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The Medline ReNewal Reprocessed Biosense Webster CS Catheter is indicated for electrophysiological mapping of cardiac structures, i.e., stimulation and recording only. The catheter is designed for use in the coronary sinus.

The reprocessed catheters are diagnostic bi-directional 7F deflectable mapping electrophysiology EP catheters. The devices have the ability to map electrical activity within the Coronary Sinus (CS) through electrodes along the catheters' pre-shaped tip. The catheters have a braided bi-directional tip section that provides the user with two 180° opposed single plane curves (available curves are DF and FJ). The tip is deflected with a Rocker Lever, and the high torque shaft permits the tip's plane to rotate to ease accurate positioning of the catheter tip at the desired site. The Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID are equipped with an Electronically Erasable Programmable Read Only Memory (EEPROM) that is used to store unique catheter identification information.

The provided document is a 510(k) premarket notification from the FDA for a reprocessed medical device: "Medline ReNewal Reprocessed Biosense Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID".

This document is not about an AI/ML medical device. It's about a reprocessed catheter and demonstrates substantial equivalence to existing predicate devices based on non-clinical performance data. Therefore, the specific questions related to AI/ML device acceptance criteria, study methodologies (like MRMC, standalone performance, training sets, expert consensus for ground truth), and effect sizes of AI assistance are not applicable to this document.

The document discusses "non-clinical testing" and "functional performance studies" for the reprocessed catheters to demonstrate their equivalence to new, original equipment manufacturer (OEM) catheters.

Here's an attempt to extract the relevant information from the provided text, while noting the limitations regarding the AI/ML specific questions:

Acceptance Criteria and Device Performance (based on non-clinical testing for a reprocessed device):

The document does not provide a table of precise quantitative acceptance criteria with corresponding performance metrics for the reprocessed catheter in the way one would expect for an AI/ML device's diagnostic performance. Instead, it states that the functional characteristics of the subject device (reprocessed catheter) have been evaluated and found to be substantially equivalent to the predicate device. This substantial equivalence is based on various non-clinical tests.

The types of non-clinical tests performed and implicitly, the areas where acceptance criteria would have been applied (though not explicitly listed with values), include:

The evidence for "proof" that the device meets "acceptance criteria" is the FDA's determination of substantial equivalence (SE) to legally marketed predicate devices. This SE determination is based on the provided non-clinical testing data which, by inference, met the internal acceptance criteria set by Medline ReNewal and deemed sufficient by the FDA for establishing SE.

Regarding the AI/ML specific questions:

1. A table of acceptance criteria and the reported device performance: As explained above, for this reprocessed medical device, specific quantitative metrics are not provided in the summary. The acceptance is based on demonstrating substantial equivalence through various functional, mechanical, cleaning, biocompatibility, and sterilization tests.

2. Sample sizes used for the test set and the data provenance: The document mentions "non-clinical testing data" and "functional performance studies" but does not specify the sample sizes (e.g., number of catheters tested) or the provenance (country of origin, retrospective/prospective) of this data. It is inherently laboratory/bench testing data, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable. For a reprocessed physical device, "ground truth" would be established through laboratory methods and validated testing protocols against known engineering and biological standards, not through human expert consensus in the medical imaging sense.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no expert adjudication of diagnostic outputs occurred.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a reprocessed physical catheter, not an AI/ML diagnostic algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an AI algorithm. Its "standalone" performance would refer to its physical properties and functionality outside of human use, as evaluated through the non-clinical tests.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of diagnostic "ground truth" for AI. For this device, "ground truth" refers to the established performance and safety specifications of the original predicate device, against which the reprocessed device's performance is compared through physical and chemical testing.

8. The sample size for the training set: Not applicable. This is a reprocessed physical medical device, not an AI/ML algorithm that undergoes "training."

9. How the ground truth for the training set was established: Not applicable. No training set or ground truth in the AI/ML context exists for this device.

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The Medline ReNewal Harmonic ACE+7 Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, plastic, pediatric, gyneoologic, thoracic, exposure to orthopedic structures (such as spine and joint space), sealing and transection of lymphatic vessels, and other open and endoscopic procedures. The instruments allow for the coagulation of vessels up to and including 7 mm in diameter using the Advanced Hemostasis hand control button.

