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The ReNew XR Handpieces and tips are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic procedures.

The ReNew XR Handpiece is also indicated for reference length measurement of tissue during endoscopic and laparoscopic surgical procedures.

The ReNew XR Handpiece with Reference Markings is a reusable laparoscopic surgical device used, in combination with legally marketed interchangeable end effectors, such as scissors, graspers, and dissectors (all of which are outside of the scope of this submission). It is indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic procedures and it is also indicated for reference length measurement of tissue during endoscopic surgical procedures where instruments are inserted into the body through a cannula. The ReNew XR Handpiece with Reference Markings is pressure tested to ensure that insufflation can be retained during laparoscopic surgery. The ReNew XR Handpiece with Reference Markings does not produce energy but can be connected to any commercially available and legally marketed standard monopolar electrosurgical generator. In combination with such a generator, the ReNew XR Handpiece with Reference Markings delivers monopolar electrocautery (electrical) energy to the patient, in which the current is applied through a handheld active electrosurgical generator through a return electrode attached to the patient is part of the electrical circuit. The Relew XR Handpiece with Reference Markings can be used with a legally marketed third party electro-surgical high frequency generator which complies with IEC 60601-1-1 safety and IEC 60601-1-2 electromagnetic compatibility requirements. After use in a procedure, the subject device can be reprocessed via a validated cleaning and steam sterilization procedure as described in the Instructions for Use.

Like the predicate device, the subject devices are made of six primary components including the Handle Assembly, Turning Knob, Top Cover, Cautery and Flushing Port Assembly, Inner Rod and Outer Tube Assembly.

Variations of the subject devices include varying handle length and presence of a ratcheting mechanism.

The provided text describes a 510(k) premarket notification for electrosurgical handpieces. It outlines the device, its intended use, and comparisons to a predicate device. However, it does not contain the specific information required to answer your questions about acceptance criteria for an AI/ML powered device, its performance against those criteria, or details regarding study design for evaluating such a device.

The product in question, the "ReNew XR Handpiece," is a mechanical surgical instrument, not an AI/ML powered device. The document focuses on regulatory compliance for a medical device that facilitates laparoscopic surgeries, including reference length measurement.

Therefore, I cannot extract the information you requested about acceptance criteria, study details, and ground truth for an AI/ML powered device from the provided text.

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The ReNew single patient use disposable scissor tips are to be used with the ReNew Laparoscopic Hand Pieces and they are indicated for cutting and coagulation of tissue in endoscopic and laparoscopic surgical procedures.

This Traditional 510(k) Submission is being submitted for an update to the ReNew Disposable Scissor Tips. The current ReNew Disposable Scissor Hub Assembly is being updated in an effort to decrease assembly labor. The threaded joint between the front hub and backhub is being replaced by overmolding the backhub directly onto the front hub. Due to this change an additional change needed to be made to the heat shrink on the scissor tip. An adhesive is needed to seal the heat shrink to the backhub to prevent moisture passing through and to prevent an electrical pathway.

This submission is also intended to "catch up" incremental modifications to the predicate device [510(k): K962119] that were incorporated over time.

The subject devices are made of ten (10) primary components which includes the following:

• Front Hub
• Overmolded Back Hub
• Disc Spring
• Yoke
• Yoke Pin
• Crimp Pin
• Short Blade
• Long Blade
• Surgislip Lubricant
• Heat Shrink with Adhesive Polymer

There are no medicinal substances associated with the subject devices. There is no use of animal tissue in manufacturing of the subject devices, and they are not made with Natural Rubber Latex, Bisphenol-A, Vinyl (PVC) or Phthalates.

The subject devices are supplied as sterile. In accordance to 21 CFR § 801.109, Subpart D, the labeling for the devices will indicate for prescription (Rx) use only.

The provided text describes a 510(k) submission for an updated medical device, the "ReNew Laparoscopic Instruments Disposable Scissor Tips." This submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria based on AI/ML performance.

The document discusses mechanical and biocompatibility testing for the updated scissor tips, mainly to show that design changes (related to the hub assembly and heat shrink) do not adversely affect performance or safety compared to the predicate device.

Therefore, the requested information regarding AI/ML device performance, acceptance criteria, sample sizes for AI/ML test and training sets, expert ground truth establishment for AI/ML, MRMC studies, standalone AI performance, etc., cannot be extracted from this document as it is not an AI/ML medical device submission.

