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510(k) Data Aggregation
(51 days)
The Disposable Laparoscope Trocar has applications in abdominal, thoracic, and gynecologic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The proposed device is a basic equipment used during laparoscopic surgical, and the surgical device will enter into abdominal cavity via the passage established by the trocar. The proposed device is available in 5mm, 10mm, 12mm, 15mm four diameters to accommodate different sizes surgical instrument.
The document provided is a 510(k) Summary for a medical device called "Disposable Laparoscope Trocar." This summary describes the device and its equivalence to predicate devices, focusing on non-clinical testing. It does not contain information about acceptance criteria for a device performance study in the context of diagnostic accuracy, AI, or human reader performance.
Instead, the "acceptance criteria" discussed are related to standard engineering and biocompatibility tests for a surgical instrument. The study described is a series of non-clinical bench tests and an in-vivo animal study to demonstrate the safety and foundational performance characteristics of the trocar.
Therefore, many of the requested categories (such as sample size for test set, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, etc.) are not applicable to this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the benchmarks set by the predicate and reference devices, and by compliance with relevant ISO and ASTM standards. The reported device performance is mainly comparative to these existing devices and standards.
| Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Subject Device K201641) |
|---|---|
| Biocompatibility: Complied with ISO 10993 standards for Cytotoxicity, Sensitization, Intracutaneous, System Toxicity, Pyrogen. | Comply with ISO 10993 standards (for Cytotoxicity, Sensitization, Intracutaneous, System Toxicity, Pyrogen) |
| Insertion Force: Comparable to predicate/reference devices (e.g., BLTC12 Average 4.2 N, B5LT Average 2.35 N) | RJTC-A5: Average 2.25 N |
| RJTC-A15: Average 4.08 N | |
| Removal Force: Comparable to predicate/reference devices (e.g., BLTC12 Average 10.19 N, B5LT Average 6.27 N) | RJTC-A5: Average 6.37 N |
| RJTC-A15: Average 10.31 N | |
| Leak Resistance: No Leakage | No Leakage |
| Snap Feature Retention Force: Comparable to predicate/reference devices (e.g., BLTC12 Average 11.98 N, B5LT Average 1.69 N) | RJTC-A5: Average 1.8 N |
| RJTC-A15: Average 11.8 N | |
| Sterilization Assurance Level (SAL): 10^-6 | 10^-6 |
| Endotoxin Limit: 20 EU per device | 20 EU per device |
| Ethylene Oxide Sterilization Residuals: Complies with ISO 10993-7:2008 | (Tested, implied compliance) |
| Bacterial Endotoxin Limit: Complies with USP | (Tested, implied compliance) |
| Seal Strength: Complies with ASTM F88/F88M-15 | (Tested, implied compliance) |
| Seal Leaks (Dye Penetration): Complies with ASTM F1929-15 | (Tested, implied compliance) |
| Tip Integrity: Maintained after insertion (from in vivo study) | (Evaluated, implied satisfactory) |
| Visualization Performance (for optical type): Adequate (from in vivo study) | (Evaluated, implied satisfactory) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for each specific bench test, but implied to be sufficient for statistical validity in engineering tests. For the in vivo study, it mentions a "porcine model," implying a number of animal subjects were used, but the exact count is not given.
- Data Provenance: Not specified where these tests were conducted, beyond the applicant being Beijing Biosis Healing Biological Technology Co., Ltd. (China). The tests are presumably retrospective data collected during device development.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This is not applicable as the evaluation involves physical and chemical property testing, not subjective expert assessment of clinical data or images.
4. Adjudication Method for the Test Set
- This is not applicable. Objective measurements and established testing protocols are used.
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
- This is not applicable as the device is a physical surgical tool (trocar), not an AI-powered diagnostic or assistive technology.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable as the device is a physical surgical tool and does not involve an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for these tests are the established definitions and methodologies within the cited ISO and ASTM standards, as well as the performance characteristics of legally marketed predicate devices. For biocompatibility, it's the biological response as per standardized tests. For mechanical properties, it's the quantifiable physical measurements.
- For the in vivo study, the ground truth would be the direct observation of insertion force, fixation force, visualization, and tip integrity in a live biological model.
8. The Sample Size for the Training Set
- This is not applicable as there is no "training set" in the context of a physical medical device. This is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- This is not applicable for the same reason as above.
