(52 days)
The PK AIM is indicated for open, general surgery (including plastic and re-constructive) or in any procedure in which cutting, vessel ligation (sealing and cutting), coagulation, grasping and dissection is performed. The device has been designed to seal and cut vessels (up to and including 3 mm in diameter), tissue bundles, and lymphatics when used with the Olympus ESG-400 Generator.
This device is not intended to be used for tubal ligation or female sterilization.
Both predicate PK AIM 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. Both predicates (Olympus OFJ and Olympus PK AIM connect/plug into the Olympus ESG-400 generator (K141225). The generator and subject device make up a medical electrical system. The PK AIM 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.
The provided text describes a 510(k) premarket notification for the "PK AIM" device, a cutting and coagulation instrument. The submission aims to expand the device's intended use based on its substantial equivalence to previously cleared predicate devices.
However, the provided document DOES NOT contain the type of detailed information requested regarding specific acceptance criteria, comprehensive device performance data tables, sample sizes for training and test sets, expert qualifications, ground truth establishment methods, or the results of MRMC studies that would typically be found in a clinical study report or a more detailed performance evaluation section of a submission.
The document primarily focuses on demonstrating substantial equivalence by comparing the proposed device's design, materials, and technological characteristics to its predicates and summarizing performance testing that supports the expanded indications.
Therefore, I cannot fully complete all sections of your request based solely on the provided text. I will fill in what information is available and indicate where the information is missing.
Request Details and Available Information from Document:
1. A table of acceptance criteria and the reported device performance
- The document does not explicitly state quantitative acceptance criteria (e.g., "sealing success rate must be > X%") or provide a detailed table of reported device performance against such criteria.
- Instead, it states that "All study endpoints were met" for lymphatic sealing and "Bench Ex Vivo Design Verification testing demonstrated that the requirements defined in the protocol were met."
- For the lymphatic sealing study, the reported performance is qualitative:
- Proposed PK AIM: "All vessels sealed with the proposed PK AIM test article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal."
- Predicate OFJ: "All vessel seals with the OFJ control article had no tissue sticking and no charring. All vessel seals had no leakage of lymph and had complete hemostasis immediately and at 30 seconds to one minute post seal."
- The conclusion for the device's equivalence to the predicate OFJ in lymphatic sealing is "The proposed PK AIM test article performed equivalent to the predicate OFJ control article as evaluated by the study surgeon."
- For the bench/ex-vivo tissue study, the conclusion is "This bench ex vivo tissue test data confirms that the proposed PK AIM tissue performance is substantially equivalent to the predicate Olympus Thunderbeat OFJ."
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance (as stated in document) |
|---|---|
| Not explicitly quantitative criteria. | Lymphatic Sealing (in vivo porcine model): |
| Equivalence to predicate OFJ. | * Proposed PK AIM: No tissue sticking, no charring, no leakage of lymph, complete hemostasis immediately and at 30 seconds to one minute post seal. |
| * Predicate THUNDERBEAT OFJ (Control): No tissue sticking, no charring, no leakage of lymph, complete hemostasis immediately and at 30 seconds to one minute post seal. | |
| "All study endpoints were met." | * "The proposed PK AIM test article performed equivalent to the predicate OFJ control article as evaluated by the study surgeon." |
| Not explicitly quantitative criteria. | Bench/ex-vivo tissue study (swine liver, swine kidney, bovine cardiac muscle): |
| "requirements defined in the protocol were met." | * "This bench ex vivo tissue test data confirms that the proposed PK AIM tissue performance is substantially equivalent to the predicate Olympus Thunderbeat OFJ." |
| Substantial equivalence to predicate devices. | * "In summary, bench testing confirmed that the proposed Olympus PK AIM is substantially equivalent to the predicate Olympus PK AIM and Olympus OFJ devices and presents no new questions of safety or efficacy." (General conclusion regarding overall testing for substantial equivalence, including performance against predicate devices.) |
2. Sample sizes used for the test set and the data provenance
- Lymphatic Sealing Study (Test Set):
- Sample Size: 1 animal (porcine model).
- 15 mesenteric lymph vessels sealed with the test device (PK AIM).
- 16 mesenteric lymph vessels sealed with the control device (Thunderbeat OFJ).
- Data Provenance: Acute GLP (Good Laboratory Practice) study conducted by American Preclinical Services (APS) in Minneapolis, MN (USA). This is a prospective animal study.
- Sample Size: 1 animal (porcine model).
- Bench/ex-vivo tissue study (Test Set):
- The document states "ex-vivo swine liver, swine kidney and bovine cardiac muscle tissue" but does not specify the number of tissue samples or seals performed.
- Data Provenance: GLP ex-vivo study conducted by American Preclinical Services (APS). This is a prospective bench study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: One "study surgeon."
- Qualifications of Experts: The document states "The study surgeon evaluated each seal..." but does not provide details on the qualifications or experience of this surgeon.
4. Adjudication method for the test set
- The document states: "The study surgeon evaluated each seal immediately post seal and then again 30 seconds to one minute post seal."
- This suggests a single evaluator (the study surgeon). Therefore, there was no multi-expert adjudication method mentioned (e.g., 2+1 or 3+1). The "ground truth" seems to be based on the real-time observation and assessment by the single study surgeon during the procedure.
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
- No MRMC study was done. This document describes the testing of an electrosurgical device for cutting and coagulation, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a medical device (electrosurgical instrument), not an algorithm. The "performance" is the physical effect of the device on tissue, assessed by a human surgeon.
7. The type of ground truth used
- For the Lymphatic Sealing Study: Real-time expert observation and assessment by a single study surgeon (clinical endpoint observation: integrity of seal, tissue sticking, char, leakage of lymph, hemostasis). This is a direct physical outcome as ground truth.
- For the Bench/ex-vivo tissue study: Comparison of tissue changes from the test device to the predicate, likely assessed visually or histologically, and confirmed against defined protocol requirements (design verification). This is a direct physical outcome comparison.
8. The sample size for the training set
- This information is not applicable/not provided as this is a physical device submission, not an AI/machine learning device that would require training data. The "training" for this device would be its design and manufacturing processes, which are validated, not "trained" in the sense of machine learning.
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI/machine learning device.
§ 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.