The document details the following:

1. Acceptance Criteria and Device Performance (Non-AI/ML):

The acceptance criteria are implicitly defined by the successful completion of various engineering and biological validation tests. The device performance is deemed acceptable if it meets these criteria, demonstrating equivalence to the predicate device and establishing safety and effectiveness.

2. Sample Size and Data Provenance (Non-AI/ML context):

• Sample sizes for testing: Specific numbers are not provided in this summary. The tests were "bench performance testing" and "animal testing." These typically involve a statistically relevant number of units to demonstrate consistency and reliability, but the exact N is not disclosed here.
• Data Provenance: Not explicitly stated as "country of origin" for testing data. The animal study was conducted in compliance with FDA Good Laboratory Practice Regulations.

3. Number of Experts and Qualifications:

Not applicable for this type of device submission as it does not involve human interpretation of AI outputs or image reading. The testing is primarily engineering and biological.

4. Adjudication Method:

Not applicable, as there's no AI output to adjudicate.

5. MRMC Comparative Effectiveness Study:

Not applicable. This is not an AI/ML device.

6. Standalone Performance Study:

Not applicable for a surgical instrument. The performance testing is integral to the device's function.

7. Type of Ground Truth:

For this device:

• Bench Performance: Performance specifications and engineering standards define the "ground truth" (e.g., successful cut, proper assembly, specified thermal spread).
• Biocompatibility: Established biological safety standards (ISO 10993 series) define the "ground truth" for material safety.
• Animal Testing: Pre-determined performance specifications observed in animal models established the "ground truth" for coagulation performance.

8. Sample Size for Training Set:

Not applicable. This is not an AI/ML device.

9. How Ground Truth for Training Set was Established:

Not applicable. This is not an AI/ML device.

In summary, the provided document is a 510(k) summary for a mechanical/electrosurgical device modification, not an AI/ML device. Therefore, the specific criteria and study details requested for an AI/ML device performance evaluation are not present in this document.

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The ReNew XR Handpiece is indicated for cutting, grasping, dissecting, and coagulating tissue during endoscopic (inclusive of laparoscopic) surgical procedures.

The ReNew XR Handpiece is a reusable laparoscopic surgical device used, in combination with legally marketed interchangeable end effectors, such as scissors, and dissectors (all of which are outside of the scope of this submission), to cut, grasp, and dissect various tissues for use in endoscopic, including laparoscopic, surgical procedures where instruments are inserted into the body through a cannula. The ReNew XR Handpiece is pressure tested to ensure that insufflation can be retained during laparoscopic surgery. The ReNew XR Handpiece does not produce energy, but can be connected to any commercially available and legally marketed standard monopolar electrosurgical generator. In combination with such a generator, the ReNew XR Handpiece delivers monopolar electrocautery (electrical) energy to the patient, in which the current is applied through a hand-held active electrode and travels back to the electrosurgical generator through a return electrode attached to the patient, so that the patient is part of the electrical circuit. The ReNew XR Handpiece can be used with a legally-marketed third party electrosurgical high-frequency generator which complies with IEC 60601-1-1 safety and IEC 60601-1-2 electromagnetic compatibility requirements. After use in a procedure, the subject device can be reprocessed via a validated cleaning and steam sterilization procedure as described in the Instructions for Use.

The subject devices are made of six primary components including the Handle Assembly, Turning Knob, Top Cover, Cautery and Flushing Port Assembly, Inner Rod and Outer Tube Assembly.

Variations of the subject devices include varying handle length, presence of a ratcheting mechanism, and single-piece vs. modular (three piece) instruments.

The subject devices are supplied as non-sterile and intended for cleaning and sterilization by a medical facility before use.

The provided document is a 510(k) premarket notification for a medical device called the "ReNew XR Handpiece." It's a regulatory submission to the FDA (Food and Drug Administration) to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission focuses on comparing a new device to an existing one, rather than presenting a detailed study of the new device's performance against specific acceptance criteria in the way a clinical trial might.

Therefore, the document does not directly provide the information requested in your prompt regarding acceptance criteria and a study proving the device meets them, especially in the context of AI performance or clinical efficacy against predefined metrics. This is because the device is a surgical handpiece, not an AI-powered diagnostic or assistive tool, and the focus of a 510(k) is on safety and substantial equivalence, not novel clinical efficacy studies.

However, I can extract information related to performance testing and equivalence to address parts of your request where applicable, and explain why other parts are not present in this document.

