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1. The PK Needle is indicated for resection of soft tissue in laparoscopic and general surgical procedures.
2. The PK Spatula is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.
3. The PK J-Hook is indicated for resection and coagulation of soft tissue and blood vessels in laparoscopic and general surgical procedures.

The Olympus PK Electrosurgical Instruments: PK Needle, PK Spatula, and PK J-Hook are bipolar electrosurgical instruments with the capability to resect, cut, and coagulate soft tissue and blood vessels in laparoscopic and general surgical procedures. They pass through a 5mm cannula or operating laparoscope working channel of 5mm or larger diameter. The devices are activated via buttons on the handle or by a foot pedal and plug into compatible Olympus generators (ESG-400 and ESG-410). The generator and device make up a medical electrical system.

This FDA 510(k) summary (K213831) describes the Olympus PK Electrosurgical Instruments (PK Needle, PK Spatula, PK J-Hook). The submission is a modification to the device labeling to add compatibility with an Olympus generator, ESG-410 cleared under K203277. The document states that the devices themselves are unchanged from their original clearances in terms of intended use, design, performance, and technological characteristics.

Therefore, the study information requested is based on the original clearances of these devices (K142154 for PK Needle, K142289 for PK Spatula, and K142350 for PK J-Hook) and the specific testing performed for the current submission to confirm compatibility with the new generator.

Here's the breakdown of the acceptance criteria and study information provided in the document:

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

The document does not provide a specific table of quantitative acceptance criteria with reported numerical device performance as typically expected for software or diagnostic device studies. Instead, it refers to compliance with recognized consensus safety standards and successful completion of non-clinical testing.

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 relates to electrosurgical instruments and their compatibility with a new generator. The testing described is primarily non-clinical (electrical, mechanical, functional). Therefore, the concept of a "test set sample size" as applied to patient data or images (common in AI/ML devices) is not directly applicable here. The document mentions "testing was conducted" on the subject device. Details on the specific number of devices tested for each non-clinical performance category are not provided within this summary.

Data provenance: Not applicable as this submission primarily concerns non-clinical hardware compatibility performance rather than patient data analysis.

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 review for medical imaging or diagnostic devices, is not relevant for this type of electrosurgical instrument compatibility submission. The "ground truth" for electrosurgical instruments is their ability to perform cutting and coagulation safely and effectively, and this is assessed through engineering testing against established standards.

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

Not applicable. Adjudication methods are typically used for expert consensus on clinical findings in diagnostic studies. This is a non-clinical performance and compatibility submission.

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/ML device or a diagnostic device. It is an electrosurgical instrument.

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

Not applicable. This is not an AI/ML algorithm. The performance of the device is described as "algorithm only" in the sense that its electrosurgical function is inherent to its design and energy delivery, rather than requiring human interpretation of an output. However, it is an instrument used by a human surgeon.

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

Not applicable in the typical sense. The "ground truth" for this device's performance is established by engineering specifications, recognized international safety and performance standards (e.g., IEC 60601 series, ISO 14971), and the original performance characteristics of the predicate devices. Performance is measured against these technical benchmarks.

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

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

Not applicable. This is not a machine learning device that requires a training set.

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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."

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