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The CUSA Excel Ultrasonic Surgical Aspirator System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g.: bone) tissue is desirable, including Neurosurgery, Plastic and Reconstructive Surgery, General Surgery, Orthopedic Surgery, Gynecological Surgery, Thoracic Surgery, Laparoscopic Surgery and Thoracoscopic Surgery.

The CUSA Excel Ultrasonic Surgical Aspirator System (CUSA) is an ultrasonically vibrating surgical device which, in combination with irrigation and aspiration, fragments, emulsifies and removes unwanted tissue. It allows the selective dissection of target tissue while preserving vessels, ducts and other delicate structures. The CUSA Excel System consists of a console which provides control and power functions, a surgical handpiece which provides ultrasonic mechanical energy, a titanium handpiece tip and flexible irrigation flue, and a suction/irrigation system (manifold tubing and cooling water canister). A tip has been added to the CUSA Excel system to enable it to abrade bone. Testing was completed to demonstrate that the tip will abrade bone. The tip is manufactured from the same materials as in the other CUSA Excel tips.

The provided text is a 510(k) summary for the Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip. This document describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance metrics (such as accuracy, sensitivity, specificity), sample sizes for test sets or training sets, expert qualifications, adjudication methods, or results from comparative effectiveness studies.

The text simply states: "Testing was completed to demonstrate that the tip will abrade bone." This is a general statement and does not provide quantified performance data or details of a study that would establish specific acceptance criteria.

Therefore, I cannot fulfill the request to provide the detailed information required for the table and all the numbered points because the provided document does not contain this type of performance study data.

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XKnife RT 3 with Non-Stereotactic Module is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic, collimated beam, computer planned, LINAC based treatment.

The device is a module of the XKnife RT system that allows radiotherapy treatment planning using non-stereotactic CT image sets. As in traditional radiation treatment planning, external fiducial markers (rather than a stereotactic frame) now provide a reference from which an isocenter may be specified.

The provided text describes a 510(k) summary for the Radionics XKnife RT 3 with Non Stereotactic Module. However, it does not contain any information about acceptance criteria, device performance metrics, or study details (sample size, ground truth, expert qualifications, adjudication, MRMC, or standalone performance).

The document primarily focuses on:

• Identification of the submitter and device: Radionics XKnife RT 3 with Non Stereotactic Module.
• Predicate devices: XPlan 2.2 with the Body Module, XKnife RT System, Stereotactic KTF System.
• Device description: A module for the XKnife RT system that allows radiotherapy treatment planning using non-stereotactic image sets (e.g., CT scans) where anatomical landmarks, rather than a stereotactic frame, define the isocenter.
• Intended Use/Indications for Use: Radiosurgery and radiotherapy treatment for stereotactic and non-stereotactic, collimated beam, computer-planned, LINAC-based treatment.
• Statement of testing: "Sufficient testing has been completed to insure that the module can import, localize and generate a treatment plan using a non-stereotactic CT scan."

Without specific numerical acceptance criteria, performance metrics, or study design details, I cannot fill out the requested table or answer the other questions. The document only makes a general statement that "sufficient testing has been completed."

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The Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors.

The NBN-D is a dual cannula device made from stainless steel hypodermic needles. The device requires suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated to cut the tissue. The device is designed to be used with the Radionics CRW system.

This submission is for a medical device called the Radionics Nashold Biopsy Needle - Single Use, a disposable biopsy needle intended for stereotactic biopsy of brain tumors. The provided text is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study with acceptance criteria and performance metrics for a novel technology. Therefore, much of the requested information regarding detailed study design, acceptance criteria, and specific performance results for the device itself is not available in the provided text.

However, I can extract the available information and highlight what is missing based on your request.

Acceptance Criteria and Device Performance Study Information

1. Table of Acceptance Criteria and Reported Device Performance

• Tissue Acquisition Efficacy: Ability to consistently obtain sufficient tissue samples for diagnosis.
• Cutting Mechanism Effectiveness: Clean and precise tissue cutting.
• Biocompatibility: No adverse reactions with biological tissue.
• Sterility: Maintenance of sterility.
• Usability with CRW system: Compatibility and proper functioning when used with the specified Radionics CRW system.
• Structural Integrity: Resistance to bending, breaking, or dulling during use. | This information is not explicitly stated in the provided 510(k) summary or FDA letter. The submission relies on substantial equivalence to predicate devices, implying that its performance is comparable to established biopsy needles. Specific quantitative performance data (e.g., success rate of tissue acquisition, sample size, or integrity after use) is not given. |
  | Intended Use | The device is intended for single patient use in stereotactic biopsy of brain tumors. | The device's intended use matches the stated criteria: "The Radionics Nashold Biopsy Needle is intended for single patient use in stereotactic biopsy of brain tumors." This is a qualitative match. |
  | Material Composition | The device is made from stainless steel hypodermic needles. | The device description states: "The NBN-D is a dual cannula device made from stainless steel hypodermic needles." This is a qualitative match. |
  | Mechanism of Action | Requires suction provided by a syringe to draw tissue, inner cannula rotated to cut tissue. | The device description states: "The device requires suction provided by a syringe to draw the tissue into the needle. The inner cannula is then rotated to cut the tissue." This is a qualitative match. |