Explanation of Missing Information:

• Acceptance Criteria and Reported Device Performance (Table): This document does not present specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) for an AI or diagnostic device. Instead, it focuses on demonstrating that the device is "substantially equivalent" to a predicate device through various types of engineering and biocompatibility testing. The "performance" here refers to its functional safety and similarity to an existing device, not performance on a diagnostic task.
• AI-Specific Questions (MRMC, Standalone AI performance): The ReNew XR Handpiece is an electrosurgical device, not an AI-enabled device. Therefore, questions about AI assistance, multi-reader multi-case (MRMC) comparative effectiveness studies, or standalone AI algorithms are not applicable to this submission.
• Ground Truth for Test Set & Training Set, Experts & Adjudication: These concepts are relevant for studies evaluating diagnostic or AI system performance where a "ground truth" needs to be established (e.g., presence of disease confirmed by pathology). For a surgical handpiece, the "ground truth" relates to its functional integrity, material properties, and safety, which are evaluated through different means (bench testing, material analysis, sterilization validation, biocompatibility).

Information that can be extracted from the document:

1. Table of Acceptance Criteria and Reported Device Performance

As explained above, direct acceptance criteria and performance metrics for clinical efficacy are not provided for this type of device and submission. However, the document does state that "Bench performance testing was performed as design verification testing and to establish Substantial Equivalence to the predicate device." The implicit acceptance criterion is that the device performs safely and comparably to the predicate device in the tested aspects.

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

• Test Set (for performance testing): Not specified in terms of distinct "test sets" or sample sizes in the way a clinical study would. The performance testing refers to "nonclinical (ex vivo and animal) testing, electrical safety testing, cleaning and sterilization, and biocompatibility testing." These are typically engineering or lab-based tests, not human subject clinical trials.
• Data Provenance: Not specified, but generally, such tests are conducted at the manufacturer's facility or contract labs in the country where the manufacturer operates (USA, in this case). The report does not indicate retrospective or prospective classification in the clinical sense, as it describes laboratory and engineering verification.

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

• This question is not applicable. The "ground truth" for this device revolves around its physical and functional properties, not diagnostic accuracy. Testing involves engineering standards, material science, and biological safety evaluations performed by specialized labs and engineers, not clinical experts establishing diagnostic "ground truth."

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

• Not applicable for the reasons stated above. Adjudication methods like "2+1" or "3+1" are used in clinical studies where expert consensus is needed to define a "true" diagnosis for evaluating an algorithm's performance.

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 not an AI-powered tool.

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

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

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

• The "ground truth" for this device's performance is established through adherence to recognized performance standards, material specifications, and regulatory requirements. For example:
  • Biocompatibility: Adherence to ISO 10993 standards.
  • Electrical Safety: Compliance with IEC 60601-1-1 and IEC 60601-1-2.
  • Functional performance: Bench testing (e.g., pressure retention, cutting/coagulation capabilities) against engineering specifications and comparison to the predicate device's established performance.
  • Sterilization: Validation according to established protocols to ensure sterility assurance levels.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

In summary, this FDA 510(k) submission demonstrates the safety and substantial equivalence of a surgical handpiece to an existing device through engineering, functional, and biocompatibility testing, rather than through clinical efficacy studies involving human readers, AI algorithms, or diagnostic performance metrics.

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Cutting and Dissecting Various Abdominal Tissue during Endoscopic (inclusive of laparoscopic) Surgical Procedures.

The subject device ReNew V Handpiece Laparoscopic Instruments is a modification to its legally marketed predicate device ReNew Laparoscopic Instruments (K962119). The predicate device ReNew Laparoscopic Instruments (K962119) included the Reusable Hand Piece and the Disposable and Reusable Scissor Tips. The incremental modifications declared in this Traditional 510(k) Submission apply to the subject device ReNew V Handpiece Laparoscopic Instruments which is a Reusable Handpiece (Handle/Shaft) Assembly only. There are no changes to the predicate Disposable and Reusable Scissor Tips (K962119).

The subject device ReNew V Handpiece Laparoscopic Instruments feature a 5mm diameter shaft for use when introduced with 5, 10/11, and 12mm instrument ports of a laparoscope or a cannula. The subject device is made of five (5) primary components, which include: Handle, Contact Pin Assembly, Turning Knob, Shaft Assembly and Flushing Port. The subject device includes variable configurations of 25cm, 34cm, and 42cm lengths; and it will be available in two optional configurations as a non-ratcheted or ratcheted Handpiece.

