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Titanium needles are intended for interstitial Brachytherapy procedures involving Nucletron mHDR remote afterloading equipment.

The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures.

Interstitial needles can be used for treatment of carcinoma where no lumen or cavity is available. More and more brachytherapy treatments are carried out where CT and MR based imaging is used for volume and target delineation. The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images.

The Titanium Needle is inserted into the treatment area, using standard interstitional insertion techniques. CT markers are inserted into the Titanium Needles for visualisation. Radiographic images are obtained to determine the precise location within the body. This information is then used for Brachytherapy treatment planning purposes.

The Titanium Needle Set is used as an accessory to the Nucletron microSelectron remote afterloaders.

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. Therefore, many of the requested elements for a study proving acceptance criteria will not be 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 provided document (K080871) is a 510(k) summary for "Titanium Needle Sets." In a 510(k) submission for this type of device, the primary "acceptance criterion" is often demonstrating substantial equivalence to a predicate device, particularly for devices like interstitial needles which are accessories to a larger system. Performance is generally assessed through design specifications, material compatibility, and intended use alignment rather than through new clinical outcome studies with predefined statistical acceptance criteria typical of novel therapies or diagnostics.

The document states:

• "The Titanium Needle Set as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment, mHDR and is intended for interstitial Brachytherapy procedures."
• "The Titanium Needles are fully CT/MR compatible and can be used in order to have minimal artefacts on the acquired images."
• "The modified device has the same intended use as the legally marketed predicate device cited."
• "The Titanium Needle Set is substantially equivalent to the cleared predicate device, Interstitial Needle Set, 510(k)#: K953946."

Based on the available text, specific quantitative acceptance criteria and reported device performance metrics (e.g., sensitivity, specificity, accuracy, or a specific range of artifact reduction) are not detailed. The "performance" is implicitly demonstrated through the claim of CT/MR compatibility with minimal artifacts and the overall substantial equivalence to the predicate.

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

This document does not describe a clinical study with a "test set" in the context of diagnostic or interventional performance. The "test" in this submission would likely refer to engineering verification and validation testing (e.g., material compatibility, dimensional accuracy, sterilization efficacy, imaging compatibility) rather than a clinical trial. Therefore, sample sizes for a clinical test set are not applicable here.

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, as no clinical "test set" requiring ground truth established by experts is described for this type of 510(k) submission.

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

Not applicable, as no clinical "test set" requiring adjudication for ground truth is 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. This device is an interstitial needle for brachytherapy, not an AI-powered diagnostic or decision support tool.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable, as no clinical "test set" requiring ground truth is described. For a device like this, the "ground truth" would relate to its physical properties and performance (e.g., actual dimensions matching specifications, material composition, artifact presence in imaging under controlled conditions).

8. The sample size for the training set

Not applicable. This document is not describing a machine learning or AI algorithm development.

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

Not applicable. This document is not describing a machine learning or AI algorithm development.

In summary:

The provided 510(k) document is for a medical device accessory (Titanium Needle Set) and aims to demonstrate substantial equivalence to a legally marketed predicate device. This type of submission typically relies on comparing design, materials, and intended use, along with non-clinical performance data (e.g., imaging compatibility, mechanical robustness, biocompatibility), rather than extensive human-in-the-loop clinical studies with statistical acceptance criteria. Therefore, most of your requested information related to comprehensive clinical study design and performance metrics is not present in this regulatory submission.

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Temporary implant for ventilation and drainage of middle ear.
Temporary implant for ventilation or drainage of the middle ear.

The umbrella-type implant comes mounted on a tiny single-use trocar point. Its penetrating edge penetrates the tympanic membrane and simultaneously forms a passage to draw the ventilation tube into that passage at a controlled rate until the ventilation tube is implanted. The trocar is immediately withdrawn. The procedure requires the use of a specially designed trocar handle. The tubes are available with or without retention wires.

Here's an analysis of the provided text regarding the acceptance criteria and study for the 77 ETD Trocar Ventilation Tube:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative or pass/fail format that would be typical for a device performance study. Instead, it justifies the device's safety and effectiveness through a comparison to a predicate device and by highlighting design modifications that are presented as improvements or at least not introducing new risks. Therefore, the "acceptance criteria" inferred here are based on the claims made about the device's design and its impact on the procedure and patient safety.

