Search Results
Found 3 results
510(k) Data Aggregation
(89 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 of the device can be used on vessels (arteries and veins) and lymphatics up to an including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It's also indicated for adult, children and adolescent ENT procedures (3 years of age and above), including tonsillectorny, for the ligation and division of vessels, tissue bundles 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/Divider is a sterile, single use, hand-held electrosurgical device that incorporates radio frequency (RF) tissue fusion technology for a desired tissue effect when used with the ForceTriad™ Energy Platform (Force Triad), the Valleylab™ LS10 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/Divider attaches to a compatible electrosurgical generator with a 10-foot cord containing a proprietary connector. The generator can identify the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue/Divider via the radiofrequency identification (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.
This document describes the FDA's decision to clear the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356) for an expanded indication to include children aged 3 to less than 12 years. The key basis for this clearance is the demonstration of substantial equivalence to a previously cleared device (K182451).
The provided text details a clinical study to support the expanded indication but does not provide specific acceptance criteria in a quantitative table format that directly correlates to a device's performance in terms of metrics like sensitivity, specificity, or accuracy, which are typical for AI/diagnostic devices. This is because the BiZact device is a surgical instrument, not an AI or diagnostic device. Its performance is assessed through safety and effectiveness in a surgical context, primarily focusing on clinical outcomes.
Therefore, I will interpret "acceptance criteria" here as the clinical safety and effectiveness benchmarks that the device needed to meet for the expanded indication, and "device performance" as the clinical outcomes observed in the study.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider (K193356)
Given that this is a surgical device, not an AI or diagnostic tool, the "acceptance criteria" are based on clinical safety and effectiveness endpoints for the surgical procedure it facilitates. The study primarily aimed to demonstrate that expanding the indication to include children (3 to <12 years) does not introduce new safety or effectiveness concerns compared to its existing use in adults and adolescents.
1. Table of Acceptance Criteria (Clinical Endpoints for Expanded Indication) and Reported Device Performance
| Acceptance Criterion (Clinical Endpoint) | Reported Device Performance in Clinical Study |
|---|---|
| Primary Objective: Intra-operative blood loss (quantitatively assess effectiveness). | Significantly less than the benchmark derived from a large meta-analysis. (This met the primary objective). |
| Safety: Occurrence of device-related adverse events (AEs). | 0 out of 60 subjects had adverse events related to the use of the BiZact™ Tonsillectomy Device Advanced Bipolar Tissue Sealer/Divider. |
| Safety: Occurrence of serious adverse events (SAEs). | 0 out of 60 subjects qualified as serious AEs. |
| Safety: Device-related readmissions/hospitalizations to manage adverse events. | None of the subjects were admitted or readmitted to the hospital during this study for adverse events. (Note: Four subjects had 5 dehydration events requiring outpatient IV fluids, but no hospital admission.) |
| Overall Effectiveness and Safety for Expanded Population. | The clinical study demonstrated that the addition of children patients (3 to <12 years) does not raise new questions of safety or effectiveness, supporting the conclusion that the device is substantially equivalent to the predicate for this expanded indication. The device performed as expected, with favorable clinical outcomes and a low incidence of device-related or serious adverse events. Tonsillectomy-related AEs (e.g., fever, vomiting, throat pain) were observed, but these were related to the procedure itself, not the device, and were largely manageable. |
2. Sample Size and Data Provenance for the Test Set (Clinical Study)
- Sample Size: Sixty (60) pediatric subjects.
- Data Provenance: The document does not explicitly state the country of origin. It indicates it was a "multi-center" study, suggesting multiple sites potentially within one or more countries. It was a prospective clinical study.
3. Number of Experts and Qualifications for Ground Truth Establishment (Clinical Study)
- Number of Experts: Investigators (referring to the operating surgeons/clinicians at each site) and an Independent External Medical Monitor. The exact number of investigators is not specified (since it was multi-center). Only one Independent External Medical Monitor is mentioned.
- Qualifications: "Investigators" are physicians performing the tonsillectomy and assessing patients. The "Independent External Medical Monitor" typically holds medical qualifications (e.g., MD) and experience in clinical trial oversight, often specializing in the relevant medical field (ENT/pediatrics in this case), to ensure patient safety and data integrity. Specific years of experience are not provided.