The subject device ReNew V Handpiece Laparoscopic Instruments can be used to deliver Monopolar High-Frequency (HF) electrical current through the active electrode contacting the patient for cutting or coagulation, dispersing energy through the patient to an inactive patient return electrode and back to the High-Frequency (HF) Generator. The subject device can be used with a U.S. FDA cleared Electrosurgical High-Frequency (HF) Generator which complies with the IEC 60601-1-2 EMC (Electromagnetic Compatibility) testing requirements. The subject device will be marketed with two (2) accessories, which include; Ring Inserts, and Cautery Post. In accordance to 21 CFR § 801.109, Subpart D, the subject device labeling is intended for Prescription use (Rx) only.

The provided text describes a 510(k) submission for the "ReNew V Handpiece Laparoscopic Instruments" and indicates that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device (ReNew Laparoscopic Instruments, K962119).

Crucially, the document does not contain acceptance criteria for specific performance metrics nor does it detail a study that proves the device meets such criteria in terms of clinical effectiveness. Instead, the submission focuses on demonstrating substantial equivalence through engineering and biocompatibility testing, asserting that there were no safety or effectiveness issues raised in these tests, and that the fundamental technology and intended use are identical to the predicate device.

Therefore, many of the requested items (like sample sizes for test and training sets, expert consensus, MRMC studies, standalone performance, etc.) are not applicable because the device's substantial equivalence was established through non-clinical performance and biocompatibility testing, not clinical performance studies with specific metrics for diagnostic or therapeutic efficacy.

Here's a breakdown of the available information:

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

Since this is a 510(k) summary for a surgical instrument, the "acceptance criteria" are primarily related to safety, functionality, and manufacturing quality, rather than clinical performance metrics. The document states that testing was performed against the device's performance specifications criterion, but doesn't list the specific numerical acceptance criteria.

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

• Sample Size: Not explicitly stated for each test. The testing was bench-based (laboratory), not clinical data from patients.
• Data Provenance: The testing was conducted by Microline Surgical, Inc. in the USA as part of their internal quality system and product development procedures. It is prospective in the sense that the tests were performed specifically for this submission.

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. Ground truth, in the context of expert consensus for clinical data, is not relevant here as the evaluation was based on engineering and laboratory testing of the device itself, not interpretation of clinical outcomes or images by experts.

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

• Not Applicable. Adjudication methods are typically for resolving discrepancies in expert interpretations of clinical data. This was a technical/engineering evaluation.

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 surgical instrument (handpiece) and not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.

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

• Not Applicable. This device is a manual surgical instrument and does not involve an algorithm or AI.

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

• Not Applicable in the clinical sense. The "ground truth" for each specific test (e.g., axial pull, electrical safety, biocompatibility) would be defined by the relevant engineering standards, material specifications, and regulatory requirements that the device was tested against. For instance, in biocompatibility, the ground truth is the absence of a cytotoxic or allergenic response as defined by ISO standards.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. See point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described is a series of bench performance tests and biocompatibility tests. The document states:

• "The bench performance testing was performed based upon the subject device Renew V Handpiece Laparoscopic Instruments performance specifications criterion to determine the substantial equivalence with its legally marketed predicate device."
• "A full design verification testing was performed including the following: axial pull, impact, thread shear, ball pull, autoclave, electrical handle, electrical safety, insulation tube adhesion, flushing flow, insufflation, stiffness, trocar, tip torque, ratchet strength, biocompatibility, sterilization and cleaning (automated and manual), distribution and packaging testing."
• "There were no safety or effectiveness issues raised in the bench testing results."
• Biocompatibility testing was conducted pursuant to ISO 10993-1:2009/AC: 2010 and 21 CFR Part 58, covering Cytotoxicity, Kligman Maximization Test, Intracutaneous Injection Test, Acute Systemic Injection, and Rabbit Pyrogen Test.
• "There were no safety or effectiveness issues raised in the biocompatibility testing results."

This body of non-clinical evidence demonstrated that the modified device, the ReNew V Handpiece Laparoscopic Instruments, maintained the safety and performance characteristics of its predicate device, thereby supporting its "Substantial Equivalence" determination by the FDA. No animal or human clinical performance data was deemed necessary for this 510(k) submission, as there was "no change to the fundamental technology and intended use."