The Medline ReNewal Reprocessed Harmonic ACE+7 Shears (models HARH23, HARH36, and HARH45) are used for coagulation and mechanical transection of soft tissue during laparoscopic and open procedures. The devices allow the surgeon to grasp, coagulate, and transect soft tissue with a single instrument. The devices are hand-actuated with a shaft and tissue effector that can be rotated. The energy delivery can be activated with hand activation or with an optional generator foot switch.

This document is a 510(k) summary for the Medline ReNewal Reprocessed Harmonic ACE+7 Shears, which is a reprocessed medical device. It aims to demonstrate substantial equivalence to a legally marketed predicate device.

Acceptance Criteria and Device Performance (Based on the document):

The document primarily focuses on demonstrating substantial equivalence to the predicate device (Ethicon Harmonic ACE+7 Shears, K132612) through comparisons of various characteristics and performance testing. The "acceptance criteria" here implicitly refer to meeting the performance and safety profiles of the original device after reprocessing.

1. Table of Acceptance Criteria and Reported Device Performance:

The document outlines performance testing conducted to ensure equivalency after reprocessing. The acceptance criteria are implied to be achieving results comparable to or within acceptable ranges of the original, new device.

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

The document broadly states that the functional characteristics were "evaluated." It does not specify the exact sample sizes (N) for each of the performance tests listed. The data provenance is implied to be from prospective testing conducted by Medline ReNewal as part of their 510(k) submission process for the reprocessed device. There is no indication of country of origin for the testing, other than the submitting company being based in the USA.

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

This document describes technical and functional performance testing of a physical medical device, not an AI/algorithm-based diagnostic device. Therefore, the concept of "experts used to establish ground truth" (e.g., radiologists, pathologists) for interpreting test results is not applicable in the same way as for diagnostic AI. The "ground truth" for the device's performance is established by the direct measurements and results of the physical and biological tests against established engineering and safety standards. The individuals conducting and analyzing these tests would be qualified engineers, technicians, and potentially toxicologists/biologists. The document doesn't specify how many or their exact qualifications.

4. Adjudication Method for the Test Set:

Not applicable in the context of this device's performance testing. Adjudication methods like 2+1 or 3+1 are typical for human interpretation of medical images or data, not for direct physical performance measurements. The results of the tests would be objectively measured and compared to predefined criteria.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This type of study is relevant for evaluating the impact of an AI system on human reader performance in diagnostic tasks, which is not the subject of this 510(k) submission for a reprocessed surgical instrument.

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

This is not applicable as the device is a physical surgical instrument (Harmonic ACE+7 Shears), not an AI algorithm. Its performance is inherent to the reprocessed device itself.

7. The type of ground truth used:

The "ground truth" for this reprocessed device is established through various physical, electrical, mechanical, and biological measurements against established engineering specifications and safety standards for the original device and similar devices. This includes:

• Direct measurements of cutting time, burst pressure, and other functional parameters.
• Results from standardized cleaning and sterilization validation protocols.
• Outcomes of biocompatibility testing.
• Comparisons against the performance data of the original predicate device (implicitly serving as a benchmark for acceptable "ground truth" performance).

8. The sample size for the training set:

Not applicable. This device is a physical reprocessed medical instrument and does not involve AI or machine learning models that require training sets.

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

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

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The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation 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 surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc.

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 Maryland Jaw Sealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to activate a knife, which divides the tissue along the seal line.

The request is for information on the acceptance criteria and study proving device performance for the Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737, and LF1744), as detailed in the FDA 510(k) summary K182588.

Based on the provided document, the device is a reprocessed version of a legally marketed predicate device. The submission primarily focuses on demonstrating that the reprocessed device is substantially equivalent to the original predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers with 510(k) K141153) through performance testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the functional characteristics of the proposed reprocessed devices have been evaluated and found to be equivalent to the predicate devices. The acceptance criteria are implied to be that the reprocessed device performs comparably to the new predicate device across various tests.

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

The document does not specify the exact sample sizes used for each of the performance tests. It broadly states "The functional characteristics of the proposed devices have been evaluated..." without providing numerical details for the test sets.