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

This information is not provided in the given text. A 510(k) submission primarily focuses on demonstrating substantial equivalence to existing predicate devices, often through comparison of design, materials, and intended use, rather than presenting a novel clinical study with a test set of patient data to prove effectiveness. If any testing was done (e.g., bench testing for mechanical properties), details about the sample size and data provenance are not included here.

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

This information is not provided. Given that this is a 510(k) submission for a biopsy needle and not an AI/diagnostic device, the concept of "ground truth" and expert adjudication in the context of a test set for performance evaluation is generally not applicable in the same way as for an image analysis or diagnostic support system. If any expert evaluation for tissue integrity or diagnostic quality was performed on samples, it is not detailed here.

4. Adjudication Method for the Test Set

This information is not provided. As with point 3, the concept of an adjudication method for a test set is typically associated with studies involving diagnostic performance or interpretation, which is not the primary focus of this 510(k) submission for a biopsy needle.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Improvement with AI vs. Without AI Assistance

This information is not applicable and not provided. A MRMC comparative effectiveness study is relevant for AI-assisted diagnostic tools (e.g., image analysis software). The Radionics Nashold Biopsy Needle is a physical medical device, not an AI or diagnostic software, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to its clearance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable and not provided. This type of study is relevant for algorithms performing tasks independently. As the device is a physical biopsy needle, this concept does not apply.

7. The Type of Ground Truth Used

This information is not explicitly stated or readily applicable in the context of this 510(k) submission. For a biopsy needle, "ground truth" might refer to histological confirmation of tissue obtained by the needle, or the accuracy of the biopsy procedure itself. However, the provided document does not detail such studies or the ground truth establishment method.

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. The Radionics Nashold Biopsy Needle is a physical, mechanical device, and does not involve an algorithm that requires a training set.

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

This information is not applicable and not provided. As explained in point 8, there is no training set for this type of device.

Summary of Available Information from the 510(k) (K032054):

The provided text from K032054 primarily focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices (MRI Devices Corporation's Daum Neurocut Neurobiopsy Needle, Ad-Tech's Brain Biopsy Needle For Stereotaxic, and Elekta Instrument's Leksell Sedan Biopsy Needle). It describes the device's design, materials, and intended use. It does not contain detailed performance studies, specific acceptance criteria with quantitative results, or information about clinical trials, test sets, or ground truth establishment that would be typically found for novel diagnostic algorithms or devices requiring extensive clinical validation. The FDA's decision to clear the device is based on its similarity to legally marketed devices, subject to general controls.

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The VariLink 2 MMLC is intended to assist the radiation oncologist team in the delivery of radiation to well defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. With Radionics' Treatment Planning Software, the MMLC enables static conformal treatments to be performed with finely shaped field patterns. The Varilink 2 MMLC can be used as part of IMRT (Intensity Modulated Radiotherapy) or general conformal radiation.

The device is an optional accessory for the Radionics Mini-Multileaf Collimator (MMLC), mounted on a Varian C-Series Linear Accelerator (Linac). VariLink 2 allows Intensity Modulation Radiation Therapy (IMRT) functionality to be used on a Varian Linac. The Radionics' Treatment Planning software generates treatment plans with segmented beams, in which the intensity within the irradiation field is not constant (as in conventional treatments) but varies across the field. This requires the LINAC to suspend the beam between segments to allow the MMLC to change fields. VariLink 2 uses the Varian gating board to suspend the beam to allow MMLC to change the shape of the field.

The provided text does not contain detailed acceptance criteria and the study that proves the device meets them. The document is a 510(k) summary for the Radionics VariLink 2, which focuses on establishing substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria.

The relevant section {1} states: "System testing verifies that the device is ready for clinical use. A rigorous test of the functionality of VariLink 2 was conducted using a Varian C-Series Linac with the Gating Board Interface."

This statement confirms that some testing was performed to verify functionality, but it does not provide any specific acceptance criteria, performance metrics, or details about the study design or results. Without further information beyond what is present in this 510(k) summary, it is impossible to complete the requested tables and answer the questions.

