(29 days)
The AMBIENT Super MULTIVAC® 50 Wand with Integrated Finger Switches is indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in the following arthroscopic and orthopedic procedures.
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Articular Cartilage Bursectomy Chondroplasty Fascia Ligament Scar Tissue Soft Tissue Synovectomy Tendon
Knee: ACL/PCL Notchplasty
Shoulder: Acromioplasty Subacromial Decompression
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Articular Labrum Capsule Cysts Ligament Loose Bodies Plica Removal Scar Tissue Soft Tissue Synovial Membrane Tendon
Hip: Acetabular Labrum
Knee: Capsular Release Cartilage Flaps Discoid Meniscus Lateral Release Meniscal Cystectomy Meniscectomy Villusectomy
Shoulder: Frozen Shoulder Release Glenoidale Labrum
Wrist: Triangular Fibrocartilage (TFCC)
All Joints (Hip, Knee, Shoulder, Wrist, Ankle, Elbow): Articular Cartilage Ligament Tendon
Knee: ACL/PCL Medial Retinaculum
Shoulder: Glenohumeral Capsule Rotator Cuff
Wrist: Carpal Ligaments Wrist Tendons
The AMBIENT Super MULTIVAC° 50 Wand with Integrated Finger Switches ("Wand") is a bipolar, high frequency electrosurgical device used for specific indications in orthopedic and arthroscopic surgeries. The AMBIENT feature provides accurate (± 3° C) real-time temperature monitoring of the circulating irrigating fluid between 20° C and includes a user adjustable alarm set point. The Wand is designed for use up to five minutes of cumulative active ablation time at the default set point of 7 and is to be used only with the QUANTUM® 2 Controller ("Controller").
This document describes the premarket notification (510(k)) for the AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device.
Based on the provided text, the device in question is an electrosurgical cutting and coagulation device, not an AI/ML-driven medical device for which the requested information would typically apply (like a diagnostic imaging algorithm). Therefore, many of the requested criteria regarding AI/ML model acceptance (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance, etc.) are not relevant to this submission type and are not present in the provided text.
This 510(k) summary focuses on demonstrating substantial equivalence through performance bench testing and technological characteristics comparison, not through clinical or AI/ML performance metrics.
Here's the information that can be extracted from the provided text, in relation to the closest applicable sections of your request:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present "acceptance criteria" in a quantitative table format that would typically be found for AI/ML performance. Instead, it lists the types of performance bench testing conducted and states that the device "continues to meet the design requirements and supports substantial equivalence with the predicate device."
| Test Category | Reported Device Performance/Conclusion |
|---|---|
| Transit Conditioning | Performed; Implicitly met design requirements as stated in conclusion. |
| Visual Inspection Post-Transit | Performed; Implicitly met design requirements as stated in conclusion. |
| IEC Testing | Performed; Implicitly met design requirements as stated in conclusion. |
| Ambient Accuracy Testing | Performed; Implicitly met design requirements (± 3° C for temperature monitoring), as stated in conclusion. |
| Ablation Performance Testing (at Default Set Point and Suction) | Performed; Implicitly met design requirements as stated in conclusion. |
| Coagulation Testing | Performed; Implicitly met design requirements as stated in conclusion. |
| Ablation Performance Testing (at Default Set Point & Suction & Use Limiting Feature) | Performed; Implicitly met design requirements as stated in conclusion. |
| Use-Limiting Feature | Performed; Activation of fuse allows up to 7 minutes of use (vs. 40 minutes for predicate) and an overall connection time up to 8 hours. |
| Overall Conclusion | "All testing demonstrates that the AMBIENT® Super MULTIVAC° 50 Wand with Integrated Finger Switches performs as intended and has acceptable performance when used in accordance with its labeling." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for each bench test. The wording "All devices used for verification testing were sent to an ArthroCare approved supplier for sterilization" implies multiple units were tested, but the exact number is not provided.
- Data Provenance: Not applicable as this is bench testing of a physical device, not an AI/ML system using patient data. The tests were performed in-house by ArthroCare or an approved supplier.
3. 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. Ground truth for electrosurgical device performance is established through engineering and biophysical measurements (e.g., precise temperature, ablation rate, coagulation effectiveness), not expert human interpretation of medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study assessing observer performance.
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
- No MRMC study was done, as this is not an AI-assisted diagnostic device. The submission explicitly states: "No clinical data are included in this submission."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical electrosurgical device, not an algorithm. Bench tests evaluate the device's functional performance directly.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this type of device is established through quantitative engineering and biophysical measurements in controlled laboratory settings (e.g., temperature sensors, material removal rates, impedance measurements, and visual inspection of tissue effects).
8. The sample size for the training set
- Not applicable, as this is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable, as this is not an AI/ML device that requires a training set.
Summary of Device and Evidence:
The AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches is an electrosurgical device. The 510(k) submission (K180848) establishes substantial equivalence to a predicate device (K083306) primarily through bench testing. The key change from the predicate appears to be related to the integrated cable and potentially a change in the use-limiting scheme (7 minutes of active ablation time vs. 40 minutes for the predicate, though the overall connection time remains 8 hours). The submission relies on engineering and functional performance data, not clinical data or data from AI/ML model validation studies.
§ 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.