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Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

Trocars and cannulae are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery.

The Trocar Cannula is available with a threaded sleeve with a 5mm inner diameter and 100mm length. The Cannula is equipped with a sealing system for maintenance of pneumoperitoneum during insertion and withdrawal of instruments and with a luer stopcock port for insufflation and desufflation of the operative cavity.

Trocar Obturator is available in bladeless configuration sized 5 mm.. Bladeless optical obturators are equipped with a clear tip and a video laparoscopy channel to allow trocar insertion under direct visual quidance and minimize the risk for internal injury

The reprocessed device has the same intended use as the original device and does not incorporate new technology or design changes.

The provided text is a 510(k) premarket notification for reprocessed trocars. It details the device, its intended use, and substantial equivalence to a predicate device. However, it does not contain the specific acceptance criteria, device performance data, study design, or validation results needed to answer your request fully.

The document states that a previous 510(k) (K062497) included information for trocars limited to one reprocessing cycle, and this current 510(k) (K100080) "includes data to demonstrate that the Trocars, models B5LT and CB5LT, can undergo two (2) reprocessing cycles without changing the safety and effectiveness of the device." This implies a study was conducted, but the details of that study are not present in the provided excerpts.

To address your request, I will indicate where the information would typically be found in a complete submission or what is inferred from the available text.

Here's a breakdown of the requested information based on the provided text and general 510(k) content expectations:

1. Table of acceptance criteria and the reported device performance

Explanation: The document explicitly states: "This 510(k) includes data to demonstrate that the Trocars, models B5LT and CB5LT, can undergo two (2) reprocessing cycles without changing the safety and effectiveness of the device." This sets the acceptance criteria at maintaining safety and effectiveness. However, the specific metrics and the actual performance results demonstrating this are not included in the provided pages.

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 provided in the excerpt. A complete 510(k) submission for reprocessing validation would typically include specific numbers of devices tested.
• Data Provenance: Not stated in the excerpt. It would usually be prospective testing of reprocessed devices.
• Country of Origin: Not specified for the data itself, but the applicant (Ascent Healthcare Solutions) is located in Phoenix, Arizona, USA, and the manufacturing site is in Lakeland, FL, USA.

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/Not mentioned. This type of information (expert review for ground truth) is more common for diagnostic imaging AI submissions. For a reprocessed medical device, the "ground truth" is typically established through direct physical, mechanical, and functional testing of the device itself against established specifications, rather than expert interpretation of data.

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

• Not applicable/Not mentioned. Adjudication methods are typically used in clinical or image-based studies where expert consensus is required for ground truth determination. Device performance testing for reprocessing generally involves 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 submission for a reprocessed surgical device, not an AI or diagnostic imaging device that would typically involve an MRMC study.

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

• Not applicable. This is for a physical medical device, not an algorithm. The performance being evaluated is that of the reprocessed trocar itself. The "standalone performance" here would effectively be the results of the physical and functional tests on the device.

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

• The "ground truth" for this type of device validation would be established through:
  • Validated test methods: Objective measurements of physical, mechanical, and functional properties (e.g., integrity, sealing, penetration force, material strength, sterility, biocompatibility) according to pre-defined specifications and industry standards.
  • Comparison to original device specifications: Ensuring the reprocessed device performs identically to the new, predicate device.
  • Safety and effectiveness demonstration: Ensuring no compromise in patient safety or clinical effectiveness due to reprocessing.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning submission with a "training set." The validation involves direct testing of the reprocessed devices.

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

• Not applicable, as there is no "training set" in this context.

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Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.

Trocars and cannulae are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery. Trocar Cannulae is available with smooth or threaded sleeve in sizes 5-12mm inner diameter and 75- 100mm length. Cannulae are equipped with a sealing system for maintenance of pneumoperitoneum during insertion and withdrawal of instruments and with a luer stopcock port for insufflation and desufflation of the operative cavity. Trocar Obturator is available in bladed configuration, sized 5-12 mm. Bladed obturators are equipped with a safety shield designed to expose the blade during insertion but to retract over the tip once the operative cavity has been penetrated, so as to reduce the risk for vascular or visceral injury.

The provided text describes the 510(k) summary for a reprocessed trocar device (K070059). However, it does not contain the specific details required to complete your request regarding acceptance criteria and a study proving device performance in the context of an AI/human-in-the-loop system.

The document is for a medical device (reprocessed trocars) and pertains to its substantial equivalence to a predicate device based on manufacturing and performance testing, not an AI or digital health device that would typically have acceptance criteria presented in the manner you've outlined.

