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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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