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The Blunt Tip Trocar Port has applications for surgery in the legs for establishment of a port of entry for endoscopic instruments.

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I am sorry but this document is a letter from the FDA regarding the clearance of a medical device (Blunt Tip Trocar Port) and does not contain the detailed study information required to answer your request. The document confirms that the device can be marketed but does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number or qualifications of experts, or adjudication methods for a test set.
3. Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
4. Details on the type of ground truth used or the sample size and ground truth establishment for a training set.

The letter is a regulatory approval, not a scientific study report.

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The Vaso View™ Dissection/Vessel Harvesting System has applications in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/ vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.

The VasoView™ Dissection/Vessel Harvesting System is a single-use device provided sterile. It is designed to be used in conjunction with a 5mm Extended Length Endoscope. The cannula has a tapered tip for tissue separation. Initial tissue separation is performed under endoscopic visualization with the clear tapered tip. The elliptical bulb aids tissue separation, and insufflation holds open the cavity created. The cannula tip may also be used for dissection and isolation of structures in the cavity. This tip is clear to allow for endoscopic visualization during tunneling. A handle is provided to assist with advancement of the cannula. The device is configured to accept a 5mm endoscope through the inner lumen of the cannula. The Origin BTT Port is used to provide a port of access for insertion of endoscopic instruments into an extremity or extraperitoneal space. The device consists of a valve body assembly with a balloon on the sleeve. The valve body assembly contains an internal flapper valve and seal to prevent gas leakage when instruments are inserted or withdrawn. It also includes built-in converter doors to allow insertion of instruments of different diameters than the main seal. The external distal end of the sleeve has a balloon. A 30cc syringe is provided for inflation/deflation of the balloon.

The provided text describes a "Special 510(k): Device Modification" for the Guidant Corporation/ORIGIN VasoView™ Dissection/Vessel Harvesting System (K981700). This type of submission is for modifications to a previously cleared device. Therefore, the focus is on demonstrating that the modified device remains substantially equivalent to the original predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the same way a de novo device might.

Based on the provided document, here's what can be inferred and stated regarding acceptance criteria and supporting studies:

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

Explanation: For a 510(k) submission, especially a "Special 510(k) for Device Modification," the primary "acceptance criterion" is often demonstrating substantial equivalence to a legally marketed predicate device. This means showing that the modified device is as safe and effective as the predicate, either by having the same technological characteristics and intended use, or by having different technological characteristics that do not raise new questions of safety or effectiveness and are supported by appropriate data.

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

   The document does not detail a specific "test set" or clinical study with a sample size for this modification. The assessment is based on the comparison to the predicate 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. The document does not describe a clinical study requiring expert ground truth establishment for a test set.

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

   Not applicable. The document does not describe a clinical study 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 device is a surgical instrument, not an AI-assisted diagnostic tool.

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

   Not applicable. This device is a surgical instrument, not an algorithm.

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

   Not applicable in the context of a clinical performance study. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate device, against which the modified device is compared. The assessment relies on material compatibility and functional similarity to the cleared predicate.

8. The sample size for the training set:

   Not applicable. The document does not describe a machine learning or AI device that would require a training set.

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

   Not applicable.

Summary of the Study/Evidence:

The "study" presented here is a demonstration of substantial equivalence through a comparison of device characteristics.

• Evidence Type: Benchmarking against an existing, cleared predicate device (ORIGIN System VasoView™ Balloon Dissection System, K964171).
• Key Arguments for Equivalence:
  • Identical Intended Use: Both devices are used for minimally invasive vessel harvesting and tissue separation in specified anatomical regions.
  • Identical Function: The modified device performs the same core functions of tissue separation, cavity creation, and endoscopic visualization.
  • Identical Technological Characteristics: The core design and mechanism of action are the same.
  • Similar Materials: The patient contact materials (Polycarbonate, Loctite™ adhesive) are the same as those used in existing cleared ORIGIN products, implying pre-established biocompatibility.

Conclusion from the document: The FDA found the device "substantially equivalent" to the predicate, permitting its marketing based on the comparison provided in the 510(k) submission and the established safety and effectiveness of the predicate device.

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has applications in open and endoscopic surgery. It is primarily indicated for patients undergoing endoscopic surgery that require ligation or ligation and transection of tissue including blood vessels, ducts and other structures in the extremies, extraperitoneal space, abdominal cavity and the chest wall. It is indicated for patients undergoing surgical procedures in the extremities including but not limited to saphaenous vein harvesting for peripheral or coronary artery bypass grafting.

