(29 days)
The Mitek VAPR™ System, when used with a VAPR™ 2.3mm Side Effect Electrode, is intended for resection, ablation and excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
The devices described in this 510(k) are sterile, disposable electrodes designed for use with the Mitek VAPRTM System.
The provided text describes a Special 510(k) Premarket Notification for a device modification, the Mitek Products VAPR™ 2.3mm Side Effect Electrode. This submission focuses on demonstrating substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria or comparing the device to a human reader. Therefore, much of the requested information regarding acceptance criteria, study details, and human-in-the-loop performance is not present in this type of regulatory document.
Here's a breakdown of the information that can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. A Special 510(k) for a device modification typically focuses on demonstrating that changes made to a previously cleared device do not alter its fundamental safety and effectiveness. The acceptance criteria here are implicitly related to meeting design control requirements and showing that the modified device performs as intended and is equivalent to the predicate. The document states: "Mitek has provided certification of compliance to 21 CFR 820.30 Design Control requirements, descriptions of Mitek's subcontractor Design Control and Risk Analysis procedures, and the results of validation testing for the device modification." The specific "results of validation testing" are not detailed.
2. Sample Size Used for the Test Set and the Data Provenance:
This information is not provided as a typical clinical study with a test set. The "validation testing" likely refers to engineering or bench testing, not a clinical trial with a patient test set. Therefore, details about data provenance (e.g., country of origin, retrospective/prospective) are not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not provided. As this is not a study requiring human interpretation (e.g., image analysis), there is no "ground truth" to be established by experts in that context. The "truth" in this submission relates to the device meeting engineering specifications and being safe and effective for its intended use, as demonstrated through design controls and validation testing.
4. Adjudication Method for the Test Set:
This information is not provided. No clinical test set requiring adjudication in this manner is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
This information is not provided. The device in question is an electrosurgical electrode, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not provided. The device is an instrument used by a surgeon, not a standalone algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for this type of submission is in adherence to regulatory standards, design control requirements, and validated performance specifications (which are not detailed in this document). It is not based on expert consensus, pathology, or outcomes data in the context of a clinical trial.
8. The Sample Size for the Training Set:
This information is not applicable and not provided. This is not a machine learning or AI device that would have a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable and not provided.
In summary, the provided document is a regulatory submission for a device modification, focusing on demonstrating substantial equivalence through compliance with design controls and validation testing, rather than a clinical study evaluating diagnostic performance or AI effectiveness. Therefore, most of the requested information pertaining to clinical study design and AI evaluation is absent.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.