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Laparoscopic surgical manual instruments are designed to be used endoscopically through cannula to perform cutting, grasping, dissecting, retracting, and manipulating functions. The Ergonomic handle is intended to be used with 5mm inserts available from K&W and previously cleared under K973259.

Symmetry® laparoscopic surgical manual instruments consist of a handle and a 5mm shaft, which hold various 5 mm inserts cleared under K973259. The shaft comes in two lengths: 33 cm and 45 cm. One handle can be used in combination with a variety of different 5 mm inserts. The handles have monopolar posts which allow them to be used for electrosurgery.

The ergonomic laparoscopic handles have an adjustable grip. They may be used in one of the three handle positions: pistol grip, hybrid, and inline. To change the handle position, retract the position adjustment button and lock the grip in the chosen position. The handle comes in two sizes.

This document describes the Ergonomic Handle (K173272), which is an accessory to laparoscopic surgical manual instruments. The device allows for adjustable grip angles to improve surgeon comfort. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and supporting studies, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify sample sizes for any of the testing conducted (biocompatibility, sterilization, electrical safety, mechanical testing).

The data provenance is not explicitly stated beyond the testing being performed in support of the substantial equivalence determination for the device. Given the context of a 510(k) submission, this typically refers to testing conducted by the manufacturer or a contracted lab under their direction, likely within the US, but this is an inference. It is retrospective in the sense that the testing was performed on completed device designs to demonstrate compliance, rather than in a prospective clinical trial.

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

This document describes pre-market testing for a medical device (laparoscopic handle). These types of tests (biocompatibility, sterilization, electrical safety, mechanical) do not typically involve human experts establishing "ground truth" in the way it's understood for AI/diagnostic studies. The "ground truth" here is defined by compliance with established scientific standards and regulatory requirements. The experts involved would be the testers and engineers conducting the studies, and potentially external auditors or consultants specializing in those regulatory standards. Their qualifications would be in their respective fields (e.g., microbiology for sterilization, toxicology for biocompatibility, electrical engineering for safety, mechanical engineering for mechanical testing). No specific number or qualifications of such experts are provided in this document.

4. Adjudication Method for the Test Set

As mentioned above, the tests are primarily objective measurements against established standards, not subjective assessments requiring adjudication. Therefore, no adjudication method like 2+1 or 3+1 is applicable or mentioned for the described testing. The assessments are based on whether predefined metrics (e.g., bacterial kill rate, material toxicity, electrical leakage) meet specified limits.

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

No MRMC comparative effectiveness study was done or is mentioned. This type of study is typically performed for diagnostic or AI-assisted interpretation devices to compare human performance with and without AI. This device is a surgical instrument handle, not an interpretive medical device.

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

N/A. This device is a manual surgical instrument handle, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the performance assessment of this ergonomic handle is defined by:

• Compliance with recognized international and national standards: ISO 10993 series (biocompatibility), ISO 17665-1 (sterilization), ANSI/AAMI ES60601-1 and IEC 60601-2-2 (electrical safety).
• Engineering specifications and test protocols: for mechanical reliability (shaft deflection, electrical safety after simulated use).
• Demonstration of substantial equivalence to a predicate device (K150127) through comparing technological characteristics and ensuring no new issues of safety or effectiveness are raised.

8. The Sample Size for the Training Set

N/A. This device is a physical surgical instrument, not an AI/machine learning system, so there is no "training set."

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

N/A. Since there is no training set, this question is not applicable.

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The Symmetry Sharp Kerrison® Rongeur is indicated for cutting bony tissue of the spine. The Symmetry Sharp Kerrison® Rongeur is a manually operated instrument that consists of a Handle and Tips (available in single use or reusable).

The Symmetry Sharp Kerrison Rongeur is designed to have detachable tips that are disposable. The detachable tips are provided as either sterile single use or as nonsterile reusable tips. The reusable tips must be cleaned and sterilized before use. The sterile, disposable tips are available in 4 cup sizes: (1, 2, 3, and 4 mm); which are identifiable by etchings on each device. The Reusable Tips for the Symmetry Sharp Kerrison® Rongeur Handle are available in 3 cup sizes: (2, 3, and 4 mm); which are identifiable by etchings on each device. The reusable tips have a mating code etched on each pair to ensure that only matched pairs are used. Each tip is designed with a shaft key that fits into its mating slot on the detachable instrument handle. The tip has cups, one within the stationary footplate and the other within the upper sliding shaft, performing the cutting of the bony tissue in the spine area. The various cup sizes within the working tips provide the surgeon various cutting configurations needed for the different characteristics of the bony tissue within the spine. The Symmetry Sharp Kerrison® Rongeur Handle operates with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The detachable, reusable instrument handles of this device are provided non-sterile and must be cleaned and sterilized prior to use. The instrument handles are available in three shaft lengths: (5, 6, and 7 inches).