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Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) are intended to protect the ReNew Reusable Tips (Scissors, Graspers and Dissectors) and to facilitate the sterilization process by allowing steam penetration and air removal. When used in conjunction with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap, sterility of the enclosed sterilization trays (Catalog #3708 and #3709) is maintained until used.

The Microline Surgical ReNew Sterilization Trays (Catalog #3709) are used to secure the ReNew Reusable Tips (Scissors, Graspers and Dissectors). Catalog #3708 measures at 7.8" length , 4.31" width, and 1.22" height , in dimensional measurements, as intended load during the transport, sterilization and storage between their intended use. Similarly, Catalog #3709 measures at 6.32" length, 3.32" width, and 1.21" height, in dimensional measurements as intended load during the transport, sterilization and storage between their intended use.

The ReNew Sterilization Tray (Catalog #3708 & 3709) have been validated with the ReNew Reusable Tips (Scissors,Graspers and Dissectors) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 280.52 grams, for Catalog number 3708, and 148.195 grams for Catalog #3709. The validation included Cleaning Validation (Automated and Manual) Testing and Steam Sterilization Cycles. The validated prevacuum cycle parameters are as follows: time: 4 minutes at temperature 132 °C, with a dry time of 30 minutes. The validated gravity cycle parameters are as follows: Time: 30 minutes at 121 °C with a dry time of 20 minutes, as well as time: 15 minutes at temperature 132 °C with a dry time of 20 minutes.

Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) intended purpose is to secure the ReNew Tips (Graspers, Dissectors, and Scissors) devices during its transportation, and storage purposes.

Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) consist of a base, a lid and device holding brackets. The lid can be fastened to the base by means of a locking tab, which is designed as a part of the lid. The brackets are constructed from biomedical grade silicone material. These brackets are used to secure the intended devices during their transport, sterilization and storage purpose. The ReNew Sterilization Trays (Catalog #3708 and #3709) are intended to be used for ReNew Tips sterilization purpose which are non-porous devices including graspers, dissectors, and scissors.

The Microline Surgical ReNew Sterilization Trays (Catalog #3708 and #3709) are medical devices intended to protect reusable tips and facilitate the sterilization process.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state a "sample size" for a test set in the traditional sense of a clinical trial or a large-scale data analysis. Instead, it refers to validation studies for sterilization and cleaning.

• Test Sample Description:
  • ReNew Sterilization Tray (Catalog #3708) with a calculated total weight of 280.52 grams (when loaded with ReNew Reusable Tips, wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap).
  • ReNew Sterilization Tray (Catalog #3709) with a calculated total weight of 148.195 grams (when loaded with ReNew Reusable Tips, wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap).
• Data Provenance: The studies were conducted by Microline Surgical, Inc., or their contract manufacturer (Symmetry Medical, Inc.) in the USA. The data appears to be prospective as it involves validation testing specifically for these devices.

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

The document mentions "sterilization validation testing" and "cleaning validation testing" but does not specify the number of experts or their qualifications involved in establishing a "ground truth" for these tests. For sterility validation, common practice involves microbiologists and sterilization experts, but this information is not detailed in the provided text. The Acceptance Criteria are based on established standards (AAMI TIR12:2010 and EN ISO 17664:2004), implying that the "ground truth" is adherence to these recognized industry and regulatory benchmarks.

4. Adjudication Method for the Test Set:

Not applicable. The document describes engineering and performance validation tests against pre-defined acceptance criteria based on standards, rather than expert review or adjudication of complex cases.

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 sterilization tray, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This is a physical medical device for sterilization, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this device's validation is based on established industry standards and scientific principles for sterilization and cleaning efficacy. Specifically:

• Sterility Validation: Achieved a Sterility Assurance Level (SAL) of 10⁻⁶ using the biological indicator (BI) overkill method, which is a universally accepted method for demonstrating sterility. This is a scientific and technical ground truth.
• Cleaning Validation: Conducted via Automated and Manual Testing against defined criteria (not explicitly detailed but implied by "Cleaning Validation Testing"). This is a technical ground truth.
• Compliance with Standards: Adherence to AAMI TIR12:2010 and EN ISO 17664:2004, which are recognized standards for reprocessing reusable medical devices.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set." The development would involve design, prototyping, and testing cycles, but not in the context of data-driven machine learning.

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

Not applicable, as there is no "training set" for this type of device. The design and performance validation are based on engineering principles, material science, and established sterilization protocols.

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The Renew NCP-5 External Counterpulsation System is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased VO2, and increased blood flow. It is intended for use under the oversight of a healthcare professional.