The data provenance is not explicitly stated in terms of country of origin. Given it is an FDA submission for a device manufactured by "Surgical Instrument Service and Savings Inc (dba Medline ReNewal)" and the predicate is from "Covidien," it can be inferred that the testing and data would be primarily from the United States, following U.S. regulatory guidelines. The data is retrospective in the sense that it relies on established standards and comparisons to an already legally marketed predicate device, rather than a novel prospective clinical trial for the reprocessed device's primary effectiveness.

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

The document does not mention the use of experts to establish ground truth for this type of device comparison study. The tests listed are primarily engineering and laboratory-based performance evaluations (e.g., electrical, mechanical, material, and in-vitro or ex-vivo tissue property tests). For biocompatibility and histopathology, qualified laboratories and pathologists would perform the evaluations, but their specific number and qualifications are not detailed in this summary.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of clinical outcomes or interpretations by multiple readers/experts. The testing involves objective measurements against established engineering and biological standards.

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

Not applicable. This is not a study involving AI or human readers for diagnostic interpretation. It is a performance evaluation of a reprocessed surgical instrument.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the performance evaluation of this reprocessed device is established by:

• Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers, K141153). The reprocessed device is deemed substantially equivalent if its performance matches or falls within acceptable ranges compared to the predicate.
• Industry Standards: Compliance with international and national standards (e.g., IEC 60601 series for electrical safety, ISO standards for biocompatibility and sterilization, and internal performance specifications), which represent a form of accepted "ground truth" for device safety and performance.
• Laboratory-based measurements: Objective measurements of physical, chemical, and biological properties through various tests (e.g., burst pressure, protein residuals, cytotoxicity).
• Histopathology: Evaluation of tissue effects, performed by qualified personnel (likely pathologists), forms a 'ground truth' for tissue interaction.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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The Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissection Devices models SCD 391 and SCD 396 are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The devices can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space) and other open and endoscopic procedures. The Sonicision Cordless Ultrasonic Dissection Devices can be used to coagulate isolated vessels up to 5 mm diameter.

The Sonicision Cordless Ultrasonic Dissector Device, models SCD391 and SCD396, are sterile, single-use components to which the Sonicision Reusable Generator and Reusable Battery Pack attach. (The Sonicision Reusable Generator and Reusable Battery Pack are not included in this submission and will not be reprocessed by Medline ReNewal.) This component provides control for device functions such as selecting power levels, blade placement and position, grasping, coagulating and dissecting tissue. The Cordless Ultrasonic Dissection Devices can coagulate vessels up to 5 mm in diameter. Furthermore, they are designed to be inserted and extracted through a compatible 5 mm trocar when used endoscopically.

Here's an analysis of the acceptance criteria and study information based on the provided text:

The document is a 510(k) premarket notification for a reprocessed medical device, specifically the Medline ReNewal Reprocessed Sonicision Cordless Ultrasonic Dissector, Models SCD 391 and SCD 396. The core of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving novel clinical effectiveness or superiority. Therefore, the testing described focuses on demonstrating that the reprocessed device performs as intended and is as safe and effective as the original, rather than establishing new performance benchmarks for all surgical devices.

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

The document doesn't provide a direct table of specific numerical acceptance criteria alongside reported performance for each test. Instead, it lists types of performance tests conducted to establish equivalence. The general acceptance criterion for all the tests is that the reprocessed device must demonstrate equivalence to the predicate device in terms of safety and effectiveness.

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

• Sample Size: The document does not specify the exact sample sizes (N numbers) used for each individual performance test. It only states that the functional characteristics "have been evaluated."
• Data Provenance: The data provenance is not explicitly stated. However, since this is a submission for a reprocessed device by Medline ReNewal, the testing would have been conducted by Medline ReNewal or their contracted testing facilities. Given the nature of performance testing for medical devices, it's generally done in a controlled laboratory environment. The origin of the reprocessed devices themselves would be from various healthcare facilities where they were originally used before being sent for reprocessing. The testing itself is prospective in the sense that Medline ReNewal performed these tests on their reprocessed devices.

