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Precise three-dimensional placement of needles into a sterile Field of the human body for diagnostic and therapeutic purposes, including brachytherapy for prostate cancer

The modified PGK device includes a stereotactic bridge made of stainless steel and an aluminum protractor, which is attached to the bridge. The template in the modified PGK device, which substitutes the guidance device in the predicate PGK, is made of teflon. A post and bracket attachment to the template is made of stainless steel. The modified PGK is manufactured by Associated Design and Manufacturing (Registration #1122860) at 814 N. Henry St., Alexandria, Virginia.

Here's an analysis of the provided text to extract information about acceptance criteria and a study demonstrating device performance:

This 510(k) submission (K980997) is for a modified PGK device used for brachytherapy in prostate cancer. The submission establishes substantial equivalence to existing devices (K911974 and K905198/K914945). The "study" described is primarily a comparison of clinical outcomes and advantages compared to a predicate device, rather than a formal, controlled randomized clinical trial with pre-defined acceptance criteria for a new device.

1. Table of Acceptance Criteria and Reported Device Performance

- Urethral necrosis: 0 
- Incontinence: 0 
- Chronic infection: 2 
- Recurrent hematuria: 2 
- Stricture: 0 
- Late proctitis: 2 
- Fistula: 0 
- Enteritis: 0 
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| - Avoidance of complications related to specific patient characteristics (e.g., TURP, pubic arch, large prostate). | - Pubic arch interference: "completely eliminated with the transischiorectal space approach."

• Large prostates: Can be used on patients with prostatic volumes up to 150 cm³ (predicate not recommended for >60 cm²).
• TURP defects: None developed incontinence in over 200 patients (including 30 with TURP defects).
• Obstructive urinary symptoms: Not contraindicated; successfully treated patients with such symptoms.
• Urethral stenosis: No patient had urethral stenosis requiring TURP.
• Rectal wall implantation: Likelihood minimized as prostate is separated from the rectum by ~1 cm. |
  | Device Performance (Mechanical/Functional): | |
  | - Accurate guidance for needle insertion. | - Template is precision bored to accept 18 gauge needles.
• 2.5 mm spacing chosen for correction of needle placement.
• Template allows rotation for needed adjustments.
• Post and bracket attachment stabilizes needle insertion, avoiding human error during extraction of afterloading needles. |
  | - Sterile and safe handling of radioactive materials. | - Needles and seeds in strand delivered sterilized.
• Template, post/bracket, Mick applicator, surgical equipment sterilized with glutaraldehyde.
• Loose seeds, seed assembly, bowls temperature sterilized at facility.
• Radiation safety considerations are the same as predicate, governed by NRC license. Pre- and post-implant QA, implant control, and radiation survey forms completed. |
  | - Reliable dosimetry. | - Dosimetry performed in two phases using a special computer program.
• Initial calculation for peripheral dose (16,000 cGy for Iodine125, 12,000 cGy for Palladium103).
• Adjustments for prostate movement and accurate seed accounting.
• Three-dimensional isodose curves determined with reference to final treatment plan.
• Five mm CT images taken for final verification of implanted sources. |

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

• Test Set Description: The "study" refers to clinical experience with the modified PGK device and a comparative analysis against published data for transperineal approaches.
• Sample Size (Modified PGK Device):
  • 130 patients for the morbidity and complications comparison in Table 1, with a time period of 6-24 months.
  • "Over 200 patients" treated with the transischiorectal approach, including 30 with TURP defects, with none developing complications of incontinence (URPI booklet, tab 5). Number in Table 1 seems to be a subset of this broader experience.
• Data Provenance:
  • Referred to as "Preliminary Report" and "URPI booklet," suggesting the data comes from the developers of the device.
  • Country of Origin: Not explicitly stated, but the submission is to the US FDA, and the addresses of the submitting company and manufacturing are in the US.
  • Retrospective/Prospective: The data presented from the Journal of Urology article and the URPI booklet appears to be retrospective clinical experience rather than a prospectively designed clinical trial for this 510(k) submission. Table 1 outlines outcomes from a time period (6-24 months for 130 patients) implying collected historical data.

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

• The text does not explicitly state the number of experts used to establish "ground truth" for the test set.
• The "ground truth" for the clinical data (patient outcomes, complications, PSA levels, prostate volume) would traditionally be established by treating physicians and medical records.
• The submission is from "Panos Koutrouvelis, M.D." who is also the contact person and the author of the Journal of Urology article presenting the preliminary report, suggesting he is a primary expert involved in the clinical experience and data interpretation. Other clinicians involved in the "URPI booklet" or patient care would also contribute to this "ground truth."
• Qualifications of Experts: Panos G. Koutrouvelis, M.D. (later Ph.D. in the FDA letter). His article is published in the Journal of Urology, indicating peer-reviewed clinical expertise in urology and brachytherapy. The URPI booklet also implies a clinical institution's involvement.

4. Adjudication Method for the Test Set

• The text does not describe an explicit adjudication method for the test set data.
• Given that the data appears to be from retrospective clinical practice summarized in a preliminary report and booklet, it's unlikely a formal, independent adjudication process (like 2+1 reads for imaging) was used beyond standard clinical record-keeping and possibly review for the publications.

