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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:

• Prevacuum cycle: 4 minutes at 132°C, 30 minutes dry time
• Gravity cycle: 30 minutes at 121°C, 20 minutes dry time
• Gravity cycle: 15 minutes at 132°C, 20 minutes dry time |
  | Limits of Reuse | Validation completed (Specific limit not detailed in abstract) |
  | Design Tolerance Analysis | Completed (Specific findings not detailed) |
  | Shelf-Life Validation | Completed (Specific findings not detailed) |
  | Biocompatibility | Not deemed necessary (Implies materials are known to be biocompatible for this use or testing was not required for substantial equivalence) |
  | Bench Testing | Not deemed necessary (Implies similar performance to predicate or testing was not required for substantial equivalence) |
  | New Validation (Design for Manufacturing/Assembly/Packaging) | Not deemed necessary (Implies processes are sufficiently similar to predicate) |
  | Protection of ReNew Reusable Tips | Designed to secure and protect tips during transport, sterilization, and storage |
  | Facilitation of Sterilization (Steam Penetration & Air Removal) | Lids and bases designed with evenly distributed hole patterns |
  | Maintenance of Sterility (with wrap) | Maintained until used, when used with 2 layers of FDA-cleared 1-ply polypropylene sterilization wrap |

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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Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is intended to protect the M/L-10 Clip Applier handpiece (Catalog #1002) and to facilization 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 tray (Catalog# 3706) is maintained until used.

The Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) is used to secure the M/L-10 Clip Applier handpiece (Catalog #1002) which measures at 17.13" length, and 0.90"width in dimensional measurements, as the intended load during the transport, sterilization and storage between its intended uses.

The ML-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the M/L-10 Clip Applier handpiece (Catalog #1002) wrapped in 2 layers of FDA-cleared 1-ply polypropylene wrap weighing a calculated total weight of 1663.10 grams. The M/L-10 Clip Applier Sterilization Tray (Catalog# 3706) has been validated with the following Steam Sterilization Parameters: Pre-vacuum, Time: 4 minutes at Temperature of 132 °C. The Gravity Cycle parameters include: Time: 15 minutes and Temperature of 132 °C.

Microline Surgical MIL-10 Clip Applier Sterilization Tray (Catalog #3706) intended purpose is to secure the M/L-10 Clip Applier device during its transportation, sterilization, and storage purposes.

The subject device ML - 10 Clip Applier Sterilization #3706) consists of a case, a cover and brackets. The MIL-10 Clip Applier Sterilization Tray (Catalog #3706) Lid is 19.875" (Width) x .450" (Height); and the Base is 19.875" (Length) x 5.50" (Width) x 1.450" (Height) in dimensions. The ML-10 Clip Applier Sterilization Tray (Catalog #3706) cover and lid (case) are constructed of Stainless Steel material, which could be reused with Steam Sterilization method. The brackets are constructed from Aluminum, Stainless Steel, and biomedical grade Silicone. The ML-10 Clip Applier Sterilization Tray surface is coated with Nylon Coating Powder. The sterilization tray cover is secured to the case by means of assembled hardware and a locking tab, designed as part of the case and cover have an evenly distributed hole pattern in relation to the tray size to support the steam sterilization process. The brackets are designed to secure the ML-10 Clip Applier for sterilization purpose. The subject device MIL-10 Clip Applier Sterilization Tray is non-patient and non-blood/fluid contact during its intended use. The ML - 10 Clip Applier Sterlization Tray (Catalog #3706) is a metal tray and packaged in bubble wrap, single wall, 32 lbsfinch edge, crushed corrugated brown cardboard shipping box, which does not need any special handling requirements during shipment.

This document describes the Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog #3706) and its substantial equivalence to a predicate device. The information provided focuses on the safety and effectiveness of the sterilization tray itself, rather than detailing a study that measures device performance against a specific clinical condition using AI.

Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, MRMC study, AI effect size, standalone algorithm performance) are not applicable or cannot be extracted from this document, as they relate to the evaluation of AI/algorithm performance in a clinical context, which is not the subject of this 510(k) submission.