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the device "Symmetry Sharp Kerrison® Rongeur":

This document describes a medical device called the "Symmetry Sharp Kerrison® Rongeur," which is a manual rongeur used for cutting bony tissue of the spine. The information provided heavily emphasizes comparison to a predicate device (K130541 Kerrison Disposable Tip Rongeur) to establish substantial equivalence for FDA 510(k) clearance. The testing described primarily focuses on validating the safety and performance characteristics for a mechanical surgical instrument, not an AI/ML-driven device. Therefore, many standard questions related to AI/ML device studies (e.g., sample sizes for training/test sets, expert adjudication, MRMC studies, standalone performance) are not applicable or directly addressed in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each test (e.g., number of rongeurs tested for cleaning, sterilization, or durability). It refers to standard validation activities but doesn't quantify the number of units or cycles performed for each test.

• Data Provenance: The studies are described as "Design verification and validation testing" which are prospective tests conducted by the manufacturer specifically for this submission. The origin (e.g., country) is not specified beyond the manufacturer's location (Antioch, TN, USA).

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

This information is not applicable and not provided. The "ground truth" for a mechanical device like a rongeur is based on objective performance metrics (e.g., sterilization efficacy, cutting performance, corrosion resistance) measured against defined standards or engineering specifications, not expert consensus on interpretations.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring adjudication.

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

Not applicable. This is a mechanical surgical instrument, not an AI/ML diagnostic or assistive device.

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

Not applicable. This is a mechanical surgical instrument.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the performance tests relies on:

• Established Standards: Primarily ISO standards for sterilization (SAL of 10-6), ASTM standards for shelf life.
• Engineering Specifications: Criteria for residual proteins/hemoglobin/carbohydrates, number of cuts/reuse cycles for durability, and absence of corrosion. These are objective, measurable parameters.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable. There is no training set for this mechanical device.

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The Symmetry Surgical Quad-Lock® Container System is indicated for use by hospitals and by health care facilities to: · organize and protect stainless steel, aluminum, plastic* and silicone surgical instruments that will be sterilized · allow sterilization of the contained instruments by prevacuum steam, ethylene oxide, and low temperature hydrogen peroxide sterilization cycles (validated modalities and parameters are shown in Table 1) · When sterilized by prevacuum steam sterilization, the Quad-Lock® Containers maintain the sterility of the contents for up to 180 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised · When sterilized by ethylene oxide or low temperature hydrogen peroxide cycle types the Quad-Lock® Containers maintain the sterility of the contents when sterilized by any of the above for up to 30 days during storage and transport within the healthcare facility, as long as the integrity of the container has not been compromised The system has not been tested for maintenance of sterility after transportation outside the health care facility. The system is intended for use with stainless steel, aluminum, plastic and silicone surgical instruments. *The use of plastic instruments has only been confirmed for steam sterilization. For effective sterilization and drying of any size Symmetry Surgical Quad-Lock® Sterilization Container, the recommended maximum combined weight of the single container, lid. basket/tray contents is defined in Table 1. For each cvcle type the qualified lumen size is the minimum length that has been qualified for use are shown in Table 1. Container System Compatibility by Cycle Type details are shown in Table 2.

The Symmetry Surgical Quad-Lock® Container System provides a means to organize and protect stainless steel, aluminum, titanium, plastic and silicone surgical instruments during sterilization and storage. The filter lids, security lids, and container bottoms are made from anodized aluminum. The security lids help ensure sterility during storage and protect the container lid when the containers are stacked. The Container System includes the container base, filter lid, security lid, filters and other accessories.

The provided text describes the acceptance criteria and a study to demonstrate the performance of the Symmetry Surgical Quad-Lock™ Container System.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample size used for the test set and the data provenance:
The document does not specify numerical sample sizes for the test set for its performance studies (sterilization efficacy, shelf life, reuse testing, biocompatibility, or functional strength).
The data provenance is not explicitly mentioned as a country of origin or whether it's retrospective or prospective; however, the submission is from "Symmetry Surgical, Inc." which is based in Antioch, TN, USA, suggesting the studies likely occurred in the US. The studies are described as "performance testing" and "non-clinical tests," implying they were conducted specifically for this submission, making them prospective in nature for this application.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies are described as laboratory-based performance testing rather than studies requiring expert interpretation of results for ground truth establishment (e.g., medical image analysis).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and therefore not provided in the document. The studies described are objective performance tests (e.g., sterilization assurance levels, material properties) that do not typically involve human adjudication in the way medical diagnostic studies do.

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:
This information is not applicable and therefore not provided in the document. The device is a sterilization container system, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and therefore not provided in the document. The device is a physical medical device (sterilization container), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth for the performance studies appears to be based on objective, measurable criteria derived from scientific and engineering principles for sterilization, material integrity, and functionality. For instance, "sterilization efficacy" ground truth is defined by achieving a specified Sterilization Assurance Level (SAL of 10-6), which is typically confirmed through validated microbiological testing (e.g., biological indicators). Shelf life is determined by maintaining sterility over time, also verified through microbiological methods. Biocompatibility relies on established in vitro evaluation standards.

8. The sample size for the training set:
This information is not applicable and therefore not provided in the document. The product is a physical device, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this type of device.

