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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

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.

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The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Fletcher type applicator is accepted by up-to-date clinical guidelines. The Kobold® Fletcher-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.

The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus with a Henschke type applicator is accepted by up-to-date clinical guidelines. The Kobold® Henschke-model Tandem and Ovoid Applicator Set is intended for continuous use of up to 24 hours of contact with patient.

The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the vagina is accepted by up-to-date clinical guidelines. The Kobold® Vaginal Cylinder Applicator Set is intended for continuous use of up to 24 hours of contact with patient.

The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set is indicated for use in any patient case where high dose rate (HDR) radiation treatment of the cervix, vagina, and uterus with a Miami type applicator is acceptable by up-to-date clinical guidelines. The Kobold® Miami Cylinder Set is intended for continuous use of up to 24 hours of contact with patient.

The CT Compatible / MR Unsafe HDR Kobold® Fletcher-model Tandem and Ovoid Applicator Set design is based on the conventional modified Fletcher GYN applicator. Kobold manufactures versions compatible with HDR afterloaders. This applicator is mainly utilized for HDR radiation boosts to the cervix and parametrial tissues in conjunction with external beam radiation therapy. This GYN set consists of precision manufactured intrauterine tandems and a pair of interlocking vaginal colpostats with Fletcher type unshielded barrel or cylinder ovoids (all components are designed to allow for customization of the treated geometry). The distance between the two lateral ovoids is adjustable with a lock knob. Four differing tandem geometries are provided in the set: one straight, one with slight curvature, one with medium curvature, and one with maximal curvature. These allow for maximal accommodation of the uterine shape and flexure.

The CT Compatible / MR Unsafe HDR Kobold® Henschke-model Tandem and Ovoid Applicator Set design is based on the conventional modified Henschke GYN applicator. Kobold manufactures versions compatible with HDR afterloaders. This applicator is mainly utilized for HDR radiation boosts to the cervix and parametrial tissues in conjunction with external beam radiation therapy. This GYN set consists of precision manufactured intrauterine tandems and a pair of interlocking vaginal colpostats with Henschke type unshielded ovoids (all components are designed to allow for customization of the treated geometry). The distance between the ovoids is adjustable with a lock knob. Four differing tandem geometries are provided in the set: one straight, one with slight curvature, one with medium curvature, and one with maximal curvature. These allow for maximal accommodation of the uterine shape and flexure.

The CT Compatible / MR Unsafe HDR Kobold® Vaginal Cylinder Applicator Set design is based on conventional cylindrical HDR delivery systems with a connector interface compatible with major manufacturers' afterloaders. This applicator is particularly useful in providing an HDR radiation as definitive treatment, adjuvant treatment, or as a treatment boost to the vaginal walls with or without external beam radiation therapy. The set consists of precision manufactured vaginal cylinders of varied diameters for optimal radiation treatment delivery and anatomical customization.

The CT Compatible / MR Unsafe HDR Kobold® Miami Cylinder Applicator Set design is based on conventional modified Miami applicators with a connector interface compatible with major manufacturers' afterloaders. This applicator set is particularly useful when the vaginal vault space is limited or narrow due to tumor, restricted anatomy, or fibrosis. It can also be useful to treat tumors that extend from the uterus or cervix down onto the vaginal wall. The set consists of a precision manufactured intrauterine tandems and a full set of variable diameter Miami cylinders (all components are designed to allow for customization of the treated geometry). The distance that the tandem is inserted can be customized for each case. Various tandems are provided: straight. slight curvature. medium curvature, and maximal curvature. These allow for maximal accommodation of the uterine flexure.

This document is a 510(k) summary for several medical devices: Kobold® Fletcher-model Tandem and Ovoid Applicator Set, Kobold® Henschke-model Tandem and Ovoid Applicator Set, Kobold® Vaginal Cylinder Applicator Set, and Kobold® Miami Cylinder Applicator Set.

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria with specific quantitative performance metrics. The stated "acceptance criteria" are effectively the characteristics of the predicate devices. The "reported device performance" is essentially that the new devices match these characteristics or exhibit similar performance where differences exist (e.g., sterilization methods, which are tested for efficacy independently).

• For HDR radiation treatment of cervix and uterus (Fletcher/Henschke models)
• For HDR radiation treatment of vagina (Vaginal Cylinder model)
• For HDR radiation treatment of cervix, vagina, and uterus (Miami Cylinder model) | Substantially equivalent to predicate. |
  | Afterloader Compatibility:
• GammaMed®, VariSource® (predicate) | Elekta: microSelectron®, Flexitron®; Varian: GammaMed®, VariSource® (with click-fit connector). (Expanded compatibility) |
  | Design Geometry: Flexible | Flexible |
  | Materials: Titanium, Ultem®, Stainless Steel, Silicone, High Temperature Vinyl | Titanium, Ultem®, Stainless Steel, Silicone, High Temperature Vinyl |
  | Packing: Tray | Tray |
  | Sterility: Provided Non-Sterile | Provided Non-Sterile |
  | Sterilization Methods, Sterilization Conditions:
• Steam 18 min at 273°F (134°C), 44psi (3 bar) Dry 15 min; no Sterrad® compatibility documented (predicate) | Steam 4 min at 270°F (132°C), 44psi (3 bar) Dry 15 min. (Different sterilization cycle parameters) |
  | Biocompatibility: Documented | Documented |
  | Anatomical Sites: Uterus, Cervix (Fletcher/Henschke); Vagina (Vaginal Cylinder); Cervix, Vagina, Uterus (Miami Cylinder) | Uterus, Cervix (Fletcher/Henschke); Vagina (Vaginal Cylinder); Cervix, Vagina, Uterus (Miami Cylinder) |
  | Environmental Compatibility: CT/MRI Compatible (predicate) | CT Compatible / MR Unsafe (A key difference, noted in the device name and description). |
  | Performance Characteristics (overall) | Substantially equivalent |
  | Bench Testing: Documented in accordance with known standards | Documented by manufacturer for predicate device. (Implying the new device meets similar standards) |

