(87 days)
The PK AIM is intended for mono polar cutting & coagulation, grasping, bipolar coagulation of selected soft tissues and sealing vessels up to and including 3.0 mm in diameter during electro surgery. This device is not intended to be used for tubal ligation or female sterilization.
Both predicate and proposed PK AIM devices can be described as 2 in 1 devices with a pencil type handle that combines the technologies of a monopolar pencil and a bipolar forceps. The device has buttons that allow hand activation and a sliding toggle switch to allow the surgeon to switch between a forceps, and a pencil device. Foot pedals connected to the generator are also available to allow for foot pedal activation of the device. The proposed device plugs into the Olympus ESG-400 generator (K141225). The generator and device make up a medical electrical system. The instrument is to be used only with the Olympus ESG-400 Generator.
The proposed device is comprised of a mixture of plastics, metals heatshrink and epoxy.
This document describes a 510(k) premarket notification for the PK AIM electrosurgical cutting and coagulation device. The submission aims to demonstrate substantial equivalence to existing predicate devices, specifically for the additional claim of sealing vessels up to 3.0 mm in diameter.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state formal "acceptance criteria" with numerical thresholds, as would be common for diagnostic AI/ML devices with performance metrics like sensitivity, specificity, or AUC. Instead, the performance testing focuses on demonstrating that the subject PK AIM is substantially equivalent to its predicates, particularly for the new vessel sealing claim, meaning its performance is comparable and raises no new safety or effectiveness concerns.
However, we can infer some performance metrics from the Summary of Performance Testing section:
| Performance Aspect | Acceptance Criteria (Inferred/Implied) | Reported Device Performance (PK AIM) |
|---|---|---|
| Vessel Sealing Capability | Seal arteries within a certain size range. | Sealed 1.00 mm to 3.49 mm size arteries. |
| Burst Pressure of Sealed Arteries | Statistically equivalent burst pressures to the predicate device and exceed a certain threshold (e.g., 360 mmHg). | Burst pressures of sealed arteries were statistically equivalent to the predicate PKS OMNI. Burst pressure of sealed arteries exceeded 360 mmHg. |
| Thermal Spread (Acute Study) | Qualitative assessment of thermal damage comparable to predicate. | Evaluated thermal spread in a swine model. (No specific quantitative metric provided, but implied to be acceptable given the "no differences" conclusion in the chronic study). |
| Qualitative Sealing Characteristics (Acute Study) | Sealing characteristics comparable to predicate. | Evaluated qualitative sealing characteristics in a swine model. (No specific quantitative metric provided, but implied to be acceptable). |
| Thermal Imaging (Acute Study) | Collection of thermal imaging data. | Provided collection of thermal imaging while sealing vessels. (No performance metric, but rather a data collection). |
| Thermal Spread (Chronic Study) | Negligible or acceptable thermal damage/collateral effects after 21 days, comparable to predicate. | Evaluated thermal spread in a swine model. Necropsy pathology of post-splenectomy and ovariectomy sealed vessel sites showed no differences between sealing performed by test and control devices. This indicates acceptable long-term thermal effects. |
| Qualitative Sealing Characteristics (Chronic Study) | Sealing characteristics maintained for 21 days, comparable to predicate. | Evaluated qualitative sealing characteristics. Necropsy pathology showed no differences between sealing performed by test and control devices. |
| Animal Survival (Chronic Study) | Animals survive a minimum of 21 days with acceptable health. | 11 animals survived a minimum of 21-days following the surgical procedure. Their health was deemed acceptable prior-to, during, and following the 21-day survival period at which time they were euthanized and grossly examined. |
| Overall Comparison | Demonstrated similar functionality to control device for sealing arteries, veins, & AV bundles up to 3mm. | The test results concluded that the subject PK AIM test article demonstrated similar functionality to the control article (Gyrus ACMI (PKS) OMNI) for sealing arteries, veins and artery vein bundles up to 3mm in diameter. The device was found to be substantially equivalent with no new issues of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The studies described are in vivo animal studies and ex vivo bench testing, not human patient data.
-
Ex Vivo Bench Testing:
- Sample Size: Not explicitly stated as a total number of vessels, but it confirmed sealing of 1.00 mm to 3.49 mm size arteries.
- Data Provenance: Laboratory bench testing. (No country of origin specified, but typically conducted internally or at specialized testing facilities).
- Retrospective/Prospective: Prospective.
-
Acute GLP Study (Swine Model):
- Sample Size: Quantities of 11 and 12 blood vessels were sealed by the subject PK AIM and predicate PK OMNI, respectively.
- Data Provenance: Swine model, likely a controlled laboratory setting (GLP - Good Laboratory Practice implies a standardized, prospective study).
- Retrospective/Prospective: Prospective.
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Chronic GLP Study (Swine Model):
- Sample Size: 11 animals survived a minimum of 21 days. The number of vessels sealed per animal is not specified but would be multiple.
- Data Provenance: Swine model, controlled laboratory setting (GLP).
- Retrospective/Prospective: Prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not describe the use of human experts to establish "ground truth" in the context of diagnostic performance (e.g., radiologists reviewing images). Instead, the studies involve direct observation, measurement, and pathological analysis by scientific personnel.
- Ex Vivo Bench Testing: Ground truth is established by objective measurements (e.g., visual confirmation of sealing, burst pressure measurements using pressure gauges/equipment). This does not involve expert consensus in the human interpretation sense.
- Acute and Chronic GLP Studies:
- Histopathology Report: A Histopathology Report is attached to the acute study, implying pathological assessment. This would typically be performed by a veterinary pathologist or similar qualified expert in animal tissue analysis. The number of pathologists is not specified.
- Necropsy Pathology: A necropsy pathology of post-splenectomy and ovariectomy sealed vessel sites was performed in the chronic study. This would also be conducted by a veterinary pathologist. The number of pathologists is not specified.
- Animal Health Report: An Animal Health Report attached to the chronic study, suggesting assessment by a veterinarian or animal care expert.
- Qualifications: "GLP Study" implies that all personnel involved in the study (including pathologists and veterinarians) would meet specific qualifications and adhere to good laboratory practice standards.
4. Adjudication Method for the Test Set:
Not applicable in the AI/ML diagnostic sense. The studies rely on objective measurements and pathological assessments, where "adjudication" between human readers is not a concept employed. Discrepancies in pathological findings, if any, would be resolved through standard pathology practices (e.g., review by a senior pathologist, consensus discussion).
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 device is an electrosurgical instrument, not an AI/ML diagnostic tool intended to assist human readers in interpreting data. Therefore, an MRMC study and analysis of human reader improvement with AI assistance are not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
Not applicable. The PK AIM is a physical surgical device, not a software algorithm. Its performance is inherent to the device itself.
7. The Type of Ground Truth Used:
- Ex Vivo Bench Testing:
- Direct Physical Measurement: Burst pressure of sealed arteries, direct observation of sealing, measurement of artery size.
- Acute and Chronic GLP Studies (Swine Model):
- Pathology: Gross examination, histopathology (microscopic examination of tissue samples), necropsy pathology.
- Outcomes Data: Animal survival, qualitative assessment of health, comparison of sealed vessel sites to control.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set. The "training" for the device's functionality comes from its engineering design and manufacturing.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/ML algorithm.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.