(59 days)
The KVac Wands (Ambient® KVac™ Wand with Integrated Finger Switches and KVac™ Integrated Cable Wand) are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.
The KVac Wands are bipolar, sterile, high frequency electrosurgical devices designed for ablation, and resection of soft tissue and hemostasis of blood vessels during arthroscopic and orthopedic surgery. The KVac Wands will be offered in two versions: the KVac Wand with Integrated Cable (KVac ICW) and the Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS). The two wands are identical in all design and functional aspects, as well as principle of operation, with the exception of the Integrated Finger Switches on the Ambient KVac IFS and the Proprietary Ambient Technology on the Ambient KVac IFS. The shafts of the Wands feature a 50 degree bend in the distal end, which terminates in the electrode tip. The electrode tip consists of a flat, tungsten screen welded to Platinum/Iridium lead wires, which pass through an alumina ceramic spacer that serves as a ground. Openings in the electrode screen overlay a spacer suction lumen, which connects with internal suction tubing that runs through and exits the handle and is connected to OR wall suction. The handpiece is connected to the Quantum/Quantum 2 Controller via an integrated cable, which terminates in an 18-pin connector.
Your request is for information on acceptance criteria and study details for the provided document. However, the document provided is a 510(k) premarket notification for a medical device (ArthroCare® KVac™ Wand) and does not contain detailed acceptance criteria tables or specific studies proving the device meets those criteria in the way you've outlined.
The document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than providing detailed performance studies with acceptance criteria as might be seen for novel devices requiring PMAs or more extensive clinical trials.
The document explicitly states that no animal or clinical data are included in the submission. The performance testing section specifically refers to "Performance Testing - Bench" for evaluating design specifications and comparing to the predicate.
Given these limitations, I cannot provide the exact information you requested in the format of a table with specific acceptance criteria and detailed study results, sample sizes, expert qualifications, etc., as that information is not present in the provided text.
However, I can extract what is available regarding performance testing and the comparison to an older device:
1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with numerical targets. Instead, it states that:
- "The test results demonstrate that the KVac Wands meet all design and performance specifications and are substantially equivalent to the predicate device."
- "All testing demonstrates that the KVac Wands perform as intended and have acceptable mechanical properties when used in accordance with its labeling."
The "reported device performance" is qualitative and comparative:
- Performance bench testing was conducted to verify designs meet specifications and to evaluate performance compared to the predicate device.
- Testing involved tissue models (muscle, cartilage, meniscus, tendon).
- High, default, and low ablation and coagulation settings were used.
- Compared the amount of tissue removed (ablation depth) and thermal effect depth created.
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 specified for the bench tests.
- Data Provenance: Bench testing, likely conducted internally by ArthoCare Corporation (Austin, TX, USA). It is not clinical data (animal or human), so terms like retrospective/prospective don't apply in the same way.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. Since no clinical data was used, there would be no ground truth established by external clinical experts in the context of human or animal studies. The "ground truth" for bench testing would be the measured physical properties evaluated against internal design specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and is not typically relevant for bench testing of medical devices where objective measurements are taken against specifications.
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 or comparative effectiveness study involving human readers/AI was mentioned or conducted, as this device is an electrosurgical wand, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This is not applicable as the device is an electrosurgical wand, not an algorithm/AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the bench testing described, the "ground truth" would be objective measurements of physical parameters (e.g., ablation depth, thermal effect depth) against predefined engineering specifications. This is not derived from expert consensus, pathology, or outcomes data.
8. The sample size for the training set
- Not applicable as this is not an AI/machine learning device. No "training set" was used.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/machine learning device.
Summary of Device Performance and Justification of Equivalence (from the document):
The submission demonstrates substantial equivalence primarily through non-clinical performance data (bench testing):
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Performance Testing - Bench:
- Tests Performed: Functional testing, ablation life, coagulation, biocompatibility, and electrical safety testing.
- Purpose: Verify designs meet performance specifications and evaluate performance compared to the predicate device.
- Tissue Models: Muscle, cartilage, meniscus, and tendon.
- Settings: High, default, and low ablation and coagulation settings.
- Measurements: Amount of tissue removed (ablation depth) and thermal effect depth created.
- Conclusion: "The test results demonstrate that the KVac Wands meet all design and performance specifications and are substantially equivalent to the predicate device."
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Technological Comparison to Predicate Device (Ambient Super MultiVac Wand, K083306):
- The document explicitly states: "The technological characteristics of the proposed subject devices are the same as the predicate device. No changes or modifications have been made to the intended use, fundamental scientific technology, or principle of operation previously cleared in 510(k) K083306."
- Several minor design differences (e.g., shaft length, outer diameter, number of internal suction ports, electrode screen attachment method, material for active wire connection point) are listed and justified as either improving performance (e.g., better access, improved visibility, better plasma resistance, improved fixation) or manufacturability without affecting safety or efficacy.
- Conclusion on Substantial Equivalence: "Non-clinical performance data such as design verification, tissue effect testing (histology, thermal margins) demonstrated that the subject devices are substantially equivalent to the predicate devices and are safe and effective when used as intended." And "The differences between the KVac Wands and the predicate device do not raise any new concerns about the safety or effectiveness of the subject devices."
§ 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.