(128 days)
NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.
The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor. It is a single use instrument, supplied sterile and pre-loaded. The NeuGuide device comprises three elements, the anchor-suture unit, an applicator, and a thimble with work channel.
The provided text describes the NeuGuide device, specifically its indications for use, comparison to a predicate device, and performance data. However, it does not include detailed "acceptance criteria" for performance metrics like accuracy, sensitivity, or specificity, nor does it provide a "study that proves the device meets the acceptance criteria" in the context of typical AI/software device studies.
Instead, the document focuses on the mechanical, material, and functional characteristics of the NeuGuide device itself, along with general performance tests to confirm its safety and fundamental functionality compared to a predicate device.
Given this, I will extract and infer information from the provided text to best answer your request, focusing on the available performance data described.
Here's the breakdown of the information that can be extracted or reasonably inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are essentially a "pass" or "fail" for various engineering and biocompatibility tests. No specific numerical thresholds are given in the summary, just the conclusion of "Pass according to predefined acceptance criteria."
| Test Category | Specific Test | Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity | Passed ISO 10993-1, 5, 6, 10, 11, 18 | Demonstrated biocompatible |
| Intracutaneous reactivity | Passed ISO 10993-1, 5, 6, 10, 11, 18 | Demonstrated biocompatible | |
| Sensitization | Passed ISO 10993-1, 5, 6, 10, 11, 18 | Demonstrated biocompatible | |
| Implantation | Passed ISO 10993-1, 5, 6, 10, 11, 18 | Demonstrated biocompatible | |
| Acute systemic toxicity | Passed ISO 10993-1, 5, 6, 10, 11, 18 | Demonstrated biocompatible | |
| Extractable and Leachable testing | Passed ISO 10993-1, 5, 6, 10, 11, 18 | Demonstrated biocompatible | |
| Corrosion | Anchor - Cyclic potentiodynamic polarization | Passed ASTM F2129 | Passed |
| Applicator - Boil test | Passed ASTM F1089 | Passed | |
| Applicator - Copper sulfate corrosion test | Passed ASTM F1089 | Passed | |
| Suture Testing | Anchor to suture attachment force | USP 37-NF32 standards | Passed |
| Suture diameter | USP 37-NF32 standards | Passed | |
| Suture tearing force | USP 37-NF32 standards | Passed | |
| Anchor Strength & Fixation | Anchor spurs shear force | Predefined acceptance criteria | Passed |
| Anchor deployment | Predefined acceptance criteria | Passed | |
| Anchor pull-out force (porcine ligament in situ) | Predefined acceptance criteria | Passed | |
| Functional Testing | Entire system functionality | Predefined acceptance criteria | Passed |
| MRI Compatibility | Magnetic field interactions | MR Conditional labeling | Demonstrated MR Conditional |
| MR related heating | MR Conditional labeling | Demonstrated MR Conditional | |
| Artifact test | MR Conditional labeling | Demonstrated MR Conditional | |
| Sterilization Validation | ETO validation to SAL 10-6 | Predefined acceptance criteria | Passed |
| LAL endotoxin pyrogenicity | Predefined acceptance criteria | Passed | |
| ETO residual levels | Predefined acceptance criteria | Passed | |
| Packaging Validation | Sterile barrier validation (To and after 1 year) | Supports 1 year shelf life | Supports 1 year shelf life |
| Shelf Life Validation | Functional validation of product (after 1 year) | Supports 1 year shelf life | Supports 1 year shelf life |
| Transportation Validation | Functional testing after transportation | Predefined acceptance criteria | Passed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for most tests. For "Anchor pull-out force in porcine ligament in situ," the sample is "porcine ligament in situ," which implies an ex vivo or in vivo animal model, but the number of samples is not given.
- Data Provenance: The tests are largely laboratory-based performance tests for a medical device (NeuGuide) developed by Pop Medical Solutions Ltd. in Israel. The document does not specify country of origin for test data beyond the company's location. The testing appears to be prospective with respect to the device's design confirmation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the studies described. The "ground truth" here is determined by engineering standards (e.g., ASTM, ISO, USP) and the physical properties of the device materials and mechanics, not by expert interpretation of medical images or clinical data.
4. Adjudication Method for the Test Set
Not applicable. The tests are based on objective measurements and compliance with established standards, not expert adjudication of subjective assessments.
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 a manual surgical instrument, not an AI or imaging diagnostic device that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual instrument, not an algorithm or AI system. Its performance is always human-in-the-loop (the surgeon). The studies focus on the intrinsic properties and functionality of the device itself.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the various tests described is based on established engineering standards, material science specifications, and validated laboratory methodologies. For example:
- Biocompatibility: ISO 10993 standards.
- Corrosion: ASTM F2129, ASTM F1089.
- Suture testing: USP 37-NF32 standards.
- MRI Compatibility: Standards for MR Conditional labeling.
- Sterilization: ETO validation to SAL 10-6.
For functional tests like "Anchor pull-out force," the "ground truth" would be the measured physical force required for pull-out, compared against a predefined engineering specification.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 884.4530 Obstetric-gynecologic specialized manual instrument.
(a)
Identification. An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following:(1) An amniotome is an instrument used to rupture the fetal membranes.
(2) A circumcision clamp is an instrument used to compress the foreskin of the penis during circumcision of a male infant.
(3) An umbilical clamp is an instrument used to compress the umbilical cord.
(4) A uterine curette is an instrument used to scrape and remove material from the uterus.
(5) A fixed-size cervical dilator is any of a series of bougies of various sizes used to dilate the cervical os by stretching the cervix.
(6) A uterine elevator is an instrument inserted into the uterus used to lift and manipulate the uterus.
(7) A gynecological surgical forceps is an instrument with two blades and handles used to pull, grasp, or compress during gynecological examination.
(8) A cervical cone knife is a cutting instrument used to excise and remove tissue from the cervix.
(9) A gynecological cerclage needle is a looplike instrument used to suture the cervix.
(10) A hook-type contraceptive intrauterine device (IUD) remover is an instrument used to remove an IUD from the uterus.
(11) A gynecological fibroid screw is an instrument used to hold onto a fibroid.
(12) A uterine sound is an instrument used to determine the depth of the uterus by inserting it into the uterine cavity.
(13) A cytological cervical spatula is a blunt instrument used to scrape and remove cytological material from the surface of the cervix or vagina.
(14) A gynecological biopsy forceps is an instrument with two blades and handles used for gynecological biopsy procedures.
(15) A uterine tenaculum is a hooklike instrument used to seize and hold the cervix or fundus.
(16) An internal pelvimeter is an instrument used within the vagina to measure the diameter and capacity of the pelvis.
(17) A nonmetal vaginal speculum is a nonmetal instrument used to expose the interior of the vagina.
(18) A fiberoptic nonmetal vaginal speculum is a nonmetal instrument, with fiberoptic light, used to expose and illuminate the interior of the vagina.
(b)
Classification. (1) Class II (special controls). The device, when it is an umbilical clamp with or without a cutter, a uterine tenaculum which is sterile and does not use suction and is intended for single use, a nonmetal vaginal speculum, or a fiberoptic nonmetal vaginal speculum, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 884.9.(2) Class I for the amniotome, uterine curette, cervical dilator (fixed-size bougies), cerclage needle, IUD remover, uterine sound, and gynecological 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 § 884.9.