Search Results

This device is indicated for use in adult males with known or suspected prostate cancer.

The Stepping Unit holds an ultrasound imaging probe and facilitates manual linear and rotational positioning of the probe. The Stepping Unit consists of a Cradle designed to hold a specific ultrasound probe and a Carriage that moves longitudinally along the Stepping Unit. A Grid Platform connected at one end of the Stepper provides support for the Disposable Template Grid. The Stepping Unit connects to the Stabilizer.

The Stabilizer provides a base for the Stepping Unit and offers fixation and support during insertion and final placement of the ultrasound imaging probe. On certain models, a fine tune mechanism is used to micro-adjust the probe or instrument to the ideal orientation. The Stabilizer mounts to an operating room table or is supported by a floor stand.

The Disposable Template Grid is a single-use, sterile grid that consists of rows and columns of holes (channels) spaced 5mm apart. These channels are labeled and provide placement of needles in predefined areas of the prostate.

Here's a summary of the acceptance criteria and study information for the CIVCO Medical Instruments Co., Inc. devices, based on the provided text:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission for substantial equivalence for a medical device (specifically a stepping unit, stabilizer, and disposable template grid used in prostate procedures), the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are generally focused on demonstrating that the new/modified device is as safe and effective as a legally marketed predicate device. The evidence provided is primarily through:

• Comparison to Predicate Devices: Showing similarity in technological characteristics and intended use.
• Literature Review: For expanding indications of use for existing devices.
• Verification and Validation Testing: Specifically for the new EX3 Stepper, confirming its new features meet specifications and do not compromise overall safety/effectiveness.

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

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

• Sample Size for Test Set: Not explicitly stated. The verification and validation testing for the EX3 Stepper (longitudinal movement, encoder reporting, electrical safety, and compatibility with treatment planning software) would have involved specific test units, but the number of units tested is not detailed in this summary.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. The verification and validation testing would have been conducted internally or by a contracted lab, likely in the US (where CIVCO is headquartered). This would be prospective testing on the physical device. The literature review for expanded indications of use would involve published, likely retrospective or prospective, clinical data (of various origins) that has already been peer-reviewed and published.

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

• This type of information is generally not applicable or explicitly stated for a 510(k) submission concerning a mechanical device like a stepping unit. The "ground truth" for mechanical function, electrical safety, or general utility for specific surgical procedures isn't typically established by expert consensus in the same way as an AI diagnostic algorithm's output would be. Instead, the "ground truth" here is the established safety and efficacy of the predicate device, engineering specifications, and universally accepted standards (e.g., IEC 60601-1 for electrical safety).
• For the validation with "treatment planning software," it implies functionality was checked against expected outputs, likely by engineers or possibly clinical users, but no explicit "expert" review process is described for establishing a ground truth.

4. Adjudication Method for the Test Set

• Not applicable/mentioned. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies, especially for evaluating diagnostic accuracy where there might be disagreements among human readers or between AI and human readers. This submission focuses on the mechanical and electrical performance of hardware, not diagnostic interpretation.

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

• No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This study type is highly specific to evaluating the clinical impact of AI-assisted diagnostic tools on human performance, which is not the subject of this 510(k) submission. This device is a mechanical accessory (stepping unit, stabilizer, template grid) used during procedures, not an AI diagnostic tool.

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

• Not applicable. This device is a mechanical accessory, not an algorithm or AI system. The EX3 Stepper has "firmware in the encoders report position," which is a functional component, but not a standalone algorithm in the typical sense of AI. Its performance (accuracy of position reporting) was verified.

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

• For EX3 Stepper's new features (encoders, continuous movement, electrical safety): The "ground truth" would be established engineering specifications, measurable physical properties, and adherence to recognized electrical safety standards (IEC 60601-1 and IEC 60601-1-1). For compatibility with treatment planning software, the ground truth would be the expected data output/interaction defined by the software's specifications.
• For expanded indications of use of existing devices: The "ground truth" for safety and effectiveness in cryotherapy, transperineal template-guided biopsy, and fiducial marker placement was established through a literature review. This means previously published clinical studies and outcomes data effectively served as a form of "ground truth" demonstration of safe and effective use.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI/machine learning device that requires a training set. The firmware on the EX3 Stepper's encoders is for reporting position, not for learning or prediction from data.

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

• Not applicable, as there is no training set for this device.

Ask a specific question about this device

The Burdette Medical Systems, Inc. Interplant™ system is used in planning and performing a prostate brachytherapy implant procedure to provide ultrasound probe alignment and radioactive seed implantation. The Interplant™ device will use standard 125-Iodine (125 I) or 103-Paladium (103 Pd) isotope permanent implant radiation seeds for the treatment of prostate cancer. The system will allow volume measurement and dose calculation, relevant prostate anatomy and dose visualization, and post-treatment seed localization.

