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510(k) Data Aggregation
(25 days)
The Mitek EXOJET* system is indicated for orthopedic surgical procedures where the cutting and removal of soft tissue, hard tissue, or bone is required, with control of bleeding during those procedures as needed. Specific functions include cutting, ablation, and shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in a variety of small and large joint arthroscopic procedures.
Mitek's EXOJET Tissue Management System consists of reusable power control unit; sterile, disposable pump cartridge and tubing assembly, and sterile, disposable handpieces. It provides the same functions as the predicate device including cutting, evacuation, and electrocauterization. The various handpieces are designed to provide the additional functions of cutting, drilling, reaming, decorticating, and smoothing of bone The handpiece includes a rotating burr, which is driven by a liquid-jet driven motor. It is also available with a variety of burrs and drills.
The EXOJET Tissue Management System is a medical device for orthopedic surgical procedures performing functions such as cutting, evacuation, and electrocauterization. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the context of an AI/ML device.
Therefore, the requested information for acceptance criteria and a study proving the device meets those criteria, particularly in the context of AI/ML performance, cannot be extracted from this document. The document describes a traditional medical device (arthroscope and accessories) and its functions, and its FDA clearance process through substantial equivalence. There is no mention of any AI/ML components or associated performance metrics like sensitivity, specificity, or AUC, nor any studies evaluating such performance with human readers.
Below is a table summarizing the information that can be extracted or inferred from the provided text, primarily regarding the device and its regulatory clearance process, rather than AI/ML-specific performance studies.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance | Comments |
|---|---|---|
| Device Description: The device provides cutting, evacuation, and electrocauterization functions. | The EXOJET Tissue Management System provides these functions, including additional functions of cutting, drilling, reaming, decorticating, and smoothing of bone via various handpieces and a liquid-jet driven motor. | This is a functional description, not a performance metric with a pass/fail threshold. |
| Indications for Use: Indicated for orthopedic surgical procedures requiring cutting and removal of soft tissue, hard tissue, or bone, and control of bleeding. Specific functions include cutting, ablation, shaping of soft tissue, and decorticating, removing, and smoothing of bone and other bone-related tissue in various arthroscopic procedures. | The Mitek EXOJET system is indicated for these specified procedures and functions. | This is an intended use statement, not a performance metric. The 510(k) process determined substantial equivalence for these indications. |
| Biocompatibility: Device must be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic. | Biocompatibility studies demonstrated the EXOJET Tissue Management System to be non-toxic, non-irritating, non-sensitizing, and non-cytotoxic. | This is a safety criterion, and its fulfillment is stated. No specific numerical thresholds or detailed study results are provided, typical for a 510(k) summary where only a statement of compliance is given after testing. |
| Substantial Equivalence: Device must be substantially equivalent to a legally marketed predicate device. | The EXOJET Tissue Management System was found substantially equivalent to the Hydrocision ARTHROJET System with Cautery and TurboBurr (K020688, K002764, K993009, K982266). | This is the primary regulatory "acceptance criterion" for 510(k) clearance. The FDA's letter states the device is substantially equivalent to the predicate. |
As for the specific points related to AI/ML device studies:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This document does not describe an AI/ML study.
- 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): Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of AI/ML. For biocompatibility, the "ground truth" would be results from standard biocompatibility tests. For functional equivalence, it would be direct comparison to the predicate device.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the provided text is for a conventional medical device seeking 510(k) clearance, not an AI/ML-powered device. Therefore, the specific criteria and study details requested, which are pertinent to AI/ML performance evaluation, are not present. The "study" referenced in the document implicitly refers to the testing and comparisons performed to establish substantial equivalence and biocompatibility, as required for a 510(k) submission, rather than a clinical performance study with statistical endpoints for an AI/ML algorithm.
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