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 MRMC comparative effectiveness study was done.
• This device is a medical instrument (guidance system for brachytherapy), not an AI/imaging diagnostic device that would typically involve "human readers" or AI assistance in interpretation.
• The comparison is a clinical outcomes comparison between two different procedural approaches (CT-guided transischiorectal vs. ultrasound-guided transperineal) using different devices.

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

• Not applicable. This is a physical guidance device, not a standalone algorithm.

7. The Type of Ground Truth Used

• The ground truth for the clinical outcomes (e.g., PSA levels, complications, success of seed placement as verified by CT, patient symptoms) is based on clinical outcomes data and expert assessment from the treating physicians and follow-up medical records.
• Specifically, this includes:
  • Pathology/Diagnosis: The device treats "known or suspected disease of the prostate," implying pathological diagnosis of prostate cancer as the initial ground truth for patient selection.
  • Imaging Data (CT): CT images are used for treatment planning, seed placement guidance, and "final verification of implanted radioactive sources." This radiological confirmation serves as a form of ground truth for successful seed delivery.
  • Outcomes Data: PSA levels, self-reported symptoms, and physician-assessed complications (e.g., retention, incontinence, stricture) form the basis of the reported outcomes and safety profile.
  • Expert Consensus/Clinical Judgment: The reporting of benefits and complications relies on the clinical judgment and experience of the medical professionals involved.

8. The Sample Size for the Training Set

• Not applicable. This device is a mechanical guidance system, not an AI or machine learning algorithm requiring a "training set" in the computational sense. The "learning" for this device would be the clinical experience and iterative improvements in its design and usage based on observed outcomes, as described in the comparison to the predicate device and the advantages highlighted.

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

• Not applicable. See point 8.

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A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator. This device performs the same function as the reusable magazines sold by Mick Radionuclear Instruments, Inc.

A single patient use disposable device to hold radioactive seeds, in magazine fashion, in the MICK radionuclear 200-TP applicator.

The provided documents are a 510(k) clearance letter from the FDA and an "Indications For Use" statement for the NIT Radionuclide Seed Magazine.

These documents do not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device evaluations.

The FDA clearance is for a physical medical device (radionuclide seed magazine) under the traditional 510(k) pathway, which focuses on substantial equivalence to a predicate device rather than performance metrics from AI/ML models.

Therefore, I cannot fulfill your request for information about acceptance criteria, study details, training/test set specifics, or MRMC studies, as none of this information is present in the provided text.

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The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.

The N.T., Inc. Radionuclide Seed Applicator is a manually operated device intended to apply a radionuclide source into the body for radiation therapy.

This looks like a 510(k) clearance letter from the FDA for a medical device called the "NIT Radionuclide Seed Applicator." This type of document declares that a device is "substantially equivalent" to a legally marketed predicate device, meaning it's considered safe and effective for its indicated use.

However, a 510(k) clearance letter does not typically contain detailed acceptance criteria or a study outlining specific performance metrics, sample sizes, ground truth establishment, or expert qualifications in the way you've described for an AI/CADe device.

The questions you've asked are highly relevant for the evaluation and clearance of AI-powered medical devices (often referred to as AI/CADx or AI/CADe). These types of devices typically undergo rigorous performance studies to demonstrate their efficacy, and the information you requested would be standard in their regulatory submissions and subsequent clearance documents.

Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria and the detailed study information. The document is a regulatory approval for a physical, manually operated medical device (a radionuclide seed applicator), not an AI-driven diagnostic or assistive technology.

To answer your questions, I would need a different type of document, specifically a regulatory submission summary or a published study for an AI/CADe device.

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The intended use of the Worldwide Medical Technologies Seed Implant Needle is to introduce radionuclide seeds of I-125 or Pd-103 (purchased by the user directly from another manufacturer) into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.

Worldwide Medical Technologies Seed Implant Needle Set

The provided documents are a 510(k) premarket notification letter from the FDA and an "Indications For Use" statement for the "Worldwide Medical Technologies Seed Implant Needle Set." These documents relate to the regulatory clearance of a medical device and do not contain information about acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot extract the requested information (table of acceptance criteria and reported device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) from these documents.

The documents primarily confirm that the device is "substantially equivalent" to predicate devices, allowing it to be marketed. They do not detail the specific studies or data used to establish device performance against defined criteria.

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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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The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid for the placement of radionuclide seeds into the body. Coordinate system assure to place the template in proximity to, but not touching the perineum for seed placement into and around the prostate.

The N.I.T., Inc. Needle Guiding Template is a device with needle guidance holes in a grid

The provided text is a 510(k) clearance letter from the FDA for the NIT Needle Guiding Template (Seed Applicator). It is a regulatory document confirming substantial equivalence to a predicate device, which allows the company to market the device.

This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications. The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the device and we have determined the device is substantially equivalent...". This means the clearance is based on the device being similar enough to an already approved device, rather than requiring new performance studies meeting specific acceptance criteria as would be needed for a novel device or pre-market approval (PMA).

Therefore, I cannot fulfill your request for the tables and information about the study, as the provided text does not contain this data.

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For the manual application of a radionuclide source into the body for radiation therapy.

Prostate Seeding Needle

This document is a 510(k) premarket notification letter from the FDA for a Prostate Seeding Needle. It's a regulatory approval document and does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot answer your request based on the provided text. The document primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

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Ask a specific question about this device

Ask a specific question about this device