(103 days)
Precision GI is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract.
The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a motorized, automated, rotational, cutting EUS-Biopsy needle with an echogenic tip inserted and operated through the instrument channel of an ultrasound imaging endoscope.
The Limaca Precision GI FNB needle is available in one size - 20G.
The Precision GI Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device is a battery-operated, motorized, automated rotational cutting biopsy device with an echogenic needle tip, advanced and operated by the physician through the accessory instrument channel of an ultrasound imaging endoscope.
This document describes the regulatory clearance of the Precision GI device, an Endoscopic ultrasound-guided Fine Needle Biopsy (EUS-FNB) device manufactured by Limaca Medical Ltd. It is intended for fine needle biopsy of submucosal lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal tract.
The information provided in the document focuses on demonstrating substantial equivalence to a predicate device (EndoDrill® Model X biopsy instrument by Bibbinstruments AB, K212423) and, as such, does not contain a typical clinical study with specific acceptance criteria and detailed performance metrics as would be found in a study designed to prove the device meets pre-defined performance thresholds in a clinical setting.
Instead, the document details bench testing and a preclinical study to support the safety and effectiveness and demonstrate that the differences in technological characteristics do not raise new issues of safety or effectiveness.
Therefore, I cannot populate the table and answer all questions in the requested format as a conventional clinical study with explicit acceptance criteria and corresponding reported performance values is not presented.
However, I can extract the information available from the provided text regarding the performance data and study types:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative "acceptance criteria" for clinical performance. Instead, it lists various "Performance Data" obtained from bench tests and a preclinical study to support substantial equivalence to a predicate device. The implied acceptance criterion for these tests is that the Precision GI device is "as safe and effective" and does not raise new issues of safety or effectiveness compared to the predicate.
| Acceptance Criterion (Implied) | Reported Device Performance (Summary) |
|---|---|
| Safety and Effectiveness | Bench tests and a preclinical study were performed to demonstrate that the device is "as safe and effective as the EndoDrill® Model X biopsy instrument" and that "minor technological differences... raise no new issues of safety or effectiveness." Specific tests conducted include: Dimensional Attributes and EUS compatibility, Shaft insertion/withdrawal force, Stopper lock operation force, Sample Acquisition, Echogenicity, Needle Deformation, Endurance to Distribution Environmental Hazards, Handle resistance force, Extender friction torque, Stylet withdrawal force, Stylet hold-in-position force, Sheath bonding strength, Axial stopper strength, Stylet bonding strength, Handle bending torque durability, Needle bonding torque strength, Tissue wrapping, Needle cyclic loading durability, Needle bonding durability, Needle tissue Penetration force, Needle bonding tensile strength, biocompatibility, and sterilization. The document concludes that "Performance data demonstrate that the Precision GI is as safe and effective as the predicate device." |
| Sample Acquisition | The reduced motor speed (800RPM vs. predicate's higher speed) "provides a good sample acquisition as demonstrated in bench tests and preclinical study." Specific quantitative metrics for sample acquisition (e.g., sample size, diagnostic yield) are not provided in this summary. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "bench tests and preclinical study."
- Bench Tests: These typically involve testing of devices in a lab setting, not human subjects. Sample sizes would refer to the number of devices or components tested. This information is not provided.
- Preclinical Study: This likely refers to in vitro or in vivo animal studies. The specific sample size (number of animals or specimens) and data provenance are not provided in this summary. The country of origin of the data is not specified, but the submitter is Limaca Medical Ltd. from Ein Ha Emeq, Israel.
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)
This information is typically relevant for studies involving diagnostic accuracy where human interpretation informs the "ground truth." Since the document describes bench and preclinical studies for a biopsy instrument, and not a diagnostic AI device, this information is not applicable and therefore not provided. The performance data focuses on mechanical and functional aspects of the device and its ability to acquire samples, rather than the diagnostic interpretation of those samples.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this information is specific to human-read diagnostic studies or studies involving agreement among multiple reviewers, which is not the focus of the provided performance data.
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. The Precision GI is a biopsy instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as the Precision GI is a biopsy instrument and not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the "Sample Acquisition" assessment in the preclinical study, the ground truth would likely be based on:
- Histopathology/Pathology: Evaluation of the acquired tissue samples to determine quality, diagnostic yield, and preservation, which would be interpreted by pathologists.
- Visual observation/measurement: For aspects like needle deformation, echogenicity, etc., the "ground truth" would be direct measurement or observation against predetermined specifications or comparisons to the predicate device's performance.
The document summary does not explicitly state how "good sample acquisition" was determined (e.g., specific metrics or expert pathology review process).
8. The sample size for the training set
Not applicable. "Training set" refers to data used to train AI/machine learning algorithms. This device is a biopsy instrument, not an AI device.
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.