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510(k) Data Aggregation
(89 days)
These AEM Instruments incorporate the use of AEM technology and are intended for use in delivering monopolar electrosurgical energy during laparoscopic procedures only. AEM Instruments are intended for use with the AEM Monitoring System and electrosurgical generators having compatibility with the AEM Monitor. Scissors Inserts are intended for use on soft tissue only.
The AEM enTouch® 2X Scissors Inserts are designed for use with the ES8000 / ES8200 series AEM enTouch® Handles. All scissors will fit through standard 5.5mm trocars.
The provided document is an FDA 510(k) Premarket Notification for the Encision AEM enTouch® 2X Scissor. It details the device, its intended use, design changes from a predicate device, and the testing conducted to demonstrate substantial equivalence.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The core of the device's validation is presented in the "Risk Analysis: Risk Assessment Summary" table (pages 9-10). This table directly lists the changes from the predicate device, associated risks, verification methods, acceptance criteria, and results.
| Change (from Predicate) | Risk | Verification Method / Standard Used | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|---|
| Addition of Indicator | Impossible or difficult assembly into handle due to indicator diameter being too large | Direct Measurement (Calipers) - same as predicate | Diameter of indicator is less than diameter of rod passes | 22 of 22 samples have indicator diameters less than their rod diameters - Pass |
| Rod actuation force is too high due to the indicator diameter being too large | Handle with insert mechanical actuation - same as predicate; ISO 7741:1986/(R)2017, Scissor Test Methods | No binding or impaired mechanical function passes | 22 of 22 samples have no binding or mechanical functional impairments - Pass | |
| Indicator scraping off | Visual inspection under magnification during mechanical testing - same as predicate; ISO 10993-1:2009/(R)2013, Biocompatibility | No visual evidence of chipping, delamination, or cracking to the indicator passes | 22 of 22 samples have no visual evidence of chipping, delamination or cracking to the indicator - Pass | |
| Indicator not attached to rod due to embrittlement from E-beam sterilization | Visual inspection after E-beam sterilization - same as predicate; ISO 11137-1:2006/(R)2010, Radiation Sterilization | No visual evidence of chipping, delamination, or cracking to the indicator passes | 22 of 22 samples have no visual evidence of chipping, delamination or cracking to the indicator - Pass | |
| Indicator not attached to rod due to damage during cleaning and sterilization at the hospital | Visual inspection after cleaning and sterilization - same as predicate; ISO 17664:2017, Cleaning; ISO 17665-1:2006/(R)2013, Steam Sterilization | No damage to the epoxy region passes | 22 of 22 samples have no damage to the epoxy region - Pass | |
| Indicator delaminates from the rod or cracks due to damage from shipping or use | Visual inspection after ship testing - same as predicate; ASTM D4169-16, Ship Testing | No visual evidence of chipping, delamination, or cracking to the indicator passes | 22 of 22 samples have no visual evidence chipping, delamination, or cracking to the indicator - Pass | |
| Indicator color does not permanently change to orange after cleaning and autoclaving | Visual inspection of indicator color change after environmental conditioning - same as predicate; ISO 11607-1:2006/(R)2010, Sterile Barrier Systems | Color changes from black to orange passes | 22 or 22 samples had color change from black to orange - Pass | |
| Indicator residue contacts patient | Visual inspection under magnification during mechanical testing - same as predicate; ISO 10993-1:2009/(R)2013, Biocompatibility | No visual evidence of chipping, delamination, or cracking to the indicator passes | 22 of 22 samples have no visual evidence of chipping, delamination, or cracking to the indicator - Pass | |
| Indicator changes to orange during transportation/storage due to product being exposed to extreme temperature/humidity | Visual inspection after max dose irradiation, environmental conditioning, aging and ship testing - same as predicate; ASTM D4169-16, Ship Testing | Indicator remains black after ship testing | 22 of 22 samples have remained black after ship testing - Pass | |
| 2-Use Scissor | Poor cutting performance due to dull blade edge | Cut test simulation after simulated use and reprocessing – same as predicate; ISO 7741:1986/(R)2017, Scissor Test Methods; ASTM F1079-87, Surgical Scissors | After a single simulated surgery followed by cleaning and sterilization, shall pass cut test | 15 of 15 samples pass cut test after a simulated surgery, cleaning and sterilization - Pass |
| User misinterprets indicator's color change as verification of sterility | Correct Use of device based on indicator color and labeling in Quick Use Guide instructions (when received from OR); IEC 62366-1:2015, Medical Device Usability | Black color is correctly identified by Central Processing personnel | 20 of 20 samples were correctly identified as black - Ok to reprocess - Pass | |
| User does not dispose insert with orange indicator after second use | Correct Use of device based on indicator color and labeling in Quick Use Guide instructions (when received from OR); IEC 62366-1:2015, Medical Device Usability | Orange color correctly identified by Central Processing personnel | 20 of 20 samples were correctly identified as orange - do not reprocess - Pass | |
