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The Unimicro Trocar kit,Model: Auto-Locking Trocar, and Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.

The Auto-Locking Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Auto-Locking Trocar is available in three (3) sizes: 5mm, 10mm and 12mm. The cannula assembly has a universal seal ,a valve,and a stopcock.This device has a bladed tip with an internal shield, which is designed to cover the cutting edges once the body cavity has been entered.

The Hasson Trocar has application in a variety of endoscopic procedures to provide a port for entry for endoscopic instruments. The Hasson Trocar is available in two (2) sizes: 10mm and 12mm.This device has a blunt tip, which is designed for open Laparoscopy. The cannula assembly has a fixation device, a universal seal, a valve, and a stopcock.

The Bladeless Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments. The Bladeless Trocar is available from 5-12mm: The cannula assembly (10mm to 12mm type) has a universal seal, a valve, and a stopcock. The cannula assembly (5mm type) has a stopcock.

The document is a 510(k) summary for the Unimicro Trocar Kit. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All the test results demonstrate Unimicro Trocar kit meet the requirements of its pre-defined acceptance criteria and intended uses." However, the specific numerical or qualitative acceptance criteria for each performance test (Obturator Compatibility, Insertion & Cannula Stability, Air Leakage) are not explicitly stated in this summary. It only indicates that they were met.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "A series of safety tests were performed" and "The performance testing conducted on subject device and predicate device," but does not provide specific numbers for the devices tested.
• Data Provenance: The tests were non-clinical ("non-clinical testing") and likely conducted in-house or by a third-party lab affiliated with the manufacturer, Unimicro Medical Systems (ShenZhen) Co., Ltd. The manufacturer is based in Shenzhen, Guangdong Province, China. The data would therefore be retrospective in the context of the 510(k) submission, meaning the tests were completed before the submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a medical instrument (trocar kit), not a diagnostic algorithm or image analysis device that requires expert ground truth for its performance evaluation in the way medical AI would. The performance is assessed through engineering and biocompatibility testing.

4. Adjudication Method for the Test Set

Not applicable. As this is not a diagnostic or AI-driven device, there is no "ground truth" established by human experts that would require adjudication. Performance is determined by objective physical and biological tests against established technical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. The Unimicro Trocar Kit is a physical medical device, not an AI or diagnostic tool that would involve human readers or image interpretation.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The Unimicro Trocar Kit is a physical medical device, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance of the Unimicro Trocar Kit is established through adherence to recognized international standards (e.g., ISO 10993 series for biological evaluation, ISO 11135-1 for sterilization) and pre-defined engineering acceptance criteria for functional performance (e.g., obturator compatibility, insertion/cannula stability, air leakage). This is a technical ground truth, not an "expert consensus," "pathology," or "outcomes data" in the typical sense for diagnostic devices.

8. Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for this device.

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The Unimicro Veress Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

The Unimicro Veress Needle is a sterile and single-use product. It incorporates a spring-loaded blunt stylet mechanism. It is used to establish peritoneum prior to trocar and cannula insertion in laparoscopic procedures. The Unimicro Veress Needle, available in 120 mm and 150 mm lengths, has applications in gynecological laparoscopy and other laparoscopic procedures.

The provided document is a 510(k) summary for the Unimicro Veress Needle. It outlines non-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing specific performance metrics against acceptance criteria. Therefore, directly addressing all points of your request for a study proving device acceptance criteria is not fully possible from this document, as it focuses on non-clinical performance and comparison.

However, I can extract the relevant information regarding acceptance criteria and testing where available.

Description of the Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria:

The Unimicro Veress Needle underwent non-clinical testing to demonstrate its safety and effectiveness, and to establish substantial equivalence to its predicate device (Unimax Veress Needle, K111441). The acceptance criteria for these tests were "pre-defined," and the device "met the requirements of the pre-defined acceptance criteria." The specific numerical or qualitative values of these pre-defined acceptance criteria are not explicitly stated in the provided text. The study involved a series of in vitro and in vivo preclinical physical, mechanical, and biocompatibility tests.