However, I can provide the available information related to the acceptance criteria and the essential performance characteristics of the sterilization tray.

Acceptance Criteria and Reported Device Performance for Microline Surgical M/L-10 Clip Applier Sterilization Tray (Catalog #3706)

The evaluation of the Microline Surgical M/L-10 Clip Applier Sterilization Tray focuses on its ability to protect a medical device and facilitate sterilization while maintaining sterility. The primary performance characteristic evaluated is its sterility assurance level (SAL).

1. Table of Acceptance Criteria and the Reported Device Performance

The Study Proving Device Meets Acceptance Criteria:

The document broadly states that Microline Surgical, Inc. "successfully completed a full sterilization using Steam Sterilization method" and that "The acceptance criteria required that the sterilization methods demonstrate a sterility assurance level (SAL) of 10⁻⁶ using the biological indicator (BI) overkill method, which met as required."

While the document references relevant standards (AAMI TIR12:2010 and EN ISO 17664:2004), it does not provide detailed methodology, specific protocol numbers, or raw data from this sterilization study. It summarizes the outcome of the study.

Additional Information (Based on the document's content):

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 the sterilization testing (e.g., number of trays or sterilization cycles tested).
• The data provenance is not explicitly stated beyond "Microline Surgical, Inc." completing the study. Given Microline Surgical is a US company, and the FDA submission, the testing would typically adhere to US/international regulatory standards. It's a prospective study in the sense that the testing was conducted specifically for this submission to demonstrate the device's performance.

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. This is not a study requiring expert readers or ground truth establishment in a diagnostic context. The "ground truth" for sterilization is defined by achieving a 10⁻⁶ SAL, typically verified through biological indicators and laboratory analysis.

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

• Not applicable. This relates to the adjudication of diagnostic assessments, which is not relevant to sterilization validation.

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-assisted diagnostic tool.

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

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

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

• For the sterilization study, the "ground truth" is typically established by microbiological testing results (absence of viable microorganisms in biological indicators after sterilization), demonstrating a 10⁻⁶ Sterility Assurance Level, as per recognized sterilization standards (AAMI TIR12:2010, EN ISO 17664:2004).

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. No training set was used.

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The Microline Flexible Ligating Shears are intended for simultaneous cutting and cauterization of soft tissue during minimally invasive abdominal laparoscopic surgery. The device may also be used for cutting natural, non-metallic sutures during surgery.

The Microline Flexible Ligating Shears system consists of the following: Microline Flexible Ligating Shears Microline Universal Power Supply Single or multiple access port device such as the TransEnterix SPIDER Single Port. The Microline Flexible Ligating Shears are designed to provide thermal ligation and division during minimally invasive abdominal laparoscopic surgery. The Microline Flexible Ligating Shears consist of a sterile single patient use handpiece. The device has heating elements at the distal tip which are activated by a finger switch located on the handpiece of the device. The Microline Universal Power Supply is designed to allow the surgeon control of the heating element power of the device in order to accommodate for individual patient anatomy. An instrument cord is attached to the handpiece and is plugged into the dedicated Microline Universal Power Supply. The Microline Flexible Ligating Shears are designed to be used with an Introducer such as the SPIDER Single Port Device. The Microline Flexible Ligating Shears are supplied sterile in a Tyvek/Mylar sterilization pouch on a mounting card and thermoformed tray, placed in a fiberboard carton. The device is intended to be used by a trained physician for a single patient use during minimally invasive abdominal laparoscopic surgery. The Microline Flexible Ligating Shears power cable is attached to the instrument handpiece and connects to the Microline Universal Power Supply. The Universal Power Supply is supplied nonsterile for reusable use outside the sterile field. The Microline Flexible Ligating Shears incorporates Hi and Low heating modes that are used to cauterize and cut soft tissue. The heating elements in the tip are activated by a physician controlled finger switch located on the handpiece of the device. The Microline Flexible Ligating Shears is intended to provide general purpose cauterization, spreading, and grasping of soft tissue during minimally invasive or open surgical procedures.

