(102 days)
The Reprocessed DePuy Mitek Ablation Wands for use with the VAPR Electrosurgical System are intended for resection, ablation, excision of soft tissues, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, hip, ankle, elbow and wrist.
Reprocessed DePuy Mitek Ablation Wands are radiofrequency surgical devices intended for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Ablation wands are powered by a radiofrequency generator or controller. The device variations include various diameters, lengths, or electrode configurations. The materials of construction are generally polycarbonate handles, stainless steel shafts, PET insulation, tungsten electrodes, alumina ceramic tips and PVC suction lines. The electrode design contributes to the performance differences across different model devices.
The provided text describes a 510(k) premarket notification for a reprocessed medical device, the Reprocessed DePuy Mitek Ablation Wand. It does not contain information about an AI/machine learning device, nor does it provide the detailed specifics about acceptance criteria involving performance metrics like accuracy, sensitivity, or specificity, or the methodology for a multi-reader multi-case (MRMC) study.
The document discusses the substantial equivalence of the reprocessed device to its original (OEM) predicate devices based on various performance tests conducted to ensure that the reprocessing activities did not affect the form or function of the device and that it performs as well as the original, new device.
Therefore, many of the requested details about acceptance criteria and study methodology for an AI/ML device, such as sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this document.
However, I can extract the acceptance criteria and performance data for this reprocessed medical device as presented in the document:
Acceptance Criteria and Device Performance for Reprocessed DePuy Mitek Ablation Wand
The acceptance criteria are implicitly defined by demonstrating that the reprocessed device performs equivalently to the original, new device in various tests. The study's goal was to prove substantial equivalence, meaning the reprocessed device is as safe and effective as the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test | Performance Acceptance (Implicit) | Reported Device Performance |
|---|---|---|---|
| Cleaning | Residual Protein and Carbohydrates | Levels below acceptable limits. | Testing performed; no specific levels reported, but deemed acceptable for clearance. |
| Visual Inspection | No visible residue remaining. | Testing performed; no specific findings reported, but deemed acceptable for clearance. | |
| Cleaning Performance Qualification | Demonstrated effective cleaning. | Testing performed; no specific findings reported, but deemed acceptable for clearance. | |
| Functional | Thermal Effects Performance Testing | Equivalent thermal performance to predicate device. | Performed; "The subject device performed equivalent to the predicate." |
| Probe Bending Performance Testing | Equivalent bending resistance/performance to predicate device. | Performed; "The subject device performed equivalent to the predicate." | |
| Probe Drop Performance Testing | Equivalent durability/performance after drop to predicate device. | Performed; "The subject device performed equivalent to the predicate." | |
| Sterilization and Packaging | EtO Sterilization Testing | Sterility assurance level (SAL) achieved. | Testing performed; deemed acceptable. |
| EtO Residuals Testing | Ethylene Oxide (EtO) residuals below acceptable limits. | Testing performed; deemed acceptable. | |
| Simulated Shipment Testing | Device integrity and functionality maintained after simulated shipment. | Testing performed; deemed acceptable. | |
| Product Stability | Shelf Life Testing (1-year Accelerated Aging) | Maintains safety and effectiveness after 1 year accelerated aging. | Testing performed; deemed acceptable. |
| Real-Time Shelf Life studies | On-going to confirm long-term stability beyond accelerated aging. | "on-going and are not complete for inclusion in this submission. " | |
| Biocompatibility | Cytotoxicity | Non-cytotoxic. | Testing performed; deemed acceptable. |
| Irritation | Non-irritating. | Testing performed; deemed acceptable. | |
| Acute Systemic Toxicity | No acute systemic toxic effects. | Testing performed; deemed acceptable. | |
| Material Mediated Pyrogenicity | Non-pyrogenic. | Testing performed; deemed acceptable. | |
| Sensitization | Non-sensitizing. | Testing performed; deemed acceptable. | |
| Electrical Safety / EMC | IEC 60601-1-2 EMC Testing | Meets electromagnetic compatibility standards. | Testing performed; deemed acceptable. |
| IEC 60601-2-2 Electrical Safety Testing | Meets electrical safety standards for high-frequency equipment. | Testing performed; deemed acceptable. | |
| Software Verification and Validation | Software Testing | N/A (Device does not contain software). | "Software Testing is not applicable, because the device does not contain software." |
| Mechanical and Acoustic Testing | Mechanical and Acoustic Performance Testing | N/A (Not required to demonstrate safety/effectiveness for this device). | "Mechanical and acoustic performance testing was not required to demonstrate safety and effectiveness of the device." |
| Animal Study | Animal Performance Testing | N/A (Not required to demonstrate safety/effectiveness for this device). | "Animal performance testing was not required to demonstrate safety and effectiveness of the device." |
| Clinical Studies | Clinical Testing | N/A (Benchtop performance testing sufficient for substantial equivalence). | "Clinical testing was not required to demonstrate the safety and effectiveness of the Reprocessed DePuy Mitek Ablation Wand. Instead, substantial equivalence is based upon benchtop performance testing." |
2. Sample size used for the test set and the data provenance
The document indicates "side by side" testing with predicate devices. Specific sample sizes for each test are not provided. The data provenance is presumed to be from the manufacturer's internal testing facilities, as is typical for 510(k) submissions, but a specific country of origin for the data generation or whether it was retrospective/prospective is not mentioned. Given the nature of benchtop testing, it would be prospective.
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 this reprocessed device relates to its physical, functional, and electrical performance compared to a new, predicate device, not to diagnostic interpretation requiring expert consensus. Performance is measured against engineering specifications and industry standards.
4. Adjudication method for the test set
Not applicable. Performance testing for this device does not involve human interpretation requiring adjudication.
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
Not applicable. This is a reprocessed medical device, not an AI/machine learning diagnostic aid.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm. Its performance is measured directly through benchtop tests.
7. The type of ground truth used
The "ground truth" for this device is based on engineering specifications, established performance standards, and comparison to the performance of the new, predicate device. For cleaning, it refers to the absence of residues. For functional performance, it's the measured performance (e.g., thermal effects, bending, drop) being equivalent to the predicate. For biocompatibility, it's meeting ISO standards.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning 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.