1. A table of acceptance criteria and the reported device performance

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the non-clinical tests. It also does not discuss data provenance in terms of country of origin or whether the study was retrospective or prospective, as these are typically considerations for clinical studies and not explicitly for non-clinical lab testing of a medical device's physical properties.

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 applicable and not provided in the document. The tests described are non-clinical, mechanical, and biocompatibility tests conducted in a laboratory setting. Ground truth in this context would typically refer to established scientific standards (e.g., ISO standards) and objective measurements rather than expert consensus on interpretations of data (as would be the case for medical imaging or diagnostic devices).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessment. The tests performed are objective 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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices often involving human interpretation and AI assistance, neither of which are discussed for this device. The document explicitly states "non-clinical testing" and compares the device to a predicate based on physical, mechanical, and biocompatibility properties.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and not provided. The device is a physical Veress Needle, not an algorithm or software. Therefore, the concept of standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the non-clinical tests described would be based on objective measurements against established engineering, material, and biological safety standards (e.g., force values, operational efficiency, compliance with ISO 10993 standards for biocompatibility). It is not based on expert consensus, pathology, or outcomes data.

8. The sample size for the training set

This information is not applicable and not provided. The concept of a "training set" is relevant for machine learning algorithms, which are not involved with this physical medical device.

9. How the ground truth for the training set was established

This information is not applicable and not provided as there is no training set for a physical medical device.

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The Monopolar Laparoscopic Accessories is a family of instruments which includes forceps, scissors, and probes which are intended to be used in general laparoscopic surgical procedures requiring the use of Monopolar electrosurgical cutting and/or coagulation.

The Monopolar Laparoscopic Accessories includes Grasping Forceps, Monopolar Scissors, and Monopolar Probe/Electrodes. The devices are disposable, single use, individually packaged devices that are composed of biocompatible materials. Scissors and forceps have a handle with rotating wheel attached to an insulated shaft with different tips, which allows the shaft and tip to rotate. They include a male cautery connector when attached to standard monopolar cautery cables and their generators. Probes/Electrodes have an insulated shaft with a thermally conductive metal tip electrode. The proximal end of the shaft is attached to a handle made of an injection molded, medical grade plastic.

This document describes the premarket notification (510(k)) for Unimicro Medical Systems' Monopolar Laparoscopic Accessories. It focuses on demonstrating substantial equivalence to a predicate device, not on specific AI device performance. Therefore, many of the requested categories related to AI performance, such as sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone algorithm performance, and training set details, are not applicable in this context.

Here's a breakdown of the available information:

1. Table of acceptance criteria and reported device performance:

The document describes the types of tests performed and indicates that the device met the pre-defined acceptance criteria, but it does not provide a table with specific quantitative acceptance criteria or detailed results. Instead, it states: "All the test results demonstrate the performance of Monopolar Laparoscopic Accessories meets the requirements of its pre-defined acceptance criteria and intended uses." and "The results of the non-clinical testing demonstrate that the Monopolar Laparoscopic Accessories is as safe and effective as the predicate devices."

The tests conducted include:

Note: The document references safety tests conducted in accordance with several IEC and ISO standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18, ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 11135-1). These standards would contain specific acceptance criteria, but they are not detailed in this submission summary.

2. Sample size used for the test set and data provenance:

• Sample Size: Not specified. The document mentions "a series of in vitro and in vivo preclinical physical, mechanical and biocompatibility tests," but does not provide specific sample quantities for each test.
• Data Provenance: The tests were conducted by the manufacturer, Unimicro Medical Systems (ShenZhen) Co., Ltd. The document does not specify the country of origin for the data (e.g., patient data, if applicable), as the tests are primarily bench/biocompatibility tests on the device itself. The study appears to be entirely prospective in the sense that these tests were conducted specifically for this submission.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

• This is not applicable for a medical device that does not involve diagnostic or AI-driven interpretations requiring expert ground truth. The tests are physical, mechanical, and biocompatibility assessments.