Therefore, I cannot provide the requested information for the following reasons:

1. No Acceptance Criteria or Reported Performance: The document does not list any specific numerical acceptance criteria (e.g., accuracy, precision, sensitivity, specificity thresholds) or the actual reported device performance against such criteria.
2. No Details on Study Design: The summary mentions "system testing" and a "rigorous test of the functionality" but provides no information on the methodology, sample size, type of data used, ground truth establishment, expert involvement, or adjudication methods.
3. No Standalone or MRMC Study Details: There is no mention of whether a standalone algorithm performance study or a multi-reader, multi-case (MRMC) comparative effectiveness study was conducted.
4. No Training Set Information: The document does not describe a training set, how its ground truth was established, or its sample size.

In summary, the provided text confirms that functional testing was done but lacks the specific details required to answer your questions comprehensively.

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A Pole Needle is an injection needle, which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. The nerve is localized either by using electrical stimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic or a radiofrequency lesion may be made.

There are four types of needles: SMK Sluijter-Mehta Cannulae, RF Pole, Pole and Flexible Needles.
SMK Cannulae is used in radiofrequency (RF) lesion procedures for the relief of pain. The device allows a injection of local anesthetic to relieve the pain of RF. A SMK-TC electrode is then placed into the cannulae to create the lesion. The length of the cannula is insulated except for a section of the tip. The RF energy is then transferred from the electrode through this uninsulated portion which heats the surrounding tissue to create a lesion.
RF Pole is used for percutaneous facet denervations. The device consists of a shaft of hypodermic tubing which is insulated except for 5mm at the tip. Plastic tubing and an electrical lead are unitized in a single flexible leader portion which connects to the shaft. The lead is insulated and feed through the plastic tube. A Luer hub on the tubing allows injection of local anesthetic. The needle can be connected to a Radionics generator for stimulation and lesioning. The RF pole does not allow for temperature monitoring.
Pole is used for percutaneous stimulation and injection. The design of the pole is similar to the RF pole except for the exposed tip. Only the beveled surface, 1mm, is uninsulated. The pole is intended to be connected to a stimulus generator.
Flexible Injection Needle is used for prognostic block injections of local anesthetics or injection of contrast media. The device consists of hypodermic tubing attached to PVC tubing. The needle has no electrical connection. The tubing has a Luer hub to allow the injection with a syringe at a more remote position from the needles field.

The provided text is a 510(k) Summary for the Radionics Pole Needles. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the text does not contain any information regarding specific acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement for the purpose of demonstrating device performance.

This document is a regulatory submission for premarket notification, often used to demonstrate substantial equivalence to a legally marketed predicate device rather than presenting detailed performance study results against specific acceptance criteria. The FDA's letter (K021942) also confirms that the device is substantially equivalent to a predicate, which means it meets the regulatory requirements based on that comparison, not necessarily on a new clinical performance study.

Therefore, I cannot populate the requested table or answer the questions related to the study that proves the device meets acceptance criteria, as that information is not present in the provided text.

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XPlan 2.2 software is a stereotactic LINAC-based ration treatment planning system. XPlan 2.2 with the Body System localizes lesions to be treated using CT scans, MR scans, and digitized anglographic film. XPlan 2.2 with the Body System provides stereotactic planning system for treatment of tumors. The conformal stereotactic radiation therapy treatments are delivered over multiple fractions.

The above system consists of stereotactic treatment planning software and hardware to immobilize and localize the patient.

No information about acceptance criteria or a study proving the device meets said criteria can be found in the provided text. The document is a 510(k) summary for a medical device (Radionics XPlan 2.2 with the Body System) and an FDA clearance letter. It primarily focuses on demonstrating substantial equivalence to predicate devices and detailing the device's intended use and regulatory classification. There is no mention of specific performance metrics, clinical studies, or data used to validate the device's accuracy or efficacy.

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To record electrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures.

The Recording and Stimulating Electrode is a passive probe guided stereotactically to record electrical activity or evoke a response through stimulation for the purpose of brain mapping during foretional neurosurgical procedures.

The provided text is a 510(k) summary for a medical device called "Recording and Stimulating Electrode." It focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a performance study with detailed acceptance criteria and results.

Therefore, the input document does not contain information related to acceptance criteria, a study proving device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, or multi-reader multi-case studies.

The document primarily states:

• The device is a "Recording and Stimulating Electrode" intended "To record electrical activity or evoke a response through stimulation for the purpose of brain mapping during functional neurosurgical procedures."
• It is considered substantially equivalent to two predicate devices: Radionics Microelectrode Kit (K991399) and Microrecording Systems Consultants, LLC, Microelectroencephalography Professional System 5000 (K991077).
• No applicable performance standards have been issued under section 514 of the Food, Drug & Cosmetic Act.
• The FDA has made a substantial equivalence determination, allowing the device to be marketed.

Without a detailed performance study described in the provided text, it is impossible to populate the requested table and answer the specific questions about acceptance criteria, study details, and ground truth establishment.

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Ask a specific question about this device