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(127 days)
The Ultravision™ Visual Field Clearing System is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery.
The Ultravision 5mm Trocar component also establishes a path of entry for instruments used in laparoscopic surgery.
The Ultravision™ Visual Clearing System removes surgical smoke from the visual field during laparoscopic surgery by means of electrostatic precipitation. The System consists of the Ultravision Generator, the Ionwand Sterile Pack, and the Ionwand 5mm Trocar. The Ionwand is connected to the energy source and is then introduced into the body cavity near the smoke generating electrosurgical device. The Ultravision™ 5mm Trocar is a new accessory device intended for use only with the Ultravision™ Visual Field Clearing System to introduce the Ionwand while providing a pathway for laparoscopic instruments through one 5 mm trocar incision. The Ultravision™ 5mm Trocar provides an alternative to the currently available Ultravision™ Visual Field Clearing System Ionwand™ Sterile Pack for introduction of the Ionwand. The Ultravision™ 5mm Trocar is a standard dilating laparoscopic trocar compatible for use with 5mm instruments. The trocar design includes a discrete lumen that is positioned separate from the main trocar channel and which accepts the Ionwand component of the system. The trocar design allows the distal tip of the Ionwand to exit the trocar some 12mm from its distal point and at an angle to the trocar body that positions the Ionwand at a point close to but not interfering with the 5mm energy instruments that are intended to be accommodated by the trocar. The Ultravision™ 5mm trocar and Ionwand are provided packaged together in the same sterile barrier packaging. The trocar may be used with or without the Ionwand component of the system.
The provided text describes the regulatory clearance (510(k) submission) for the Ultravision™ Visual Field Clearing System, specifically focusing on the new 5mm Trocar component. It details the device's function, comparison to predicate devices, and the nonclinical testing performed to demonstrate substantial equivalence.
Based on the provided information, the device is not an AI/ML medical device. It's a surgical device for clearing smoke during laparoscopic surgery. Therefore, many of the typical acceptance criteria and study components associated with AI/ML devices (like MRMC studies, expert consensus for ground truth on training data, etc.) are not applicable here.
However, I can extract the acceptance criteria and the study (nonclinical testing) that proves the device meets them from the provided text, interpreting them in the context of a physical medical device.
Here's the information as requested, with "N/A" for sections not applicable to this type of device or not explicitly mentioned in the document:
Acceptance Criteria and Device Performance for Ultravision™ Visual Field Clearing System (K170178)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the successful results of the specified nonclinical tests, demonstrating equivalence to predicate devices. The reported device performance is that it "Pass"-ed all these tests and was found "Equivalent" to the predicate.
| Acceptance Criteria (Test) | Description of Test | Reported Device Performance (Result) |
|---|---|---|
| Performance of the system to clear the visual field of smoke and particulate matter | Performance comparison to the predicate device under simulated use conditions | Equivalent to predicate - Pass |
| Usability | Complexity of use compared to the predicate and reference device | Equivalent to predicate and reference - Pass |
| Ionwand removal and reinsertion | Repeated insertions/removals performed and forces both quantitative and qualitative evaluations performed | Equivalent to predicate and reference - Pass |
| Leak resistance and sealing, maintenance of pneumoperitoneum during use | Pressure tests under high and low pressures with and without instruments or Ionwand inserted, including multiple cycles of use | Equivalent to predicate or reference - Pass |
| Strength, resistance to bending | Tensile or pressure forces applied to shaft, trocar, and connections | Equivalent to predicate or reference - Pass |
| Dimensional Verification | Confirmation of dimensional characteristics by dimensional evaluation | Pass |
| Luer fitting | Confirmation of compliance with industry standard luer fitting | Pass |
| Electrical Safety | Dielectric breakdown, radio-frequency applied parts, capacitive coupling | Pass |
| Biocompatibility per ISO 10993 | Appropriate biocompatibility based on tissue contact and duration | Pass |
| Sterilization and shelf life studies | Validated sterilization cycle according to industry standard, shelf life studies on accelerated aging conditions including product and package evaluations | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- The document does not explicitly state the numerical sample sizes for each nonclinical test (e.g., how many units were tested for strength, how many cycles for reinsertion). It describes the type of tests performed.
- Data Provenance:
- Country of Origin: Not specified, but the applicant (Alesi Surgical Ltd) is based in Cardiff, GB (United Kingdom). The tests were presumably conducted internally or by a contracted lab.