| Stainless Steel Material Modification | Corrosion | Visual inspection after max dose irradiation, environmental conditioning, aging and ship testing - same as predicate; ASTM A967-17, Stainless Steel Passivation | No visual evidence of corrosion or rust | 22 of 22 samples have no evidence of corrosion or rust - Pass |
| Embrittlement, breakage of assembly, leading to loss of function | Pouch drop testing IEC 60601-1 after max dose irradiation, environmental conditioning, aging and ship testing - same as predicate; IEC 60601-1 edition 3.1, Electrical Safety | No bend in the rod | 22 of 22 samples have no bend in their rod - Pass | |
| Intermittent power output at the tip | Direct measurement (resistance - multimeter) - same as predicate; IEC 60601-1 edition 3.1, Electrical Safety | Resistance is less than 5 ohms | 22 of 22 samples have a resistance less than 5 ohms - Pass | |
| Rod Diameter Reduction | Impossible or difficult assembly into handle due to the rod being bent as a result of the reduced diameter for indicator application | Handle with insert mechanical actuation - same as predicate; IEC 60601-1 edition 3.1, Electrical Safety | Any difficulty with actuation is a failure | 22 of 22 samples do not have any difficulty with actuation - Pass |
| (Continued) Rod bend | Straightness inspection - same as predicate; ASTM F2819-10, Rod Straightness; ASTM D4169-16, Ship Testing | Rod gap meets straightness requirement | 22 of 22 Samples have a rod gap that meets straightness requirement - Pass | |
| Sterility Process Change | Instrument becomes non-sterile during shipping | Instrument packaging sterile barrier seal integrity testing; ISO 11607-2:2019, Sterile Barrier System; ASTM F2096-11, Seal Integrity Bubble Test | The insert and sterile barrier shall withstand ship testing, with minimal cosmetic damage. After ship testing, the insert shall remain functional. The sterile barrier shall maintain product sterility | 22 of 22 samples maintained a sterile barrier after ship testing - Pass |
2. Sample Size Used for the Test Set and Data Provenance
The sample sizes for the various tests are explicitly stated in the "Risk Assessment Summary" table:
- 22 samples for most mechanical, visual, and material integrity tests (e.g., indicator diameter, actuation force, indicator scraping, embrittlement, etc.).
- 15 samples for cutting performance tests.
- 20 samples for usability/indicator interpretation tests by Central Processing personnel.
Data Provenance: The document indicates that all testing was "bench testing" (page 8). This implies the data were collected in a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective in the context of clinical use, as these were all bench tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not explicitly addressed in the provided document. The ground truth for this device's performance is established through adherence to recognized industry standards (e.g., ISO, ASTM) and internal design control procedures. For the "Usability" tests (Correct Use of device based on indicator color), it mentions "Central Processing personnel," implying trained individuals are the evaluators, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method (like 2+1 or 3+1 consensus). The tests are based on objective measurements (e.g., calipers, multimeter, visual inspection against criteria) or adherence to pass/fail benchmarks from recognized standards. For the usability tests regarding indicator color interpretation, it implies direct observation of correct identification rather than a consensus process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was performed. The document explicitly states: "No animal or clinical testing is required" (page 8). This is a bench-tested device with minor modifications from a predicate, demonstrating substantial equivalence through engineering and laboratory tests, not comparative clinical performance or human reader studies.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
This question is not applicable to this device. The Encision AEM enTouch® 2X Scissor is a surgical instrument, not an AI/algorithm-based diagnostic or therapeutic system. Its performance is inherent to its physical design and material properties, not an algorithm.
7. Type of Ground Truth Used
The ground truth used for proving device performance is primarily objective engineering measurements, adherence to established international and domestic standards (ISO, ASTM, IEC), and internal design control procedures. These tests aim to ensure the device meets predefined physical, mechanical, electrical, and functional specifications, as well as sterility and biocompatibility requirements. For the "user interpretation" aspect of the indicator, the ground truth is simply the correct identification of the color (black for reprocess, orange for dispose).
8. Sample Size for the Training Set
This question is not applicable. Since this device is not an AI/machine learning system, there is no concept of a "training set" for an algorithm. The testing described focuses on validating the physical and functional aspects of the manufactured device.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned or implied for this device, this question is not applicable.
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