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

The document does not describe a specific clinical study with a test set of human subjects or data. The submission relies on a comparison to a predicate device and statements about the inherent properties of the materials and design. The only "testing" mentioned is MRI compatibility testing, which is a bench test, not a clinical study on a test set.

• Sample Size (Test Set): Not applicable, no clinical test set described.
• Data Provenance: Not applicable, no clinical data described beyond material properties and design rationale.

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

Not applicable. No ground truth for a test set is established as there is no clinical test set described. The evaluation is based on engineering design, material properties, and comparison to existing technology.

4. Adjudication method for the test set

Not applicable, as no test set or clinical study is 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. This is not an AI/software device, and no MRMC study or any clinical comparative effectiveness study is described.

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 an algorithm, so standalone performance is not relevant in this context.

7. The type of ground truth used

The "ground truth" in this context is implicitly established by:

• Material properties and historical use: The safety of gilded silver, pure titanium, and surgical stainless steel is well-established through their long history of use in medical devices.
• Engineering design principles: Claims about precise cuts, secure placement, and reduced trauma are based on the mechanical design of the device and how it interacts with the tympanic membrane.
• Predicate device comparison: The substantial equivalence argument relies on the established safety and effectiveness of the existing K 973226 models.
• MRI compatibility testing: This bench testing provides "ground truth" for the device's behavior in an MRI environment.

8. The sample size for the training set

Not applicable, as no training set for a machine learning algorithm or clinical data for training is described.

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

Not applicable, as no training set is described.

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Manually operated surgical device intended for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Manually operated surgical device intended for creating a surgical space by dissecting layers of connective tissue along natural planes to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Manually operated surgical device intended for providing a well anchored and gas tight instrument channel to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

The Pajunk Trocars together with the Trocar Sleeves, the Pajunk Balloon Systems and the according accessories are manually operated surgical devices used by physicians for making incisions into the patient's body to allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

The Paiunk Trocar Sleeves are rigid tubes placed with the help of Trocars or Obturators into the patient's body to allow insertion of endoscopes and endoscopic accessories.

The trocars are used together with the trocar sleeves for puncture of the patient's body. The trocar is then removed to allow insertion of endoscopes and endoscopic accessories.

The Pajunk Safety-Trocar features a sharp, beveled tip that is covered by an inside, spring loaded, blunt obturator (Veress-concept). During puncture, the obturator is pushed into the shaft against the force of the spring and thus releases the cutting tip which can now penetrate the skin layers. As soon as the abdominal space is reached, the blunt obturator is moved forward by the spring, covers the cutting tip and prevents injuries in the abdomen.

The PAJUNK distension balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where dissection of tissue in the extraperitoneal space under direct view is essential.

The PAJUNK structural balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel together with a mechanical support of the extraperitoneal work space is needed. The inflation of the balloon causes a continuing dissection and anchoring in the extraperitoneal work space.

The PAJUNK Ring-Anchor balloon system is indicated for laparoscopic procedures specially in extraperitoneal surgery, where a solid anchored and gas-tight entry port with an instrument channel is needed.

The disposable valve top is used with the Pajunk trocar sleeves and provides the same intended use. The valve is used instead of the trap door valve. The top is made out of polymer instead out of chromated brass. The metal tube is reusable and identical to the ones of the Paiunk trocar sleeves. The advantage is the easier cleaning, sterilization and assembling procedure.

The Pajunk fixable slide cones with or without a fixation thread and with suture holders on both sides have been designed for first puncture technique according to Hasson in laparoscopic applications.

The reducer sleeve is inserted into the actually used trocar sleeve to reduce the diameter for improved quide and gas-tight insertion of endoscopic surgical instruments with outer diameters smaller than the nominal inner diameter of the trocar sleeve.

If the actually applied trocar sleeve does not provide sufficient space for needed endoscopes and endoscopic accessories or endoscopic surgical instrument it can be replaced with a larger trocar sleeve.

The trocar stop with fixation thread is used to fixate the insertion of the trocar sleeve. The trocar sleeve is fixed by hand with a screw.

This document is a 510(k) Summary of Safety and Effectiveness for Pajunk GmbH's Trocars, Trocar Sleeves, Distension System, and Anchoring System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way a clinical trial might.

