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510(k) Data Aggregation
(271 days)
AMBIENT TURBOFLASH 90 IFS
The Ambient TurboFlash 90 IFS Wand is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in arthroscopic and orthopedic procedures including: Ablation and Debridement (ACL/PCL, Acromioplasty, Articular Cartilage, Bursectomy, Chondroplasty, Fascia, Ligament, Notchplasty, Scar Tissue, Soft Tissue, Subacromial Decompression, Synovectomy, Tendon), Excision and Resection (Acetabular Labrum, Articular Labrum, Capsule, Capsular Release, Cartilage Flaps, Cysts, Discoid Meniscus, Frozen Shoulder Release, Glenoid Labrum, Lateral Release, Ligament, Loose Bodies, Meniscal Cystectomy, Meniscectomy, Plica Removal, Scar Tissue, Soft Tissue, Synovial Membrane, Tendon, Triangular Fibrocartilage (TFCC), Villusectomy), and Coagulation (ACL/PCL, Articular Cartilage, Carpal Ligaments, Glenohumeral Capsule, Ligament, Medial Retinaculum, Rotator Cuff, Tendon, Wrist Tendons). These procedures are applicable to specific joints or all joints (ankle, elbow, hip, knee, shoulder, and wrist).
The Ambient TurboFlash 90 IFS Wand is a bipolar, sterile, single-use, high frequency electrosurgical device which consists of a distal electrode tip composed of tungsten and titanium, a ceramic spacer-cap, a stainless steel shaft, internal suction tubing, and a molded handle with integrated finger switches. The Ambient TurboFlash 90 IFS is only compatible with the Quantum™ 2 Controller which incorporates a "Use Limiting" feature that prevents the re-use of the device.
Here's an analysis of the provided text regarding the acceptance criteria and study for the ArthroCare Ambient® TurboFlash™ 90 IFS Wand:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes modifications to an existing predicate device and focuses on establishing substantial equivalence through non-clinical performance testing. It does not explicitly define quantitative "acceptance criteria" in the traditional sense (e.g., "sensitivity must be > X%") or report quantitative "device performance" metrics against such criteria in a table format. Instead, the "acceptance criteria" are implied by successful completion of various tests demonstrating equivalence or improved characteristics without adverse effects.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Ablation and Coagulation Performance Equivalence | "Ablation and coagulation testing" successfully evaluated the device, demonstrating that proposed modifications "do not affect the safety or efficacy of the device." The rationale for design changes (e.g., smaller profile tip) also implies that performance in these areas should be maintained or improved for surgical access. |
| Electrical Safety Compliance | "Electrical safety testing including Hipot, continuity, and IEC 60601-2-2:2009" was successfully conducted, indicating compliance with relevant standards. |
| Tip Strength | "I Tip strength testing" was performed successfully. |
| Suction Rate | "Suction rate testing" was successfully performed. |
| Ex Vivo Performance | "Ex vivo performance testing" was successfully conducted. While specific metrics aren't provided, the conclusion is that the modifications "do not affect the safety or efficacy." |
| Ambient Temperature Measurement | "Ambient temperature measurement testing" was successfully performed. |
| Manufacturing Efficiency and Surgical Access (Improved) | The one-piece spacer-cap and revised screen securing method were proposed to "Facilitates the manufacturability of a smaller profile tip which provides the surgeon better access to tight joint spaces" and "more efficient manufacturability; and a smaller profile tip to provide surgical access to tight joint spaces." This is an improvement over the predicate, not a maintained criterion. |
| Therapy Delivery Flexibility (Improved) | The resistor change allowing a maximum ablation set point of 10 (vs. 9 in predicate) "Provides the surgeon more flexibility in delivering therapy." This is an improvement over the predicate, not a maintained criterion. |
| Substantial Equivalence to Predicate Device (Overall) | The overall conclusion of the non-clinical performance testing is that "This testing demonstrated that the proposed modifications for the Ambient TurboFlash 90 IFS are substantially equivalent and do not affect the safety or efficacy of the device" and that it "is substantially equivalent to the Ambient Super TurboVac 90 IFS cleared via K083306. Both the subject and the predicate devices have the same indications for use and utilize the same fundamental scientific technology. The proposed modifications are not substantial and do not significantly affect the safety or efficacy of the device." |
2. Sample Size Used for the Test Set and the Data Provenance:
The document describes non-clinical bench testing and ex vivo performance testing. It does not mention a "test set" in the context of human subjects or clinical data. Therefore, the concepts of "sample size used for the test set" and "data provenance (e.g. country of origin of the data, retrospective or prospective)" are not applicable to this type of submission. The data provenance would be laboratory testing conducted by the manufacturer, ArthroCare Corporation, based in Austin, Texas.
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 as the submission is based on non-clinical bench and ex vivo testing, not on clinical data requiring expert review for ground truth establishment.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set:
This information is not applicable for the same reasons as #3.
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 submission is for an electrosurgical device, not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies or AI assistance for human readers are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. This is not an algorithmic or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is established through objective engineering and performance testing standards and measurements. This includes:
- Engineering specifications and design verification.
- Conformity to recognized electrical safety standards (e.g., IEC 60601-2-2:2009).
- Quantitative measurements in ablation, coagulation, tip strength, suction rate, and temperature.
- Ex vivo performance assessments against expected functional outcomes.
8. The Sample Size for the Training Set:
This information is not applicable. This is not an AI/machine learning device that requires a training set. The device design and performance are based on engineering principles and established medical device development processes, not data-driven model training.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as there is no training set for this type of device.
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