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The Flex™ Monopolar Maryland Dissector is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The FlexTM Monopolar Needle Knife is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The Flex™ Monopolar Spatula is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting, coagulating, dissection, and manipulation of tissue.

The Flex™ Needle Driver is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.

The Flex™ Fenestrated Grasper is a single use endoscopic device with applications in endoscopic surgical procedures to facilitate dissection and manipulation of tissue.

The Flex™ Monopolar Scissor is a single use electrosurgical device intended to be used in conjunction with an electrosurgical generator with applications in endoscopic surgical procedures to facilitate cutting of tissue.

The Flex™ Laser Fiber Holder is a single use endoscopic device with applications in endoscopic surgical procedures to house and introduce a laser fiber.

The Flex™ Instruments are endoscopic instruments used for endoscopic minimally invasive surgical procedures to manipulate dissect, and cut tissue. Devices are either monopolar endoscopic instruments for tissue manipulation and cutting/coagulation, or non-powered endoscopic instruments for tissue manipulation dissection, and cutting. The instrument shafts have a rigid proximal section and flexible steerable distal "end effector" section. The flexible shaft section and end effector tip have a maximum diameter of 4mm. The steerable function provides 5 degrees of freedom. There are seven different instrument types. Four of the instruments are monopolar electrosurgical devices for cutting and coagulation of tissue.

The Flex™ Endoscopic Instruments are electrosurgical and non-powered endoscopic instruments for use in endoscopic surgical procedures for tissue manipulation, dissection, cutting, and coagulation. The product family includes a Monopolar Maryland Dissector, Monopolar Needle Knife, Monopolar Spatula, Needle Driver, Fenestrated Grasper, Monopolar Scissor, and Laser Fiber Holder.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Acceptance Criteria:

The study conducted to prove the device meets acceptance criteria is a suite of nonclinical performance tests and analyses, rather than a single clinical trial. This includes:

• Bench Testing: Mechanical and simulated use testing to evaluate device function and durability.
• Dimensional Verification: To confirm the device dimensions.
• Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Conducted in accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
• Biocompatibility Testing: Conducted according to ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11.

The submission concludes that "Test results of all nonclinical testing were acceptable and demonstrate that the device is safe and effective for its intended use."

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

The document does not specify a distinct "test set" with a defined sample size in the context of the type of studies typically seen with AI algorithms or diagnostic devices. The tests performed are engineering evaluations (bench testing, dimensional, electrical, biocompatibility), which would involve a sample of manufactured devices or materials. The document does not provide the exact number of devices or material samples used for each specific test.

The data provenance is from laboratory and engineering testing conducted by the manufacturer, Design Standards Corporation. There is no indication of clinical data (e.g., country of origin, retrospective/prospective clinical studies) being used for this 510(k) submission, as it focuses on demonstrating technological equivalence to predicate devices through bench and material testing.

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

This information is not applicable for this type of submission. The "ground truth" for engineering and biocompatibility tests is established by adherence to recognized standards (e.g., IEC, ISO) and internal specifications, not by expert consensus on clinical data.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for interpreting ambiguous cases, typically involving human readers. The tests performed here are objective engineering and laboratory tests with defined pass/fail criteria.

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

No, an MRMC comparative effectiveness study was not done. This type of study focuses on comparing human reader performance with and without AI assistance, which is irrelevant for this Class II surgical instrument that relies on mechanical, electrical, and biocompatibility safety and performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not done. This device is a physical surgical instrument, not a software algorithm that performs diagnostic or analytical functions independently.

7. Type of Ground Truth Used

The "ground truth" is based on:

• Engineering Specifications: For dimensional, functional, and durability tests.
• Defined Standards: For electrical safety (IEC standards) and biocompatibility (ISO standards).
• Predicate Device Characteristics: For demonstrating substantial equivalence.

There is no mention of expert consensus, pathology, or outcomes data being used as ground truth for this submission.

8. Sample Size for the Training Set

This information is not applicable. This device does not employ an AI algorithm or machine learning model that requires a training set. The "training set" concept is relevant for AI-powered devices, not for traditional surgical instruments.

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

This information is not applicable, as no training set was used.

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The Sureline™ Laparoscopic Clip Applier with Implantable Titanium clips is intended for use in a variety of laparoscopic procedures to occures to occures and blood vessels. The tissue being ligated should be consistent with the size of the clip.

The Sureline TM Laparoscopic Clip Applier with implantable titanium clips is a disposable single patient use device fabricated from biocompatible stainless steels and biocompatible medical grade polymers. The product is also available as a reusable clip applier and disposable clip cartridge. The disposable clip applier and disposable clip cartridge contain 20 titanium clips. The clip cartridge is attached to the clip applier handle via a lock/release mechanism, and inserted through a trocar to gain a lockrelease moonamamic clip cartridge jaws with the open clip in the jaws is placed around the vessel or other tubular structure. 13 placed around the clip applier handle/trigger drives a Actuation/oomproom.com/close the cartridge jaws, thereby mechanism within the ourinessel. Release/decompression of forming the clip securely around the jaws of the cartridge to open and the clip applici nandio.ingger all.ge jaws. The automatic feeding cartridge releases the next clip into the jaws for another application. The cartridge is sized to fit through a 10 mm cannula. The overall shaft The cartridge is sized to in through andle is approximately 33 mm, consistent with other endoscopic instruments.

This submission (K044602) for the Sureline™ Laparoscopic Clip Applier with Implantable Titanium Clips does not contain the details of a study with acceptance criteria and reported device performance.

The document is a 510(k) summary, which is typically a declaration of substantial equivalence to a predicate device. It focuses on the device's description, intended use, technological characteristics, and a conclusion of substantial equivalence.

Here's a breakdown of why the requested information cannot be provided from the given text:

• No performance data is presented. The document explicitly states that "The new device has the same intended use and the same basic technology as the predicates identified in the premarket notification... and does not pose any new questions concerning safety and effectiveness" (Section 7). This implies that a new performance study to establish acceptance criteria was likely not a primary component of this 510(k) submission, as it relies on the known performance and safety of the predicate devices.
• The document is a summary. A 510(k) summary is designed to provide an overview and publicly available information, not the full details of any internal testing or validation studies that might have been conducted.

Therefore, since the provided text does not contain the specific information requested about acceptance criteria and the study proving it, I cannot complete the table or answer the specific questions.

Information that is available:

• Device Name: Sureline™ Laparoscopic Clip Applier with Implantable Titanium Clips
• Intended Use: For use during laparoscopic surgery to occlude a variety of vessels or other tubular structures.
• Predicate Devices: Vitalitec International (K981645), Microsurge Sureline (964109), United States Surgical Corporation (K883081, K890941), Ethicon Endosurgery (K920387), Pilling Weck (K851251, K905837)
• Basis for regulatory clearance: Substantial equivalence to predicate devices, implying similar design, materials, and intended use as devices already on the market.

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