The provided document is a 510(k) summary for a medical device, the Microline Flexible Ligating Shears. It describes the device, its intended use, and comparative testing against predicate devices to establish substantial equivalence. However, this document does not describe a study involving an AI/algorithmic device or a comparative effectiveness study with human readers.

The device described is a surgical instrument. The performance testing mentioned is for the physical functionality, sterilization, biocompatibility, and electrical safety of the surgical shears themselves, not for an artificial intelligence or algorithmic system that processes data or assists human interpretation.

Therefore, many of the requested criteria (e.g., sample size for AI test sets, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this document as it's not about an AI-powered device.

Here's an attempt to address the applicable points based on the provided text, while explicitly noting where information is not present or not relevant to an AI context:

Device Name: Microline Flexible Ligating Shears

This document describes the 510(k) clearance process for a surgical instrument, not an AI or algorithmic device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI performance (e.g., accuracy, sensitivity, specificity of an algorithm) does not apply here. The "acceptance criteria" are related to the device's physical functionality, safety, and equivalence to predicate devices.

The "studies" conducted are verification and validation tests to ensure the device performs its intended mechanical/electrical functions and meets safety standards, rather than evaluating an algorithm's performance on a dataset.

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

The document focuses on establishing substantial equivalence to predicate devices, which implies that the device must meet similar performance and safety standards. Explicit quantitative "acceptance criteria" for performance metrics like "sensitivity" or "specificity" (common in AI device evaluation) are not defined in the context of this mechanical device. Instead, the "performance" demonstrated is that the device functions as intended and is safe.

2. Sample sizes used for the test set and the data provenance
This document discusses physical and electrical tests performed on the device itself, not performance on a data test set for an algorithm. Therefore, "sample size" in the context of data points or images is not relevant. The "test set" would refer to the number of physical devices or components subjected to a particular test (e.g., sterilization validation might use multiple samples, but the exact number isn't specified in this summary). There's no data provenance mentioned as it's a physical device.

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, refers to expert-labeled data. For this physical surgical device, "ground truth" is established by engineering specifications, safety standards, and functional performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This refers to adjudication of discordant expert readings for AI 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 is not an AI-assisted device. The document explicitly states, "clinical data was not necessary for evaluation of substantial equivalence." This means a clinical study, which an MRMC study would be, was not performed or deemed necessary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a human-operated surgical instrument, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the AI sense. For this device, "ground truth" for its performance is derived from:

• Engineering specifications and design: The device is designed to perform specific mechanical and electrical functions.
• International and national standards: Compliance with standards like ISO 11137-2 (sterilization), ANSI/AAMI/ISO 10993-1 (biocompatibility), and IEC 60601-1 (electrical safety).
• Functional testing: Direct observation and measurement of the device's ability to cut, cauterize, grasp, and connect to power.
• Comparison to predicate devices: The "ground truth" for substantial equivalence is that the device is as safe and effective as previously cleared devices.

8. The sample size for the training set
Not applicable. There is no AI model or algorithm being "trained" for this device.

9. How the ground truth for the training set was established
Not applicable. As there's no training set for an AI model, there's no ground truth establishment process for it.

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The MiSeal Reposable Thermal Ligating Shears are intended for the simultaneous cutting and cauterization of soft tissue during surgery, and cutting of natural or synthetic, nonmetallic sutures during surgery.