- Retrospective or Prospective: These are laboratory/benchtop tests and simulated use conditions, not clinical studies on patients. Therefore, the terms "retrospective" or "prospective" as typically applied to patient data are not directly applicable. These were newly conducted tests to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: N/A. Ground truth in this context (performance of a physical device) typically relies on engineering specifications, physical measurements, and standardized testing protocols rather than expert consensus on subjective interpretations.
- Qualifications of Experts: N/A. The qualification of personnel performing the tests would be governed by internal quality systems and standards for medical device manufacturing and testing, but not explicitly stated as "experts" for ground truth establishment in the way it's done for AI models interpreting medical images.
4. Adjudication Method for the Test Set
- Adjudication Method: N/A. Adjudication methods (like 2+1 or 3+1) are typically used for establishing ground truth from multiple human readers in image interpretation tasks. For physical device testing, results are typically objective measurements against predefined acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No. This device is not an AI/ML system or diagnostic imaging tool that would benefit from an MRMC study. Its function is direct surgical smoke clearance and trocar access, not interpretation by human readers.
- Effect Size of Human Readers Improvement: N/A, as no MRMC study was conducted or relevant for this device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: N/A. This is a physical medical device, not an algorithm. Its "performance" is its physical and functional operation.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this device's performance is established by:
- Predicate Device Performance: Demonstrating "equivalence" to the legally marketed predicate device (Ultravision™ Visual Field Clearing System, DEN150022) under simulated use conditions.
- Industry Standards and Specifications: Adherence to standards like ISO 10993 for biocompatibility, industry standards for luer fittings, and general engineering principles for strength, sealing, etc.
- Established Methods for Sterilization and Shelf-Life Validation: Following recognized protocols for these critical aspects.
- Objective Measurements: Dimensional verification, pressure tests, electrical safety measurements provide objective data points.
8. The Sample Size for the Training Set
- Sample Size for Training Set: N/A. This device is not an AI/ML system that requires a "training set" in the computational sense. Device design and development are based on engineering principles and iterative testing, not statistical training on a data set.
9. How the Ground Truth for the Training Set was Established
- Ground Truth for Training Set Establishment: N/A. As there is no training set as understood in AI/ML, there is no method for establishing ground truth for it. The development and refinement of the device would involve engineering design, prototyping, and testing against functional requirements and safety standards.
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(184 days)
The EntriPort Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments. The Trocar may be used with or without visualization for primary and secondary insertions.
The EntriPort Mini Surgical Trocar System has applications in a variety of endoscopic procedures to provide a means of entry and access for endoscopic instruments.
The EntriPort Surqical Trocar System is a broad range of surgical trocars and accessories intended for use as the means for providing surgical access for various instruments during endoscopic surgery.
The EntriPort Surgical Trocar System includes both full size and mini devices, which are available in disposable (single patient use) and reposable (at least one reusable, and one disposable component) configurations. Reusable components are limited to the Reusable Cannula and accessories of the Open Entry (Hasson) Trocar.
This document, a 510(k) Summary for the ConMed EntriPort Surgical Trocar System (K142464), details a premarket notification for a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone study with specific acceptance criteria and performance metrics for a novel AI device. Therefore, much of the requested information regarding AI device evaluation is not present in this document.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table with specific, quantifiable acceptance criteria and reported device performance linked to those criteria for an AI device. Instead, it states that "Product performance testing demonstrates devices comply with design specifications and applicable sections of ISO 11607-1:2006, ISO 11135-1:2007, AAMI/ANSI ST67:2011, AAMI/ANSI ST81:2004(R)2010, ISO 10993-7:2008, ISO 14971:2007, ISO 594/1:1986, and ISO 594-2:1998." It also mentions "Performance testing, including blade insertion forces, entry wound defect size, instrument insertion and removal, maintenance of pneumoperitoneum, and trocar insufflation rate, demonstrates the device performance is substantially equivalent to the predicate devices."
This is general and focuses on compliance with existing standards and substantial equivalence to a predicate, not on novel performance metrics for an AI system.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. The document describes non-clinical bench and simulated use testing, but it does not specify sample sizes for these tests, nor does it refer to "test sets" or "data provenance" in the context of an AI study.
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)
This information is not provided. The document does not describe the establishment of a ground truth by experts, as it is not a study evaluating an AI algorithm's diagnostic or predictive capabilities.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Again, this is relevant for studies involving human interpretation or consensus, which is not described here for an AI device.
