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The CUSA NXT Extended Length Tip for soft tissue is an accessory to the CUSA NXT and CUSA Selector Ultrasonic Surgical Aspirator Systems that are indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft and hard (e.g. bone) tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The Extended Length Tip (ELT) has been designed to be used with the 35kHz Handpiece of the CUSA Selector and CUSA NXT Ultrasonic surgical aspirators. Ultrasonic surgical aspirators facilitate the removal of cellular and other unwanted soft and hard (e.g. bone) tissue. These systems provide selective tissue disintegration with simultaneous irrigation and aspiration. The design of the 35 kHz Fine tip that is currently used with the 35kHz Handpiece has been modified to increase the working length of the device and reduce the bend angle. This will allow the device to be used in procedures where the surgeon requires a longer tip. The distal end of the ELT will have a flat annulus and two pre-aspiration holes. The ELT will be supplied sterile and is intended for single use.

The provided text describes a 510(k) summary for the Integra™ CUSA NXTTM Extended Length Tip, an accessory to ultrasonic surgical aspirator systems. The summary includes non-clinical tests to demonstrate substantial equivalence to predicate devices, focusing on the device's physical and performance characteristics rather than clinical diagnostic performance. Therefore, many of the requested fields related to diagnostic studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance) are not applicable to this submission.

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

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

The acceptance criteria are implicitly defined by demonstrating that the new tip performs "the same" as or "less" than the predicate device in terms of potential adverse effects (like heating) while maintaining equivalent functional performance (like tissue removal rate).

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 applicable. This was a non-clinical, benchtop study comparing the performance characteristics of the new tip against a predicate device, not a study involving patient data or a test set in the traditional sense of a diagnostic device.
• Data provenance: Not applicable. The tests were performed in a lab setting by the manufacturer (Integra Burlington MA, Inc.).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This was a non-clinical, benchtop study. No expert review of patient data was involved.

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

• Not applicable. This was a non-clinical, benchtop study. No adjudication of patient cases was involved.

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/diagnostic device.

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

• Not applicable. This is not an AI/diagnostic device.

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

• The "ground truth" equivalent in this context is the performance of the legally marketed predicate device (35 kHz Fine Tip, K021989). The study's goal was to demonstrate that the new device is substantially equivalent to this predicate in terms of safety and performance.

8. The sample size for the training set

• Not applicable. This is a non-clinical submission for a surgical instrument accessory, not a machine learning or AI device that requires a training set.

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

• Not applicable. No training set or associated ground truth was established for this submission.

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The Integra Radionics™ Linac Collimator Assembly Housing (LCAHART) is indicated to be mounted on the Siemens Artiste MV linac with MLC-160 Accessory Hollder as an Accessory tray to attach Integra Radionics collimators for treatment modalities such as stereotactic radiosurgery (SRS) and radiotherapy (SRT).

The Linac Collimator Assembly Housing (LCAH) consisting of a collimator sliding tray, collimator baseplate, and collimator tube. It is designed as a slide-in attachment for the Siemens MLC-160 LINAC Accessory Holder. The LCAH positions and aligns Radionics radiation beam shaping collimators to the Siemens ARTISTE LINAC (K072485) internal collimator and radiation source during radiosurgery and radiation therapy procedures.

This document describes a medical device, the Linac Collimator Assembly Housing (LCAH), and its 510(k) summary for substantial equivalence review. This type of regulatory submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

Therefore, the document does not contain specific acceptance criteria, performance data from a clinical study, or details about ground truth establishment, expert review, or statistical methodologies like MRMC studies typically found in submissions for novel devices or those requiring clinical performance validation.

