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.

AI/ML Overview

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 <881> standards	Passed
	Suture tearing force	USP 37-NF32 <861> 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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 6, 2016

POP Medical Solutions Paul Dryden Regulatory Consultant 27 Habarzel St. Tel Aviv. 6971039 IL

Re: K160569 Trade/Device Name: NeuGuide Regulation Number: 21 CFR 884.4530 Regulation Name: Obstetric-Gynecologic Specialized Manual Instrument Regulatory Class: Class II Product Code: PBQ Dated: June 10, 2016 Received: June 13, 2016

Dear Paul Dryden,

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160569

Device Name NeuGuide

Indications for Use (Describe)

NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image contains the logo for POP Medical Solutions. The logo features the letters "POP" stacked on top of each other in a stylized, blue font. Below the logo, the words "Medical Solutions" are written in a smaller, sans-serif font. Underneath that, the words "POP NeuGuide" are written in a larger, sans-serif font.

510(k) summary

1.	Submitter
Submitted by:		Pop Medical Solutions Ltd.
		Habarzel St. 27, Tel Aviv 6971039, Israel
		Phone: +972-3- 7684948
		Fax: +972-3- 7684941
Official contact:		Guy Ohad, CEO
	Date prepared:	10-June-2016
2.	Device
	Trade name:	NeuGuide
	Common name:	Pelvic ligament fixation system
Regulation/		21 CFR 884.4530 - Obstetric-gynecologic specialized manual instrument
	Classification name:
	Product Code:	PBQ - Fixation, non-absorbable or absorbable, for pelvic use
Regulatory class:		II
3.	Predicate device
Predicate device:		K120831 Neomedic Anchorsure

4. Device description

Component	Characteristics	Material
Anchor	Diameter 2.0 mmLength 9.0 mm	Nitinol
Suture	USP 0Diameter 0.4 mmLength 740 mm	Polypropylene monofilament
Applicator Shaft	Diameter 2.5 mmLength 284 mm	Stainless steel AISI 316L
Applicator Handle	Base diameter 28mmBody diameter 6 - 14.6mm	POM-C Tecaform AH MT WhitePolycarbonate
Thimble	Working channel innerdiameter 2.6 mm	DSM Somos WaterShedXC 11122

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Image /page/4/Picture/1 description: The image shows the logo for POP Medical Solutions. The logo features the letters "POP" in a stylized, blue font, with the "O"s stacked on top of the "P". Below the logo, the words "Medical Solutions" are written in a smaller, blue font. Underneath that, the words "POP NeuGuide" are written in a larger, black font.

5. Indications for use

NeuGuide is indicated for attaching sutures to ligaments of the pelvic floor.

6. Comparison with the predicate device

Both the subject and predicate devices are indicated for attaching sutures to ligaments of the pelvic floor.

The basic technological characteristics of the NeuGuide are the same as those of the predicate. Both are:

Manual delivery of an anchor-suture implant via applicator handle
. Single use, supplied sterile and pre-loaded
Fixation in the ligament utilizing a non-absorbable suture tied to an anchor

The main technological differences between the NeuGuide and the predicate include the anchor shape (two deployable spurs on the NeuGuide vs. four stationary barbs on the predicate), anchor material (Nitinol in the NeuGuide vs. PEEK in the predicate), and the use of a thimble with the NeuGuide (no thimble is utilized with the predicate). These differences do not raise new types of safety or effectiveness questions. These differences have been evaluated in performance testing, including MRI compatibility, biocompatibility, corrosion testing, pull out force, and deployment force.

Test	Details	Conclusions
Biocompatibility	Cytotoxicity, intracutaneousreactivity, sensitization,implantation, acute systemictoxicity, Extractable and Leachabletesting with risk based assessment ofthe findings	NeuGuide was demonstratedto be biocompatible
ISO 10993-1
ISO 10993-5
ISO 10993-6
ISO 10993-10
ISO 10993-11
ISO 10993-18
Corrosion	Anchor - cyclic potentiodynamicpolarizationApplicator - Boil test, copper sulfatecorrosion test	Both tests were passedaccording to predefinedacceptance criteria
Anchor - ASTM F2129
Applicator - ASTM F1089
Suture testing	Anchor to suture attachment forceSuture diameterSuture tearing force	Pass according to predefinedacceptance criteria
USP 37-NF32
USP 37-NF32 <881>
USP 37-NF32 <861>
Anchor strength andfixation forces	Anchor spurs shear forceAnchor deploymentAnchor pull-out force in porcineligament in situ	Pass according to predefinedacceptance criteria
Functional testing	Test entire system together forfunctionality	Pass according to predefinedacceptance criteria

7. Performance data

The NeuGuide has undergone and successfully passed performance testing as follows:

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Image /page/5/Picture/1 description: The image contains a logo for a medical solutions company. The logo features the letters "POP" in a stylized, blue font, with the "O" appearing to be formed by a cloud-like shape. Below the logo, the words "Medical Solutions" are written in a smaller, blue font. Underneath that, the words "POP NeuGuide" are written in a larger, black font.

MRI compatibility- 3 Tesla	Magnetic field interactions	The NeuGuide™ Anchor was
	MR related heating	demonstrated to be MR
	Artifact test	Conditional. A patient with
	MR conditional labeling	this device can be scanned
		safely, immediately after
		placement under conditions
		specified in the labeling
Sterilization validation	ETO validation to SAL 10-6	Pass according to predefined
	LAL endotoxin pyrogenicity	acceptance criteria
	ETO residual levels
Packaging validation	Sterile barrier validation at To and	Testing supports 1 year shelf
	after 1 year shelf life	life.
Shelf life validation	Functional validation of product	Testing supports 1 year shelf
	after 1 year shelf life	life.
Transportation validation	Functional testing of device after	Pass according to predefined
	transportation	acceptance criteria

8. Conclusions

NeuGuide is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.