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

This type of information (expert consensus, qualifications) is typically relevant for studies involving subjective interpretation, like imaging diagnostics or clinical endpoints, where human experts establish ground truth. For this submission, which is about the functional and safety equivalence of a reprocessed surgical instrument, the "ground truth" is established by direct physical and chemical testing against defined specifications or comparison to the performance of the new predicate device. Therefore, information about "experts establishing ground truth" in the clinical sense is not applicable or provided in this document.

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

Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or diagnostic accuracy studies where multiple readers interpret cases and disagreements are resolved. This document pertains to performance testing of a reprocessed surgical instrument, which involves objective laboratory measurements and comparisons to predetermined specifications or predicate device performance. Therefore, an adjudication method in this context is not applicable and not mentioned.

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

• MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic aids, especially those involving AI interpretation, where human readers interact with a system to make diagnoses. The Medline ReNewal device is a surgical instrument, not an AI diagnostic tool.
• Effect Size of AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.

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

• Standalone Performance: Not applicable. This is a physical surgical instrument, not an algorithm or software. Its performance is inherent to its mechanical, electrical, and material properties when used by a surgeon.

7. The type of ground truth used

The ground truth for evaluating the safety and effectiveness of the reprocessed device is established through:

• Comparison to the predicate device's known performance: The fundamental scientific technology and intended use are considered identical to the predicate.
• Pre-defined specifications and standards: Each performance test (e.g., grasping/pulling force, cutting effectiveness, cleaning, biocompatibility, sterilization) would have acceptance criteria based on established engineering standards, regulatory requirements, and the expected performance of a new device.
• Objective laboratory measurements: Physical, chemical, and biological tests are performed to directly measure different aspects of the device's function and safety.

Essentially, the "ground truth" is objective measurement against established requirements and comparison to the original device's performance.

8. The sample size for the training set

This concept of a "training set" is relevant for machine learning or AI models. Since this is a physical medical device and not an AI or software product, there is no training set in the traditional sense. The development and validation of the reprocessing procedure would involve internal process development and verification, but it's not a "training set" for an algorithm.

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

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

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The reprocessed Medline ReNewal LigaSure Impact LF4318 Curved Large Jaw, Open Sealer/Divider is a dedicated bipolar electrosurgical instrument intended for use in open surgical procedures where ligation and division of vessels is desired. The LF4318 is intended to be used with the ForceTriad energy platform to cut and seal vessels, and to cut, grasp and dissect tissue during surgery.

The indications for use include open procedures (general, urologic, vascular, thoracic, and gynecological) where ligation and division of vessels is performed. These procedures include vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, oophorectomy, etc. The LigaSure Impact 4318 can be used on vessels (arteries, veins, pulmonary vasculature, and lymph) up to and including 7 mm and tissue bundles.

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

The reprocessed Medline ReNewal LigaSure Impact, Curved, Large Jaw, Open Sealer/Divider (LF4318) is a sterile, single-use, hand-held bipolar electrosurgical instrument designed exclusively for use with the ForceTriad Energy Platform (cleared under K051644, K070162) to seal and divide vessels (including pulmonary) up to and including 7 mm in diameter, tissue bundles, and lymphatics during open general surgical procedures. The ForceTriad's' tissue-fusion (LigaSure) mode is designed to deliver precise energy to tissue for a controlled time period to achieve complete and permanent tissue fusion.
The device combines the benefits of a long, curved jaw and a shaft-based jaw mechanism for improved access and visibility to critical structures. The pistol-grip-style handle was designed for improved comfort and usability, with an integrated hand switch and cutter for the subsequent sealing and dividing of tissue. Hand controls have been symmetrically placed to facilitate handling by both left- and right-handed users. The LF4318 device connects to the ForceTriad energy platform with a 10-foot cord containing a LigaSure cable connector. This connector functions as a unique product identifier for device -specific recognition by the generator. The 10-foot cord, cable connector, and ForceTriad are not reprocessed by Medline ReNewal.

The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Medline ReNewal Reprocessed LigaSure Impact Open Sealer/Divider (Model LF4318). This submission aims to demonstrate substantial equivalence to a legally marketed predicate device (Covidien LigaSure Impact LF4318).

