(158 days)
The biopsy-needle is intended for soft-tissue biopsy (such as breast, kidney, liver, prostate).
The semiautomatic Biopsy needle– BM is a sterile, spring loaded, disule biopsy system. It consists of the following maior components: handle stylet. tincer and coring nuide.
Here's an analysis of the provided text to fulfill your request regarding acceptance criteria and the study that proves the device meets them:
Device: Semi-automatic Biopsy-Needle (BIM series)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| 1. Needle penetration capacity | Optimal and effortless insertion; stylet tip penetrates tissue easily without causing tears/lacerations. | "For all tested biopsy devices the insertion was optimal and conducted effortles sty with no difficulties at all. The acceptance criteria were met. This demonstrates that the devices works for penetration and is safe." |
| 2. Shot of the needle | Release mechanism triggers correctly; cannula covers the stylet tip (notch completely) and has enough power to push the cannula over the notch to cut tissue. (Tested for 10 mm and 20 mm notches) | "For all tested hions v device the not the not the case for hotch notch sizes (10 mm and 20 mm ) From this it can be concluded that the spring is strong enough. The acceptance criteria were met and the device works and is safe." |
| 3. Quantity of the collected samples (10 mm notch) | Collected sample length for the liver and apple tissue equals the notch size. Muscle tissue sample length > 5 mm. | "Each sample for the liver and apple equals the notch size. For muscle tissue taken with the 10 mm notch the average length is 6.72 mm... Every sample was larger than the acceptance criteria of 5 mm... The average sample size over all tissues is 8.82mm for the 10 mm notch." |
| 3. Quantity of the collected samples (20 mm notch) | Collected sample length for the liver and apple tissue equals the notch size. Muscle tissue sample length > 10 mm. | "Each sample for the liver and apple equals the notch size. For muscle tissue taken with the... 20 mm notch 11.77 mm. Every sample was larger than the acceptance criteria of... 10 mm. Therefore the criteria is met. ... The average sample size over all tissues is... 17.22 mm samples [for 20 mm notch]." |
| 4. Quality/integrity of the collected samples | Samples are cylindrical, intact, and abundant. | "All samples are cylindrical, intact and abundant. The acceptance criteria were met. Because of this the device is effective and safe." |
| 5. MR-compatibility (Artifacts & Visibility) | Needle is clearly visible under MR-guidance without any major artifacts. | "Based on the MR-tests the device is MR-compatible. The new any major artificats and is cleary visible especially compared to the needle with stainless steel." |
| 6. MR-compatibility (Heating & Induction) | No heating occurs. | "In addition no heating or cured during these tests." |
| 7. Biocompatibility | Proof of biocompatibility via Cytotoxicity, Sensitization, Acute Systemic Toxicity, and Pyrogenicity tests. | "Biocompatibility were proofen with the conducted tests." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "For the present report different Semiautomatic Biopsy Need. The 5 samples have been manufactured in 5 different lots."
- It is not explicitly stated if this means 5 distinct biopsy needles, or 5 lots of various needles (e.g., varying gauges and lengths). However, it is mentioned that "14G, 16G and 18G biopsy needles were used. The lengths ranged from 100 mm." This suggests a variety of configurations.
- Data Provenance: The tests utilized "animal tissue and apples" for penetration, shot, and sample quantity/quality tests. The document does not specify the country of origin or whether these were retrospective or prospective studies. Given the nature of a 510(k) submission, these are non-clinical (laboratory/benchtop) tests, not human clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. The tests performed are primarily objective benchtop assessments (e.g., visual inspection for penetration, measurement of sample length, microscopic observation of sample integrity, MRI scans for visibility and heating). Expert opinion is implied in setting the "acceptance criteria" for these objective measurements but not explicitly stated as involved in a ground truth establishment process for the test results themselves.
4. Adjudication Method for the Test Set
- This information is not provided. Given that the tests are largely objective measurements and visual assessments, a formal adjudication process may not have been deemed necessary, or at least wasn't detailed in this summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 semi-automatic biopsy needle, a physical medical instrument, not an AI-assisted diagnostic tool or imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm or AI system. The tests evaluate the physical performance of the needle itself.
7. The Type of Ground Truth Used
- For the physical performance tests (penetration, shot, sample quantity/quality): The ground truth is established by pre-defined objective criteria and measurements (e.g., visual confirmation of intact penetration, measurement of sample length against a standard, visual confirmation of sample morphology).
- For MR-compatibility: Ground truth is established by objective measurements from the MRI system (e.g., lack of artifacts, no measured heating).
- For Biocompatibility: Ground truth is established by standardized laboratory tests to detect specific biological reactions.
8. The Sample Size for the Training Set
- Not applicable. This is a physical medical device, not a machine learning model; therefore, there is no "training set" in the context of AI/ML. All samples mentioned were for testing the final device performance.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for this device.
§ 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.