The eSPIN is intended for use in cutting and grinding intervertebral disc material during discectomy for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade I Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems.

Device Description

The eSPIN powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and direct connection to a motor via motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator unit for discectomy. The eSPIN needs to be connected to an electrical motor or drill. The required motor/drill specifications are provided in the eSPIN User Manual. The primary changes from the cleared eSPIN are: Addition of Suction tube and irrigation system. Minor modifications to the device design.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the NLT SPINE's eSPIN device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Performance Metric	Reported Device Performance (Study/Test Conducted)
Mechanical/Physical Performance:
Bending mechanism durability of manipulator unit	Testing demonstrated durability.
Verification of tip bending angle	Testing verified the tip bending angle.
Verification of discectomy cleaning work limits	Testing verified the discectomy cleaning work limits.
Verification of motor parameters (when connected to electrical motor/drill)	Testing verified motor parameters.
Tip attachment strength under tensile force	Testing demonstrated sufficient tip attachment strength.
Durability of tip bristle and tip under rotational and tensile loading	Testing demonstrated durability under specified loading conditions.
Biocompatibility:
Biocompatibility for Intended Use	Evaluation conducted in accordance with ISO 10993; deemed biocompatible.
Clinical Performance (Safety & Efficacy related):
Confirmation that the device does not breach annulus	Cadaver studies conducted to evaluate for annulus breach.
Confirmation of radiopacity of tip under X-ray	Cadaver studies conducted to confirm tip radiopacity.
No new questions of safety or effectiveness raised by modifications	Performance data demonstrated the device is as safe and effective as the predicate, despite minor technological characteristics.
Substantial Equivalence to Predicate Device	Overall conclusion that the device is substantially equivalent to K120553.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not explicitly state a numerical sample size for the test set of the specific performance tests (e.g., how many manipulator units were tested, how many tips were tested, how many cadavers were used).

Test Set Description: The "Performance Data" section lists several types of tests:
- Bending mechanism durability of manipulator unit
- Verification of tip bending angle
- Verification of discectomy cleaning work limits
- Verification of motor parameters
- Tip attachment strength under tensile force
- Durability of tip bristle and tip under rotational and tensile loading
- Biocompatibility evaluation
- Cadaver studies
Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the nature of a 510(k) for a medical device modification, these would typically be internal, prospective verification and validation tests conducted by the manufacturer.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

There is no mention of experts being used to establish "ground truth" in the traditional sense for these performance tests. The tests described are engineering and biocompatibility evaluations, as well as cadaver studies, which rely on established measurement techniques, protocols, and scientific standards.

Regarding the cadaver studies: While general medical expertise would be involved, the document does not specify the number or qualifications of experts for judging annulus breach or radiopacity. These are objective observations.

4. Adjudication Method for the Test Set

Not applicable. The described tests are primarily objective performance verification and validation tests, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically for diagnostic imaging devices and involves human readers interpreting cases with and without AI assistance to measure reader improvement. The eSPIN is a surgical instrument.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the performance tests described are essentially "standalone" in that they evaluate the device's physical and mechanical capabilities independently. The device itself (the eSPIN) is the "algorithm" in this context, and its performance characteristics were assessed. There is no AI algorithm being evaluated in this submission.

7. The Type of Ground Truth Used

The "ground truth" for the various performance tests is based on:

Engineering specifications and standards: For mechanical durability, bending angles, work limits, motor parameters, strength, and durability.
International standards (ISO 10993): For biocompatibility.
Direct observation and measurement: For annulus breach (in cadaver studies) and radiopacity (in cadaver studies).
Predicate device's established performance: The overall goal of the submission is to demonstrate substantial equivalence to the predicate, implying that the predicate's performance serves as the benchmark or "truth" for safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This device is a mechanical surgical instrument, not an AI/machine learning algorithm requiring a "training set" of data.

