(120 days)
Endocervical Hysterectomy Electrode is indicated for treatment of following Condition
- Excision of inner cervix during supracervical hysterectomy.
Not Found
Here's an analysis of the provided text regarding the acceptance criteria and study for the Gyn LLETZ Electrode (Endocervical Hysterectomy Electrode):
Based on the provided document, the device did not undergo a study to prove its performance against specific clinical acceptance criteria in the manner typically seen for novel medical devices or AI-powered devices. This submission is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a previously legally marketed device (predicate device), rather than proving de novo safety and effectiveness through extensive clinical trials.
The provided document (K070877) is a 510(k) submission for the Gyn LLETZ Electrode.
Here's a breakdown based on your requested information:
1. A table of acceptance criteria and the reported device performance
There are no specific clinical performance acceptance criteria listed in this 510(k) submission, nor is there reported clinical device performance that would traditionally be presented in a table for a study.
The primary "acceptance criteria" for a 510(k) is demonstrating substantial equivalence to a predicate device.
Acceptance Criteria for 510(k) Submission (implied):
- Meet electrical and mechanical requirements.
- Be substantially equivalent to the predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
Reported Device Performance:
- "Meet the electrical and mechanical requirements of ANSI/AAMI HF-18 Standard for Electrosurgical Devices."
- "The subject device is substantially equivalent to the predicate device." (This is a conclusion, not a performance metric.)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not applicable. There was no clinical "test set" in the context of proving device performance described in this 510(k) submission. The submission relies on a comparison to a predicate device.
- Data provenance: Not applicable. Clinical data for device performance was not provided or referenced for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of experts: Not applicable. No clinical ground truth was established from a test set for this 510(k) submission.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. No clinical test set or adjudication method was described.
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
- MRMC study: No. This is not an AI-powered device, and no MRMC study was conducted or reported.
- Effect size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone performance: No. This is an electrosurgical electrode, not an algorithm, so standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not applicable in the context of clinical performance data. The "ground truth" for this 510(k) submission is the regulatory acceptance of the predicate device.
8. The sample size for the training set
- Sample size for training set: Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable.
Summary for this specific device and submission:
The document describes a 510(k) premarket notification for an electrosurgical device (Gyn LLETZ Electrode). The primary mechanism for clearance is demonstrating substantial equivalence to a previously cleared predicate device (Apple Medical Fisher Cone Biopsy Electrode, K061651). The submission does not include data from a clinical study with specific performance acceptance criteria, test sets, or ground truth establishment as would be expected for a novel device or an AI/ML product. Instead, it relies on meeting recognized electrical and mechanical standards (ANSI/AAMI HF-18) and a comparison to the predicate device.
§ 884.4120 Gynecologic electrocautery and accessories.
(a)
Identification. A gynecologic electrocautery is a device designed to destroy tissue with high temperatures by tissue contact with an electrically heated probe. It is used to excise cervical lesions, perform biopsies, or treat chronic cervicitis under direct visual observation. This generic type of device may include the following accessories: an electrical generator, a probe, and electrical cables.(b)
Classification. Class II (performance standards).