(90 days)
The Mitek Vapr Generator and Accessories, in combination with Vapr thermal / coagulating probes (electrodes), is designed for general surgical use, including orthopaedic and arthroscopic applications of resection, ablation, excision of soft tissue, hemostasis of blood vessels and in coagulating soft tissues. Arthroscopic surgery could include, for example, the following: Knee Meniscectomy Lateral Release Chondroplasty Synovectorny ACL Debridement Plica Removal Meniscal Cystectomy Ankle Fracture Debridement Excision of Scar Tissue Synovectomy Chondroplasty Wrist Synovectomy Carilage Drbridement Fracture Debridement Shoulder Labral Tear Resection Synovectomy Excision of Scar Tissue Acromioplasty Bursectomy Subacromial Decompresion Chondropiasy Elbow Synovectomy Tendom Debridement Chondroplasty
The Mitek Vapr™ system is comprised of four components: the electrosurgical generator, a footswitch, a handpiece with a cable to connect to the generator and five types of electrode tip configurations used in the arthroscopic procedure.
The Mitek Vapr System is designed for general surgical use, including orthopedic and arthroscopic applications for resection, ablation, excision of soft tissue, hemostasis of blood vessels, and coagulation of soft tissues.
Here's an analysis of the provided information, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Device functions as intended for general surgical and arthroscopic applications. | Preclinical animal studies and laboratory evaluations confirmed the device functions as intended. |
| Safety and effectiveness comparable to predicate device. | Preclinical animal testing supported safety and effectiveness comparable to the predicate (Oratec system). |
| Substantial equivalence to predicate device. | Concluded to be substantially equivalent to the Predicate Device (Oratec Interventions™ Model ORA 50 Electrothermal Generator and Accessories). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "Preclinical animal studies and laboratory evaluations" and "preclinical animal testing," but doesn't provide specific numbers for the animal studies or laboratory evaluations.
- Data Provenance: The studies were preclinical animal studies and laboratory evaluations. The country of origin is not specified, but the submission is to the U.S. FDA, implying the data would be acceptable under their regulations. The data is prospective in nature, as it was generated specifically to support the device's claims.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The studies were preclinical animal studies and laboratory evaluations, which typically rely on objective measurements and observations rather than expert consensus on a test set of data in the way human clinical trials might.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. As explained above, the assessment was based on preclinical animal studies and laboratory evaluations of device function and comparison to a predicate, not on a test set requiring expert adjudication in the context of diagnostic performance.
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, an MRMC comparative effectiveness study was not done. This document pertains to the 510(k) submission of an electrosurgical device, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI" is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. The device is a surgical system, not a standalone algorithm. Its performance is assessed as a physical device.
7. The Type of Ground Truth Used
- For the preclinical animal studies and laboratory evaluations, the ground truth would have been based on direct observation and measurement of the device's effects (e.g., tissue resection, ablation, hemostasis, coagulation) in an in vivo (animal) and in vitro (laboratory) setting. The comparison was also made directly against the predicate device's performance under similar conditions.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical electrosurgical system, not a machine learning or AI algorithm that requires a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" for this type of device.
§ 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.