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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K130057

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FEB 0 7 2013

510(k) SUMMARY NLT SPINE's eSPIN

Sponsor:

NLT SPINE Ltd. 6 Yad Harutzim St. Kfar-Saba Israel 44641

Contact Person:

Eti Zinger Regulatory Affairs Director NLT SPINE Ltd. Tel: +972-3-6344514 Fax: +972-3-6341599 Eti.z@nlt-spine.com

February 6, 2013 Date Prepared:

Name of Device: eSPIN

Common or Usual Name: Arthroscope and Accessories

Classification Name: Arthroscope and Accessories 21 CFR §880.1100 Product Code: HRX

Predicate Devices:

NLT SPINE's eSPIN (K120553)

Purpose of the Special 510(k) notice:

The eSPIN is a modification to previously cleared K120553 eSPIN and can be compared to the cleared device as follows:

Feature	PredicateNLT SPINE eSPIN DiscectomySystem (K120553)	ModifiedNLT SPINE eSPIN DiscectomySystem
Intended Use andIndication	The eSPIN is intended for use incutting and grinding intervertebral discmaterial during discectomy for fusionprocedures in L2-S1 spinal segmentsin skeletally mature patients with	Same
Feature	PredicateNLT SPINE eSPIN DiscectomySystem (K120553)	ModifiedNLT SPINE eSPIN DiscectomySystem
	degenerative disc disease (DDD).DDD is defined as back pain ofdiscogenic origin with degeneration ofthe disc confirmed by the history andradiographic studies. DDD patientsmay also have up to Grade ISpondylolisthesis or retrolisthesis atthe involved levels. The device isintended to be used withsupplemental spinal fixation systemsthat have been cleared for use in thelumbosacral spine (i.e. posteriorpedicle screw and rod systems
Product Code	HRX Arthroscope, 21 CFR 888.1100,Class II	Same
Principal Operator	Physician	Same
Use Location	Operating room or Medical Suite	Same
Operating Principal	Percutaneous or open surgicalDiscectomy system with standardsurgical accessories	Same
Functions of IncludedDevices	DilatationAccessExcision	DilatationAccessExcisionIrrigationSuction
Mechanics of Action	Percutaneous or open surgicalDiscectomy system with standardsurgical accessories	Same
Target Anatomy	Intervertebral procedure for L2-S1spinal segments	Same
Biocompatibility forIntended Use	Yes	Yes
Single Use	Yes (Tips)	Yes (Tips)
Configuration	Straight during insertion, and curvedduring rotation by its articulation	Straight during insertion, and curvedduring rotation by its articulation

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K130057

Intended Use

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K130057

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Technological Characteristics

The primary changes from the cleared eSPIN are:

Addition of Suction tube and irrigation system .
. Minor modifications to the device design

Performance Data

The following testing demonstrated that the eSPIN is substantially equivalent to its predicate:

. Bending mechanism durability of manipulator unit
Verification of tip bending angle .
Verification of discectomy cleaning work limits ●
Verification of motor parameters .
. Tip attachment strength under tensile force
. Durability of tip bristle and tip under rotational and tensile loading
Biocompatibility evaluation in accordance with ISO 10993 .
Cadaver studies to evaluate whether the device breaches annulus and confirm radiopacity of . tip under X-ray

Substantial Equivalence

The eSPIN has the same intended use and indications, principles of operation, and technological characteristics as the predicate. The minor differences in the eSPIN technological characteristics do not raise any new questions of safety or effectiveness. Performance data demonstrates that the eSPIN is as safe and effective as the predicate. Thus, the eSPIN is substantially equivalent to its predicate device.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

February 7, 2013

NLT Spine. Limited % Hogan and Lovells US, LLP Dr. John Smith 555 Thirteenth Street, Northwest Washington, District of Columbia 20004

Re: K130057

Trade/Device Name: eSPIN Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: January 09, 2013 Received: January 09, 2013

Dear Dr. Smith:

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. Iisting 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. John Smith

forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Peter D.R. Rimm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: eSPIN

Indications for Use:

The eSPIN is intended for use in cutting and grinding intervertebral disc material during discectorny for fusion procedures in L2-S1 spinal segments in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by the history and radiographic studies. DDD patients may also have up to Grade 1 Spondylolisthesis or retrolisthesis at the involved levels. The device is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine (i.e. posterior pedicle screw and rod systems).

Prescription Use X (Per 21 C.F.R. 801.109) AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Long H. Chen -S 1300 700 1 1=1 300369056

(Division Sign-Off) Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ K130057

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. 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 § 888.9.