Based on the provided text, the following information is either not applicable or not available:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set or performance study is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
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 device is a physical accessory for a LINAC, 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 is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical performance study is detailed.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Regulatory Context (from the provided text):

• Device Name: Linac Collimator Assembly Housing (LCAH)
• Intended Use: "The Integra Radionics™ Linac Collimator Assembly Housing (LCAHART) is indicated to be mounted on the Siemens Artiste MV linac with MLC-160 Accessory Hollder as an Accessory tray to attach Integra Radionics collimators for treatment modalities such as stereotactic radiosurgery (SRS) and radiotherapy (SRT)."
• Regulatory Mechanism: 510(k) Premarket Notification, seeking substantial equivalence.
• Predicate Devices: XKnife Radiosurgery System (K912630) and the ARTISTE MV SA (K072485).
• Conclusion for Equivalence: The LCAH is "substantially equivalent to the XKnife Radiosurgery System (K912630) and the Siemens ARTISTE MV SA (K072485). The Linac Collimator Assembly Housing (LCAH) is similar to the predicate devices in the intended use, the fundamental scientific technology of the device, and does not raise new issues of safety and effectiveness."

In the context of a 510(k) for a device like the LCAH, the "acceptance criteria" are primarily met through demonstrating equivalence to existing legally marketed devices, often through engineering analysis, mechanical testing, and comparison of specifications, rather than clinical performance studies with specific statistical endpoints. The study proving it meets criteria would be the submission itself, detailing how its design and function compare to the predicates.

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Indications For use: XKnife 5 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Radionics XKnife 5. It does not contain specific details about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment that would be required to answer your questions.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..." This indicates that the device was cleared based on substantial equivalence to a predicate device, rather than a de novo clinical trial demonstrating performance against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given document. To obtain this kind of detailed information, you would typically need to refer to:

• The 510(k) submission summary itself (which is often publicly available on the FDA website).
• Clinical study reports, if any were performed and submitted.
• The device's Instruction for Use (IFU) or technical specifications.

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The CUSA Shear Tip, an accessory of the CUSA EXcel Ultrasonic Surgical Aspirator System, is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue is desirable, including Neurosurgery, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The CUSA Shear Tip is an additional tip that is used with CUSA EXcel system to fragment fibrous tissue. The distal end of the CUSA Shear Tip has a series of opposing angled lands, instead of a flat surface. This pattern promotes refracted longitudinal waves propagating in greatly different directions at the interface to coupled tissue. No changes to the console, handpiece or suction/irrigation system were needed.

The provided text outlines a 510(k) summary for the CUSA Shear Tip, an accessory to an ultrasonic surgical aspirator system. However, it does not contain the specific details required to answer your request regarding acceptance criteria and a study proving the device meets those criteria.

The document states: "Performance testing has been completed to demonstrate that the CUSA Shear Tip can better fragment fibrous tissue." This is a general statement and lacks all the specific information you've asked for.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or any other details about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as none of that information is present in the provided text.

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The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.

The Radionics XKnife HDRT System is indicated for use in radiotherapy procedures to aid in the positioning of patients immediately prior to therapy.

The technological characteristics are similar to those found in the:

Varian Medical Systems Trilogy Radio Therapy System 510(k) K081188

HDRT software is based on Integra Radionics ImageFusion 3 software (K063230) in that it compares multiple 3D images. In the case of HDRT the images compared are: the pretreatment planning images obtained immediately before treatment. The images immediately before treatment are obtained from Varian Trilogy Linear Accelerators which incorporate CBCT devices capable of exporting DICOM images to shared drives. Based on the comparison of the images, HDRT specifies patient adjustment data, to insure that the patient is appropriately positioned for treatment. This functionality allows for slight errors in positioning of the patient to be compensated for, it also compensates for movement of internal organs.

This looks like a 510(k) premarket notification for a medical device called the Radionics XKnife HDRT System. It appears to be for a radiation therapy treatment planning system to aid in patient positioning.

Unfortunately, the provided text does not contain any information about acceptance criteria or specific studies proving the device meets those criteria. The document primarily focuses on establishing "substantial equivalence" to a predicate device, which is the basis for 510(k) clearance. This means that the FDA determined the new device is as safe and effective as a legally marketed device, but the excerpt does not detail the testing and performance metrics that would typically be associated with proving independent acceptance criteria.