Therefore, many of the requested categories for describing a study proving acceptance criteria cannot be directly extracted from this type of regulatory submission. This document primarily asserts that the new devices are substantially equivalent to existing, legally marketed predicate devices, meaning they have similar features, intended uses, and do not raise new issues of safety or effectiveness.

Here's an analysis based on the provided text, highlighting where information is available and where it is not:

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

This document does not present a table of specific acceptance criteria (e.g., performance metrics like penetration force, sealing integrity, or specific clinical outcomes) nor does it report detailed device performance data against such criteria. The "acceptance criteria" here is met through the demonstration of substantial equivalence to predicate devices.

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

Not applicable. This submission relies on an equivalency claim rather than new clinical data from a dedicated test set. The data provenance would be a comparison to existing predicate devices already on the market.

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. Ground truth, in the context of device performance, would typically be established through clinical observation or objective measurements. This document does not describe such a process for a new clinical trial. The "ground truth" for substantial equivalence is the safety and effectiveness profile of the predicate devices.

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

Not applicable. No test set requiring adjudication in the clinical study sense is 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. This device is a surgical tool, not an AI diagnostic/interpretive system. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is not an algorithm-only device. It is a manually operated surgical device used by physicians.

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

The "ground truth" for the regulatory submission is based on the established safety and effectiveness of the predicate devices already on the market. The submission asserts that the new device has "similar basic features and intended uses" to these predicates and "raise no new issues of safety and effectiveness."

8. The sample size for the training set

Not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a surgical instrument.

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

Not applicable. See point 8.

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Providing thorough irrigation and aspiration of the peritoneal cavity.Bleeders can be identified,bile,stones,tissue,blood & smoke from cautery procedures can be aspirated leaving the abdominal cavity clean and dry.

Sole purpose of these instruments are to move tissue around. Sole purpose of these instrain by means of grasping any body They can not grasp or restrain by addints the body cavity They can not grasp of resorain by de into the body cavity organ or tissue. They are introduced they can only move through a brood trough the or up and down.

Devices which create portals into an operative site enableing the introduction thru said devices, tools for the direct the introduction and/or dissecting, cutting, repairing, removal observation and/or internal tissues and/or organs.

Devices that pass thru portals into a periteal cavity allowing direct or indirect visualization by means of a camera thru said direct of internal tissues or organs may be visualized for either diagnostic or operative procedures.

Verres needles puncture through the abdominal wall to enable verres needies puncture theabdominal cavity creating space the introduction of gacce insternal body organs, allowing for the sa between the rabora and the scopic instrumentation into the peritoneal cavity.

Instruments which permit suturing internal tissues or organs thru cannula portals by pushing suture knots down to the tissue site being repaired.

Instruments which permit the grasping and manipulation of the country the countancel covity enableing a surgeon Instruments which the pritoneal cavity enableing a surgeon needles inside the peritoneal cavity enableing a surgeon needles inside the periconeal cavily charoscopic procedures.

Instruments insulated for cautery or non-insulated for non-cautery procedures which enable a surgeon to grasp, biopsy,cut,coagulate,manipulate or retrieve internal biopby, a your while performing laparoscopic procedures.

Trocar and Trocar Sleeves, Laparoscopes, Laparoscopic Forceps and Laparoscopic Instruments, FAN RETRACTORS AND FINGER DISSECTORS, TROCARS, TROCAR SLEEVES AND DILATORS, VERRES NEEDLES, KNOT PUSHER, NEEDLE HOLDERS, MONOPOLAR ELECTRODES,CAUTERY FORCERS,BIPOLAR FORCEPS & SCISSORS AND NON-CAUTERY FORCEPS

This document is a 510(k) premarket notification from the FDA for various laparoscopic instruments manufactured by Jakoubek Medizintechnik GmbH. The document is primarily focused on establishing substantial equivalence to existing devices and outlines the indications for use of several instruments. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

Therefore, I cannot provide the requested information.

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The Olympus "Trocar System according to Hasson" has been designed for first puncture technique according to Hasson in laparoscopic applications.

Trocar System according to Hasson. Common/Usual Name: Trocar, blunt and cone for laparoscopic application.