The Origin Ligator Device is a single-use endoscopic device with dual functions of ligation and transection of isolated vessels and other structures. It consists of a tube, handle assembly, and located at the distal end of the tube is the cutting blade, grasping jaws, and a clip delivery system. The cutting blade is activated independently from the grasping jaws and the clip delivery system. The Origin Ligator Device will allow both clipping and cutting operations to be performed multiple times without removing the device

The provided text is a 510(k) summary for the "ORIGIN Ligator Device," a Class I (later reclassified to Class II by the FDA letter) manual surgical instrument. This submission focuses on establishing substantial equivalence to a predicate device (ORIGIN AcuClip® Endoscopic Multiple Clip Applier, K920599) and does not contain information about the device's technical acceptance criteria or a dedicated study proving performance against those criteria.

The 510(k) summary describes the device's function and intended use, and the FDA letter confirms substantial equivalence without detailing specific performance data. Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given information.

Similarly, the other requested details (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study results, standalone performance, and training set information) are not included in this type of regulatory submission, which primarily focuses on justifying substantial equivalence based on existing predicate devices.

Summary of what cannot be provided from the given text:

• Table of acceptance criteria and reported device performance: This information is not present in the 510(k) summary or the FDA letter.
• Sample sizes (test, training): Not provided.
• Data provenance: Not provided.
• Number and qualifications of experts: Not provided.
• Adjudication method: Not provided.
• MRMC comparative effectiveness study results: Not mentioned.
• Standalone performance study results: Not mentioned.
• Type of ground truth used: Not discussed.
• How ground truth for training set was established: Not discussed.

Information that can be extracted (though not directly related to performance metrics):

• Device Name: Origin Ligator Device
• Regulatory Class: Initially Class I, then reclassified to Class II by the FDA.
• Intended Use: "It is primarily indicated for patients undergoing endoscopic surgery that require ligation or ligation and transection of tissue including blood vessels, ducts and other structures in the extremities, extraperitoneal space, abdominal cavity and the chest wall. It is indicated for patients undergoing surgical procedures in the extremities including but not limited to saphaenous vein harvesting for peripheral or coronary artery bypass grafting."
• Predicate Device: ORIGIN AcuClip® Endoscopic Multiple Clip Applier, (K920599; 7/15/92).

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The Origin Cardiac Stabilizer Occluder is indicated for use in cardiac surgery performed on the beating heart where local stabilization is required and a vessel may be temporarily occluded ... .

This Origin Cardiac Stabilizer Occluder is a single use sterile device. It consists of a stabilizer foot, and occluders. The Origin Cardiac Stabilizer Occluder may be used by attaching the stabilizer foot to the Origin Cardiac Stabilizer Clamp; then this assembly is attached to a self retaining rib retractor or sternal retractor or other stationary platform. The Origin Cardiac Stabilizer Occluder may also be used by suturing the stabilizer foot to the desired area of the heart. The stabilizer foot rests against the epicardium. Forceps may be used to position the occluder over the desired vessel. Once in position the occluder may be advanced toward the vessel and locked in place; to cause the vessel to be temporarily occluded. Following completion of the surgical procedure , the Origin Cardiac Stabilizer Occluder is removed.

The provided text is a 510(k) Summary for the "Origin Cardiac Stabilizer Occluder." This type of document is a premarket notification for new medical devices, aiming to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

Key Observation: The document does not describe any clinical studies, performance data, or acceptance criteria for the device's technical performance. Instead, it focuses on the device's description, intended use, and its substantial equivalence to existing predicate devices.

Therefore, I cannot provide the requested information from the given text alone. The document is a regulatory submission for market clearance based on substantial equivalence, not a report of a performance study.

To answer your request, if such information were available, it would typically be found in:

• A separate clinical study report.
• A section within the 510(k) submission detailing specific performance testing (e.g., bench testing, animal studies, or clinical data if substantial equivalence cannot be entirely based on predicate devices without it).
• Post-market surveillance data.

Since the provided text does not contain this information, I must state that the acceptance criteria and studying proving the device meets them are not present in this document.

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The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.

The predicate device (Endoscopic Visualization and Space Maintenance Cannula ) has applications in minimally invasive surgery and is primarily indicated for patients undergoing endoscopic surgery including laparoscopy and thoracoscopy.

The Multi-Port Cannula is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

The Multi-Port Cannula is a single- use device which consists of two movable working cannulas, seals, a stabilizer, two stationary cannulas, leur fitting, and an insufflation tube. The two movable working cannulas passes completely through the stationary cannulas which are casted to the stabilizer. The seals within the inner wall of the cannulas seal on surgical devices that are inserted through the cannulas. The stabilizer provides a seal against the tissue at the incision site and acts to stabilize the cannulas. Surgical access is achieved via standard incision. The Multi-Port Cannula is assembled and advanced through the incision site. The user may then advance endoscopic tools through the working cannulas or stationary cannulas to perform the procedure. The Origin Multi-Port Cannula has applications in minimally invasive surgery to provide a port of access during endoscopic procedures.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) Summary of Safety & Effectiveness for a medical device (Multi-Port Cannula), primarily focusing on demonstrating substantial equivalence to a predicate device based on intended use, materials, and technological characteristics. It does not detail specific performance studies with acceptance criteria, sample sizes, expert involvement, or ground truth establishment.

