Search Results

The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures when used with the Olympus ESG-400 Generator.

The PK Spatula is a bipolar electrosurgical instrument with the capability to cut and coagulate soft tissue and blood vessels in laparoscopic and general surgery. The instrument will pass through a 5mm cannula or through an operating laparoscope working channel of 5mm or larger diameter. The instrument is to be used only with the ESG-400 electrosurgical generator. The generator and device make up a medical electrical system. The instrument is to be used only with the Gyrus ESG-400 Generator and associated 5 way connector cable. The device is intended for use in a non-irrigated (dry) environment.

This document describes the PK Spatula, an electrosurgical device, and its substantial equivalence to a predicate device. Detailed acceptance criteria and extensive study information (like sample sizes for test and training sets, expert qualifications, and specific ground truth methods) as typically found in an AI/software device submission are not provided in this type of 510(k) submission for a physical medical device. This submission focuses on comparing the new device to an existing one to demonstrate similar safety and effectiveness.

Here's a breakdown of the requested information based on the provided text, recognizing the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device, "acceptance criteria" and "device performance" are typically defined by engineering specifications and functional testing, rather than metrics like sensitivity, specificity, or AUC as seen in AI/software. The document states the new device is "substantially equivalent" to the predicate.

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

This information is not explicitly provided in the document. The "performance tests" mentioned (dimensional, cutting/coagulation equivalency, forces, design features, shelf life, sterilization, biocompatibility) are laboratory-based engineering and bench tests, not clinical studies with "test sets" in the context of data analysis.

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. "Ground truth" in the context of expert consensus is typically for diagnostic/interpretive devices (e.g., radiologists reviewing images). For an electrosurgical tool, "ground truth" refers to established engineering principles and objective measurements of its physical and functional properties.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in expert interpretations, which is not relevant to the physical and functional testing of an electrosurgical device.

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 not provided. An MRMC study is relevant for AI-assisted diagnostic or interpretive devices. The PK Spatula is a surgical tool, not an AI-based diagnostic system.

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

This information is not applicable and not provided. Standalone algorithm performance is a concept for AI/software devices; the PK Spatula is a physical electrosurgical instrument.

7. The Type of Ground Truth Used

For this device, the "ground truth" for the performance testing is based on:

• Engineering specifications and objective measurements: For dimensional measurements, expected forces, and design feature testing.
• Established laboratory-based testing protocols: For cutting and coagulation equivalency (likely measured on tissue surrogates or ex vivo tissue), sterilization effectiveness, shelf life stability, and biocompatibility.
• Compliance with recognized standards: Such as ISO and IEC standards for medical devices.

8. The Sample Size for the Training Set

This information is not applicable and not provided. "Training set" is a term used for machine learning. This device's development involves engineering design and validation, not model training.

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

This information is not applicable and not provided for the same reasons as #8.

Summary of the K142289 Submission:

The provided document is a 510(k) premarket notification for a traditional medical device (PK Spatula, an electrosurgical instrument). The core of this submission is to demonstrate substantial equivalence to an already legally marketed predicate device (Gyrus PlasmaCision Laparoscopic Spatula K041633).

The "study" that proves the device meets (implied) acceptance criteria consists of:

• Bench Testing: A series of laboratory tests confirm the device's physical dimensions, mechanical strength, functionality (rotation, button activation), and performance characteristics (cutting and coagulation equivalency to the predicate).
• Biocompatibility Testing: To ensure patient safety with the materials used.
• Sterilization and Shelf Life Validation: To confirm the device remains sterile and functional over its stated shelf life.
• Compliance with Voluntary Standards: Adherence to recognized medical device standards (ISO, IEC).

The document asserts that these tests, along with a detailed comparison of intended use, design, and technological characteristics, ensure the PK Spatula is "substantially equivalent" to the predicate and "raises no new concerns or safety or effectiveness."

Ask a specific question about this device

The PKS™ (Plasmakinetic System) BiLL™ (Bipolar Laparoscopic Loop) instrument is a 5mm bipolar electrosurgical device. The device is intended to be used for the amputation/sectioning of the mobilised uterus during Laparoscopic Supracervical (Subtotal) Hysterectomy and the resection of devascularized subserosal pedunculated myomas. It is used in conjunction with the Gyrus ACMI G400 Workstation Generator.

The Bipolar Laparoscopic Loop (PKSTM BiLL™) is-a single use disposable high frequency RF bipolar accessory to be used in conjunction with the Gyrus ACMI G400 Workstation Generator. The PKSTM BiLL™ is a laparoscopic instrument. It is available in an 88mm x 215mm loop. The device is sterile for single use sterilized by gamma irradiation to an SAL of 10°0

Here's an analysis of the provided text regarding the PKS™ BiLL™ device, focusing on the requested acceptance criteria and study information:

PKS™ BiLL™ Device Study Analysis

The provided 510(k) summary for the PKS™ BiLL™ device does not contain detailed acceptance criteria and a specific study proving the device meets those criteria in the typical sense of a clinical trial. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and pre-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

No explicit acceptance criteria with numerical targets are provided in the document. The performance assessment is primarily qualitative, stating that:

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

The document mentions "Preclinical testing" and "Bench and preclinical testing". It states that this testing was done to validate mechanical design, usability, and software selection, and the performance was compared against the predicate LiNA Loop.

• Sample Size for Test Set: Not specified. The document does not provide a number of devices or subjects used in this testing.
• Data Provenance: The nature of the "preclinical testing" suggests in-house laboratory or animal testing. The country of origin of this data is not explicitly stated, but being a US-based manufacturer, it's reasonable to infer the testing was conducted in the US or by its contracted facilities. The testing is prospective in nature, as it's being conducted to validate the new device.

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

Not applicable. The "preclinical testing" described for this device focuses on engineering performance characteristics (electrical, mechanical, sterilization, biocompatibility, and functional "cut and user performance requirements") rather than diagnostic accuracy or clinical outcomes that would typically involve expert ground truth establishment for a test set. There's no mention of experts establishing a ground truth for this type of performance testing.

4. Adjudication Method

Not applicable. As the "preclinical testing" primarily involves engineering and functional performance, clinical adjudication methods like 2+1 or 3+1 for ground truth are not relevant to the described studies.

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

No. The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The evaluation focuses on substantial equivalence based on technological features and in-vitro/pre-clinical performance compared to predicates, not on the improvement of human readers with or without AI assistance.

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

Not applicable/Not relevant. This device is an electrosurgical instrument, not an AI algorithm. Its performance is inherent to its design and how it interacts with the G400 Workstation Generator, meaning "standalone" performance without human interaction (as in, no one is operating the laparoscopic loop) is not a practical concept for this device type. The "cut and user performance requirements" inherently involve human interaction for usability.

7. Type of Ground Truth Used

For the described preclinical testing, the "ground truth" implicitly refers to:

• Engineering specifications and regulatory standards: (e.g., IEC 60601, ISO 10993, ISO 11607, ISO 11137).
• Performance characteristics of the predicate device (LiNA Loop): The new device's performance was "compared against the performance characteristics of the predicate LiNA Loop" and found to "exhibit comparable performance characteristics."

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set." Its function is based on established electrosurgical principles and mechanical design.

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

Not applicable. See point 8.

Ask a specific question about this device