Here's why the information is missing and what it does provide:

What the document does provide:

• Device Name: Reprocessed Trocars
• Predicate Device: ENDOPATH III Bladeless Trocars, ENDOPATH III Blunt Tip Trocars, ENDOPATH III Dilating Tip Trocars (K032676)
• Indications for Use: Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures including thoracic, gynecologic laparoscopy and other abdominal procedures.
• Technological Characteristics: "The design, materials, and intended use of Reprocessed Trocars are identical to the predicate devices. The mechanism of Reprocessed Trocars is identical to the predicate devices... There are no changes to the claims, indications, clinical applications, patient population, performance specifications, or method of operation."
• Performance Data (Testing performed):
  • Biocompatibility
  • Validation of reprocessing
  • Sterilization Validation
  • Function test(s)
  • Packaging Validation
• Conclusion: "Performance testing demonstrates that Reprocessed Trocars perform as originally intended. Ascent Healthcare Solutions concludes that the modified devices (Reprocessed Trocars) are safe, effective, and substantially equivalent to the predicate devices as described herein."

Why your specific questions cannot be answered from this document:

• Acceptance Criteria Table: The document states that performance testing was conducted, but it does not list specific acceptance criteria values or the reported device performance in a quantitative table format. It only states that the device "perform[s] as originally intended" and is "substantially equivalent."
• Sample Size for Test Set and Data Provenance: This information is not provided. The testing mentioned (biocompatibility, reprocessing validation, etc.) would have involved samples, but the specifics are not detailed. This is not a study on diagnostic accuracy or clinical outcomes that would typically have a "test set" in the context of AI.
• Number of Experts, Qualifications, Adjudication Method: These points are relevant for studies establishing ground truth for diagnostic or AI-assisted tasks. Since this document describes a physical medical device (trocars) undergoing performance and reprocessing validation, these concepts are not applicable.
• MRMC Comparative Effectiveness Study, Effect Size: No such study is mentioned or implied. This is a premarket notification for a reprocessed device, not an AI device demonstrating improvement over human performance.
• Standalone Performance: While the "function test(s)" could be considered a form of standalone performance assessment, it's not described in terms of an algorithm, and no specific metrics are given.
• Type of Ground Truth: For a physical device like a trocar, "ground truth" would be established through engineering specifications, material standards, and successful mechanical function tests, not expert consensus or pathology in the typical sense of AI/diagnostic imaging.
• Sample Size for Training Set, How Ground Truth for Training Set Was Established: These are entirely irrelevant for a reprocessed physical medical device. There is no AI model or "training set" involved in this submission.

In summary, the provided document relates to the regulatory clearance of a reprocessed surgical instrument. It does not describe an AI medical device or a study with "acceptance criteria" and "device performance" in the context of diagnostic accuracy, human-in-the-loop performance, or a comparison to human experts as you've requested.

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Reprocessed Endoscopic Trocars are indicated for use to establish a port of entry for endoscopic instruments in patients requiring minimally invasive surgical procedures.

The reprocessed device has the same intended use as the original device and does not incorporate new technology, new materials, or design changes. The product code for the original device, GCJ, falls within 21 CFR §876.1500 for Endoscopes and Accessories. An Endoscope and Accessory device is defined within the code as used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye. The accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. The Endoscopic Trocars and Cannulas specified in this submission are used in endoscopic procedures and are considered accessories to the endoscope. Endoscopic Trocars and Cannulas are designed to establish a port of entry for endoscopic instruments used during minimally invasive surgery. Surgical Endoscopic Trocars and Cannulas are available in a variety of configurations and materials as well as trocar and cannula sets. Trocar seals vary between single-port and multi-port seals. Endoscopy generally pertains to the use of a surgical instrument in conjunction with an endoscope inserted into the same body cavity. The endoscope permits visual inspection, with or without magnification, of the interior of the body cavity and permits observation of the surgical instrument during an operation for therapeutic or diagnostic purposes. Endoscopic surgery is conducted through a cannula that extends across the abdominal wall and provides channels where instruments, such as scopes, retractors and staplers, can be inserted to perform surgery. As part of this procedure, the abdominal cavity is inflated with an insufflation gas, such carbon dioxide, to maintain the abdomen in a distended state and provide increased instrument maneuvering capability within the cavity. Valves are typically provided in the trocars to form seals around the instruments to prevent leakage of the insufflation gas.

Here's an analysis of the provided text regarding the acceptance criteria and study for the reprocessed trocars, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define quantitative acceptance criteria for the reprocessed trocars. Instead, it describes various tests performed to demonstrate that the reprocessed devices perform as originally intended and are substantially equivalent to predicate devices. The "reported device performance" is a general statement of successful completion of these tests.

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

The document does not specify the sample size used for the test set for any of the performance tests (Biocompatibility, Reprocessing Validation, Sterilization Validation, Function Tests, Packaging Validation).

The data provenance is not explicitly stated in terms of country of origin or whether the studies were retrospective or prospective. Given the context of a 510(k) submission to the FDA, it is highly likely that the testing was conducted in the US, but this is not confirmed. The description suggests these were laboratory and bench tests.

