The ELID (Endoscopic Less Invasive Decompression) system intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation.

Device Description

The ELID (Endoscopic Less Invasive Decompression) System consists of instrumentation intended to aid the user in completing steps necessary to perform lumbar decompression. Instruments include a bone needle, flat blade dilator, dilator tubes, and rongeurs. Instruments in the ELID (Endoscopic Less Invasive Decompression) System are supplied non-sterile, reusable, and manufactured from aluminum per ASTM B211, Nitinol per ASTM 2063, or stainless steel per ASTM A564.

AI/ML Overview

The provided text is a U.S. FDA 510(k) Clearance Letter and a 510(k) Summary for the ELID (Endoscopic Less Invasive Decompression) System. While it describes the device, its indications for use, technological characteristics, and a list of performance tests conducted, it does not provide specific acceptance criteria or detailed study results that demonstrate the device meets those criteria.

The "Performance Data" section states that certain tests were conducted and their results "show that the strength of the ELID (Endoscopic Less Invasive Decompression) System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." However, it does not quantify this performance, nor does it specify the acceptance criteria for each test.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance. The document only lists the types of tests performed (Cleaning Validation, Sterilization Validation, Biocompatibility, Usability Testing, Particulate Analysis) but doesn't provide the detailed results or the specific quantitative acceptance thresholds for these tests.
Sample sizes used for the test set and the data provenance. The document mentions "test modes" but does not detail the sample sizes for these tests or the origin of any data (e.g., human or ex-vivo samples, country of origin, retrospective/prospective).
Number of experts and their qualifications for ground truth establishment. This type of information is typically relevant for AI/ML-based devices relying on expert annotations, which is not clearly indicated as a component of the ELID system described. The ELID system seems to be a set of physical surgical instruments.
Adjudication method. Similar to the point above, this is generally for AI/ML performance evaluation against expert ground truth.
MRMC comparative effectiveness study. This is typically for AI/ML devices assisting human readers/interpreters, which doesn't seem to be the primary function of the ELID system.
Standalone performance. This again relates to AI/ML algorithms. The ELID system appears to be a set of manual surgical instruments.
Type of ground truth used. For an AI/ML device, this could be expert consensus, pathology, or outcomes data. For the ELID system, ground truth would likely refer to engineering specifications and performance evaluations for mechanical properties, biocompatibility, etc. The document does not specify this in detail.
Sample size for the training set. Not applicable, as this is a physical medical device, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established. Not applicable.

In summary, the provided document is a regulatory clearance letter acknowledging substantial equivalence based on a set of non-clinical performance tests, but it does not disclose the detailed quantitative acceptance criteria or the specific results of these tests, nor does it describe AI/ML related study methodologies like those you've requested. The "Performance Data" section only states that the results "show that the strength... is sufficient for its intended use and is substantially equivalent."

Summary

U.S. Food & Drug Administration 510(k) Clearance Letter

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 27, 2025

LESspine Innovations
℅ Hannah Taggart
Regulatory Associate
Empirical Technologies
4628 Northpark Drive
Colorado Springs, Colorado 80918

Re: K243774
Trade/Device Name: ELID (Endoscopic Less Invasive Decompression) System
Regulation Number: 21 CFR 888.1100
Regulation Name: Arthroscope
Regulatory Class: Class II
Product Code: HRX
Dated: August 1, 2025
Received: August 1, 2025

Dear Hannah Taggart:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Page 2

K243774 - Hannah Taggart Page 2

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

Page 3

K243774 - Hannah Taggart Page 3

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

JESSE MUIR -S
Digitally signed by JESSE MUIR -S
Date: 2025.08.27 14:42:07 -04'00'

Jesse Muir, Ph.D.
Assistant Director
DHT6C: Division of Restorative, Repair, and Trauma Devices
OHT6: Office of Orthopedic Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known): K243774

Device Name: ELID (Endoscopic Less Invasive Decompression) System

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

K243774 510(K) SUMMARY

Submitter's Name: LESspine Innovations
Submitter's Address: 200 Summit Drive, Suite 505
Burlington MA 01803
Submitter's Telephone: 617-820-2900
Contact Person: Hannah Taggart, MS
Empirical Technologies
719- 457-1152
htaggart@empiricaltech.com
Date Summary was Prepared: August 1, 2025
Trade or Proprietary Name: ELID (Endoscopic Less Invasive Decompression) System
Device Classification Name: Arthroscopic Accessories
Classification & Regulation #: Class II per 21 CFR §888.1100
Product Code: HRX
Classification Panel: Orthopedic

DEVICE DESCRIPTION AND TECHNOLOGY

INDICATIONS FOR USE

The ELID (Endoscopic Less Invasive Decompression) System is intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation.