The Renew"" NCP-5 External Counterpulsation System (ECS) is comprised of the following major components, a switch panel, laptop PC computer, a foldable treatment bed, main unit, and a set of patient cuffs. The device is a microprocessor-controlled system that sequentially inflates then deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks in synchrony with the heart cycle to achieve the desired therapy.

This document describes a 510(k) premarket notification for the Renew™ NCP-5 External Counterpulsation System. Unfortunately, the provided text does not contain details about acceptance criteria, a specific study proving the device meets those criteria, or information relevant to an AI/ML-based device evaluation.

The document focuses on:

• The FDA's 510(k) clearance for the Renew™ NCP-5 External Counterpulsation System.
• The device's intended use and technological characteristics (external counterpulsation).
• Biocompatibility, electrical safety, EMC compatibility, and software/firmware validation.
• A "literature review regarding the use of external counterpulsation in healthy patients" to support an additional indication.
• The conclusion of substantial equivalence to its predicate device (ACS Model NCP-2 External Counterpulsation Device).

There is no mention of an AI/ML component in the Renew™ NCP-5 External Counterpulsation System. Therefore, the requested information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/ML device cannot be extracted from this text.

To answer your specific questions, I would need a different document that details the validation of an AI/ML medical device.

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The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.

The Renew Insert is a simple, easy to use device consisting of two components: a soft silicone insert and a plastic fingertip applicator. The Insert is soft and easily deformable, making it safe and comfortable to use. The applicator is flexible and is preassembled inside the Insert and does not come in contact with the anal canal. Renew Inserts are available in two sizes, Regular and Large to accommodate a range of anatomies and incontinence severities. Users are instructed to start with the Regular size and move to the Large size if they experience an inadvertent loss of the Insert or stool leakage around the Insert. The device is provided and non-sterile in individual, single-use blister packs.

Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the Renew Insert meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the effectiveness endpoints of the pivotal study. The "reported device performance" refers to the results achieved in that study.

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

• Test Set Sample Size:
  • Effectiveness (ABL frequency): Modified ITT Cohort, n=85 subjects.
  • Effectiveness (Wexner Score): Modified ITT Cohort, n=77 subjects (those with both pre-treatment and post-treatment Wexner scores).
  • Safety: ITT Cohort (all subjects who used the Renew Insert at least once), n=91 subjects.
  • Usability (Pivotal Study): Primarily n=85 (Modified ITT) or n=91 (ITT) for overall satisfaction.
  • Usability (Pilot Study): n=22 subjects for ease of insertion.
• Data Provenance: The pivotal clinical study was multi-center and conducted in the United States. It was a prospective study.

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

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" for the test set in the traditional sense of independent reviewers adjudicating findings (e.g., image interpretation).

Instead, the study relied on:

• Subject-reported outcomes: Daily diaries for ABL frequency, and self-reported Wexner scores (a validated clinical tool derived from subject reporting and physician assessment components).
• Investigator observation/assessment: For adverse events, digital rectal exams, and anoscopies. The document mentions "investigators" assessed AEs, but does not specify their number or qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication Method for the Test Set

The document does not describe a formal adjudication method (like 2+1 or 3+1) for the core effectiveness endpoints (ABL frequency, Wexner score). These metrics are primarily based on subject diaries and clinical assessments by the study investigators.

For safety, adverse events were "assessed by the investigators." There is no mention of an independent adjudication committee for adverse events.

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. The Renew Insert is a medical device (an anal insert), not an AI-powered diagnostic or assistive technology for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable here.

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

This question is not applicable. The Renew Insert is a physical medical device, not an algorithm. Its performance is its direct efficacy and safety when used by patients.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this device's performance is primarily based on:

• Clinical outcomes data: Reduction in accidental bowel leakage (ABL) episodes (recorded in daily diaries) and improvement in Wexner scores (clinical assessment tool).
• Safety outcomes data: Absence of serious adverse events and objective assessment of anal/rectal mucosa health (digital rectal exams and anoscopies).
• Patient-reported outcomes: Subjective feedback on ease of use and overall satisfaction.

8. The Sample Size for the Training Set

This question is not applicable. The Renew Insert is a physical medical device, not a machine learning model that requires a "training set." The clinical studies conducted were for verification and validation of the device's performance in humans.

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

This question is not applicable, as there is no "training set" for a physical medical device.

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Ask a specific question about this device

Ask a specific question about this device

Ask a specific question about this device