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The Stryker Integrated Bipolar Cord and Tubing Sets are intended to provide irrigation and energy simultaneously to bipolar forceps specifically designed for irrigation.

The subject devices are the Integrated Tubing and Bipolar Cord Sets. They are integrated irrigation tubing and electrical cord sets to be used with irrigating bipolar forceps, and interface with both the irrigation unit and the electrosurgical generator.

There are two types of sets available from Stryker: one type that is for use with a rotary irrigator unit and one type that is for use with a gravity irrigation unit. Additionally, each type is available with either "flying leads" or a "unitized lead".

This document describes the Stryker Integrated Bipolar Cord and Tubing Sets and their substantial equivalence to a predicate device. The information provided is primarily focused on the device's technical specifications, design principles, and validation tests to demonstrate its safety and performance. However, it does not involve a study showing how a device meets acceptance criteria in the context of diagnostic accuracy, human performance improvement with AI, or standalone algorithm performance, as often found in AI/ML medical device submissions.

Therefore, many of the requested categories are not applicable (N/A) because this is a 510(k) summary for an electrosurgical accessory, not a diagnostic or AI-powered device.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present acceptance criteria in the form of specific performance metrics (e.g., sensitivity, specificity, accuracy) typically seen for diagnostic devices. Instead, it details various Verification and Validation (V&V) Testing conducted to ensure the device performs as intended and is safe. The "acceptance criteria" here are implied by the successful completion and passing of these standard tests. The "reported device performance" is that the device passed these tests, indicating it met the underlying requirements for each test.

• ANSI/AAMI ES60601-1:2005 (General Requirements for Basic Safety and Essential Performance)
• ANSI/AAMI IEC 60601-1-2:2007(R)2012 (Electromagnetic Compatibility)
• ANSI/AAMI IEC 60601-2-2:2009 (Particular Requirements for High Frequency Surgery Equipment) | Passed |
  | Sterilization Validation | Must achieve a Sterility Assurance Level (SAL) of 10^-6 and comply with ANSI/AAMI/ISO 11135:2014 for Ethylene Oxide sterilization. | The device's sterilization validation demonstrated that it achieved a 10^-6 SAL in compliance with ANSI/AAMI/ISO 11135:2014. |
  | Sterilization Validation | ANSI / AAMI / ISO 11135: 2014 Sterilization of health care products–Ethylene Oxide-Requirements for the development, validation and routine control of a sterilization process for medical devices. | Passed (10^-6 SAL achieved) |
  | Packaging Design Verification Testing | Packaging must protect the device during shipping and storage, maintaining package integrity and seal strength after accelerated aging. | The packaging passed T=0 Design Verification (shipping simulation), and integrity tests (visual inspection, gross leaks, seal strength) after 1.5 and 3 years of accelerated aging, demonstrating effective packaging. |
  | T=0 Design Verification | ASTM D4169 (Performance Testing of Shipping Containers and Systems) | Passed |
  | T=1.5 Year Accelerated Aging 60C | ASTM F1886/F1886M (Integrity of Seals for Flexible Packaging by Visual Inspection) | Passed |
  | T=3 Year Accelerated Aging 60C | ASTM F2096 (Detecting Gross Leaks in Porous Medical Packaging by Internal Pressurization), ASTM F88-15 (Seal Strength of Flexible Barrier Materials) | Passed |

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

The document does not explicitly state the sample sizes for each V&V test. These tests are typically conducted on a representative number of units according to the specific testing standards (e.g., ISO, ASTM, ANSI/AAMI), but the exact numbers are not detailed in this summary.

• Test Set Sample Size: Not explicitly stated for each test.
• Data Provenance: The data comes from internal testing and validation studies conducted by Stryker Instruments. The country of origin for the data is not specified but would typically be where Stryker conducts its R&D and manufacturing (e.g., USA). The studies are prospective in the sense that they are specifically designed and executed for regulatory submission to demonstrate compliance.

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

N/A. This device is an electrosurgical accessory, not a diagnostic device requiring expert interpretation for "ground truth." The "ground truth" for these performance tests is defined by objective physical, electrical, and biological standards and measurements rather than expert consensus on medical images or patient conditions.

4. Adjudication Method for the Test Set

N/A. As explained above, there are no "interpretations" to adjudicate for device accessories. Acceptance is based on meeting objective physical/electrical/biological criteria.

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

N/A. This is not an AI/ML device, nor a diagnostic imaging interpretation device, so an MRMC study is irrelevant.

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

N/A. This is not an algorithm-based device. It is a physical medical device (cord and tubing set).

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

The "ground truth" for the performance tests described is based on objective measurement standards defined by international and national organizations (ISO, ASTM, ANSI/AAMI). For example:

• Biocompatibility: Absence of cytotoxic effects, systemic toxicity, irritation, sensitization as per ISO standards.
• Electrical Safety: Compliance with specified electrical leakage currents, insulation resistance, and electromagnetic compatibility limits per ANSI/AAMI IEC 60601 standards.
• Mechanical Performance: Ability to withstand physical stresses, maintain specified dimensions (e.g., durometer readings), and pressure integrity.
• Sterilization: Achieving a 10^-6 Sterility Assurance Level as defined by ISO 11135.
• Packaging: Maintaining integrity against environmental and handling stresses as per ASTM standards.

8. The Sample Size for the Training Set

N/A. This device does not use a training set as it is not an AI/ML device. The "training" here refers to the design and development cycle, where engineers would iteratively design and test prototypes.

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

N/A. As above, no "training set" in the context of AI/ML. The design and engineering "ground truth" is established through engineering specifications, design inputs derived from intended use, and existing regulatory standards for medical devices of this type.

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