Search Results

The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is indicated for use in adult and adolescent pediatric patients to visualize cardiac structures; blood flow and other devices within the heart.

The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is inserted into the heart via intravascular access. The reprocessed ViewFlex Xtra is a sterile, single use, temporary, intracardiac catheter indicated for use in adult and adolescent pediatric patients. The ViewFlex catheter shaft is a 9 French catheter constructed with radiopaque tubing with a useable length of 90 cm. The shaft is compatible with a 10 French or larger introducer for insertion into the femoral or jugular veins. The catheter tip is a 64-element linear phased array transducer housed in silicone. The distal portion of the shaft is deflectable in four directions allowing for left-to-right and anterior-to-posterior deflection. The handle of the device has two deflection mechanisms that correspond with the movement of the distal shaft in the four planes of movement. The ViewFlex Xtra is compatible with ViewMate II, ViewMate Z and Philips CX50 ultrasound consoles. Each device is marked and tracked and taken out of service once the maximum number of cycles has been reached.

The provided text is a 510(k) summary for the Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter, a reprocessed medical device. It does not contain information about an AI/ML-driven device, nor does it specify "acceptance criteria" in the context of diagnostic performance metrics like sensitivity or specificity. Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, many of the requested details, such as sample sizes for test/training sets, expert qualifications, adjudication methods, or effects of AI assistance, are not applicable or cannot be extracted from this particular document.

However, I can extract the "performance" details in the context of the non-clinical testing conducted to prove substantial equivalence.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Equivalence)

The document primarily focuses on demonstrating that the reprocessed device performs comparably to the original predicate device through various non-clinical tests. These tests effectively serve as the "acceptance criteria" for demonstrating substantial equivalence rather than diagnostic performance in an AI/ML context.

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

Not applicable. This document describes a reprocessing approval based on non-clinical engineering and biological tests, not statistical analysis of patient data or diagnostic performance of an AI model. There is no "test set" in the sense of a dataset for an AI model.

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 context of AI/ML is not relevant here. The "ground truth" for this submission is established through validated scientific methods for medical device performance, safety, and equivalence.

4. Adjudication method for the test set

Not applicable. No adjudication method is described, as there is no "test set" requiring expert consensus.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

Not applicable. This applies to AI/ML devices that assist human readers in diagnostic tasks. The Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter is a reprocessed physical medical device, not an AI system.

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

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

For this type of device (reprocessed catheter), the "ground truth" is established through:

• Validated engineering specifications: Proving the device meets its design requirements in terms of mechanical, electrical, and dimensional properties.
• Biological safety testing: Ensuring biocompatibility and effective sterilization.
• Functional performance testing: Demonstrating the device performs its intended function (e.g., ultrasound imaging capability) identically to the original device.
• Regulatory standards and guidelines: Adherence to established FDA regulations for reprocessing.

8. The sample size for the training set

Not applicable. 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. There is no training set for an AI/ML model.

Ask a specific question about this device

The Medline ReNewal Reprocessed LigaSure Curved Small Jaw, Open Sealer/Divide LF1212A is a bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgical specialties as urologic, thoracic, plastic and reconstructive. Procedures may include, but are not limited to, bowel resections, gall bladder procedures. Nissen fundoplication, and adhesiolysis.

The instrument is also indicated for open ENT procedures in adults (thyroidectomy, radical neck dissection, parotidectory, and tonsillectorny) for ligation and division of vessels, lymphatiss and tissue bundles 2 - 3 mm away from unintended thermally-sensitive structures such as nerves and parathyroid glands.

The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.

The Medline ReNewal Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A is a sterile, single-use, hand-held bipolar electrosurgical instrument designed for use with compatible Covidien generators that include vessel sealing capabilities to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open general surgical procedures. Covidien electrosurgical generators that include vessel sealing capabilities deliver precise energy through the device to tissue for a controlled tissue response to achieve complete and permanent tissue fusion while producing minimal sticking, charring, and thermal spread to adjacent tissue. The surgeon first grasps the vessel or tissue with the jaws of the instrument. Once the surgeon is confident that the instrument is placed correctly, he or she initiates a seal by pressing a hand switch or footswitch. The instrument creates a seal by application of RF electrosurgical energy to vascular structures (vessels and lymph) or tissue bundles interposed between the jaws of the instrument. Once the seal cycle is complete, the surgeon actuates a blade within the instrument to divide tissue along the seal line. The 10-foot cord, cable connector, and generator are not reprocessed by Medline ReNewal.

The provided text is a summary of a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed LigaSure Curved, Small Jaw Open Sealer/Divider LF1212A.

The key aspect of this document is demonstrating substantial equivalence to an existing predicate device (K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A). The study's purpose is not to prove the device meets pre-defined clinical acceptance criteria for a novel functionality, but rather to show that the reprocessed device performs as safely and effectively as the original, legally marketed device.

Therefore, the "acceptance criteria" here largely refer to demonstrating performance consistent with the predicate device across various functional and safety aspects.