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The VasoView™ Balloon Dissection System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used to form elongated working cavities during thoracoscopic procedures involving exposure and dissection of structures external to the parietal pleura, including, nerves, blood vessels and other tissues of the chest wall.

The VasoView™ Balloon Dissection System is a single-use device which consist of a, tubular body with a distal transparent conical tapered tip, an elastomeric balloon adjacent to the tapered tip, luer extension, and syringe. It is designed to accept a 5mm diameter rigid endoscope for visualization through the tapered tip. The VasoView™ Balloon Dissection System is provided sterile This dissection cannula is used to advance along specific anatomic tracts to isolate structures. After the cannula advancement, sequential balloon inflation forms an elongated cavity in the desired location.

The provided text does not contain information related to software or AI/ML device performance, acceptance criteria, or a study evaluating such a device. The document is a 510(k) summary for a physical medical device called VasoView™, a balloon dissection system.

Therefore, I cannot extract the requested information regarding acceptance criteria and studies proving the device meets those criteria, as the information is not present in the provided context for an AI/ML device.

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The Airlift Jr.™ Balloon Retraction System has applications in minimally invasive surgery. It is indicated when endoscopic surgery is indicated and may be used as an alternative to insufflation for retracting organs and tissues thus creating a working cavity for endoscopic surgery. The Airlift Jr.™ Balloon Retraction System is used in conjunction with the Laparoliff™ previously cleared under premarket notification K921103 September 9, 1993. The predicate device (Airlift™ Balloon Retraction System) has applications in laparoscopic surgery and is indicated and may be used as an alternative to insufflation for retracting organs and creating a working cavity for laparoscopic surgery. The predicate device is also used in conjunction with the Laparoliff™ .

The Airlift Jr.™ Balloon Retraction System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

The Airlift Jr.™ Balloon Retraction System is a single-use device which consist of an inflatable balloon, balloon sheath, tether and scrap, inflation bulb, and an attachment assembly which includes a connector drape and tool holder. The Airlift Jr.™ Balloon Retraction System is provided sterile and is developed to be used in conjunction with an Origin Laparolift Retraction System. This device is used to lift and retract organs and tissues to provide a space for endoscopic surgery without the use of gas insufflation.

The retraction of organs and tissues is achieved by first making a small incision then inserting the Airlift Balloon device. The Airlift Balloon is then attached to the Laparolift (mechanical distention arm) by means of the attachment assembly (tool holder and connector drape). The Laparolift is used to lift the Airlift Balloon device, and therefore the organs and tissues are raised to the height typically achieved by gas insufflation thus creating a working cavity for surgery. This function is equivalent to those described for the predicate device: Airlift™ Balloon Retraction System K942678, same as (Lifting Distention Balloon System, the predicate device will be refered to hence forth as Airlift™ Balloon Retraction System). The new device: Airlift™ Jr. has a balloon size of 4.1 inches deployed. The predicate device: Airlift™ Balloon Retraction System has a balloon size of 5.4 inches deployed. (See comparable chart on page 16-17).

This document is a 510(k) summary for the ORIGIN® Medsystems, Inc. Airlift Jr.™ Balloon Retraction System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving that the device meets specific acceptance criteria through a dedicated study with defined performance metrics.

Therefore, many of the requested elements (acceptance criteria, specific study details like sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and detailed ground truth establishment) are generally not applicable or not explicitly provided in a 510(k) summary focused on substantial equivalence for this type of device.

Here's an analysis based on the provided text, indicating which elements are not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable/Not Provided: This 510(k) summary does not define specific quantitative acceptance criteria or report performance metrics against such criteria in the way a clinical trial or device performance study would for a new technology seeking to prove efficacy or diagnostic accuracy. The basis for substantial equivalence is primarily on material, technological characteristics, and intended use similarity to a predicate device.

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

Not Applicable/Not Provided: No "test set" in the context of a performance study is mentioned. The submission relies on demonstrating similarity to a previously cleared device.

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

Not Applicable/Not Provided: Ground truth establishment by experts for a test set is not part of this type of submission.

4. Adjudication Method for the Test Set

Not Applicable/Not Provided: No adjudication method is mentioned as there is no "test set" or performance evaluation described.

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/Not Provided: This device is a mechanical retraction system, not an AI-based diagnostic or assistive software. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant and not mentioned.

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

Not Applicable/Not Provided: This is a mechanical device, not an algorithm. Standalone performance as described is not relevant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not Applicable/Not Provided: The concept of "ground truth" for proving diagnostic or predictive accuracy is not applicable to this device's submission. The "truth" in this context is the predicate device's established safety and effectiveness.

