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510(k) Data Aggregation
(49 days)
The Medline ReNewal Reprocessed ArthroWands models ASHA 4250-01; ASH 4250-01; ASHA 2530-01; ASHA 3730-01; ASHA 4830-01; and ASH 4830-01 and Medline ReNewal Reprocessed Smith & Nephew Dyonics model 72202140 ablation wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
Ablation and Debridement: ACL/PCL (knee); acromioplasty (shoulder); articular cartilage (all joints); bursectomy (all joints); chondroplasty (all joints); fascia (all joints); notchplasty (knee); scar tissue (all joints); soft tissue (all joints);subacromial decompression (shoulder); synovectomy (all joints); and tendon (all joints).
Excision and Resection: acetabular labrum (hip); articular labrum (all joints); capsular release (knee); cartilage flaps (knee); cysts (all joints); discoid meniscus (knee); frozen shoulder); glenoidale labrum (shoulder); lateral release (knee); ligament (all joints); loose bodies (all joints); meniscal cystectomy (knee); meniscectomy (knee); plica removal (all joints); soft tissue (all joints); synovial membrane (all joints); tendon (all joints); triangular fibrocartilage (TFCC); (wrist); and villusectomy (knee). Coagulation: ACL/PCL (knee); articular cartilage (all joints); carpal ligaments (wrist); glenohumeral capsule (shoulder); ligament (all joints); medial retinaculum (knee); rotator cuff (shoulder); tendon (all joints) and wrist tendons (wrist).
Ablation wands are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic procedures, including knee, shoulder, ankle, hip, elbow, and wrist joints. The device is powered by a separate generator. The generator is not included in the scope of the study and will not be reprocessed.
This document is a 510(k) premarket notification for reprocessed electrosurgical cutting and coagulation devices. It details the substantial equivalence determination made by the FDA. The document does not describe the acceptance criteria and study for a medical device's performance in the context of AI/ML or clinical efficacy, but rather focuses on the substantial equivalence of reprocessed medical devices to predicate devices.
Therefore, most of the requested information regarding acceptance criteria, performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods (as typically applied to AI/ML device evaluations) are not applicable to this type of submission.
However, I can extract information related to the performance testing conducted to demonstrate substantial equivalence for the reprocessed devices:
1. A table of acceptance criteria and the reported device performance:
The document describes various performance tests conducted to demonstrate equivalence to the predicate devices. It doesn't present a table of specific acceptance criteria values alongside reported device performance values in the way one would for a novel device's clinical efficacy. Instead, it lists the types of tests performed and states that the devices were "found to be equivalent."
| Type of Test | Reported Device Performance |
|---|---|
| Sterilization validation | Found to be equivalent to the predicate devices |
| Biocompatibility | Found to be equivalent to the predicate devices |
| Cytotoxicity, sensitization, irritation | Found to be equivalent to the predicate devices |
| Pyrogenicity, and acute systemic toxicity | Found to be equivalent to the predicate devices |
| Electrical testing | Found to be equivalent to the predicate devices |
| Electromagnetic compatibility (per IEC 60601-1-2) | Found to be equivalent to the predicate devices |
| Electrical safety (per IEC 60601-1 and IEC 60601-2-2) | Found to be equivalent to the predicate devices |
| Basic safety (per IEC 60601-1 and IEC 60601-2-2) | Found to be equivalent to the predicate devices |
| Performance qualification: simulated use | Found to be equivalent to the predicate devices |
| Performance qualification: critical function bending equivalence test | Found to be equivalent to the predicate devices |
| Performance qualification: critical function suction equivalence test | Found to be equivalent to the predicate devices |
| Performance qualification: critical function thermal tissue damage equivalence test | Found to be equivalent to the predicate devices |
| Performance qualification: critical function drop equivalence test | Found to be equivalent to the predicate devices |
| Performance qualification: critical function device equivalence integrity | Found to be equivalent to the predicate devices |
| Performance qualification: product stability | Found to be equivalent to the predicate devices |
| Cleaning | Found to be equivalent to the predicate devices |
| Protein, and hemoglobin (residue testing) | Found to be equivalent to the predicate devices |
2. Sample size used for the test set and the data provenance:
The document does not specify the sample sizes used for each of the performance tests listed. The data provenance is implied to be from laboratory testing performed by Surgical Instrument Service and Savings Inc. (dba Medline ReNewal) as part of their reprocessing validation, conducted in the United States. It's retrospective in the sense that the studies are conducted after the reprocessing process is established.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. For reprocessed devices, "ground truth" refers to the original device's performance characteristics. Equivalence testing compares the reprocessed device to the original (predicate) specifications, not human expert interpretation.
4. Adjudication method for the test set:
This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments. The tests described are objective engineering and performance validations.
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:
This information is not applicable. This document concerns reprocessed electrosurgical tools, not AI/ML-assisted diagnostic or interpretive devices. No MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This document does not describe an AI/ML algorithm.
7. The type of ground truth used:
The "ground truth" in this context is the established performance specifications and safety profiles of the original, legally marketed predicate devices. The reprocessed devices are evaluated against these known characteristics to demonstrate that they perform "as good as" the original devices.
8. The sample size for the training set:
This information is not applicable. There is no "training set" in the context of validating reprocessed physical medical devices.
9. How the ground truth for the training set was established:
This information is not applicable. As there is no training set, there is no ground truth to establish for it in this context.
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