4. Adjudication method for the test set:

• Not applicable, as this is related to expert consensus for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:

• No, an MRMC study was not done. This device is a surgical accessory, not an AI diagnostic tool that would typically involve human readers interpreting cases.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

• Not applicable. This device is a physical surgical tool and does not employ an algorithm.

7. The type of ground truth used:

• The "ground truth" for the device's performance is based on the specifications outlined in the referenced international standards (e.g., IEC, ISO) for physical, mechanical, and biocompatibility properties. The tests assess whether the device meets these engineering and safety standards.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established:

• Not applicable. This is not an AI device that requires a training set.

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The Unimicro Disposable Retrieval Endo-Pouch is intended for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.

The Unimicro Disposable Retrieval Endo-Pouch is a sterile and single-use specimen container designed for use in retrieving specimens during endoscopic surgery. The Unimicro Disposable Retrieval Endo-Pouch is supplied in a dispending tube for ease of insertion through a standard 10,11or 12mm trocar sheath.

The document is a 510(k) premarket notification for the Unimicro Disposable Retrieval Endo-Pouch. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness through clinical studies with acceptance criteria based on outcome measures.

Therefore, the information typically requested in your prompt (such as acceptance criteria for device performance in terms of accuracy, sensitivity, specificity, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and how ground truth for training data was established) is not applicable to this 510(k) submission for a medical device that retrieves tissues, organs, and calculi during surgical procedures.

Instead, the submission relies on demonstrating similarity in intended use, design, principles of operation, materials, performance, and sterilization to a predicate device. The "acceptance criteria" here refers to the successful completion of non-clinical (bench) testing to ensure the device performs as expected and meets safety requirements.

Here's a breakdown of the relevant information from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "A series of preclinical physical, mechanical and biocompatibility tests were performed to assess the safety and effectiveness of the Unimicro Disposable Retrieval Endo-Pouch. All the test results demonstrate the performance of Unimicro Disposable Retrieval Endo-Pouch meets the requirements of its predefined acceptance criteria and intended uses."

While the specific acceptance criteria and detailed quantitative results for each test are not provided in this summary document, the general categories of tests and the conclusion are stated.

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. Standard practice for non-clinical bench testing generally involves a sufficient number of units to demonstrate reproducibility and robustness, but specific numbers are not typically included in a 510(k) summary.
• Data Provenance: Not explicitly stated, but these are bench tests conducted by the manufacturer, Unimicro Medical Systems (ShenZhen) Co., Ltd., in China. The data would therefore be prospective in the sense that the tests were conducted specifically for this submission, but not in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. This is a non-clinical device that collects specimens. There is no "ground truth" to be established by clinical experts in the context of the described bench tests. The tests evaluate physical, mechanical, and biological properties according to engineering and biocompatibility standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not Applicable. As these are non-clinical bench tests evaluating device properties, there is no need for expert adjudication of results in the way it would be applied to a diagnostic imaging algorithm. Test results are typically objective measurements.

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 a device for specimen retrieval, not a diagnostic AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a medical device, not an algorithm. Bench testing evaluates the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• Not Applicable. For non-clinical bench testing, the "ground truth" or reference standard would be the pre-defined engineering specifications, material properties, and biocompatibility standards (e.g., ISO 10993 suite). These are objective criteria.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is a physical medical device, not a machine learning model.

9. How the ground truth for the training set was established:

• Not Applicable. (See point 8).