Here's an analysis of the acceptance criteria and the study information, extracting what's available from the document:

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

The document does not explicitly present a table of "acceptance criteria" with specific pass/fail thresholds for each test, nor does it provide a direct numerical "reported device performance" against such criteria. Instead, it states that the functional characteristics "have been evaluated and found to be equivalent to the predicate devices based on the following tests."

However, we can infer the type of performance evaluation conducted:

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

The document does not specify the sample size for any of the tests conducted.
The document does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the testing). The nature of the tests (e.g., simulated use, burst pressure, histopathology, cleaning, biocompatibility) suggests they are prospective bench and lab-based studies, rather than clinical 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)

The document does not provide information on the number of experts used or their qualifications for establishing ground truth, as this type of preclinical testing typically relies on predefined material properties and functional parameters rather than expert interpretation of complex clinical data. For histopathology, it would typically be a pathologist, but no specifics are given.

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

The document does not describe any adjudication method. This is generally not relevant for the types of bench and lab tests listed.

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 MRMC study was performed or described. The device is a reprocessed electrosurgical instrument, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This section is for AI/software devices. The device is a physical electrosurgical instrument.

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

The "ground truth" for the performance tests would be established through:

• Physical and electrical measurements: For electrical safety, device integrity, blade function, shaft rotation, handle locking, device recognition.
• Material and mechanical properties standards: For burst pressure, product stability.
• Microscopic evaluation/laboratory analysis: For histopathology (tissue effect), seal quality, tissue sticking, cleaning (protein, carbohydrates).
• Standardized biological assays: For biocompatibility (sensitization, irritation, pyrogenicity, acute systemic toxicity).
• Sterility testing: For sterilization validation.

These are objective measurements and standardized tests designed to demonstrate equivalence to the predicate device's established performance specifications.

8. The sample size for the training set

Not applicable. This device is a physical instrument, not a machine learning model that requires a training set. The term "training set" would not apply here.

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

Not applicable. See point 8.

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The Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Medline ReNewal Reprocessed St. Jude Livewire Electrophysiology Catheters are commonly placed at the high right atrium, right ventricular apex and His bundle, and in the coronary sinus, and are used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.

The Medline ReNewal Reprocessed St. Jude Medical Livewire Electrophysiology Catheter (K151617) underwent performance testing to demonstrate substantial equivalence to its predicate device, the St. Jude Medical Livewire Electrophysiology Catheter (K022380).

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a list of functional performance studies, cleaning validation, biocompatibility testing, packaging/sterilization validation, and product stability tests performed. However, it does not explicitly define specific numerical acceptance criteria for each test nor provides detailed quantitative results (e.g., "bond strength was X N, meeting the criteria of >Y N"). Instead, it states that the functional characteristics were "evaluated and found to be substantially equivalent to the predicate device."

Here’s a summary of the tests performed, which implicitly form the basis for acceptance:

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

The document does not specify the exact sample sizes used for each of the performance tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth:

This information is not applicable and not provided in the context of this 510(k) summary, as it describes a reprocessed medical device's physical and functional performance, not an AI/algorithmic medical device requiring expert ground truth for classification or diagnosis.

4. Adjudication Method for the Test Set:

This information is not applicable and not provided for the reasons stated in point 3. The testing involves laboratory and benchtop evaluations of device properties.

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

An MRMC comparative effectiveness study was not performed, as it is not relevant for the type of device (reprocessed catheter) described. This type of study is typically used for diagnostic imaging or AI devices that interact with human readers/clinicians.

6. Standalone (Algorithm Only) Performance:

Standalone performance (algorithm only) was not performed, as it is not relevant for this reprocessed physical medical device. This concept applies to AI/software as a medical device.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance evaluation is based on established engineering and biological standards relevant to medical devices, as well as comparison to the performance characteristics of the original, new device (predicate device). For instance, for bond strength, the "ground truth" would be the required mechanical integrity, and for cleaning, it would be the absence of specified contaminants below acceptable thresholds.

8. Sample Size for the Training Set:

This information is not applicable and not provided. The listed tests are for verifying the performance of the reprocessed device itself, not for training an algorithm.

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

This information is not applicable and not provided for the reasons stated in point 8.

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