This document is a 510(k) summary for the Olympus Trocar System according to Hasson. It states that the device is substantially equivalent to predicate devices for its intended use, which is for "first puncture technique according to Hasson in laparoscopic application."

Based on the provided text, there is no acceptance criteria or study information that would allow me to populate the table or answer the specific questions about device performance, sample sizes, ground truth, or expert involvement.

The 510(k) process for this type of device (a Class II surgical instrument) typically relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring extensive clinical trials with acceptance criteria directly related to performance metrics like sensitivity, specificity, or reader improvement. The focus is on demonstrating that the new device is as safe and effective as the predicate device.

Therefore, the table and answers below reflect the absence of this information in the provided document.

Acceptance Criteria and Device Performance

Detailed Study Information (Based on provided text):

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. The document does not describe a clinical "test set" or a performance study with human subjects or data in the way an AI/diagnostic device would. The 510(k) process for this device relies on a demonstration of substantial equivalence to predicate devices, not on a new clinical study with a test set.

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. As no specific "test set" or ground truth establishment relevant to an AI or diagnostic claim is described, expert involvement for this purpose is not mentioned. The FDA reviewers (Celia M. Witten, Ph.D., M.D., Director, Division of General and Restorative Devices) are the experts who evaluated the submission for substantial equivalence.

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

   • Not Applicable. No test set or adjudication method for clinical performance is described.

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. This device is a surgical instrument (trocar system), not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

   • Not Applicable. This device is a manual surgical instrument; it is not an AI algorithm, and therefore, a standalone algorithm performance study is irrelevant and was not performed.

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

   • Not Applicable. The concept of "ground truth" as it applies to diagnostic or prognostic AI systems is not relevant here. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the predicate devices to which the Olympus Trocar System is being compared, assuming those predicates were legally marketed.

7. The sample size for the training set:

   • Not Applicable. As this is not an AI/machine learning device, there is no "training set."

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

   • Not Applicable. No training set exists for this device.

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Both the Auto Suture* Cannula** and the Auto Suture* Modified Versaport* Trocar (K954108) are intended for use in a variety of gynecologic, general, thoracic, and urologic endoscopic procedures to create and maintain a port of entry

The Auto Suture* Cannula** is a two piece device which consists of a reusable sleeve and a disposable plastic housing with seal adapter. While the Auto Suture* Modified Versaport* Trocar (K954108) is a totally disposable trocar with cannula.

The provided text is a 510(k) summary for a surgical instrument (Trocar Cannula) from 1997. This type of submission focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use, rather than conducting extensive clinical studies with acceptance criteria for performance metrics like accuracy, sensitivity, or specificity that are common for diagnostic AI devices.

Therefore, the requested information regarding acceptance criteria, study details, human reader performance, and ground truth establishment is not applicable to this 510(k) summary for a manual surgical instrument.

Here's why each point isn't applicable:

1. A table of acceptance criteria and the reported device performance: Not present. The 510(k) process for this type of device relies on comparing design, materials, and intended use to a legally marketed predicate, not on quantitative performance metrics.
2. Sample size used for the test set and the data provenance: Not applicable. No clinical "test set" in the context of diagnostic performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic performance is not relevant for this device.
4. Adjudication method for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable. This is not an AI device.
9. How the ground truth for the training set was established: Not applicable. This is not an AI device.

The 510(k) summary provided details about:

• Submitter and Contact Person: United States Surgical Corporation, Janet G. Johnson.
• Date Prepared: August 9, 1996.
• Classification Name: Manual Surgical Instrument for general use.
• Common Name: Trocar Cannula.
• Proprietary Name: Trademark name not yet determined.
• Predicate Device: Auto Suture* Modified Versaport* Trocar (K954108).
• Device Description: A two-piece device consisting of a reusable sleeve and a disposable plastic housing with seal adapter. Compared to the predicate which is totally disposable.
• Intended Use: For use in various endoscopic procedures (gynecologic, general, thoracic, urologic) to create and maintain a port of entry.
• Materials: Component materials are in accordance with ISO Standard #10993-1, indicating biocompatibility assessment.

In summary, the provided document is a regulatory submission for a physical medical device, not a diagnostic AI or imaging device, and therefore the requested information regarding performance studies and acceptance criteria is not found within this context.

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