8. The Sample Size for the Training Set

Not Applicable/Not Provided: There is no "training set" as this is not a learning algorithm or AI device.

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

Not Applicable/Not Provided: Not applicable for the reasons mentioned above.

Summary of the 510(k) Submission's Approach to Substantial Equivalence:

The submission focuses on the following to establish substantial equivalence:

• Predicate Device: The ORIGIN Airlift™ Balloon Retraction System (K942678).
• Identical Characteristics: The Airlift Jr.™ shares "identical material, and technological characteristics" as the predicate device, despite a smaller balloon size (4.1 inches vs. 5.4 inches for the predicate).
• Identical Intended Use: Both devices are for retracting organs and tissues to create a working cavity for endoscopic/laparoscopic surgery as an alternative to gas insufflation, used in conjunction with the Laparolift™.
• Device Description:
  • Components: Single-use device consisting of an inflatable balloon, balloon sheath, tether and strap, inflation bulb, and an attachment assembly (connector drape and tool holder).
  • Function: Inserted through a small incision, attached to the Laparolift, which then lifts the balloon and thus organs/tissues to create a surgical cavity.
  • Materials: Patient contact components (Inflation Balloon, Containment Sheath, Tether and Strap, Tube Inflation) are made of polyurethane and/or polyurethane-coated nylon, which are materials already cleared for biocompatibility in existing ORIGIN products (including the predicate device).

This 510(k) relies on the premise that since the Airlift Jr.™ is fundamentally the same in intended use, materials, and technological characteristics as the already cleared predicate device, it is equally safe and effective, and therefore does not require new, extensive clinical studies to establish "acceptance criteria" or "performance."

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The Resposable Trocar System has applications in endoscopic surgery, for establishment of a port of entry for endoscopic instruments. It may be used for endoscopic transabdominal, extraperitoneal, thoracoscopic, gynecologic or abdominal procedures. The Reusable Cannula must be used in conjunction with a complete Origin Trocar of the same size. The Sensing Tip Trocar has applications in gynecologic and abdominal surgery for puncture of the abdominal cavity and establishment of a port of entry for endoscopic instruments.

During abdominal surgery the Resposable Trocar is inserted through the abdominal wall and the trocar cannula is left in place to allow the passage of endoscopes and other endoscopic instruments. This function is equivalent to those described for the predicate device: the Sensing Tip Surgical Trocar,

The Resposable Trocar System is not intended for use except as indicated. In addition, it is not intended for use when endoscopic surgery is contraindicated.

The Origin Sensing Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle, with an integral safety mechanism. As the tissue is penetrated, the tip withdraws into the cannula to help protect internal organs from exposure to the sharp tip. The disposable seal consists of an internal valve to prevent gas leakage when instruments are inserted or withdrawn. The 10mm and 12mm seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision site. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm.

The Origin Classic Tip Resposable Trocar System is a single-use obturator and seal provided sterile, used in conjunction with an Origin Reusable Cannula of the same size, provided non-sterile. When assembled, this device is used to puncture the incision site and to provide a port of access for insertion of endoscopic instruments. The trocar consists of a sharp, pyramidal tip connected to an obturator and handle. The disposable seal consists of an internal valve and seal to prevent gas leakage when instruments are inserted or withdrawn. The 10/12mm Seal will include a built-in converter cap to prevent leakage and allow insertion of instruments of different diameters than the main seal. The seal is to be assembled with the Origin Reusable Cannula. The Reusable Cannula will be available with or without an external valve for gas insufflation, and an external gripping mechanism to assist in retaining the device in the incision cite. The cannula is to be assembled with the disposable seal. The Reusable Cannula will be available in four sizes 5mm, 5mm short, 10mm and 12mm.

I am sorry, but based on the provided text, I cannot provide the requested information. The text describes a "Resposable Trocar System" and its substantial equivalence to a predicate device, focusing on its intended use, materials, and technological characteristics.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details.

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The 5mm Endoscope shares the same intended use as the predicate device. The 5mm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a 5mm diameter endoscope as their visualization component.

The 5mm Endoscope is a rigid endoscopic device which is comprised of a shaft, scope body, illuminator port, eyepiece, light fiber optics, image rod, and front window. The 5mm Endoscope is a rigid endoscope which may be used to visualize the interior of body cavity or surgical working cavity during endoscopic procedures. The endoscope may also be used in conjunction with surgical devices which accept a 5mm diameter endoscope as their visualization component.

I am sorry, but the provided text describes a 5mm Endoscope, a rigid endoscopic device, and its comparison to a predicate device. It does not contain any information about acceptance criteria, device performance, a study, or any of the other specific data points you requested (e.g., sample size, ground truth, expert qualifications, MRMC study, standalone performance, training set details).

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or any of the other details about a study, as this information is not present in the given input.

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