(60 days)
The BiZact device is a bipolar instrument intended for use in open surgical procedures where ligation of vessels, tissue bundles and lymphatics is desired.
The tissue fusion function of the device can be used on veins) and lymphatics up to and including 3mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It is also indicated for adult and adolescent ENT procedures (12 years of age and above), including tonsillectomy, for the ligation and division of vessels, tissue bundles and lymphatics 2-3 mm away from unintended thermally sensitive structures.
The BiZact device has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use for these procedures.
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider is a sterile, single use, hand-held electrosurgical device that incorporates RF tissue fusion technology for a desired tissue effect when used with the ForceTriad Energy Platform (ForceTriad), the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (VLLS10GEN), or the Valleylab™ FT10 Energy Platform (VLFT10GEN) for ligation and division of vessels, tissue bundles, and lymphatics during open general surgical procedures.
The BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider attaches to a compatible electrosurgical generator with a 10-foot cord containing a proprietary connector. The generator can identify the BiZact™ device via the RFID tag embedded in the connector (VLLS10GEN and VLFT10GEN) or with a barcode on the connector (ForceTriad). The generator delivers energy to the device using a defined algorithm that adjusts the generator output as a function of the electrical resistance of the tissue. The combination of the BiZact instrument and the generator algorithm achieve complete and permanent tissue fusion.
Based on the provided text, the device in question is the BiZact Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (BZ4212A). This document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical study in the way an AI/ML device would.
The core of this submission is not about a new AI/ML device with acceptance criteria for algorithm performance. Instead, it's about a medical device (an electrosurgical instrument) that is seeking to expand its Indications for Use to include an adolescent population (12-21 years of age), building upon its previous clearance for adults (22+ years of age).
Therefore, many of the questions about AI/ML specific studies (sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this type of device and submission.
Here's an attempt to address the relevant points based on the provided text, and to explicitly state when information is not available or not applicable for this device type:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not describe acceptance criteria in the typical sense for an AI/ML device's algorithmic performance. Instead, it demonstrates continued acceptable performance and substantial equivalence to a predicate device. The "acceptance criteria" here are implicitly tied to the safety and performance standards relevant to electrosurgical devices.
| Acceptance Criteria (Implied / Relevant Performance Factors for Electrosurgical Device) | Reported Device Performance (from "Performance Summary") |
|---|---|
| Electrical Safety (e.g., meeting IEC 60601-1) | Meets IEC 60601-1 Basic Electrical Safety |
| Electromagnetic Compatibility (e.g., meeting IEC 60601-1-2) | Meets IEC 60601-1-2 Electromagnetic Compatibility |
| Basic Safety for HF Equipment and Accessories (e.g., meeting IEC 60601-2-2) | Meets IEC 60601-2-2 Basic Safety for HF Equipment and HF Accessories |
| Biocompatibility (e.g., meeting ISO 10993-1) | Meets ISO 10993-1 Biocompatibility |
| Device Functionality (e.g., proper operation) | Performance Testing Device Functionality conducted |
| Tissue Sealing Performance (e.g., burst strength) | Bench Tissue - burst testing (renal artery and lymph) conducted |
| In-vivo Performance (e.g., hemostasis, thermal spread) | In-vivo - acute (hemostasis, thermal spread) and chronic (hemostasis) testing conducted |
| Safety and Efficacy in Expanded Age Group (relative to predicate) | Clinical Literature Summary supports that treatments in tonsillectomy for adults and adolescents are very similar without creating additional risk concerns. No design or specification changes were made. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for specific tests. The "Performance Testing" section mentions "bench tissue - burst testing (renal artery and lymph)" and "in-vivo - acute (hemostasis, thermal spread) and chronic (hemostasis)". The sample sizes for these tests are not provided in this summary.
- Data Provenance: Not specified (e.g., country of origin). The studies appear to be laboratory/bench and animal (in-vivo) testing rather than human clinical trials for this 510(k) submission. The "Clinical Literature Summary" refers to existing literature, but its provenance is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is not a study requiring expert ground truth for classification or interpretation, as it's a physical medical device. The "Clinical Literature Summary" likely relies on the expertise of the medical community as a whole.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is not a diagnostic device with interpretative tasks requiring adjudication.
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
- Not Applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As it's not an AI/ML device, the concept of "ground truth" as it applies to diagnostic algorithms is not relevant. For the physical device, performance is evaluated against engineering specifications, physiological measurements (e.g., burst pressure, thermal spread), and clinical outcomes (e.g., hemostasis). The "Clinical Literature Summary" relies on existing medical literature regarding tonsillectomy procedures in different age groups.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device with a training set.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI/ML device with a training set.
§ 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.