Therefore, I cannot provide the requested information. The document mentions:

• Trade Name: Radionics XKnife HDRT System
• Common Name: Radiation Therapy Treatment Planning System
• Indications for Use: To aid in the positioning of patients immediately prior to therapy.
• Technological Characteristics: Compares multiple 3D images (pre-treatment planning images and images obtained immediately before treatment from CBCT devices on Varian Trilogy Linear Accelerators). Specifies patient adjustment data based on image comparison.
• Predicate Device: Varian Medical Systems Trilogy Radio Therapy System (K081188) and Integra Radionics ImageFusion 3 software (K063230) for image comparison functionality.

To answer your specific questions, information regarding acceptance criteria, device performance results, sample sizes for test/training sets, ground truth establishment, expert involvement, or MRMC studies for this device is not present in the provided text.

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The CUSA Selector™ NXT 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, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The CUSA Selector NXT Ultrasonic Surgical Aspirator consists of two components: System Console and Service Module. The System Console operates the full functions of the aspirator, but does not have an on-board aspiration source. The Service Module is an add-on that provides an integrated system look with a fully independent aspiration source. The product is being updated to improve usability and control technology within the system. It will utilize the existing set of Selector handpieces.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. This document is a 510(k) summary for a medical device (CUSA Selector NXT Ultrasonic Surgical Aspirator Module) and primarily focuses on establishing substantial equivalence to predicate devices, device description, and indications for use. It does not contain details about performance studies, sample sizes, expert involvement, or adjudication methods for verification/validation.

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For cranial fixation during CT scanning and treatment with the TomoTherapy HiArt System.

The Interfix Patient Adapters consists of two adapters, the InterFix™ CT Adapter which attaches to the CT scanner tabletop and the InterFix™ Tabletop Adapter for attachment to the TomoTherapy HiArt System tabletop. The adapters are designed to accept the Integra Radionics headrings, such as the Gill-Thomas-Cosman relocatable headring. Universal Compact Head Ring (UCHR), Intubation Headring Assembly (HRA-IM), and Tarbell-Loeffler Cosman (TLC) Pediatric Frame. The purpose of the Interfix system is to hold a patient securely and in the same position during the diagnostic CT scan and TomoTherapy HiArt Treatment. The adapters can be used to aid the user in aligning the patient to the lasers; however, the prescan is still required to ensure that the patient is in the correct position.

This device is for mechanical fixation and does not involve AI or algorithms, therefore, most of the requested information is not applicable.

Table of Acceptance Criteria and Reported Device Performance:

Study Information (Not Applicable for this mechanical device):

• Sample size used for the test set and the data provenance: Not applicable. This is a mechanical fixation device, not a diagnostic or AI-driven system that processes data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a mechanical fixation device is typically based on mechanical stability and fit, not expert interpretation of outputs.
• Adjudication method for the test set: Not applicable.
• 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-assisted device.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device does not have an algorithm.
• The type of ground truth used: For a mechanical device like this, the "ground truth" would be objective measurements of stability, reproducibility of positioning, and compatibility with the specified headrings and equipment (CT scanner, TomoTherapy HiArt System). The provided text implies that these functional requirements were met for the device to be cleared.
• The sample size for the training set: Not applicable. There is no training set for a mechanical device.
• How the ground truth for the training set was established: Not applicable.

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The CUSA Selector 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, Gastrointestinal and affiliated organ surgery, Urological surgery, Plastic and Reconstructive surgery, General surgery, Orthopedic surgery, Gynecological surgery, Thoracic surgery, Laparoscopic surgery and Thoracoscopic surgery.

The Selector Integra Ultrasonic Surgical Aspirator System (Selector) 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 Selector 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).

The Selector has been modified to enable it to fragment bone. This was accomplished by designing a new tip, which will be referred to as the Saber Tip, to work with existing system. Therefore no changes to the console, handpiece or suction/irrigation system were needed.

