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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.

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The Precision Stepper and Needle Guide is intended for use with a rectal probe in ultrasound-guided prostate brachytherapy (transperineal radioactive seed implantation), and prostate gland voluming. The Precision Stepper and Needle Guide system is an accessory to an ultrasound system used for these medical procedures in a clinical setting.

Condition to be screened, monitored, treated or diagnosed. Prostate gland voluming and treatment of prostate cancer by transperineal brachytherapy

Physiological purpose. The Precision Stepper provides equipment support and quidance for a rectal probe. When used with its Needle Guide, an ultrasonic imaging system, and a rectal probe, the Precision Stepper and Needle Guide System is an accessory to clinical procedures for prostate gland voluming and ultrasound-guided radioactive seed implantation.

The Precision Stepper and Needle Guide is a manually operated medical device used to provide mechanical support for the application of a radionuclide source into the prostate in the course of a brachytherapy procedure in a clinical setting. The Stepper guides and secures a rectal probe which is used for imaging of the prostate. The Stepper moves the transducer in precise increments, or steps. When used in conjunction with the Stepper, the Needle Guide is used to aid the clinician in guiding needles through a template into the prostate. Under the guidance of the ultrasound probe, these needles are used to implant radioactive seeds that irradiate the prostate in cancer therapy.

The provided text is related to a 510(k) premarket notification for a medical device called the "Northwest Radiation Therapy Products Precision Stepper and Needle Guide." It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission.

This document is for a physical medical device with no software component or energy source. The "Testing" section concisely states that the device "has been subject to extensive inspection and testing to verify that the device meets all its physical and performance specifications." It then mentions that "Test results are maintained in the design history file and/or device history files for this device." However, it does not provide details about these tests, their acceptance criteria, or the study design/results.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as requested in your prompt based on the provided text. The requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are commonly associated with performance evaluations of AI algorithms or software, which is not applicable to this physical, manually operated device.

The document essentially claims substantial equivalence to predicate devices (CIVCO Seed Implant Needle Guide K875241 and CIVCO Ultra-Step Stepper K871413) based on similar materials, design, principle of operation, and technology, and confirms manufacturing in accordance with U.S. Quality System Regulation (21 CFR 820).

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