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510(k) Data Aggregation
(350 days)
Green OR, LLC.
The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).
The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery.
The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery.
The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is intended for, but not limited to open abdominal, orthopaedic, and thoracic surgery.
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This document is a 510(k) Pre-market Notification for a reprocessed medical device, the Green OR Reprocessed Aquamantys Bipolar Sealer. The submission aims to demonstrate substantial equivalence to the original, legally marketed predicate devices.
1. Table of Acceptance Criteria and the Reported Device Performance:
The document lists performance testing conducted to demonstrate substantial equivalence. These tests serve as the "acceptance criteria" for the reprocessed device to perform comparably to the original. The document states that the functional characteristics "have been evaluated and found to be equivalent to the predicate devices."
| Acceptance Criteria Category | Specific Test/Property | Reported Device Performance |
|---|---|---|
| Functional Performance | RF Power Output | Evaluated and found equivalent to predicate devices |
| Saline Flow Rate | Evaluated and found equivalent to predicate devices | |
| Biocompatibility | Cytotoxicity | Evaluated and found equivalent to predicate devices |
| Sensitization | Evaluated and found equivalent to predicate devices | |
| Irritation: Intracutaneous Reactivity | Evaluated and found equivalent to predicate devices | |
| Acute systemic toxicity | Evaluated and found equivalent to predicate devices | |
| Material mediated pyrogenicity | Evaluated and found equivalent to predicate devices | |
| Sterilization Validation | Bacterial Endotoxin / LAL | Evaluated and found equivalent to predicate devices |
| Reprocessing Effectiveness | Cleaning | Evaluated and found equivalent to predicate devices |
| Residual Protein | Evaluated and found equivalent to predicate devices | |
| Residual Total Organic Carbon | Evaluated and found equivalent to predicate devices | |
| Electrical Safety | EMC and Electrical Safety (IEC 60601-2-2) | Evaluated and found equivalent to predicate devices |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific test. It broadly refers to "the functional characteristics of the subject devices have been evaluated." As this is a 510(k) for a reprocessed device, the data provenance would primarily be from laboratory testing conducted on the reprocessed units, comparing them against the specifications or performance of new, original devices (the predicates). There is no mention of clinical data or patient data (retrospective or prospective) in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This type of information (number and qualifications of experts) is typically associated with studies involving human interpretation or clinical outcomes, such as imaging diagnostic algorithms. For a device like a bipolar sealer undergoing functional and safety testing, the "ground truth" is established by objective engineering and laboratory standards and measurements, not expert human interpretation. Therefore, this information is not applicable or provided in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among human experts in cases of subjective interpretation (e.g., radiology reads). Since the described tests are objective laboratory and engineering assessments of device performance (e.g., RF power output, residual protein), such an adjudication method is not relevant or applied.
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:
An MRMC comparative effectiveness study is used to evaluate the diagnostic performance of humans, often with and without AI assistance, on a set of cases. This device (a reprocessed bipolar sealer) is a surgical tool, not a diagnostic imaging device typically associated with human "readers" or AI assistance in a diagnostic context. Therefore, an MRMC study was not conducted, and effect sizes related to human reader improvement with AI assistance are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is not an algorithm or an AI system, but a physical electrosurgical tool. Therefore, the concept of "standalone" performance for an algorithm is not applicable. The performance testing described (RF power, saline flow, cleaning, etc.) is the "standalone" performance of the reprocessed device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the specific tests listed (RF Power Output, Saline Flow Rate, Biocompatibility, Sterilization, Cleaning, Electrical Safety), the ground truth is established by objective, measurable engineering specifications, industry standards (e.g., IEC 60601-2-2), and validated test methods. For example, RF power output would be measured against the manufacturer's specified output range for a new device, and residual protein levels would be measured against established acceptance limits. It would not typically involve expert consensus, pathology, or outcomes data in the usual sense for this type of device and testing.
8. The sample size for the training set:
As this is a reprocessed physical medical device and not an AI/ML algorithm, the concept of a "training set" is not applicable. The device itself is manufactured/reprocessed and then tested, not "trained."
9. How the ground truth for the training set was established:
Since there is no "training set" for this device, this question is not applicable.
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