This 510(k) summary describes a device modification, specifically a new bone tip for an existing ultrasonic surgical aspirator system. The submission focuses on demonstrating substantial equivalence to predicate devices for the expanded use case of fragmenting bone and does not include a study or acceptance criteria in the typical sense of evaluating a diagnostic or AI-driven device.

Therefore, many of the requested categories in your prompt are not applicable to this type of regulatory submission. The document explicitly states that "no changes to the console, handpiece or suction/irrigation system were needed," only the tip was modified. This implies that the core performance of the aspirator system for soft tissue fragmentation remains established by the previous 510(k) clearances.

Here's an analysis based on the provided document, addressing the applicable points and explaining why others are not relevant:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no explicit table of acceptance criteria or reported device performance metrics in this 510(k) summary for the new bone tip. The submission relies on demonstrating substantial equivalence to predicate devices that are already cleared for fragmenting both soft and hard (bone) tissue. The acceptance is implied by the FDA's decision letter of "substantial equivalence" as detailed in the document.

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

Not applicable. This submission is for a device modification (new tip) and relies on demonstrating substantial equivalence to already-cleared predicate devices. There is no new "test set" of data or patient samples presented in this summary to evaluate the performance of this specific bone tip. The evaluation would have been based on engineering design, material compatibility, and potentially bench testing to confirm the tip's ability to fragment bone, as opposed to a clinical study with human data.

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

Not applicable. As noted above, there is no new "test set" for performance evaluation in the context of a diagnostic or AI study. The core claim is substantial equivalence to predicate devices already cleared for the indications of use.

4. Adjudication Method for the Test Set:

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

Not applicable. This is not a diagnostic or AI device that would typically involve a MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:

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

7. The Type of Ground Truth Used:

The "ground truth" in this context is the established safety and efficacy of the predicate devices for fragmenting both soft and hard tissue. The new bone tip is designed to achieve the same functional outcome as the bone tips of the predicate devices. The assessment relies on a comparison of technological characteristics and intended use.

8. The Sample Size for the Training Set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary of what the document does provide regarding acceptance:

• Acceptance Criteria (Implicit): The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices. This means proving that the modified device is as safe and effective as the predicate device(s) for its intended use, which now includes bone fragmentation.
• Study Proving Acceptance: The "study" is a comparison and justification presented in the 510(k) submission itself, stating:
  • The device (Selector Ultrasonic Surgical Aspirator System with Bone Tip) is substantially equivalent to:
    • Selector Integra Ultrasonic Surgical Aspirator System (K021989) - cleared for general ultrasonic aspiration.
    • Radionics CUSA Excel Ultrasonic Surgical Aspirator System with Bone Tip (K051947) - a predicate device that already includes a bone tip, directly supporting the expanded indication.
    • Synergetics Sonotome Ultrasonic Aspirator Tips (K020220) - another predicate for aspirator tips.
  • The modification involves designing a new bone tip (Saber Tip) to work with the existing system.
  • No changes were needed for the console, handpiece, or suction/irrigation system.
  • The technological characteristics are the same or similar to those found with the predicate devices.
  • The indications for use are aligned with the predicate devices, specifically mentioning fragmentation, emulsification, and aspiration of "soft and hard (e.g., bone) tissue."

The FDA's decision letter (starting on page 2 of the input) confirms that the FDA reviewed the submission and determined that the device is "substantially equivalent" to the legally marketed predicate devices, thereby allowing it to proceed to market. This determination is the documented acceptance.

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A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems.

The above system is a pre-processing registration (fusion) software for CT, MR and PET scans. The software provides QA tools for the user to evaluate the fusion results. The results are used with other Integra Radionics applications. The software can be used on a HP UNIX or Linux workstation.

This submission does not contain information about acceptance criteria or a study that proves the device meets acceptance criteria. The provided documents are a 510(k) summary and the FDA's clearance letter for the Integra Radionics ImageFusion 3.

