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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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(53 days)
LAP-iX is a sterile, single-patient-use electrosurgical accessory intended to conduct electrosurgical current for cutting and coagulation of tissue and/or to provide suction and irrigation functions to the surgical site.
The LAP-iX provides suction or irrigation and conducts high-frequency monopolar electrosurgical energy from compatible electrosurgical generators to a surgical site during laparoscopic and endoscopic procedures. It delivers sterile irrigation fluids to surgical site and evacuates blood and body fluids from the surgical site to aid visualization. They are used during open, endoscopic, and laparoscopic surgical procedures to ablate, remove, resect, and coagulate soft tissue where associated hemostasis is required. Depending on the shape of the handle, there are two types, PISTOL Type and TRUMPET Type. Each type also offer both Unlock Type and Lock Type. There are 8 models in total. The electrode offers two types: L-HOOK and SPOON Type. The voltage should not exceed 175Vrms (3002 standard), and set to minimum power (100W, 3002 standard). The connector (banana jack) of the subject device is compatible with all suction/irrigation pumps and electrosurgical generator in the market which have the connecting tubes or connectors of Ø10mm (Suction), Ø7mm(Irrigation) and Ø4mm(Electrode).
The provided document is a 510(k) summary for the LAP-iX electrosurgical accessory. It outlines the device's indications for use, its description, and the performance data that supports its substantial equivalence to a predicate device. However, it does not describe an AI-based device, nor does it conduct a study where device performance is measured against acceptance criteria in the way typically expected for AI/ML medical devices.
The document discusses various performance tests relevant to an electrosurgical device, such as sterilization validation, shelf-life validation, biocompatibility tests, and electrical/mechanical performance tests. These are to ensure the LAP-iX is safe and effective for its intended use, and substantially equivalent to its predicate.
Therefore, many of the requested categories for AI/ML device studies cannot be addressed using the provided text.
Here's a breakdown based on the information available and an explanation where information is not available due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
The document lists performance tests, but it does not specify acceptance criteria in a quantitative manner as typically seen for AI/ML device performance (e.g., sensitivity, specificity thresholds). Instead, it states that tests were performed "in accordance with" standards or for specific engineering parameters.
| Test Category | Acceptance Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Sterilization Validation | In accordance with ISO11737-1 | Test results support substantial equivalence |
| Shelf Life Validation | Not explicitly stated (implied to meet intended shelf life) | Test results support substantial equivalence |
| Biocompatibility (Cytotoxicity) | In accordance with ISO 10993-5 | Test results support substantial equivalence |
| Biocompatibility (Ethylene Oxide Sterilization Residuals) | In accordance with ISO 10993-7 | Test results support substantial equivalence |
| Biocompatibility (Skin Sensitization) | In accordance with ISO 10993-10 | Test results support substantial equivalence |
| Biocompatibility (Irritation) | In accordance with ISO 10993-10 | Test results support substantial equivalence |
| Performance Tests (Surface) | Not explicitly stated (visual inspection) | Test results support substantial equivalence |
| Performance Tests (Nominal size) | Not explicitly stated (dimensional check) | Test results support substantial equivalence |
| Performance Tests (Leakage) | Not explicitly stated | Test results support substantial equivalence |
| Performance Tests (Continuity) | Not explicitly stated | Test results support substantial equivalence |
| Performance Tests (Dielectric Strength Test of Electrode cable) | Not explicitly stated | Test results support substantial equivalence |
| Performance Tests (HF Leakage current Test of Electrode cable) | Not explicitly stated | Test results support substantial equivalence |
| Performance Tests (Tensile Strength Test of Electrode cable) | Not explicitly stated | Test results support substantial equivalence |
| Electrical Safety (implicit from description) | Voltage not to exceed 175Vrms (300Ω standard), set to minimum power (100W, 300Ω standard) | Device is compatible with specified electrical parameters, and assumed to meet these safety thresholds during operation with compatible devices. |
Study Proving Device Meets Acceptance Criteria:
The document explicitly states: "The following tests were performed on the subject device and the test results support that the subject device is substantially equivalent to the predicate devices." This implies that the device successfully met the internal acceptance criteria set for each test, which were designed to demonstrate its safety and effectiveness in line with the predicate device and relevant standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify the sample size for individual performance tests. For instance, it doesn't say how many units were tested for sterilization or tensile strength.
- Data Provenance: Not specified. These are engineering and bench tests, not clinical data sets from specific countries. The manufacturer is in the Republic of Korea.
- Retrospective/Prospective: Not applicable as this submission pertains to an electrosurgical accessory, not a diagnostic or prognostic data-driven device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is not an AI/ML diagnostic or predictive device that requires expert-established ground truth for a test set. The "ground truth" for these tests would be the physical properties of the device meeting predetermined engineering specifications and international standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical studies, especially those involving expert review of diagnostic images or interpretations. The tests performed are engineering and laboratory tests.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance tests would be the established engineering specifications, safety standards (e.g., ISO, electrical safety limits), and functional requirements for an electrosurgical device accessory. It does not involve expert consensus on medical findings, pathology, or outcomes data in the way an AI diagnostic device would.
8. The sample size for the training set
Not applicable. This device does not use an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device does not use an AI/ML algorithm that requires a training set.
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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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