(106 days)
The BD Trek™ Bone Marrow Biopsy System (BD Trek™ Power Driver, BD Trek™ Bone Marrow Biopsy Kit) is intended for bone marrow aspiration and biopsy in adult and pediatric patients age 2 and older.
The BD Trek™ Bone Lesion Biopsy System (BD Trek™ Bone Lesion Biopsy Kit) is intended for bone biopsy of the vertebral body and bone lesions.
The BD Trek™ Bone Lesion Biopsy System (BD Trek™ Power Driver. BD Trek™ Bone Lesion Bionsy Kit) is intended for bone marrow aspiration and biopsy.
The BD Trek™ Bone Marrow Biopsy System and Bone Lesion Biopsy System consists of a variable speed Power Driver and compatible BD Trek™ Biopsy Kits.
The BD Trek™ Power Driver is a handheld, battery-powered, reusable bone drill. The Power Driver has a variable speed function which is controlled by the amount of pressure applied to the trigger. Applying light pressure on the trigger activates the drill at a low speed and increasing trigger pressure activates higher speeds. Full depression of the trigger will activate the maximum speed. Full release of the trigger will stop the motor function.
The BD Trek™ Bone Biopsy Kits are single-use bone biopsy kits designed exclusively for use with the BD Trek™ Power Driver. The BD Trek™ Power Driver is reusable and is supplied non-sterile. The BD Trek™ Bone Biopsy Kits are supplied sterile, non-pyrogenic, and are available in different needle gauge sizes and lengths.
The provided text describes a 510(k) premarket notification for the BD Trek™ Bone Marrow Biopsy System and BD Trek™ Bone Lesion Biopsy System. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and study results in the manner of a clinical trial or a standalone performance study for an AI/algorithm-based device.
Therefore, the information required for fields like "sample size used for the test set," "data provenance," "number of experts used to establish ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone study," "type of ground truth used," "sample size for training set," and "how ground truth for training set was established" is not applicable or not available within this specific 510(k) summary, as it is related to a physical medical device (biopsy system) and not an AI or algorithm-based diagnostic tool.
However, I can extract the information provided regarding acceptance criteria validation for the device functionality.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria / Test Performed | Reported Device Performance |
|---|---|
| Membrane Penetration Force | Met predetermined acceptance criteria |
| Tissue Sampling | Met predetermined acceptance criteria |
| Reliability Testing Sterile Sleeve | Met predetermined acceptance criteria |
| Tensile Strength Needle Hub | Met predetermined acceptance criteria |
| Dead Space Measurements | Met predetermined acceptance criteria |
| Luer Testing | Met predetermined acceptance criteria |
| Creep Testing | Met predetermined acceptance criteria |
| Power Driver Battery Life | Met predetermined acceptance criteria |
| Power Driver Drive Adapter Reliability | Met predetermined acceptance criteria |
| Biocompatibility (ISO 10993-1) | Biocompatible for its intended use |
| Sterilization (ISO 11135:2014) | Sterility Assurance Level (SAL) of 10-6 confirmed |
| Electromagnetic Compatibility (IEC 60601-1-2) | Meets electrical safety and performance requirements established |
| Electrical Safety (IEC 60601-1-2) | Meets electrical safety and performance requirements established |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable / Not provided. The listed tests are for the physical device's engineering and material properties, not clinical data sets.
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 / Not provided. This information is relevant for diagnostic algorithms with human expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable / Not provided. This is for expert review of data, not physical device performance tests.
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 / Not provided. This device is a biopsy system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable / Not provided. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the performance tests listed, the "ground truth" would be established engineering specifications, chemical assay results (for biocompatibility), and microbiological validation (for sterility). The document does not detail specific "ground truth" methods beyond naming the standards.
8. The sample size for the training set:
Not applicable / Not provided. This is a physical device, not an AI model.
9. How the ground truth for the training set was established:
Not applicable / Not provided. This is a physical device, not an AI model.
Study Proving Device Meets Acceptance Criteria:
The document states that a series of "internal risk assessment procedures" were used to evaluate the technological characteristics and performance criteria. The listed tests (Membrane Penetration Force, Tissue Sampling, Reliability Testing Sterile Sleeve, Tensile Strength Needle Hub, Dead Space Measurements, Luer Testing, Creep Testing, Power Driver Battery Life, Power Driver Drive Adapter Reliability) were performed on the subject device. Additionally, biocompatibility testing (ISO 10993-1), sterilization validation (ISO 11135:2014), Electromagnetic Compatibility, and Electrical Safety Testing (IEC 60601-1-2) were conducted.
The overall conclusion is: "The subject device... met all the predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."
This indicates that internal design verification and validation studies, following established medical device standards and protocols, were conducted to demonstrate that the device meets its performance and safety requirements. The document does not provide specifics on the methodology, sample sizes, or detailed results of these individual tests, as is typical for a 510(k) summary submission which focuses on substantial equivalence rather than detailed clinical trial reports.
§ 876.1075 Gastroenterology-urology biopsy instrument.
(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.