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

The document does not describe a clinical study or a test set of patient data with a specific sample size. The testing appears to be primarily bench testing of the devices themselves, as indicated in section 7: "Extensive testing in accordance with known standards is documented by the manufacturer for predicate device in K-123912 and K-123941." This implies the current submission relies on the established performance of the predicate devices and specific engineering tests for the new devices (e.g., material testing, sterilization efficacy). There is no mention of data provenance (e.g., country of origin, retrospective/prospective) because no patient data study is described.

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

Not applicable. This submission does not involve a "test set" requiring expert ground truth, as it is a device substantial equivalence submission based on engineering and performance characteristics compared to predicate devices, not a clinical diagnostic or AI-driven aid.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set requiring adjudication is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The devices are physical medical tools (applicators for radiation treatment), not diagnostic imaging aids or AI algorithms that would involve human reader performance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done:

Not applicable. The devices are physical medical tools, not software algorithms.

7. The Type of Ground Truth Used:

Not applicable in the context of clinical "ground truth" (e.g., pathology, outcomes data). The "ground truth" for this submission are the established performance characteristics, safety profiles, and indications for use of the predicate medical devices, as well as engineering standards for materials and sterilization.

8. The Sample Size for the Training Set:

Not applicable. There is no AI component or "training set" mentioned in this document.

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

Not applicable. There is no AI component or "training set" described.

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The CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set is indicated for use in any case where high dose rate (HDR) radiation treatment of the cervix and uterus is accepted by up-to-date clinical guidelines.

The Kobold Ring and Tandem Applicator Set is intended for continuous use of up to 24 hours of contact with patient.

The CT Compatible / MR Unsafe HDR Kobold Ring and Tandem Applicator Set™ design is based on the modified conventional Ring/Tandem applicator with a click fit connector interface. This applicator is particularly useful in providing an HDR radiation boost to the cervix and parametrical tissues in conjunction with external beam radiation therapy. The applicator consists of precision manufactured intrauterine rings, ring caps, and tandems, interlocking via a ring bracket. All components are designed for a defined geometry. The rings are provided in three different angles (30 degrees, 45 degrees, and 60 degrees) with three different tandem lengths (20 mm, and 60 mm from the ring axis) provided for each ring angle. Two ring caps are provided (5.0 mm and 7.0 mm).

The provided text is a 510(k) summary for the Kobold Ring and Tandem Applicator Set, which is a medical device used in high dose rate (HDR) radiation treatment. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting acceptance criteria and a study proving the device meets those criteria from an AI/algorithm performance perspective.

Therefore, many of the requested items related to AI system evaluation (e.g., sample size for test set, data provenance, expert ground truth, MRMC study, standalone performance) are not applicable to this type of device clearance document.

However, I can extract information regarding the device's characteristics and the basis for its clearance, framed in terms of substantial equivalence.

Here's the breakdown of the information that can be extracted or deduced from the document:

1. A table of (implied) acceptance criteria and the reported device performance from the provided text:

Since this is a substantial equivalence submission for a physical medical device, the "acceptance criteria" are not standard performance metrics for an AI algorithm. Instead, they are characteristics that demonstrate the new device is as safe and effective as a legally marketed predicate device. The "reported device performance" is the comparison made to establish this equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. This document describes a physical medical device, not an AI algorithm evaluated on a dataset. The "testing" involved bench testing, not evaluation on patient data.
• Data Provenance: Not applicable for the reasons above.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. Ground truth as typically understood for AI evaluation is not relevant to this type of device clearance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable.

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

• Not applicable. This is not an AI-assisted device.

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

• Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable. For this physical device, the "ground truth" for demonstrating substantial equivalence relied on comparing its design, materials, intended use, and performance characteristics (through bench testing and documentation) to a predicate device.

8. The sample size for the training set

• Not applicable. This is not an AI algorithm.

9. How the ground truth for the training set was established

• Not applicable. This is not an AI algorithm.

Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):

The "study" presented is a 510(k) Premarket Notification which aims to demonstrate substantial equivalence to a predicate device already on the market (Kobold Fletcher Type Applicator Set; Kobold Henschke Type Applicator Set, K123912).

The core of the "proof" relies on:

• Comparison Table: A detailed comparison of the new device (K142330) with the predicate device (K123912) across various characteristics, including indications for use, afterloader compatibility, design geometry, materials, packing, sterility, sterilization methods, biocompatibility, anatomical sites, and environmental compatibility.
• Bench Testing: The document states, "Extensive testing in accordance with known standards is documented by the manufacturer for predicate device K123912" and that the predicate device's acceptance procedures are provided. This implies that the new device either underwent similar bench testing or leverages the established safety and performance of the predicate through design similarity and material equivalence. The key statement is, "The FDA has not established special controls or performance standards for this device," suggesting that meeting the requirements for substantial equivalence to a device with a known safety profile is sufficient.
• Conclusion: The submission concludes that the Kobold Ring and Tandem Applicator Set is "similar in intended use and technological characteristics to predicate device reviewed" and "similar with respect to indications for use and physical characteristics to predicate device in terms of section 510(k) substantial equivalency."

In essence, the device is deemed to meet "acceptance criteria" because it is shown to be as safe and effective as a device already legally marketed, based on direct comparison of features and relevant non-clinical (bench) testing.

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