(10 days)
The VAPR 3 Electrosurgical System, when used with a VAPR Electrode, is intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.
The VAPR LD and LP Suction Electrodes, when used with the VAPR Electrosurgical System, are intended for resection, ablation, excision of soft tissue, hemostasis of blood vessels and coagulation of soft tissues in patients requiring arthroscopic surgery of the knee, shoulder, andle, elbow and wrist.
VAPR 3 Electrosurgical System is designed to provide soft tissue ablation (vaporization), contouring, cutting and hemostasis of blood vessels during arthroscopic surgical procedures. The components of the system include a generator, handpiece and cable, electrodes, and footswitch.
The VAPR LD and LP Suction Electrodes are soft tissue ablation and dessication devices intended for use with the VAPR System. They extend the utility of the system by removing bubbles created during activation from the operating site.
The provided text details the 510(k) summary for the VAPR 3 Electrosurgical System and associated electrodes. It focuses on establishing substantial equivalence to predicate devices rather than presenting specific acceptance criteria and detailed study performance as would be expected for a novel AI/software medical device.
Therefore, many of the requested information points, particularly those related to AI/software performance metrics, ground truth establishment, expert review, and training/test set details, are not applicable or available in this document.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen for AI/software devices. Instead, it relies on demonstrating substantial equivalence to predicate devices through design control compliance, risk analysis procedures, and validation testing.
| Acceptance Criteria (Inferred from 510(k) Summary) | Reported Device Performance (Summary) |
|---|---|
| Compliance with 21 CFR 820.30 Design Control requirements | Certification of compliance provided. |
| Compliance with Mitek's subcontractor Design Control procedures | Descriptions of procedures provided. |
| Compliance with Mitek's Risk Analysis procedures | Descriptions of procedures provided. |
| Safety and Performance for intended use (tissue ablation, contouring, cutting, hemostasis) | Results of validation testing (performance testing) for the device modification submitted. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified. The document mentions "validation testing (performance testing) for the device modification" but does not provide details on the number of samples, cases, or procedures used in this testing.
- Data provenance: Not specified. It's highly likely that the testing involved in-house laboratory or simulated environments, given the nature of an electrosurgical system, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not applicable. For an electrosurgical device, performance is typically assessed through engineering tests, ex-vivo tissue studies, and potentially animal models or clinical studies (though a full clinical trial is often not required for 510(k) clearance if substantial equivalence can be shown). There is no mention of human experts establishing "ground truth" in the context of image interpretation or diagnostic accuracy.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication method: Not applicable. This concept is relevant for AI/software devices where expert consensus is needed to resolve discrepancies in annotations or diagnoses.
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 type of study is specific to diagnostic AI/software devices that assist human interpretation.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone study: Not applicable. The VAPR 3 Electrosurgical System is a hardware device operated by a surgeon. Its performance is inherent to its design and function, not an algorithm operating independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of ground truth: Not explicitly stated in terms of a "ground truth" definition as used in AI/software evaluation. For an electrosurgical system, "ground truth" would relate to the physical effects on tissue (e.g., coagulation depth, ablation speed, safety of hemostasis, tissue temperatures), typically assessed through direct measurement, histological analysis of treated tissue (ex-vivo or in-vivo animal models), and functional performance tests against specified engineering criteria.
8. The sample size for the training set:
- Sample size for training set: Not applicable. This device is not an AI/machine learning product that requires training data in the conventional sense. Its "design" and "validation" involve engineering principles, materials science, and physical testing.
9. How the ground truth for the training set was established:
- Ground truth establishment for training set: Not applicable.
§ 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.