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
No such study was done or reported. This document is for a surgical trocar system, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithmic performance study was done or reported, as the device is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
No "ground truth" in the context of AI evaluation is mentioned or used. The evaluation focuses on the physical and functional aspects of the surgical trocar system against established engineering and medical device standards.
8. The sample size for the training set
This information is not provided. The concept of a "training set" is not applicable to a physical surgical device like a trocar.
9. How the ground truth for the training set was established
This information is not provided, as there is no "training set" or "ground truth" for an AI algorithm discussed in this document.
In summary:
This 510(k) document is for a surgical trocar system, which is a physical medical device. It is not an AI-powered device, and therefore, the information typically requested for evaluating the acceptance criteria and study data of an AI device (like test/training sets, ground truth establishment, expert adjudication, MRMC studies, etc.) is not present in this document. The document focuses on demonstrating substantial equivalence to an existing predicate device based on technical characteristics, materials, intended use, and compliance with general medical device standards.
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(37 days)
Insuflow® Synergy™ XL Port (10mm and 12mm) and Insuflow® Synergy™ XLR Port (10mm and 12mm with endoscopic cannula seal) have applications in thoracic, abdominal and gynecologic minimally invasive endoscopic surgical procedures to establish a path of entry for endoscopic instruments and to heat, humidify, filter and introduce a CO2 gas stream for insufflation of the surgical cavity.
The Insuflow® Synergy™ XL and XLR Port are a gas conditioning device that attaches to the outlet port of an insufflator or other regulated CO2 source and is designed to warm and humidify the CO2 gas stream prior to insufflation via an integral path of entry device during minimally invasive surgery. The Insuflow Synergy™ XL and XLR Port consist of a sterile, disposable single use device with a filter, heater/humidifier, tubing set, and a path of entry access port device. A reusable control module houses the control and safety circuits for the system. The integral path of entry access device in the Insuflow Synergy™ XL and XLR Port is designed and constructed similarly to the Insuflow® Synergy™ Port but comes in larger sizes just as the predicate EndoPath trocar device. The Insuflow® Synergy™ XL Port and the Insuflow® Synergy™ XLR Port have access devices in 10 mm and 12 mm configurations with a single-lumen working channel configuration for conditioned gas delivery. The access device has a working channel with duckbill and tool seals for instrument entry into the surgical cavity and delivers conditioned insufflation gas through the working channel. The Insuflow® Synergy™ XLR Port has an endoscope compatible configuration that has an additional seal at the bottom of the main cannula, which serves as a means to seal off around the endoscope, forcing all gas flow out of the peripheral gas exhaust ports. This minor change is intended to reduce fogging and improve visualization. The obturator for the Insuflow Synergy™ XL and XLR Port has a transparent optical window at the distal end, which when used with an endoscope, provides visibility of individual tissue layers during insertion.
The provided text describes a 510(k) summary for the Insuflow Synergy™ XL and XLR Port devices. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria, sample sizes, expert involvement, or statistical analysis typically associated with AI/ML device evaluations.
Therefore, the requested information, particularly regarding specific acceptance criteria with numerical targets, the study proving the device meets them (including sample size, data provenance, expert qualifications, adjudication, MRMC studies, standalone performance, and ground truth establishment for test and training sets), is not present in the provided text.
The text indicates that "Extensive performance testing has been conducted to assure that the Insuflow® Synergy™ XL and XLR Port perform in accordance with its specifications and applicable standards." and lists the types of tests performed. However, it does not provide the results of these tests in a quantifiable way against pre-defined acceptance criteria, nor does it detail the methodology (sample sizes, expert involvement, ground truth) as would be expected for a diagnostic AI/ML device.
What is provided regarding "performance testing" are general categories of tests:
- Flow/pressure performance
- Gas temperature and humidity characterization
- Insertion/removal testing
- Seal leak integrity testing
- A test to confirm that the cannula seal configuration (for the XLR Port) reduces scope fogging and improves visualization.
Conclusion:
Based on the provided text, it's not possible to generate the requested table of acceptance criteria and reported device performance, nor can we answer the subsequent questions about study specifics (sample size, data provenance, expert details, adjudication, MRMC, standalone performance, ground truth establishment) as these details are not included in this 510(k) summary. This document primarily focuses on establishing substantial equivalence to predicate devices through design description and a high-level summary of testing.
