(90 days)
The device is used for drawing osteomedullary substance and/or for bone marrow explantation.
Trap Easy is a bone marrow biopsy needle, consisting of a cannula with cylindrical tip and ergonomic handle, a removable pyramidal stylet, a sample trapping device integrated into the cannula and an extraction wire.
The device is used for drawing osteomedullary substance and/or for bone marrow explantation. This device is intended to be used only by experienced and properly trained physicians and is intended to be used exclusively for bone marrow tissue biopsies.
The device is available in different models:
- 8G x 100 mm
- 8G x 150 mm
- 11G x 100 mm
- 11G x 150 mm
Trap Easy is supplied in sterile packaging and is designed for single use, non-reusable. At the end of its use, the device should be disposed of as infectious hospital waste.
This looks like a 510(k) summary, which typically does not include raw data or detailed study protocols for performance testing, but rather summarizes the results and demonstrates substantial equivalence to a predicate device. The information provided is sparse regarding the detailed breakdown of the acceptance criteria and study particulars for Trap Easy.
However, based on the provided text, here’s an attempt to extract and infer the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions acceptance criteria but does not explicitly list them with thresholds. It states that "The average lengths and diameters were compliant with acceptance criteria." and "Performed tests show that all the 50 samples have a good integrity and there were no samples ruined or divided in small parts."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sample Integrity | All 50 samples had good integrity; no samples ruined or divided into small parts. |
| Sample Length of Single Biopsy | Compliant with acceptance criteria (specific values not provided in document). |
| Sample Diameter | Compliant with acceptance criteria (specific values not provided in document). |
| Sample Removal | Easy for all samples. |
| Mechanical Functioning | Needles showed no damages to the internal mechanism after all biopsies. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 50 samples were tested for integrity, length, and diameter.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies appear to be non-clinical performance tests conducted by the manufacturer, HS Hospital Service SPA (located in Italy).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This appears to be a study of the physical characteristics and performance of a device, not an interpretative AI algorithm. Therefore, the concept of "experts to establish ground truth" as it pertains to clinical interpretation is not applicable here. The "ground truth" for the physical performance metrics (integrity, length, diameter, removal ease, mechanical function) would be established by direct measurement and observation during the testing process. The document does not specify the number or qualifications of personnel who performed these tests or evaluated the results.
4. Adjudication Method for the Test Set
Not applicable as this is a device performance test, not a clinical interpretation task requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This document describes the performance testing of a physical biopsy device, not a software or AI algorithm requiring an MRMC study.
6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
- For Sample Integrity, Length, Diameter, and Removal: The ground truth was established through direct observation and quantitative measurements during the performance tests.
- For Mechanical Functioning: The ground truth was established by direct observation and inspection for damages after the biopsies.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This is a physical device, not an AI model.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided text summarizes performance tests conducted on the "Trap Easy" device to demonstrate its performance characteristics. The tests evaluated:
- Sample integrity after biopsy: All 50 tested samples reportedly had "good integrity" with no samples being "ruined or divided in small parts."
- Sample length of single biopsy: The average lengths were reported as "compliant with acceptance criteria," although the specific criteria or measured values are not detailed.
- Sample diameter: The average diameters were also reported as "compliant with acceptance criteria," without specific values provided.
- Sample removal: It was noted that "sample removal was easy for all samples."
- Mechanical functioning of the needle: The tests concluded that "the needles didn't show any damages to the internal mechanism after all biopsies."
The studies were conducted in a manner "as similar as possible to how the biopsy device is used in a medical procedure." The overall conclusion from these tests is that "Obtained results demonstrated that the device's performances are maintained for the intended use of the device."
It appears these were non-clinical, bench-top performance tests, rather than clinical trials with human subjects. The details regarding the exact methodology, measurement tools, and statistical analysis are not available in this summary document.
§ 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.