(15 days)
The Cobra® Cardiac Surgical Probe (Probe) is intended for the coagulation of cardiac tissue using radiofrequency (RF) energy during cardiac surgery. The Probe can be used during general surgery to coagulate soft tissues. The Probe may also be used to coagulate blood and soft tissue to produce hemostasis.
The Boston Scientific Corporation Surgical Probe is a sterile, single use electrosurgical device intended to be used to coagulate soft tissues. The surgical probe transmits radiofrequency energy from electrodes which are connected to an Electrosurgical unit (non-sterile; re-useable) through an Instrument Cable (sterile; re-useable).
This appears to be a 510(k) premarket notification for a medical device, specifically an Electrosurgical Probe. The provided text focuses on the device description, intended use, comparison to a predicate device, and the FDA's substantial equivalence determination.
However, the document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria in the format requested. The "Summary of the Non-clinical Data" section merely lists types of tests performed (e.g., Fluid Path Integrity, Biocompatibility, In vivo performance) but does not provide:
- Specific acceptance criteria values.
- Reported device performance values against those criteria.
- Details of the study design (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).
The 510(k) notification process primarily aims to demonstrate substantial equivalence to a legally marketed predicate device, not necessarily to prove that a device meets specific, quantitative acceptance criteria through a detailed clinical or performance study report in the way you've outlined for AI/ML devices.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's an attempt to answer what can be inferred or directly stated from the text, with explicit notes about what is missing:
Acceptance Criteria and Study for Cobra® Cooled Surgical Probe
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria (from document) | Reported Device Performance (from document) | Comments / Missing Information |
|---|---|---|---|
| Mechanical Integrity | (Not specified quantitatively) | (Not specified quantitatively) | The document states "Fluid Path Integrity, Bond Joint Tensile Strength, Bond Joint Torsional Strength, Distal Section Fatigue, Shaft to Handle Tensile Strength" tests were conducted. However, no specific pass/fail criteria or quantitative results are provided. |
| Biocompatibility | (Not specified quantitatively) | (Not specified quantitatively) | The document states "Biocompatibility" tests were conducted. No specific criteria or results are provided. |
| In Vivo Performance | (Not specified quantitatively) | (Not specified quantitatively) | The document states "acute and chronic, In vivo performance" tests were conducted. No specific criteria or results are provided beyond the general statement that it "conformed to the requirements of 21 CFR Part 58 (Good Laboratory Practices (GLP))" where appropriate. |
| Sterilization | EO Sterilized (implied method) | Yes (implied met) | From comparison to predicate. |
| Single Use | Single Use (implied characteristic) | Yes (implied met) | From comparison to predicate. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document mentions "non-clinical tests" and "In vivo performance" but does not provide any sample sizes for these tests.
- Data Provenance: Not explicitly stated, but the tests were conducted by Boston Scientific Corporation/EP Technologies, Inc. It can be assumed these were internal company tests or contracted to a GLP-compliant lab. Country of origin and retrospective/prospective nature are not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. For a physical electrosurgical probe, "ground truth" as it relates to expert consensus for image/data interpretation (like in AI studies) is not typically established. Performance is measured against engineering specifications, biocompatibility standards, and in-vivo physiological responses. The document does not refer to experts establishing a "ground truth" in this context.
4. Adjudication method for the test set:
- Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are relevant for interpreting ambiguous data (e.g., medical images). This document describes performance testing of a physical device, where results are typically objective measurements or observations (e.g., tensile strength, integrity, tissue effect).
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 a filing for an electrosurgical probe, not an AI/ML diagnostic or assistive device. Therefore, MRMC studies are not relevant or performed in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical electrosurgical probe, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "non-clinical data," the ground truth would typically be established by engineering specifications, regulatory standards (e.g., ISO, ASTM for materials and devices), and physiological outcomes observed in in vivo models or animal studies. The document does not elaborate on the specific "ground truth" for each test, but mentions GLP compliance.
8. The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning.
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.