Here's an analysis of the acceptance criteria and the study, based on the provided text, while acknowledging that a 510(k) summary often provides high-level information without deep specifics on study methodologies:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a reprocessed device, the "acceptance criteria" are generally that the reprocessed device performs equivalently to the original device. The "reported device performance" is the demonstration through various tests that this equivalence is met.

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

The document does not specify the exact sample sizes for each of the performance tests (e.g., number of devices tested for electrical safety, number of tissue samples for histopathology). It only lists the types of tests performed.

The data provenance is not explicitly stated in terms of country of origin. However, the FDA 510(k) submission process typically requires data generated in accordance with Good Laboratory Practice (GLP) or similar standards. Given it's a US FDA submission, it's highly likely the testing was conducted in the US or in facilities compliant with US regulatory standards. The data is retrospective in the sense that the predicate device's performance already exists, and the reprocessed device is being compared against it. New prospective testing is done on the reprocessed devices.

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

For a device like this, "ground truth" isn't typically established by expert consensus in the way it would be for an AI diagnostic algorithm. Instead, it's established by:

• Engineering specifications and regulatory standards: These define acceptable performance ranges (e.g., electrical parameters, burst pressure requirements, cleanliness levels).
• Predicate device's established performance: The predicate device, already on the market, sets the benchmark for equivalent performance.
• Scientific and clinical literature: Informing what constitutes safe and effective tissue sealing and cutting.
• Pathology results: For tests like histopathology, a qualified pathologist would interpret the tissue samples, but this is part of the test result generation, not "ground truth" establishment in the AI sense.

The document does not mention the number or qualifications of experts establishing ground truth in the context of an AI study. However, the evaluation of the various tests would be performed by qualified personnel (e.g., engineers, microbiologists, toxicologists, pathologists) relevant to each specific test.

4. Adjudication Method for the Test Set

Not applicable in the context of a 510(k) for a reprocessed surgical instrument. Adjudication methods like "2+1" or "3+1" are characteristic of studies establishing ground truth for diagnostic AI, especially in image interpretation, where multiple human readers resolve discrepancies. Here, objective measurements and comparisons to established standards and predicate performance are used.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI tools where human readers interpret images or data, and the AI's impact on their performance (with or without AI assistance) is evaluated. This 510(k) is for a physical surgical instrument, not a diagnostic AI.

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

Not applicable. This device is not an algorithm. It's a physical electrosurgical instrument that is used by a human surgeon. The performance tests evaluate the instrument's physical and functional capabilities, which are inherently "standalone" in the sense that the instrument itself is being tested, but always within the context of its intended use by a human.

7. The Type of Ground Truth Used

The "ground truth" for this reprocessed device is multifactorial:

• Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (K152286 LigaSure Curved, Small Jaw, Open Sealer/Divider LF1212A). The reprocessed device must demonstrate equivalent performance across all tested parameters.
• Industry Standards and Regulatory Requirements: Technical standards (e.g., IEC 60601 series for electrical safety) and FDA regulations set minimum acceptable performance and safety thresholds.
• Objective Measurements: Laboratory tests yield objective data (e.g., electrical resistance, burst pressure, protein levels, cell viability) that can be directly compared against specified limits or predicate device data.
• Pathology: For histopathology, the ground truth would be the pathological assessment of tissue effects.

8. The Sample Size for the Training Set

Not applicable. 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. As this is not an AI/ML device, there is no training set or corresponding ground truth to establish.

Ask a specific question about this device

Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm Diameter Endoscopic Instruments have application in a variety of minimally invasive procedures to facilitate grasping, mobilization, dissection of tissue.

Medline ReNewal Reprocessed Endopath 5DCD and 5DCS 5-mm Diameter Endoscopic Instruments (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected packaged, labeled, and sterilize for an additional clinical use.

The provided document describes the FDA 510(k) clearance for the Medline Renewal Reprocessed Endopath Endoscopic Instruments (K152313). The primary goal of this submission is to demonstrate substantial equivalence to a predicate device, not necessarily to establish novel performance criteria for a new AI device. Therefore, the information requested may not be fully available in the context of this specific regulatory document.

However, based on the provided text, I can extract the following information regarding the device's acceptance criteria and the study proving it meets these criteria:

This document describes the regulatory clearance of reprocessed surgical instruments, not an AI device. Therefore, many of the typical AI-specific questions (like effect size of AI assistance, standalone performance, ground truth for training sets, etc.) are not applicable here. The "acceptance criteria" here refer to demonstrating that the reprocessed devices perform equivalently to the original predicate devices and meet established safety and functional standards for surgical instruments.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for these reprocessed devices are implicitly that they perform identically to the original, new Endopath Endoscopic Instruments manufactured by Ethicon Endo-Surgery, and maintain safety and sterility. The performance testing aims to confirm this equivalence.

Study Details (as inferable from the document):

Since this is a submission for reprocessed surgical instruments, not an AI device, the common terminology for AI studies doesn't directly apply. However, I can interpret the request in the context of this document:

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

   • The document does not explicitly state the sample size (e.g., number of reprocessed devices tested for each functional or safety test).
   • Provenance: Not specified in terms of country of origin for the data. The devices are reprocessed versions of Ethicon Endo-Surgery instruments, and the testing was performed by Medline ReNewal. It is a prospective evaluation in the sense that Medline performs these tests on their reprocessed devices to ensure quality and equivalence.