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The Bookwalter Gordon Adjustable Compression Element is indicated for use to provide hemostasis of the femoral vascular access site, during and following catheterization or cannulation procedures.

The Bookwalter Gordon Adjustable Compression Element is an adjustable metal compression device that provides an alternative to applying direct hand pressure to obtain hemostasis during vascular catheterization procedures. The device is secured to a surgical table by means of a compatible clamp which supports an articulating arm that allows positioning of the "metal hand" over the vascular access site. The hand has "fingers" that can be adjusted separately to apply compressive pressure to particular locations around the vascular access site. Once in place the Adjustable Compression Element remains securely in position thereby providing ongoing compression without intervention by the surgical staff although it can be adjusted at any time if so desired. The device is reusable and can be cleaned and sterilized in the hospital setting. The Adjustable Compression Element is constructed of high strength stainless steel for rigidity and durability during use. The system also has an available sterilization container to ensure effective reprocessing.

This document is a 510(k) Pre-market Notification for a medical device called the "Bookwalter Gordon Adjustable Compression Element." It's a regulatory submission to the FDA, and as such, it focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a novel research study with acceptance criteria for a new AI or diagnostic device.

Therefore, much of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and how ground truth was established for training sets does not apply directly to this document. This document describes a mechanical device, not a diagnostic algorithm.

However, I can extract the relevant information from the provided text regarding the device and its testing:

Device Name: Bookwalter Gordon Adjustable Compression Element

Indications for Use: To provide hemostasis of the femoral vascular access site, during and following catheterization or cannulation procedures.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• This document describes mechanical and sterilization testing of a physical device. It does not involve patient data or human subjects in the typical sense of a clinical trial.
• The "test set" would refer to the units of the device subjected to the mechanical, biocompatibility, and sterilization tests. The number of devices tested is not specified in the summary but would be detailed in the full test reports.
• Data provenance is not applicable in the context of this device's testing.

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 this device would be established by engineering specifications and validated laboratory testing, not expert clinical interpretation of data.

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

• Not applicable. This is not a study involving human readers or interpretation.

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 document pertains to a mechanical medical device, not an AI or diagnostic tool that assists human readers.

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

• Not applicable. This document is about a mechanical device.

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

• The "ground truth" for this device's performance is established by engineering specifications, material science properties, and validated laboratory testing against predefined criteria (e.g., specific force values, sterilization efficacy standards, biocompatibility standards).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" like an AI algorithm would.

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

• Not applicable. There is no concept of a "training set" for this mechanical device.

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The Symmetry Kerrison Disposable Tip Rongeurs are indicated for cutting bony tissue of the spine.

The Symmetry Kerrison Disposable Tip Rongeurs are manually operated instruments, provided with a non-sterile reusable handle and a set of sterile, disposable tips, indicated for cutting bony tissue of the spine. They represent a design modification to the predicate devices, the Codman Kerrison Laminectomy Rongeurs and the Integra Kerrison Rongeurs, introducing disposable tips to the device. The Symmetry Kerrison Disposable Tip Rongeurs handles are comprised of stainless steel, and operate with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The handles and disposable tips are provided in various sizes to help provide the surgeons with more options.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Symmetry Kerrison Disposable Tip Rongeurs":

The provided document is a 510(k) Summary for a medical device that introduces disposable tips to an existing rongeur design. It focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic accuracy or a specific performance metric against a defined acceptance criterion the way AI/ML devices typically would.

Therefore, many of the requested fields are not applicable to this type of submission. I will fill in what can be inferred and explicitly state when information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a mechanical surgical instrument, the "acceptance criteria" are not reported as numerical thresholds for sensitivity, specificity, etc., but rather as functional performance. The performance data section vaguely states that the devices perform according to their description and intended use.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "Performance testing consisting of cut testing, foot load plate testing, cycle testing and corrosion resistance." The number of devices or components tested in these non-clinical tests is not provided.
• Data Provenance: Not applicable in the context of clinical data for diagnostic or AI/ML devices. The testing is internal non-clinical performance testing.

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

• Number of Experts: Not applicable. This is not a study requiring expert interpretation or ground truth establishment in the traditional sense of a clinical or image-based diagnostic study. The "ground truth" here is the physical performance of the device against engineering specifications.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This is not a study requiring subjective interpretation or adjudication. The performance tests are objective mechanical or material tests.

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

• MRMC Study: No. This is a surgical instrument, not a diagnostic imaging device, and does not involve AI assistance or human readers.

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

• Standalone Performance: Not applicable. This is a manual surgical instrument, not an algorithm or AI device.

7. The Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" in this context would be the engineering specifications and performance benchmarks derived from the predicate devices or industry standards for similar instruments. The tests performed ("cut testing, foot load plate testing, cycle testing and corrosion resistance") are designed to verify that the device meets these physical and functional requirements.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. There is no machine learning or AI component requiring a training set.

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

• Ground Truth for Training Set: Not applicable. There is no machine learning or AI component requiring a training set.

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