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510(k) Data Aggregation
(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.
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The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Divider is a bipolar electrosurgical instrument intended for use in minimally invasive or open surgical procedures where ligation of vessels, tissue bundles, and lymphatics is desired. The LigaSure Sealer/Divider can be used on vessels (arteries and veins) up to and including 7 mm. It is indicated for use in general surgery and such surgical specialties as urologic, vascular, thoracic, and gynecologic. Procedures may include, but are not limited to, Nissen fundoplication, colectomy, adhesiolysis, hysterectomy, oophorectomy, etc.
The LigaSure system has not been shown to be effective for tubal coagulation for sterilization procedures. Do not use the LigaSure system for these procedures.
The Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737 and LF1744) are sterile, single-use, hand-held bipolar electrosurgical instruments designed for use with the Covidien electrosurgical generators to ligate (seal) and divide (cut) vessels, tissue bundles and lymphatics during open and minimally invasive general surgical procedures using radio frequency (RF) energy. A hand actuated mechanism allows the user to open and close the instrument jaws. When the instrument jaws are correctly placed over tissue or vessel to be sealed, the user operates a second control to initiate delivery of bipolar energy, which seals the tissue. When the sealing cycle is complete, the user operates a separate control to activate a knife, which divides the tissue along the seal line.
The request is for information on the acceptance criteria and study proving device performance for the Medline ReNewal Reprocessed LigaSure Maryland Jaw Sealer/Dividers (models LF1723, LF1737, and LF1744), as detailed in the FDA 510(k) summary K182588.
Based on the provided document, the device is a reprocessed version of a legally marketed predicate device. The submission primarily focuses on demonstrating that the reprocessed device is substantially equivalent to the original predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers with 510(k) K141153) through performance testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the functional characteristics of the proposed reprocessed devices have been evaluated and found to be equivalent to the predicate devices. The acceptance criteria are implied to be that the reprocessed device performs comparably to the new predicate device across various tests.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Electrical Safety & Electromagnetic Compatibility (EMC) | In accordance with IEC 60601-2-2 and 60601-1-2. (The reprocessed device meets these standards, implying equivalence to the predicate which would also meet these standards). |
| Simulated Use | Evaluated and found equivalent to the predicate devices. This implies the reprocessed devices perform as expected during simulated surgical procedures. |
| Device Integrity | Evaluated and found equivalent to the predicate devices. This suggests the physical and structural integrity of the reprocessed devices is maintained. |
| Blade Trigger Advance/Return | Evaluated and found equivalent to the predicate devices. The cutting mechanism functions correctly. |
| Activation Button Device Recognition | Evaluated and found equivalent to the predicate devices. The device properly interacts with the associated electrosurgical generators. |
| Thermal Analysis Characterization | Evaluated and found equivalent to the predicate devices. The reprocessed device's thermal performance (e.g., heat generation during use) is comparable to the predicate. |
| Tissue Sticking | Evaluated and found equivalent to the predicate devices. The reprocessed device minimizes tissue sticking during use, similar to the predicate. |
| Burst Pressure | Evaluated and found equivalent to the predicate devices. This likely refers to the strength of the seal created by the device on vessels, demonstrating its ability to occlude vessels effectively, comparable to the predicate. |
| Histopathology | Evaluated and found equivalent to the predicate devices. This suggests the tissue effects (e.g., thermal damage, seal quality) produced by the reprocessed device are similar to those of the predicate. |
| Seal Quality | Evaluated and found equivalent to the predicate devices. This is a direct measure of the effectiveness of the device in sealing vessels, confirming it performs comparably to the predicate. |
| Cleaning: Protein, and Carbohydrates (Residuals After Reprocessing) | Evaluated and found equivalent to the predicate devices. This confirms the reprocessing methods effectively remove biological contaminants to a safe level, meeting the standards necessary for a reprocessed device. (Though "equivalent to the predicate" is stated, for cleaning, the acceptance is typically passing a defined threshold for residuals, implying the reprocessed devices meet these thresholds). |
| Biocompatibility: Cytotoxicity, Sensitization, Irritation, Pyrogenicity, and Acute Systemic Toxicity | Evaluated and found equivalent to the predicate devices. This indicates that the materials and reprocessing do not induce adverse biological responses, meeting established biocompatibility standards. (Similar to cleaning, "equivalent to the predicate" here means meeting the same biological safety standards of a new device). |
| Performance Qualification | Evaluated and found equivalent to the predicate devices. This generally refers to verification that the manufacturing process consistently produces device that meets specifications. |
| Sterilization Validation | Evaluated and found equivalent to the predicate devices. This confirms the sterilization process effectively renders the reprocessed devices sterile to an acceptable sterility assurance level (SAL). |
| Product Stability | Evaluated and found equivalent to the predicate devices. This assesses the device's ability to maintain its safety and performance characteristics over its shelf life. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each of the performance tests. It broadly states "The functional characteristics of the proposed devices have been evaluated..." without providing numerical details for the test sets.
The data provenance is not explicitly stated in terms of country of origin. Given it is an FDA submission for a device manufactured by "Surgical Instrument Service and Savings Inc (dba Medline ReNewal)" and the predicate is from "Covidien," it can be inferred that the testing and data would be primarily from the United States, following U.S. regulatory guidelines. The data is retrospective in the sense that it relies on established standards and comparisons to an already legally marketed predicate device, rather than a novel prospective clinical trial for the reprocessed device's primary effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth for this type of device comparison study. The tests listed are primarily engineering and laboratory-based performance evaluations (e.g., electrical, mechanical, material, and in-vitro or ex-vivo tissue property tests). For biocompatibility and histopathology, qualified laboratories and pathologists would perform the evaluations, but their specific number and qualifications are not detailed in this summary.
4. Adjudication method for the test set
Not applicable. This is not a study requiring adjudication of clinical outcomes or interpretations by multiple readers/experts. The testing involves objective measurements against established engineering and biological standards.
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 a study involving AI or human readers for diagnostic interpretation. It is a performance evaluation of a reprocessed surgical instrument.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance evaluation of this reprocessed device is established by:
- Predicate Device Performance: The primary ground truth is the established safety and effectiveness of the legally marketed predicate device (Covidien LigaSure Maryland Jaw One Step Sealer/Dividers, K141153). The reprocessed device is deemed substantially equivalent if its performance matches or falls within acceptable ranges compared to the predicate.
- Industry Standards: Compliance with international and national standards (e.g., IEC 60601 series for electrical safety, ISO standards for biocompatibility and sterilization, and internal performance specifications), which represent a form of accepted "ground truth" for device safety and performance.
- Laboratory-based measurements: Objective measurements of physical, chemical, and biological properties through various tests (e.g., burst pressure, protein residuals, cytotoxicity).
- Histopathology: Evaluation of tissue effects, performed by qualified personnel (likely pathologists), forms a 'ground truth' for tissue interaction.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
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(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.
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