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

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of the device's performance characteristics. The tests described are objective, laboratory-based performance tests (e.g., sterilization efficacy, functional integrity, biocompatibility), which typically rely on established protocols and measurement standards rather than expert consensus on a "ground truth" in the way it might be used for diagnostic imaging or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable as the described performance tests are objective laboratory and bench tests, not assessments requiring adjudication of expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission is for a reprocessed medical device, and the testing focuses on the physical, chemical, and functional characteristics of the reprocessed device compared to the original, rather than comparing human reader performance with and without AI assistance.

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

The device in question is a physical medical instrument (trocar), not an algorithm or AI system. Therefore, the concept of "standalone (algorithm only) performance" is not applicable.

7. The Type of Ground Truth Used

For the performance tests described (Biocompatibility, Validation of Reprocessing, Sterilization Validation, Function Tests, Packaging Validation), the "ground truth" is provided by:

• Established standards and specifications: Each test would have pre-defined acceptance limits or criteria that the reprocessed device must meet. For example, sterilization validation would aim for a specific sterility assurance level (SAL), and function tests would verify that the mechanical components operate within factory specifications.
• Comparison to predicate device performance: The overall "ground truth" for substantial equivalence is that the reprocessed device performs identically to the new, original predicate device.

The document does not refer to "expert consensus," "pathology," or "outcomes data" as the ground truth for these specific performance tests.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable here. This submission is for a reprocessed physical medical device, not an AI/machine learning algorithm that requires a training set.

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

As there is no "training set" for this type of device submission, this information is not applicable.

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The ClearMedical Reprocessed Endopath® Tristar® Blunt Tip Surgical Trocar, ClearMedical Reprocessed Endopath® Tristar® Surgical Trocar, and ClearMedical Reprocessed Endopath® Dilating Tip Trocar have application in thoracic, gynecologic laparoscopy, and other abdominal procedures to establish a path of entry for minimally invasive instruments.

Reprocessed endoscopic trocars consist of an obturator and sleeve. The trocar sleeve has a stopcock valve for gas insufflation and a desufflation lever for gas evacuation. The trocar obturator are either flat bladed, pyramidal, or blunt tip. Bladed and dilating tip obturators have a safety shield that exposes the blade during insertion and retract over the tip after the operative cavity has been penetrated.

The provided text is a 510(k) summary for ClearMedical Reprocessed Trocars. It focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than reporting on a clinical or performance study of an AI/algorithm-driven device. Therefore, much of the requested information regarding acceptance criteria for an AI device, sample sizes for training/test sets, expert ground truth, MRMC studies, or standalone algorithm performance is not applicable or cannot be extracted from this document.

However, I can extract the general acceptance criteria and the type of information provided to "prove" the device meets them in the context of this 510(k) submission.

Acceptance Criteria and Device Performance (based on the provided 510(k) summary):

Study Information (Based on the provided document):

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

   • Not applicable / Not specified. This document describes a 510(k) submission for reprocessed medical devices, not an AI or algorithm-driven device that would typically involve a "test set" in the computational sense. The "test data" mentioned refers to validation of cleaning, performance, packaging, sterilization, and biocompatibility, which are laboratory/engineering tests on the reprocessed devices themselves. The specific sample sizes for these validation tests are not detailed in this summary.

2. 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 / Not specified. Ground truth, in the context of AI/algorithm performance, is not relevant to this submission. The "truth" for reprocessed devices is assessed through engineering and biological safety tests.

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

   • Not applicable / Not specified.

4. 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, not applicable. This is not an AI-assisted device.

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

   • No, not applicable. This is not an algorithm.

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

   • Not applicable in the typical AI sense. For this device, the "ground truth" equivalent would be the objective standards and specifications for the original predicate devices, and the established regulatory requirements for reprocessing, cleaning, sterilization, and biocompatibility. The performance (e.g., integrity, functionality) of the reprocessed devices is compared against these engineering and safety benchmarks.

7. The sample size for the training set:

   • Not applicable / Not specified. This is not an AI/machine learning device.

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

   • Not applicable / Not specified.

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Reprocessed Trocars and Cannulas are intended to open and maintain a port of entry during endoscopic procedures.

Not Found

I am sorry, but the provided text does not contain information about explicit acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) clearance letter from the FDA, confirming that certain reprocessed endoscopic/laparoscopic trocars and cannulas are substantially equivalent to legally marketed predicate devices.

While the letter mentions "supplemental validation data" was reviewed, it does not describe the specific acceptance criteria for that validation or the details of the study itself. It primarily focuses on the regulatory outcome (substantial equivalence) rather than the technical performance data.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert qualifications, or study design based on the provided text.

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