The MiSeal Reposable Thermal Ligating Shears system consists of the following: MiScal Reusable Handpiece, MiScal Thermal Ligating Shears Kit, Universal Power Supply 200-006R. The MiSeal Reposable Thermal Ligating Shears are designed to provide thermal ligation and division in various surgical procedures. The MiSeal Reposable Thermal Ligating Shears consist of a reusable handpiece with heating elements at the distal tip which are activated by a finger switch located on the handpiece of the device. The MiSeal Reposable Thermal Ligating Shears are designed to allow the surgeon control of the heating element power of the device in order to accommodate the individual patient anatomy. An instrument cord connects the handpiece to the dedicated Microline Surgical Universal Power Supply K070871. The MiSeal Reposable Handpiece is supplied non-sterile in a foam cavity placed in a fiberboard carton and is for multiple patient uses following cleaning and steam sterilization procedures performed per the provided Instructions for Use. The handpiece can be used multiple times if cleaning and sterilization procedures are followed. The MiSeal Disposable Kit (the functional instrument Tip and power cable portion of the applied part of the system) is supplied sterile in a die-cut chipboard Packaging Insert and Tyvek/Mylar pouch and is labeled for single use only. The tip is intended to be used by a trained physician for a single patient use in open general surgery, open vascular surgery, and laparoscopic surgical procedures. The MiSeal single use power cable is connected to the instrument handpiece and terminates at the electrical connection of the Universal Power Supply. The system power supply is supplied non-sterile for reusable use outside the sterile field. The MiSeal device incorporates Hi and Low heating modes that are used to coagulate and cut soft tissue. The heating elements in the disposable tip are activated by a physician controlled finger switch located on the handpiece of the device. The MiSeal device is intended to provide general purpose dissection, spreading, and grasping of soft tissue during minimally invasive or open surgical procedures.

Here's an analysis of the provided text regarding the MiSeal Reposable Thermal Ligating Shears, focusing on acceptance criteria and the study proving it:

Based on the provided document (K122086 510(k) Summary), the information is primarily about establishing substantial equivalence to a predicate device, as required for a 510(k) submission to the FDA. This type of submission generally does not include detailed acceptance criteria or extensive clinical study results in the same way a PMA (Pre-Market Approval) or de novo submission might.

The document states: "Preclinical and performance tests were performed to assure the MiSeal Reposable Thermal Ligating Shears functioned as intended and met all product specifications. Sufficient data was generated and analyzed to prove that the MiSeal Reposable Thermal Ligating Shears was substantially equivalent to the predicate device."

This indicates that internal performance specifications were met, and the key acceptance criterion for the FDA submission was demonstrating substantial equivalence to the predicate device (Starion Instruments Thermal Ligating Shears, K062257). However, the specific details of these internal "product specifications" and the data generated are not provided in this summary.

Therefore, I cannot populate all the requested fields with specific details. Here's what can be inferred or stated as "Not Provided" based on the document:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not provided. The document mentions "Preclinical and performance tests" but does not specify sample sizes for these tests (e.g., number of tissue samples, number of devices tested).
• Data Provenance: Not provided specific details. The tests were likely conducted internally by Microline Surgical or by a contracted lab. The document does not mention country of origin of data or whether it was retrospective or prospective. Given the nature of a 510(k), these would primarily be laboratory/bench tests or, at most, animal studies, rather than human clinical data in the traditional sense.

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

• Not applicable/Not provided. The summary describes "Preclinical and performance tests" which are typically laboratory-based engineering evaluations (e.g., tensile strength, burst pressure, temperature profiles). Ground truth in this context would be objective physical measurements rather than expert human interpretation.

4. Adjudication method for the test set:

• Not applicable/Not provided. This concept of "adjudication" (e.g., 2+1, 3+1) is typically relevant for studies involving human interpretation or clinical endpoints that require consensus among experts, such as in diagnostic imaging or pathology. For device performance testing described, direct measurements against specifications would be the primary 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:

• No. This device is an electrosurgical system, not an AI software/diagnostic device. MRMC studies are not relevant for this type of product.

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

• Not applicable. This is a surgical instrument, not an algorithm or AI system. Its performance is inherent in its physical and electrical properties when operated by a surgeon.

7. The type of ground truth used:

• Laboratory/Bench Test Results (Objective Measures): Likely based on defined physical and electrical property measurements (e.g., tissue sealing strength, burst pressure, cutting time, temperature, power output, device integrity under stress) as per specified testing protocols.
• Substantial Equivalence: The ultimate "ground truth" for the FDA submission is a comparison against the performance and characteristics of the predicate device.

8. The sample size for the training set:

• Not applicable. This is a hardware medical device, not a machine learning or AI model that requires a "training set." Device design and development typically involve iterative testing and refinement, but not in the sense of a machine learning training set.

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

• Not applicable. (See #8).

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