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510(k) Data Aggregation
(11 days)
LAPAROSCOPIC DISSECTOR
The Laparoscopic Dissector is indicated for use during minimally invasive procedures for grasping, mobilizing, dissecting and cauterizing tissue.
The Applied Medical Laparoscopic Dissector is a sterile, single use, disposable surgical instrument designed for minimally invasive surgical procedures. It fits through a trocar and is used to grasp, mobilize and dissect tissue. The dissector may be connected to a standard electrosurgical generator for performing monopolar cautery. The dissector is substantially equivalent to the predicate device in size, function, performance and indications for use.
The provided text describes a 510(k) premarket notification for a medical device, the Applied Medical Laparoscopic Dissector. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive clinical studies with acceptance criteria for specific performance metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested points regarding acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and MRMC studies are not applicable to this type of document because the review process primarily assesses non-clinical testing and substantial equivalence.
Here's an analysis of the provided information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This information is typically found in device validation reports or clinical study protocols, which are not detailed in this 510(k) summary. The document describes the tests performed but does not provide specific quantitative acceptance criteria or detailed outcomes for each test beyond a general "demonstrated substantial equivalence."
| Test Category | Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Summary) |
|---|---|---|
| Dimensional comparison to predicate device | (Implied: Within acceptable manufacturing tolerances and similar to predicate) | Substantially equivalent to predicate device K984240. |
| Dielectric withstand (generator frequency) | (Implied: Meets safety standards for insulation and voltage rating) | Established voltage rating; meets dielectric withstand requirements. |
| Dielectric withstand (mains frequency) | (Implied: Meets safety standards for insulation) | Meets dielectric withstand requirements. |
| Monopolar functionality | (Implied: Effective cauterization) | Functional and equivalent to predicate. |
| Tissue holding, dissecting, piercing, opening | (Implied: Effective and safe handling of tissue) | Effective in these functions, substantially equivalent. |
| Jaw clamping force test | (Implied: Within a specified functional range) | Functional and equivalent to predicate. |
| Thermal safety | (Implied: No excessive heat generation causing harm) | Meets thermal safety requirements. |
| Mechanical abuse | (Implied: Withstands expected forces during use) | Withstands mechanical abuse. |
| Environmental conditioning | (Implied: Maintains integrity after environmental stressors) | Maintains integrity after environmental conditioning. |
Conclusion from Testing: "Applied's performance and functional testing demonstrated that the Applied laparoscopic tissue dissector is substantially equivalent to the predicate device of K984240 and introduces no new safety and effectiveness."
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical tests submitted. It does not mention a "test set" in the context of patient data or algorithm performance. The tests performed are likely engineering and bench-top tests, for which "sample size" would refer to the number of devices or components tested. This information is not provided in the summary. Data provenance is also not applicable as it refers to clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable. The tests described are non-clinical (dimensional, electrical, mechanical, thermal), which do not typically involve human expert ground truth establishment in the way clinical studies do.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are non-clinical and do not involve human adjudication of results in the context of clinical outcomes or expert consensus.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic devices where human reader performance is being evaluated with and without AI assistance. This document describes a surgical instrument where the primary evaluation is substantial equivalence through non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical surgical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
For the non-clinical tests described, the "ground truth" would be established by engineering specifications, industry standards, and established metrics for material properties, electrical performance, mechanical strength, and thermal characteristics. For instance, dieletric withstand would be compared against a specific voltage standard, and clamping force against a defined range. There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of these tests.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical surgical instrument, not an AI or machine learning model that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" for this device.
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