(36 days)
- The Isolator® linear pen is intended to ablate cardiac tissue during cardiac surgery using . radiofrequency (RF) energy when connected directly to the ASU or to the ASU Source Switch (ASB) in Ablation mode.
- The Isolator® linear pen may be used for temporary cardiac pacing, sensing, recording, . and stimulation during the evaluation of cardiac arrhythmias during surgery when connected to a temporary external cardiac pacemaker or recording device.
The Isolator™ linear pen System is comprised of the AtriCure® Ablation and Sensing Unit (ASU), Isolator™ linear pen (Pen), Footswitch, ASU Source Switch(ASB). The Pen is a single patient use electrosurgical instrument designed for use only with the ASU and ASB. The Pen is used to ablate cardiac tissues and as a surgical pacing and mapping tool. When the Pen is connected to the ASU, the ASU provides the bipolar radiofrequency (RF) energy flowing between both electrodes of the Pen. The Operator controls the application of this RF energy by pressing the Footswitch. When the Pen is connected to an auxiliary pace, sense, or stimulation device, the Pen is designed to provide temporary pacing or monitoring.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Isolator® Linear Pen:
Disclaimer: The provided document is a 510(k) summary for a medical device. These summaries often focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria in the same way a PMA (Pre-Market Approval) or clinical trial report might. As such, direct "acceptance criteria" for performance metrics and a "study that proves the device meets the acceptance criteria" in the format typically seen for a new drug or novel medical device effectiveness claim are not explicitly detailed. Instead, the document discusses conformity to design controls and specifications.
Acceptance Criteria and Reported Device Performance
The 510(k) summary for the Isolator® Linear Pen does not provide a table of quantitative acceptance criteria and reported device performance metrics in the way one might expect for a diagnostic or AI-driven device. Instead, it states that the device was tested to conform to "design controls and specification."
| Criteria | Acceptance | Reported Performance |
|---|---|---|
| Biocompatibility | Suitable for intended use according to ISO 10993-1. | Testing conducted on all patient contacting materials in accordance with ISO 10993-1 ensured appropriate biocompatibility of all appropriate materials. |
| Design Controls & Product Specifications | Conformance to 21 CFR 820.30 and AtriCure's Quality System. | Testing determined that the modified Isolator® linear pen conformed to design controls and product specifications. |
| Substantial Equivalence | To the Isolator® linear pen cleared via K100501. | The modified Isolator® linear pen is considered substantially equivalent in indications for use, basic overall function, and materials used. |
Study Information (Based on Available Text)
The document describes pre-market testing to ensure conformity, rather than a clinical study comparing performance against a specific metric.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document states "Testing was conducted on all patient contacting materials" and "Testing per 21 CFR 820.30 and AtriCure's Quality System was performed to verify the modified Isolator linear pen conformance to design controls and specification." This implies engineering and laboratory testing rather than human subject clinical trials with a defined sample size for performance evaluation.
- Data Provenance: Not specified. Likely internal laboratory and engineering test data, given the nature of a 510(k) for a modification to a previously cleared device.
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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/Not specified. The testing described is verification of design controls and biocompatibility, not expert-adjudicated performance relative to a clinical ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/None specified.
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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:
- Not applicable. This device is an electrosurgical device, not an AI-driven diagnostic tool necessitating MRMC studies.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical surgical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For biocompatibility: Adherence to ISO 10993-1 standards (a regulatory/scientific standard).
- For design conformance: Adherence to internal product specifications and quality system regulations (21 CFR 820.30).
- For substantial equivalence: Comparison to the predicate device (K100501) based on intended use, function, and materials.
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The sample size for the training set:
- Not applicable. This is a medical device subject to design verification and validation, not an AI model requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
§ 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.