(90 days)
Used to excise target tissue, perform biopsies and control bleeding through a standard Monopolar Electrosurgical Generator.
The Wallach LOOP Electrode is a Sterile, Disposable, Single Use Electrode. Used in conjunction with an ESU (electrosurtical unit or generator) to CUT or COAG during an electorsurgical procedure.
The provided text describes a 510(k) premarket notification for the "Wallach LOOP Electrode." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through controlled studies with detailed acceptance criteria and performance metrics typically seen for AI/ML or complex diagnostics.
Therefore, the information you've requested regarding acceptance criteria, specific study details, sample sizes, expert involvement, and ground truth establishment, is largely not applicable (N/A) or explicitly detailed in this document. The purpose of this 510(k) is to show that the new device is as safe and effective as existing ones, primarily through comparison of design, materials, and intended use.
Here's a breakdown based on the provided text, indicating where information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Derived from Substantial Equivalence to Predicate) | Reported Device Performance (Wallach LOOP Electrode) |
|---|---|
| Intended Use: With an ESU for CUT and COAG | Equivalent to predicate devices |
| Sterility: Sterile, Disposable, Single Use | Yes (matches predicate) |
| Design: Loop and Ball electrodes (Tungsten Wire, Curved Loop, Square Loop, Stainless Steel Ball) | Equivalent to predicate devices |
| Material: Tungsten Wire, Stainless Steel Shaft, Stainless Steel Ball, Polyolefin Insulation | Equivalent to predicate devices |
| Conforms with ANSI/AMMI HF18-1993 | Yes |
| Sizes: Range of Ball and Loop sizes | Similar to predicate devices |
| Safety: No new hazards compared to predicate devices | Hazard analysis indicated no new hazards |
| Performance: Substantially equivalent in performance and design of operation | Testing performed indicates substantial equivalence |
Note: Specific quantitative acceptance criteria (e.g., minimum tensile strength, maximum power output, specific coagulation times) are not provided in this summary document. The "acceptance criteria" here are inferred from the demonstrated equivalence to predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: N/A. No specific "test set" in the context of an independent clinical study is described. The evaluation is based on design, materials, and a hazard analysis, along with "testing" whose specifics are not detailed.
- Data Provenance: N/A. No geographical origin or retrospective/prospective nature of data is provided. The testing mentioned is likely in-house engineering and bench testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- N/A. This 510(k) does not describe a study involving expert-established ground truth as would be relevant for diagnostic devices or those requiring expert interpretation.
4. Adjudication Method for the Test Set
- N/A. Not applicable as no expert-reviewed test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. This is an electrosurgical electrode, not a diagnostic imaging device or AI system, so an MRMC study is not relevant or described.
6. If a Standalone Performance Study (algorithm only without human-in-the-loop) was done
- N/A. This device is a physical electrode, not an algorithm. Standalone performance data, if relevant (e.g., specific electrical resistance, thermal properties), is not detailed in this summary.
7. The Type of Ground Truth Used
- N/A. The "ground truth" for this device is its physical and functional characteristics matching specified engineering standards and performing equivalently to predicate devices. It does not involve "expert consensus, pathology, or outcomes data" in the typical sense of a diagnostic or therapeutic clinical outcome study for general medical devices. The ground truth essentially relies on established performance characteristics of the predicate devices and conformity to relevant standards (e.g., ANSI/AMMI HF18-1993).
8. The Sample Size for the Training Set
- N/A. This is not an AI/ML device, so there is no training set.
9. How the Ground Truth for the Training Set was Established
- N/A. Not applicable, as there is no training set.
§ 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.