(154 days)
The Bipolar Ablation Probes are disposable, bipolar electrosurgical devices intended to be used for ablation and hemostasis of soft tissues in arthroscopic procedures. They are designed to be used with the ORATEC® Vulcan™ EAS™ generator.
The ORATEC Bipolar Ablation Probes are disposable, bipolar electrosurgical devices designed to cut or ablate soft tissues. They provide minimally invasive access to the targeted tissues. The Bipolar Ablation Probes are used in conjunction with the ORATEC Vulcan™ EAS™ RF generator to deliver bipolar radiofrequency (RF) energy for ablation of soft tissues. The probes consist of an insulated shaft, an insulated power electrode, a return electrode, and a handle. Probes may incorporate suction capability for the removal of ablated tissue from the surgical site.
The provided text is a 510(k) summary for a medical device called ORATEC Bipolar Ablation Probes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the way a clinical trial for a novel therapy would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or not explicitly detailed in this type of regulatory submission.
However, I can extract the information that is present and indicate where information is not provided.
Here's the analysis based on the provided text:
Acceptance Criteria and Study for ORATEC Bipolar Ablation Probes
The provided 510(k) summary describes ORATEC Bipolar Ablation Probes and aims to demonstrate their substantial equivalence to a predicate device, the ArthroCare Ablation Probes. As such, the "acceptance criteria" are primarily related to showing that the ORATEC probes are as safe and effective as the predicate device, and the "study" mentioned refers to comparative testing against that predicate.
1. Table of Acceptance Criteria and Reported Device Performance
No explicit quantitative acceptance criteria or detailed performance metrics are given in the 510(k) summary. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device. The performance is assessed comparatively.
| Acceptance Criteria Category (Implied by Substantial Equivalence) | Reported Device Performance (Comparative) |
|---|---|
| Safety: No new questions of safety raised by design differences. | The submission states: "These design differences [between ORATEC and ArthroCare probes] do not raise any new questions of safety or effectiveness." This implies the safety profile is equivalent to the predicate. Specific safety metrics (e.g., adverse event rates, tissue damage thresholds) are not detailed. |
| Effectiveness: Equivalent performance for ablation and hemostasis of soft tissues in arthroscopic procedures. | "The ORATEC Bipolar Ablation Probes performed equivalently to the predicate devices in bench and in clinical testing." This indicates the device successfully performs ablation and hemostasis of soft tissues, consistent with the predicate. No specific performance metrics (e.g., ablation rate, hemostasis time, tissue removal efficiency) are provided. |
| Functionality: Ability to cut/ablate soft tissues, provide minimally invasive access, deliver bipolar RF energy, and potentially incorporate suction. | The device description outlines these functions, stating the probes "are disposable, bipolar electrosurgical devices designed to cut or ablate soft tissues. They provide minimally invasive access to the targeted tissues." They are used "to deliver bipolar radiofrequency (RF) energy for ablation of soft tissues," and "Probes may incorporate suction capability." The comparison notes that both the ORATEC and predicate devices "deliver bipolar radiofrequency energy for ablation of soft tissues" and "both are capable of suction." |
| Sterility & Single Use: Provided sterile, designed for single-use only. | The comparison explicitly states both the ORATEC and predicate devices "both are provided sterile and are designed for single-use only." This is a fundamental design and use principle for the device, confirmed to be present. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided 510(k) summary. The summary mentions "bench and in clinical testing" but does not detail the number of participants, cases, or tests.
- Data Provenance: Not specified. It's likely from the US, given the FDA submission, but no country of origin is explicitly stated. The summary does not indicate if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Specified. This type of information is typically related to diagnostic image interpretation or complex clinical outcome assessments, which are not the primary focus of this 510(k) for an electrosurgical device assessing substantial equivalence. The "clinical testing" would likely have involved surgeons or other medical professionals, but their role in "ground truth establishment" in the context of diagnostic accuracy is not relevant here.
4. Adjudication method for the test set:
- Not Applicable / Not Specified. Adjudication methods (e.g., 2+1, 3+1 consensus) are typically used for establishing ground truth in diagnostic accuracy studies. For an electrosurgical device demonstrating functional equivalence, such a method would not typically be used. Performance assessment would involve direct observation of function, tissue effects, and patient outcomes (if a clinical study was performed).
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. This is an electrosurgical tool, not an AI-assisted diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is an electrosurgical device, not a standalone AI algorithm. Its function inherently involves a human operator (surgeon).
7. The type of ground truth used:
- Direct functional assessment and clinical observation. For this device, "ground truth" would likely refer to the direct observation of the device successfully ablating and achieving hemostasis in soft tissues during "bench and in clinical testing," as well as surgical outcomes in a clinical setting. It's not a diagnostic "ground truth" established by expert consensus or pathology in the sense of an image interpretation task. The primary "ground truth" in this 510(k) is the established safety and effectiveness of the predicate device.
8. The sample size for the training set:
- Not Applicable / Not Specified. As this is not an AI/machine learning device, there is no "training set" in that context. If "training set" refers to pre-clinical or in-vitro testing for design optimization, details are not provided.
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
§ 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.