Here's a breakdown of what is and is not in the provided text:

• What's present:

  • Device Name: Integra Radionics ImageFusion 3
  • Predicate Device: Radionics ImageFusion 2, 510(k), K990071
  • Intended Use/Indications for Use: "A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems." and "registering (fusing) stereotactic and non-stereotactic scans."
  • Technological Characteristics: Stated as "the same or similar to those found with the predicate devices."
  • Regulatory Information: 510(k) number (K063230), regulation number, product code, regulatory class.

• What's missing (information needed to answer the request):

  • A table of acceptance criteria and reported device performance.
  • Details of any study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
  • Information on MRMC comparative effectiveness studies or standalone performance.
  • Training set details (sample size, ground truth establishment).

To answer your request thoroughly, a performance study report or verification and validation documentation would be needed, which is not included in this 510(k) summary. 510(k) summaries primarily focus on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, especially for devices where clinical performance might be inferred from the predicate and technological similarity.

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XKnife RT 4 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment

The above system is a stereotactic treatment planning software with the ability to be used on a Linux workstation, and the ability to use PET scans as an additional image source.

This submission is a 510(k) premarket notification for the Integra Radionics XKnife RT 4, a stereotactic radiation treatment planning system. The document states that the device is substantially equivalent to a predicate device (Radionics XK.nife RT 3 with Non Stereotactic Module 510(k), K041997) and relies on this substantial equivalence rather than presenting an independent study with acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be fully provided from the given text.

Here's an explanation of why the specific sections of your request cannot be fulfilled:

1. A table of acceptance criteria and the reported device performance:
   The document does not specify any new acceptance criteria for the Integra Radionics XKnife RT 4. It asserts substantial equivalence to a predicate device, meaning its performance is considered acceptable if it is comparable to the predicate. No specific performance metrics or a table comparing them are provided.

2. Sample size used for the test set and the data provenance:
   No new clinical or performance study data is presented for the Integra Radionics XKnife RT 4. The submission relies on the established performance of its predicate device. Thus, there is no test set, sample size, or data provenance to report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   Since no new study data is presented, there is no test set for which ground truth would need to be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   As no new study data is presented, no adjudication method was used.

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:
   This device is a treatment planning system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable to this device type and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
   While the device is a software system, the 510(k) submission primarily focuses on its technological characteristics and intended use being similar to its predicate. It does not describe a standalone performance study with specific metrics, but rather relies on the established safety and effectiveness of the essentially equivalent predicate.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   As no new study data is presented, there is no new ground truth established for the Integra Radionics XKnife RT 4.

8. The sample size for the training set:
   This submission is for a medical device that appears to be rule-based or algorithm-based, rather than a machine learning model that would require a dedicated training set. No information regarding a training set or its size is provided.

9. How the ground truth for the training set was established:
   Given that this does not appear to be an AI/ML device requiring a training set, the concept of establishing ground truth for a training set is not applicable here and no information is provided.

Summary of the K061893 Submission:

The Integra Radionics XKnife RT 4 is a stereotactic radiation treatment planning system. The submission (K061893) aims to demonstrate its substantial equivalence to an already legally marketed device, the Radionics XK.nife RT 3 with Non Stereotactic Module (K041997).

The basis for acceptance is this claim of substantial equivalence. The key arguments presented for substantial equivalence are:

• Intended Use: The device is intended for "stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment," which is the same as its predicate.
• Technological Characteristics: The technological characteristics are stated to be "the same or similar to those found with the predicate devices." The notable updates for XKnife RT 4 are its ability to be used on a Linux workstation and its capability to use PET scans as an additional image source.

In a 510(k) submission based on substantial equivalence, the "study" is often a comparison of the new device's specifications and performance to the predicate device, demonstrating that any differences do not raise new questions of safety or effectiveness. The provided text, however, does not include the detailed comparison data that would typically be part of such a submission, only the summary statement that such a comparison was made and found favorable.

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