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510(k) Data Aggregation
(80 days)
ARTHROCARE ELECTROSURGERY WANDS
The ArthroCare Electrosurgery Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. Representative procedures may include the following: General Surgery: cholecystectomy, lysis of adhesions, upper GI, GI (other), splenectomy, thyroidectomy, herniorrhaphy, breast biopsy, bowel resection, pelvic adhesiolysis, removal of lesions, removal of polyps, tumor biopsy. Gynecological Surgery: lysis of adhesions, hysterectomy, salpingo-oophorectomy, burch colposuspension, myomectomy, endometriosis, ovariohysterectomy, removal of tumors.
The ArthroCarc Electrosurgery Wands are single use, disposable bipolar electrosurgical devices designed to be used in conjunction with the ArthroCare Electrosurgery System (System 2000).
Please note that the provided text is a 510(k) Summary for a medical device (ArthroCare Electrosurgery Wands) seeking substantial equivalence to existing predicate devices. It is not a research paper detailing a study designed to establish acceptance criteria for an AI/ML device and demonstrate its performance against those criteria. Therefore, many of the requested points, particularly those related to AI/ML specific studies, expert ground truth, sample sizes for training/test sets, and comparative effectiveness studies, are not applicable or cannot be extracted from this document.
The document focuses on demonstrating substantial equivalence to predicate devices through a comparison of indications for use, materials, technology, product specifications, energy requirements, and performance testing.
Here's an attempt to answer your questions based solely on the provided text, while acknowledging the limitations for an AI/ML context:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" with numerical targets and reported performance in the way an AI/ML study would. Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices, and the "reported device performance" is summarized as being safe and effective for its intended use.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance |
|---|---|
| Indications for Use | Equivalent to predicate devices (K001302, K981361, K990947). Wands are indicated for resection, ablation, and coagulation of soft tissue and hemostasis of blood vessels in open, laparoscopic, and endoscopic general surgery and general gynecology procedures. |
| Materials | Equivalent to predicate devices. |
| Technology | Equivalent to predicate devices. |
| Product Specifications | Equivalent to predicate devices. |
| Energy Requirements | Equivalent to predicate devices. |
| Safe and Effective Use | Demonstrated through performance testing for resection and ablation of soft tissue. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "performance testing," but does not provide any details about sample size (number of cases/patients), data provenance (country of origin), or whether the data was retrospective or prospective. It simply states "Performance testing has been completed to demonstrate the safe and effective use of the Electrosurgery Wands in the resection and ablation of soft tissue."
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)
This information is not provided in the document. The type of "ground truth" for a medical device like an electrosurgery wand usually involves established safety and performance benchmarks and clinical observable outcomes (e.g., successful tissue resection, coagulation, hemostasis) rather than expert labelling of data like in AI/ML.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided and is generally not applicable to the type of performance testing described for an electrosurgical device.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is specifically relevant to AI-assisted diagnostic or interpretative devices, which is not what the ArthroCare Electrosurgery Wands are. They are surgical tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The ArthroCare Electrosurgery Wands are manual surgical tools, not AI/ML algorithms, and therefore do not have a standalone algorithm-only performance. They are used by a human surgeon.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The document does not explicitly state the "type of ground truth" in the way an AI/ML study would. However, for an electrosurgical device, the "ground truth" for proving safe and effective use would likely involve:
- Direct observable outcomes: Successful tissue resection, ablation, and coagulation; effective hemostasis.
- Pathology/Histology: Confirmation of tissue effects.
- Physiological measurements: E.g., temperature, current, power delivery.
- Adverse events: Absence of unintended tissue damage or complications.
The document refers to "performance testing" to demonstrate "safe and effective use," implying these types of objective measures were used.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set or ground truth for training.
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