TECHNOLOGICAL CHARACTERISTICS

The predicates included in this submission were selected based on the best practices described in the FDA Draft Guidance document Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission. The subject and predicate devices have nearly identical technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates:

Indications for Use
Materials of manufacture
Device Components

Predicate Devices

510k Number	Trade or Proprietary	Manufacturer	Product Code	Predicate Type
K233800	Vertos mild Device Kit	Vertos Medical	HRX, HAE	Primary
K993012/K002931	METRx™ System	Medtronic Sofamor Danek, Inc.	HRX	Additional
K210741	KLS Martin Neuro Rongeurs	KLS-Martin L.P.	HAE	Reference
K152734	Vitalitec Kerrison Rongeurs	Vitalitec Medizintechnik GmbH	HAE	Reference

Page 6

	ELID System (Subject Device)	Vertos Medical mild Device Kit (K233800)	Medtronic Sofamor Danek, Inc., METRx™ System (K993021/K002931)	KLS Martin Neuro Rongeurs (K210741)	Vitalitec Kerrison Rongeurs (K152734)
Indications for Use	The ELID (Endoscopic Less Invasive Decompression) System intended to provide lumbar decompression of the spine to treat various spinal condition(s) using minimally invasive techniques and instrumentation.	The Vertos Medical mild Device Kit is a set of specialized surgical instruments intended to be used to perform lumbar decompressive procedures for the treatment of various spinal conditions.	The METRx™ Microscope is indicated for visualization of the surgical field in any area of the body cut open during a surgical procedure. When used in the cervical, thoracic, or lumbar spine either from an anterior or posterior direction, for example, the METRx™ Microscope and accessories are intended to aid the surgeon's visualization of the surgical area and allow him/her to perform any type of surgical spinal procedure such as herniated disc repair, visualization of the circumferential decompression of the nerve roots, aiding in the search and removal of nucleus material, spinal fusion, or insertion of spinal implants.	The KLS Martin Neuro Rongeurs are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column in patients two years of age or older.	Vitalitec Kerrison Rongeurs are manually operated reusable surgical instruments used for cutting or biting bone during surgery involving the skull or spinal column.
Classification	888.1100	888.1100	888.1100	882.4840	882.4840
Product Code	HRX, HAE	HRX, HAE	HRX	HAE	HAE
Sterility	Non-sterile, reusable	Sterile, single-use	Non-sterile	Non-sterile, reusable	Non-sterile, reusable
Navigation to Site	Bone Needle Material: Stainless Steel Guidewire Material: Nitinol per ASTM F2063 Size: Ø1.5mm x 500 mm	mild Initiator Material: Acrylonitrile butadiene styrene, stainless steel, polycarbonate, thermoplastic elastomer Guidewire Material: Unknown Sizes: Ø1.57 mm x 300 mm	Not Applicable	Not Applicable	Not Applicable
Dilation of Site	Flat Blade Dilator Material: 17-4 PH SS per ASTM A564 Dilator Tubes Material: 7075-T6 Al per ASTM B211 Sizes: Ø6.0mm, Ø8.0mm, Ø 12.9mm, Ø 16.3mm	mild Access Auger Material: Stainless Steel	Dilators Material: Unknown Sizes: Ø5.3 mm – Ø24.8 mm	Not Applicable	Not Applicable
Tissue/Bone Removal	Kerrison Rongeur Material: Stainless Steel Sizes: 3mm, 5mm, 4mm, 6mm	mild Bone Rongeur Material: Stainless Steel mild Tissue Sculptor Material: Acrylonitrile butadiene styrene, stainless steel, nylon, zinc-plated wire	Kerrison Rongeur Material: Unknown Sizes: 1mm, 2mm, 3mm, 4mm, 5mm	Kerrison Rongeur Material: Stainless Steel, TiAlN coating, gold plating Sizes: 1mm to 6mm	Kerrison Rongeur Material: Stainless Steel, TiAlN coating Sizes: 1mm to 6mm

Page 7

The subject device is different from the predicate device in that the subject system includes a flat blade dilator and guidewire which the predicate devices do not use during the decompression procedure. Both the subject flat blade dilator and guidewire have been cleared and remain unchanged since their previous submission.

PERFORMANCE DATA

The ELID (Endoscopic Less Invasive Decompression) System has been tested in the following test modes:

Cleaning Validation
Sterilization Validation
Biocompatibility
Usability Testing
Particulate Analysis per ASTM F1877

The results of this non-clinical testing show that the strength of the ELID (Endoscopic Less Invasive Decompression) System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

CONCLUSION

The overall technology characteristics and mechanical performance data lead to the conclusion that the ELID (Endoscopic Less Invasive Decompression) System is substantially equivalent to the predicate device.

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.