4. Adjudication Method for the Test Set (Clinical Study)
- Adjudication of adverse events was performed by the "Investigators and an Independent External Medical Monitor." This suggests a process where initial assessment is made by the site investigator, and then reviewed/confirmed by an independent monitor. The specific "2+1" or "3+1" type of formal consensus is not explicitly detailed, but there was an independent review process for AE assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This device is a surgical instrument, not an AI or diagnostic imaging system. Therefore, an MRMC study designed to assess human reader performance with or without AI assistance is not relevant to its evaluation. The study focused on clinical outcomes of using the device during surgery.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
- Not applicable. This is a surgical device, always used with human-in-the-loop (i.e., by a surgeon). There is no "algorithm only" performance to evaluate. Its function is directly tied to the surgeon's use during a procedure.
7. Type of Ground Truth Used (Clinical Study)
- Clinical Outcomes and Expert Assessment: The ground truth for safety and effectiveness was established through direct clinical observation of intra-operative blood loss, patient follow-up for adverse events, and assessment by clinical investigators and an independent medical monitor. This combines objective clinical measurements (blood loss) with subjective clinical evaluations of patient well-being and adverse event causality.
8. Sample Size for the Training Set
- Not applicable. This is a hardware surgical device, not a machine learning model. There is no concept of a "training set" for the device itself.
- However, if we consider "training" in a broader sense as prior experience or data that informed the device's design and previous clearances, then the predicate device (K182451) and its associated studies (likely including animal studies, bench testing, and potentially clinical data on adults/adolescents) could be seen as foundational.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, there is no "training set" for the device. The device's design and performance claims are based on engineering principles, bench testing (e.g., burst pressure), biocompatibility testing, a previously cleared predicate device, and prior animal/clinical studies described in previous 510(k) submissions. These prior studies would have established their ground truth through standard preclinical and clinical methods relevant to surgical devices.
Ask a specific question about this device
(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.
Ask a specific question about this device
(59 days)
The BiZact™ device is a bipolar instrument intended for use in open surgical procedures where ligation and division of vessels, tissue bundles, and lymphatics is desired.
The tissue fusion function of the device can be used on vessels (arteries and veins) and lymphatics up to and including 3 mm diameter. The BiZact device is indicated for use in open general surgical procedures.
It is also indicated for adult ENT procedures, 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 sterilization or 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 (K051644, K070162, K102913, and K110268), the Valleylab™ LS10 LS Series Single Channel Vessel Sealing Generator (K143654), or the Valleylab FT10 Energy Platform (K151649, K170170) 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 is able to identify the BiZact™ device via the RFID tag embedded in the connector (Valleylab LS10 LS Series single Channel Vessel Sealing Generator and Valleylab FT10 Electrosurgical Platform) 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 combination of the BiZact instrument and the generator algorithm achieve complete and permanent tissue fusion.
The provided document is a 510(k) premarket notification for a medical device (BiZact Tonsillectomy Device) and does not contain information about an AI/ML-based device or its performance criteria related to AI/ML tasks.
Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device's performance. The document focuses on the substantial equivalence of a physical electrosurgical device to a predicate device, based on mechanical, electrical, functional, biocompatibility, sterilization, and animal (ex-vivo/in-vivo) studies.
The request asks for:
- Table of acceptance criteria and reported device performance (for AI/ML): Not applicable, as this is not an AI/ML device. The document summarizes various engineering and biological tests, but not specific AI performance metrics like sensitivity, specificity, or AUC.
- Sample size for test set and data provenance: The document mentions "fresh porcine renal arteries" for burst pressure, "porcine model" for lymphatic and acute hemostasis studies, and a "chronic hemostasis porcine study." It does not specify sample sizes in terms of number of cases for these animal studies beyond indicating they were sufficient for verification. Data provenance is "porcine model" (animal data), which is prospective in the context of these experiments. There is no human patient data test set for AI.
- Number of experts and qualifications for ground truth: Not applicable for an AI/ML device. Ground truth in this context would be physical measurements, biological response, or pathological findings from the animal studies, not expert consensus on AI outputs.
- Adjudication method: Not applicable for an AI/ML device.
- MRMC comparative effectiveness study: Not applicable, as there's no AI component or human reader interaction with AI.
- Standalone AI performance: Not applicable.
- Type of ground truth: For the physical device, it's based on physiological and pathological outcomes in animal models (e.g., vessel burst pressure, acute hemostasis, lymphatic sealing, lateral thermal spread over time).
- Sample size for training set: Not applicable, as there is no AI training set.
- How ground truth for training set was established: Not applicable.
In summary, the provided document describes a medical device clearance for an electrosurgical tool, not an AI/ML device. Therefore, none of the requested information pertaining to AI/ML acceptance criteria and performance studies can be found or inferred from the text.
Ask a specific question about this device
Page 1 of 1