(129 days)
The Kobold Prostate HDR Template and Stepper Template are indicated for use as an accessory for high dose rate brachytherapy treatment of the prostate.
The Stainless Steel Interstitial Needles and corresponding stylets are indicated for use as an accessory for high dose rate brachytherapy treatment of the prostate.
The Kobold Prostate HDR Template and Stepper Template are accessories to be used where ultrasound-guided interstitial temporary high dose rate (HDR) brachytherapy treatment of the prostate is accepted by up-to-date clinical guidelines. The templates are ergonomically designed for freehand HDR technique. The templates are best used with biplanar transrectal ultrasound and confirmatory fluoroscopy.
The templates are single-use, disposable devices shipped nonsterile. It is customizable for almost any prostate size or shape. The templates include four suture holes at the corners to secure the template to the perineum. The templates are available in various gauge sizes to match the most common needles sizes. These devices are for continuous use of up to 24 hours of contact with the patient.
For workflows that require a stepper, the Kobold Prostate HDR Stepper Template fits into the Elekta Martinez Template Holder.
The stainless steel needles are 17 gauge in either a pencil point tip or a bevel tip. The associated stylets are inserted into needles to stiffen the needles during implantation of the needles into the patient and to stiffen the needles between radiation therapy fractions.
The Kobold Stainless Steel Interstitial Needles are intended for single use and are disposable. The maximum implantation time for these needles is less than 24 hours.
The provided text describes a 510(k) summary for the Kobold Prostate HDR Template(s) and Needle Set(s), which are accessories for high-dose rate brachytherapy treatment of the prostate. As such, these are medical devices, not an AI/ML powered device, and the information requested pertaining to AI/ML powered devices is not applicable.
Here's a breakdown of the requested information based on the provided text, with "N/A" where the information is not relevant to this type of device or not present in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility | Cytotoxicity, Irritation, Sensitization, and Systemic Toxicity testing conducted per ISO 10993. All testing passed. |
| Shelf Life | Real-Time aging testing conducted shows an initial shelf life of 5 months. |
| General Performance | Non-Clinical Performance Bench Validation Testing demonstrated that the subject device met all predetermined acceptance criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for the biocompatibility or shelf-life testing. However, it indicates these were non-clinical bench tests.
- Sample Size: Not explicitly stated as a number of units, but tests were conducted on the templates and needles.
- Data Provenance: Not applicable as these are bench tests, not patient data studies.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for medical device performance (e.g., biocompatibility, shelf life, mechanical integrity) is established through standardized testing protocols, not expert consensus on diagnostic interpretations.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for reconciling discordant expert interpretations in diagnostic studies, not for physical device performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This is not an AI/ML powered device, nor is it a diagnostic imaging device requiring human reader interpretation. No MRMC study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for these tests is based on:
- Biocompatibility: ISO 10993 standards for biological evaluation of medical devices.
- Shelf Life: Real-time aging test results in comparison to established stability criteria.
- General Performance: Predetermined engineering and design specifications for the device's function and integrity.
8. The Sample Size for the Training Set
Not applicable. This device does not involve a training set as it is not an AI/ML system.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.