(180 days)
The BEED 3,8 and BEED 2,5 device are used for electrosurgical cutting and coagulation through tissues, or within tissue planes while maintaining hemostasis.
The BEED device is available in two configurations as BEED-2,5 or BEED-3,8 and is a monopolar, Bead-Enhanced Electrosurgical Dissector (BEED) that dissects and separates tissue planes using both forward and backward strokes. Distal facing beads and lysing segments enable forward dissection. The proximal facing bead and lysing segment allow for rearward dissection.
BEED operates when connected to a compatible electrosurgical unit (ESU) via a universal 4mm monopolar connector cable, and a neutral electrode that shall be used with the ESU. The compatible ESU supplies current and voltage to the device and is typically controlled via a footswitch. The power supplied to the BEED device can range from 20- 50 Watts, depending on user preference.
The BEED-2.5 model consists of two bead-like structures, two RF electrified (monopolar) cutting edges protectively recessed between two non-conductive ceramic protrusions on the distal end and measures 5mm in width and may be preferred for smaller cuts. Whereas the BEED-3,8 model is larger and consists of three bead-like structures and three RF electrified (monopolar) cutting edges protectively recessed within three non-conductive ceramic protrusions on the distal end and measures 8mm in width.
Each BEED model is provided with a clamp-on, adjustable plastic handle that can lock along various lengths of the shaft.
This FDA 510(k) summary provides information on the BEED 2.5 and BEED 3.8 electrosurgical devices, but it does not contain a typical acceptance criteria table for the device's performance nor a detailed study description with performance metrics in the way a clinical trial or AI/ML device submission would. This document is a premarket notification for electrosurgical cutting and coagulation devices, which are typically evaluated through non-clinical performance data like electrical safety, thermal safety, sterility, biocompatibility, and functional testing, rather than studies involving human readers or AI algorithms.
Therefore, many of the specific details requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable to the information provided for this type of medical device submission.
Based on the provided text, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document mentions that the device met "all applicable acceptance criteria" for various tests, but it does not specify the numerical or qualitative acceptance criteria themselves or the exact reported performance values. It states that the device "successfully evaluated" or "met all acceptance criteria" for the tests listed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterility | Conforms to a Sterility Assurance Level (SAL) of 10^-6. Meets ISO 11137-2:2013 (R) 2019. |
| EMC and Electrical Safety | Met all applicable acceptance criteria in accordance with IEC 60601-2-2 and IEC 60601-1-2. |
| Thermal Safety | Successfully evaluated in line with FDA guidance "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery," issued March 9, 2020. |
| Biocompatibility | Met all acceptance criteria in accordance with ISO 10993-1 and FDA Guidance, "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices -Part 1: Evaluation and testing within a risk management process." |
| Design Verification | Confirmed that design inputs met design output requirements. |
| Design & User Validation | Confirmed that the IFU and packaging provide appropriate instructions and that the device meets its intended use during simulated use. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The performance data section refers to "the BEED device" being subjected to tests, implying a sufficient number of units as per the respective standards and test protocols. These are non-clinical tests, so there isn't a "test set" of patient data.
- Data Provenance: Not applicable in the context of patient data for this device type. The performance data is from a series of non-clinical, in-vitro/bench testing as per international standards and FDA guidance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" for electrosurgical device performance is established by adherence to engineering specifications, safety standards (e.g., electrical, thermal), biocompatibility norms, and functional testing protocols, not by expert consensus on clinical findings.
4. Adjudication method for the test set
- Not applicable. This concept typically applies to studies where multiple human readers interpret data, and their findings are then reconciled. For electrosurgical device testing, results are measured against predefined technical specifications and standards.
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. This is an electrosurgical device, not an AI/ML diagnostic or interpretive device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML algorithm; it's a physical electrosurgical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device is based on engineering specifications, compliance with recognized international standards (e.g., IEC 60601 series, ISO 11137-2, ISO 10993-1), and FDA guidance documents for electrosurgical devices. This includes physical measurements, electrical properties, material properties, sterility validation, and functional performance benchmarks.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
- Not applicable.
§ 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.