acceptance criteria for a medical device and the study that proves the device meets those criteria. The documents are a formal FDA communication about a 510(k) clearance for the ConMed™ VersaStim Neuromuscular Stimulator/TENS and its electrodes.

Specifically, the documents include:

• A letter granting 510(k) clearance, indicating the device is substantially equivalent to legally marketed devices.
• Information about regulatory requirements and general controls.
• An "Indications for Use" statement for the device.

There is no mention of:

• Specific acceptance criteria (e.g., performance metrics, thresholds).
• A study design or methodology.
• Sample sizes for test or training sets.
• Data provenance.
• Details about expert ground truth establishment or adjudication.
• Multi-Reader Multi-Case (MRMC) studies or their outcomes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, expert consensus, etc.).

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, or details about a study, as this information is not present in the provided text.

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These devices are intended for use with argon beam and argon plasma coagulators as flexible polypectomy snares for the cutting, resection and non-contact coagulation of polyps in the digestive tract of the human body by use of high-frequency electrosurgical energy. The argon beam provides contact-free coagulation of bleeding sites that can arise after excision of polyps and ablation of remnants of polyps. The application takes place exclusively with an endoscope.

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The provided text is related to an FDA 510(k) premarket notification for an electrosurgical device (ABCSnare Electrosurgical Probe). It is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets those criteria.

Therefore, I cannot extract the requested information from the provided text. The document focuses on the FDA's determination of substantial equivalence to a predicate device, allowing the device to be marketed, rather than detailed performance study results against specific acceptance criteria.

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For electrosurgical cutting and coagulation in shoulder, ankle, wrist, elbow, and knee arthroscopic procedures. Additionally, the SI version also has suction capability.

Not Found

This is a regulatory letter from the FDA regarding the Conmed Heatwave Hand-Controlled Electrode. It does not contain any information about acceptance criteria or a study proving that the device meets those criteria, nor does it mention AI-related performance or studies.

Therefore, I cannot provide the requested information. The document focuses on the substantial equivalence determination for a traditional electrosurgical device based on pre-amendment devices, not on performance studies with acceptance criteria, human readers, or AI.

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General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of a RF (radio frequency) electrosurgical current through an accessory electrode for . cutting and coagulation at the operative site.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for the Conmed System 2000 ESU, an electrosurgical generator. It confirms that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory obligations. However, it does not include details on specific acceptance criteria, study designs, sample sizes, expert qualifications, adjudication methods, or ground truth establishment for a device performance study.

Therefore, I cannot extract:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used, test set data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. Information on MRMC comparative effectiveness studies or effect sizes.
6. Information on standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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General-purpose electrosurgical generator used in conjunction with an electrosurgical accessory handpiece for delivery of any FF (radio frequency) electrosurgical current through an accessor selectrode for cutting and coagulation at the operative site.

Not Found

This document is a 510(k) clearance letter for a medical device called the Conmed System 5000 ESU, not a study report. It states that the device is substantially equivalent to legally marketed predicate devices.

Therefore, the document does not contain the information required to populate the acceptance criteria and study details you've requested. The request specifically asks for details about a study that proves the device meets acceptance criteria, including sample sizes, ground truth establishment, expert qualifications, and multi-reader comparative effectiveness; none of this information is present in a 510(k) clearance letter.

To fully answer your prompt, I would need access to the actual 510(k) submission (which often includes performance data and testing), or a separate study report for the Conmed System 5000 ESU.

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