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(52 days)
The SurgiQuest AirSeal™ Optical Trocar & Cannula System has applications in abdominal and thoracic minimally invasive surgical procedures to establish a path of entry for endoscopic instruments. The trocar may be used with or without visualization for primary and secondary insertions.
The subject is a surgical trocar and cannula composed of medical grade materials. The device is used to create and maintain a port of entry during endoscopic surgery. It incorporates a gas seal utilizing CO2, to maintain pneumoperitoneum during the course of surgery. It is supplied with a re-circulation and filtration pump designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. The recirculation and filtration pump is reusable. The AirSeal™ Trocar & Cannula and Tube Set are fully disposable and are intended for single use only.
Acceptance Criteria and Device Performance Study for SurgiQuest™ AirSeal™ Optical Trocar & Cannula System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state numerical acceptance criteria with pass/fail thresholds. Instead, it describes functional requirements and the types of testing performed to demonstrate compliance. The "Reported Device Performance" column reflects what the document states the testing showed.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Performance for Surgical Use: | |
| Ability to create and maintain a port of entry during simulated laparoscopic surgery. | The device has been tested to show its ability to create and maintain a port of entry during simulated laparoscopic surgery. |
| Ability to maintain adequate pneumoperitoneum during simulated laparoscopic surgery. | It has also been tested to show its ability to maintain adequate pneumoperitoneum during the course of simulated laparoscopic surgery. |
| Minimize CO2 consumption during minimally invasive surgery. | The recirculation and filtration pump is designed-to maintain pneumoperitoneum and minimize CO2 consumption during minimally invasive surgery. (Testing is implied for this design feature but not explicitly stated as a direct test of CO2 consumption rates in the summary). |
| Safety and Sterility: | |
| Compliance with electrical safety and emissions standards (IEC60601-1, IEC60601-1-2). | The unit will be tested for safety and emissions in accordance with IEC60601-1, General Requirements for Safety 1: Collateral Standard: Safety Requirements for Medical Electrical Systems and IEC60601-1-2, General Requirements for Safety -Collateral Standard: Electromagnetic Compatibility -Requirements and Tests. (Implies compliance was achieved). |
| Achieves a Sterility Assurance Level (SAL) of 10-6. | Sterility validation is in accordance with ISO 11137:2006 (Part 1) and AAMI TIR 27:2001. A Sterility Assurance Level (SAL) of 10-6 is achieved. |
| Biocompatibility (implied for medical devices) | Composed of medical grade materials. (Specific testing for biocompatibility is not detailed in this summary). |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample size used for the functional performance testing (e.g., number of simulated procedures or test subjects). It states "simulated laparoscopic surgery" for the functional tests.
For sterility validation, ISO 11137:2006 and AAMI TIR 27:2001 are referenced, which are standards for radiation sterilization dose substantiation. These standards inherently involve a statistically significant number of samples, but the exact number for this specific device is not detailed in the summary.
Data Provenance: The data provenance is internal to the manufacturer, SurgiQuest, Inc., as evidenced by the statement "The device has been tested to show..." and "The unit will be tested...". The testing appears to be primarily prospective as it's for pre-market notification to determine substantial equivalence. The country of origin for the data is implicitly the USA, where the company is based.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the use of experts to establish a "ground truth" for the functional performance testing. The description indicates engineering and performance testing against industry standards and simulated conditions, rather than expert clinical evaluation for a specific medical outcome. For the safety and sterility testing, the "ground truth" is established by adherence to recognized international standards (IEC, ISO, AAMI).
4. Adjudication Method for the Test Set
Not applicable. There is no mention of an adjudication method as the testing described does not involve subjective interpretations or multiple readers requiring consensus.
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. The SurgiQuest™ AirSeal™ Optical Trocar & Cannula System is a physical surgical device, not an AI or imaging diagnostic tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study regarding "human readers improving with AI vs without AI assistance" is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used
For functional and safety testing, the ground truth is established by:
- Performance against defined simulated conditions: For creating/maintaining port of entry and pneumoperitoneum.
- Adherence to recognized international standards: IEC60601-1, IEC60601-1-2 for electrical safety and emissions; ISO 11137:2006 and AAMI TIR 27:2001 for sterility.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the context of machine learning. The "training" for the device would be its manufacturing and design optimization processes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of device.
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