Summary of Equivalence (rather than direct performance against clinical criteria):

The submission demonstrates substantial equivalence by comparing the Unimicro Disposable Retrieval Endo-Pouch to the predicate device, Unimax Specimen Retrieval System (K103510), across several parameters:

• Intended Use: Identical ("receptacle for the collection and extraction of tissue, organs and calculi during general and laparoscopic surgical procedures.")
• Design: Both consist of a flexible polymer bag and an introducer structure that fits through a trocar port.
• Principles of Operation: Implied to be identical given design and intended use.
• Materials: Both use "Various polymer Stainless."
• Performance: Supported by the statement "The result of bench testing indicates that the new device is as safe and effective as the predicate device" and that the non-clinical tests "demonstrate the performance... meets the requirements of its predefined acceptance criteria and intended uses."
• Sterilization: Both are EO Sterilized.
• Biocompatibility: Both adhere to ISO 10993 standards (with slightly updated versions for the proposed device, reflecting current standards).

In conclusion, this 510(k) submission establishes equivalence through non-clinical testing against predefined engineering and biocompatibility standards, rather than through clinical studies with performance metrics like sensitivity/specificity or expert-adjudicated ground truth.

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The Unimicro Suction Irrigation Tubing set is available with an array of probe designs to facilitate lavage during laparoscopic surgery. This device has applications in laparoscopic, general, thoracic and urology procedures to provide suction and irrigation functions to help flush blood and tissue debris from the operative site during laparoscopy to aid visualization.

The Unimicro Suction Irrigation Tubing set is indicated for use in patients undergoing a laparoscopic surgical procedure. It is designed to deliver-sterile irrigation fluids to surgical sites during laparoscopic procedures and to evacuate blood, tissue debris, and smoke from the surgical site.

The suction irrigation set consists of a hand piece equipped with two trumpet style valves, a probe, and connecting lines of tubing, one set designed to attach to a supply of irrigation fluid, and the other designed to attach to an aspiration pump. The valves allow controlled irrigation and aspiration during a surgical procedure.

The hand piece of the suction irrigator is designed to allow instruments to be introduced through the suction irrigation probe to reach the operative site. The instrument adapter is adjustable to allow a variety of instruments and diameters. It is a single use, disposable device and is sold sterile.

The provided text is related to a 510(k) premarket notification for a medical device called the "Unimicro Suction Irrigation Tubing set." This document is a regulatory submission to the FDA, demonstrating that a new device is as safe and effective as a legally marketed predicate device.

The study described is a non-clinical study for the Unimicro Suction Irrigation Tubing set. The goal is to demonstrate "substantial equivalence" to a predicate device (Unimax Suction Irrigation Set, K103509).

Here's the breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Integrity of tubing and connections
• Functionality of trumpet valves (irrigation and aspiration)
• Flow rates
• Leakage
• Component strength | "All the test results demonstrate the performance of Unimicro Suction Irrigation Tubing set meets the requirements of its pre-defined acceptance criteria and intended uses." (Specific performance metrics are not provided in this summary.) |
  | Biocompatibility Tests:
• Cytotoxicity Test
• Intracutaneous Reactivity Test
• Maximization Sensitization Test | The text indicates these tests were performed and imply the results met acceptance criteria for safety, as the conclusion states the device is "safe and effective." |

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: Not specified in the provided summary.
• Data Provenance: The tests were performed by "Unimicro Medical Systems (ShenZhen) Co., Ltd." which is based in Shenzhen, Guangdong Province, China. The study appears to be prospective as it's a series of non-clinical tests conducted on the device as part of the submission process.

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 is a non-clinical performance and biocompatibility study of a medical device (suction/irrigation tubing set), not a diagnostic algorithm that requires expert ground truth establishment for medical image interpretation or clinical outcomes.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is a non-clinical performance and biocompatibility study. Adjudication methods are typically used in clinical studies with human assessors or when resolving discrepancies in ground truth establishment for diagnostic algorithms.

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 a non-clinical study for physical device performance and biocompatibility. It does not involve human readers, AI assistance, or comparative effectiveness in a clinical diagnostic context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical medical instrument (tubing set), not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context refers to the pre-defined technical specifications, performance standards (e.g., flow rates, pressure limits, material strength), and biocompatibility requirements for medical devices. These are typically established through engineering standards, regulatory guidelines (e.g., ISO standards for biocompatibility), and internal product specifications.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. This is a physical medical device, not an AI model.

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