(168 days)
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).
The eSpin powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and a motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator for discectomy. The eSpin needs to be connected to an Electrical Motor. The required motor specifications are provided in the eSpin User Manual.
The NLT SPINE eSpin device is a medical device intended for discectomy procedures. The provided text, K120553, is a 510(k) Premarket Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing novel acceptance criteria and proving performance against them through a detailed study like one would for a new technology or higher-risk device.
Therefore, the supplied text does not contain specific acceptance criteria, detailed performance metrics (like sensitivity, specificity, accuracy), or a study design for proving these metrics. It describes the device, its intended use, and states that performance testing in bench and cadaver models demonstrated substantial equivalence to the predicate device.
However, based on the information provided, here's an attempt to structure an answer, highlighting what is and is not present:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission focused on substantial equivalence, explicit "acceptance criteria" and quantitative performance metrics (e.g., sensitivity, specificity, or specific success rates) are not provided in the document for the eSpin device itself. The primary acceptance criterion for a 510(k) is demonstrating that the new device is "as safe and effective" and "substantially equivalent" to a predicate device.
| Acceptance Criteria (Inferred from 510(k) process) | Reported Device Performance (from K120553) |
|---|---|
| Safety and Effectiveness equivalent to predicate device | Demonstrated through bench and cadaver models. "eSpin is as safe and effective as its predicate device." |
| Similar Indications for Use | "The eSpin has substantially similar indications for use... as compared to the predicate device." |
| Similar Technological Characteristics | "The eSpin has... substantially similar... technological characteristics as compared to the predicate device." |
| No New Questions of Safety and Effectiveness | "Any minor differences between the device and the predicate do not raise new questions of safety and effectiveness." |
2. Sample size used for the test set and the data provenance
The document states "Performance testing in bench and cadaver models".
- Sample Size: Not specified. The number of bench tests or cadaver models used is not reported.
- Data Provenance: The location of the testing (e.g., country of origin) is not specified. It is likely conducted by the manufacturer, NLT SPINE Ltd. in Kfar-Saba, Israel, or a contract lab. The testing is prospective in the sense that it was conducted specifically to support this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance testing described (bench and cadaver models) would not typically involve expert radiologists or similar for "ground truth" establishment in the context of diagnostic or interpretive accuracy. Instead, it would involve direct measurement of physical properties, material analysis, mechanical testing, and functional assessment.
4. Adjudication method for the test set
Not applicable. The type of performance testing (bench and cadaver models) does not involve adjudication methods like 2+1 or 3+1, which are typically used for assessing agreement among human reviewers in diagnostic studies.
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 eSpin device is a surgical instrument (arthroscope and accessories for discectomy), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The eSpin is a physical surgical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For "bench and cadaver models," the ground truth would be based on:
- Bench Testing: Engineering specifications, material properties, mechanical test standards, and direct measurements of cutting/grinding efficacy and safety parameters (e.g., material removal rate, damage to surrounding tissue, tip integrity).
- Cadaver Models: Direct observation and assessment of the device's ability to cut and grind intervertebral disc material as intended, without damaging adjacent structures, and evaluating its handling characteristics in a simulated surgical environment. This is typically assessed by surgeons or technical experts.
8. The sample size for the training set
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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NLT SPINE eSpin Traditional 510(k) Premarket Notification
510(k) SUMMARY
As required by 21 C.F.R. § 807.92
Sponsor:
NLT SPINE Ltd. 6 Yad Harutzim St. Kfar-Saba lsrael 44641
Contact Person:
Eti Zinger Regulatory Affairs Director NLT SPINE Ltd. Tel: +972-3-6344514 Fax: +972-3-6341599 Eti.z@nlt-spine.com
Date Prepared: August 10, 2012 - .
Name of Device: eSpin
Common or Usual Name: Arthroscope and Accessories
Classification Name: Arthroscope and Accessories 21 CFR §888.1100 Product Code HRX
Predicate Devices
- . Spine View enSpire Discectomy System (K110992)
Intended Use / Indications for Use
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).
Page 1 of 2
Image /page/0/Picture/19 description: The image shows the logo for NLT Spine. The logo consists of a stylized spine graphic on the left, followed by the text "NLTSPINE" in a bold, sans-serif font. Below "NLTSPINE" is the text "NonLinear Technologies" in a smaller, sans-serif font.
AUG 9 2012
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Technological Characteristics
The eSpin powered system consists of a hand-held instrument (manipulator unit), a set of disposable tips, and a motor adaptor. In addition, set of instruments are to access the disc space and to position the manipulator for discectomy. The eSpin needs to be connected to an Electrical Motor. The required motor specifications are provided in the eSpin User Manual.
Performance Data
Performance testing in bench and cadaver models demonstrated that the eSpin is substantially equivalent to its predicate.
Substantial Equivalence
The eSpin is as safe and effective as its predicate device. The eSpin has substantially similar indications for use and technological characteristics as compared to the predicate device. Any minor differences between the device and the predicate do not raise new questions of safety and effectiveness. The company's bench and cadaver testing demonstrate that the eSpin is as safe and effective as its predicate.
Page 2 of 2
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the left side of the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
9 2012 AUG
NLT Spine Limited % Hogan & Lovells US, LLP Mr. John J. Smith 555 Thirteenth Street, Northwest Washington, District of Columbia 20004
Re: K120553
Trade/Device Name: eSpin Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope and Accessories Regulatory Class: II Product Code: HRX Dated: August 09, 2012 Received: August 09, 2012
Dear Mr. 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, 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
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Page 2 - Mr. John J. Smith
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 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/ResourcesforYou/Industry/default.htm.
Sincerely yours
Mark N. Malkerson
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative 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):__ K120553
Device Name: eSpin
Indications for Use:
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).
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
| Concurrence of (Division Sign-Off) | |
|---|---|
| (ODRH, Office of Device Evaluation (ODE)) | |
| Division of Surgical, Orthopedic, and Restorative Devices | |
| Page | _ of _ |
| 510(k) Number | 14120533 |
| Page | Page 1 of 1 |
§ 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.