The Interplant™ system for brachytherapy was developed to address the need for a comprehensive system and procedure for prostate seed implants. The Interplant in system compresses the requirement for separate multiple procedures into one online setting, This product integrates all of the delivery system components (needles, template guide, probe stepper) with the dose planning system for 125-Iodine (125 I) and 103-Paladium (103 Pd) implants. The system is designed for real-time dose planning in the Operating Room (OR) and for performing post-implant seed localization assessment. Real time ultrasound image plane acquisition with automatic probe position determination makes it possible to complete the image acquisition needed for dose planning within about a minute. The interplant™ system provides the needed components for seed implant procedures except the seeds themselves and uses existing ultrasound imaging equipment. This will enable the physician to focus on the procedure, providing immediate feedback for improved quality assurance.

The Real-Time Brachytherapy Radiation Seed Implant Program and System includes all technology, computer software, and hardware, and methods associated with the implant of radioactive "seeds" or pellets in the prostate. System elements include the user interface, real-time image acquisition, image contouring, dose calculation and display software, dose volume histograms, isodose surface contours, post-implant seed localization, and the patient scheduling spreadsheet software.

The System consists of a two-dimensional and three-dimensional image visualization and brachytherapy dose system employing 2D ultrasound imaging for use in radioactive seed implants of the prostate. The software for the brachytherapy seed implant and dose calculation system was developed on a Pentium-based processor with supporting graphics and digitizing hardware.

This 510(k) summary does not contain information on acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) submission for Burdette Medical Systems, Inc.'s Interplant™ system, which is a brachytherapy dose planning and implant system. It primarily focuses on demonstrating substantial equivalence to already marketed predicate devices.

Here's what can be extracted from the provided text, and what is missing:

Missing Information:

The provided text does not contain any of the following information:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for the test set and their qualifications.
• Adjudication method for the test set.
• Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done.
• Effect size of human reader improvement with AI vs. without AI assistance.
• Whether a standalone (algorithm only) performance study was done.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How the ground truth for the training set was established.

Information Extracted from the Document:

While the core request about acceptance criteria and a study proving their fulfillment cannot be answered from this document, here's what the document does provide:

• Device Name: Interplant™
• Intended Use: To provide precision ultrasound probe alignment and radioactive seed implantation in the treatment of prostate cancer. The system allows volume and dose calculation, image visualization, and post-treatment seed localization. It uses standard 125-Iodine (125 I) or 103-Paladium (103 Pd) isotope permanent implant radiation seeds.
• Technological Characteristics:
  • Integrates delivery system components (needles, template guide, probe stepper) with a dose planning system for 125-I and 103-Pd implants.
  • Designed for real-time dose planning in the Operating Room (OR) and post-implant seed localization assessment.
  • Real-time ultrasound image plane acquisition with automatic probe position determination allows image acquisition for dose planning within about a minute.
  • Includes a user interface, real-time image acquisition, image contouring, dose calculation and display software, dose volume histograms, isodose surface contours, post-implant seed localization, and patient scheduling spreadsheet software.
  • Employs 2D and 3D image visualization and brachytherapy dose system using 2D ultrasound imaging for prostate seed implants.
  • Software developed on a Pentium-based processor with supporting graphics and digitizing hardware.
• Regulatory Classification: Class II, 21 CFR 892.5730/Procode: 90 MUJ (Medical charged-particle radiation therapy system).
• Predicate Devices:
  1. Multimedia Medical Systems, Inc. B3DTUA TherapacPLUS dose planning
  2. SSGI Prowess 500 and Prowess 2000 dose planning K924240
  3. CIVCO Medical Instruments Ultra-Step stepper K875241
  4. B&K Medical Systems HP-100 stepper/stand
  5. Tayman Medical Accuseed stand/stabilizer K963302
  6. COTAN stand/stabilizer
  7. Northwest stand/stabilizer
  8. Maroon Bels, Inc. Brachystand and Brachystepper K972672
• Submission Type: 510(k) Premarket Notification, seeking substantial equivalence.

Conclusion:

This document is a regulatory submission for premarket notification (510(k)), not a study report. The primary goal of a 510(k) is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than to present detailed clinical study results with acceptance criteria. Therefore, the specific information requested about acceptance criteria and a study proving performance against them is not typically found in this type of summary. Such information would be expected in a more comprehensive clinical or validation study report, which is usually referenced or summarized within a 510(k) but not fully detailed.

Ask a specific question about this device