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

   • This concept is not directly applicable. "Ground truth" for these devices is typically established by comparing their performance to the known specifications and performance of original, new devices, and against recognized industry standards (e.g., ISO, ASTM, IEC). The testing itself provides the data, and expert interpretation occurs during the evaluation of these results against the predicate's performance and safety standards. There's no mention of a panel of experts for subjective assessment typical in AI evaluation.

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

   • Not applicable in the context of this type of device and testing. Performance data from laboratory tests (e.g., force measurements, electrical readings) are quantitative and do not require expert adjudication in the same way clinical image interpretation might. Visual inspections would be performed according to established criteria, not consensus.

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:

   • Not applicable. This is not an AI device or a diagnostic imaging study.

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

   • Not applicable. This is a physical surgical instrument, not an algorithm.

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

   • The "ground truth" here is the performance specifications and safety profile of the original, new predicate devices (Ethicon Endopath Endoscopic Instruments), coupled with established engineering, biological, and sterilization standards (e.g., IEC 60601 series for electrical safety, biocompatibility standards, sterilization validation standards). The reprocessed device's performance is compared against these benchmarks.

7. The sample size for the training set:

   • Not applicable. There is no machine learning "training set" for physical reprocessed instruments.

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

   • Not applicable, as there is no training set for an AI model.

Ask a specific question about this device

Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology is indicated for soft-tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to, or substitute for, electrosurgery, lasers, and steel scalpels in general, otorhinolaryngolic (ear, nose and throat [ENT]), plastic, pediatic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and other open procedures.

Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology (originally manufactured by Ethicon Endo-Surgery) are cleaned, refurbished, tested, inspected, packaged, and sterilized for an additional clinical use.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, Medline ReNewal Reprocessed Harmonic FOCUS+ Shears without Adaptive Tissue Technology. The focus of the acceptance criteria and study is on demonstrating substantial equivalence to a predicate device, rather than on a new AI/algorithm-driven device with standalone performance or human-in-the-loop studies.

Therefore, the requested information on AI-specific criteria (like effect size of AI assistance, standalone algorithm performance, training set details, and expert adjudication methods for a test set based on expert ground truth) is not applicable to this document. This document describes the testing for substantial equivalence of a reprocessed surgical instrument.

Here's the information that can be extracted from the provided text, tailored to the context of a reprocessed medical device:

Acceptance Criteria and Device Performance (for a Reprocessed Surgical Instrument)

The study focuses on demonstrating substantial equivalence of the reprocessed device to the predicate device. The acceptance criteria are implicit in the performance testing conducted to show that the reprocessed device maintains the functional characteristics and safety profile of the original device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test performed (e.g., number of reprocessed devices tested for "simulated use" or "tissue sticking"). The nature of these tests for a physical device would involve a defined number of units or test cycles, but these numerical details are not provided in the summary.

Data Provenance: The data provenance is from the manufacturer (Medline ReNewal) and is part of their submission to the FDA for a 510(k) premarket notification. It is derived from testing conducted specifically for this reprocessed device to demonstrate its equivalence. The document does not specify the country of origin of the data or explicitly state whether it's retrospective or prospective, but testing for a 510(k) submission is typically prospective for the purpose of the submission.

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

Not Applicable. This is a submission for a reprocessed physical medical device, not an AI/software device that relies on expert interpretation to establish ground truth for a test set. The "ground truth" for this device would be its physical and functional specifications and performance against established standards and the predicate device, demonstrated through objective tests.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used when human interpretation of data (e.g., images for a diagnostic AI) is ambiguous and requires expert consensus to establish a definitive ground truth. For a physical device undergoing performance testing, the results are typically quantitative or directly observable and do not require this type of expert adjudication process.

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

No. An MRMC study is relevant for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This document describes a reprocessed surgical instrument, which does not involve human readers interpreting cases with or without AI assistance.

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

Not Applicable. This device is a physical surgical instrument. The concept of "standalone algorithm performance" does not apply. The device's performance is inherently "standalone" in that it performs its physical function.

7. The Type of Ground Truth Used

The "ground truth" for this reprocessed device is established through:

• Predicate Device Specifications and Performance: The original manufacturer's specifications and the known performance characteristics of the legally marketed predicate devices (K133314, K124033, K100597) serve as the benchmark.
• Industry Standards: Compliance with relevant industry standards, such as IEC 60601-1 for electrical safety.
• Objective Performance Metrics: Direct measurement of physical and functional characteristics (e.g., grasping force, cutting effectiveness, residual levels after cleaning, sterility validation).
• Biocompatibility Testing: Ensuring that the reprocessed device does not pose new or increased biological risks.

8. The Sample Size for the Training Set

Not Applicable. This document describes a reprocessed physical medical device, not an AI/machine learning model that requires a training set.

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

Not Applicable. As there is no training set for an AI model, the concept of establishing ground truth for it does not apply.

Ask a specific question about this device