The X-Sten MILD Tool Kit is a set of specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.

Device Description

The X-Sten MILD Tool Kit is a set of specialized surgical tools for retracting, grasping and excising tissue in the lumbar spine. The kit consists of the following components:

MILD Tissue Retractor Cobra Device 8.5 Gauge, 8.5" working length .
MILD Trocars and Handles- 7 Gauge, 6.5" working length ●
MILD Portals 6 Gauge, 6.5" working length ●
Surgical Clamp 14" length .
The Trocars, Portals (cannula) and Retractor devices contain stainless steel shafts and plastic handle components. The radiopaque tip and pistol-grip handle aid the user in the Minimally Invasive Lumbar Decompression (MILD) Retractor device positioning and Under fluoroscopic imaging guidance, the MILD Retractor device is advancement. inserted through the Portal into the posterior lumbar spine to retract and grasp tissue. An accessory Clamp can be used to position the Portal and allow handling outside of the fluoroscopic imaging field. A cutting mechanism on the MILD Retractor is advanced by depressing a handle trigger. Excised tissue is removed using an integrated member.

AI/ML Overview

Acceptance Criteria and Device Performance for X-Sten MILD Tool Kit

This document outlines the acceptance criteria and the study that proves the X-Sten MILD Tool Kit meets these criteria, based on the provided 510(k) submission.

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary for the X-Sten MILD Tool Kit primarily focuses on demonstrating substantial equivalence to predicate devices. As such, the "acceptance criteria" are implicitly tied to the performance characteristics of these predicate devices and the general safety and effectiveness requirements for similar surgical instruments. Direct quantitative acceptance criteria are not explicitly stated in the provided text. Instead, the performance is reported qualitatively through successful testing.

Acceptance Criteria (Implicit)	Reported Device Performance
Mechanical Strength and Integrity: The device must possess adequate strength and integrity to safely and effectively perform its stated intended use (retracting, grasping, and excising tissue in the lumbar spine).	The X-Sten MILD Tool Kit Retractor and Access instruments passed the designated mechanical test criteria established for the product assemblies, verifying they have adequate strength and integrity to safely and effectively perform the stated intended use.
Functional Performance (Retraction, Grasping, Excising Tissue): The device must be able to successfully retract, grasp, and excise tissue from the posterior lumbar spine using image-guided techniques.	Cadaver evaluations demonstrate that tissue can be simultaneously retracted, grasped and excised from the posterior lumbar spine using image guided techniques.
Biocompatibility: Patient-contacting materials must meet established biocompatibility standards.	The patient contacting stainless steel materials were tested for "Externally Communicating Devices, Tissue/Dentin/Bone, Limited Contact", less than 24 hours, as described in ISO 10993 and the FDA Blue Book Memorandum #G95-1. The biocompatibility is substantially equivalent to the predicate devices, and the results fulfill the acceptance criteria for biocompatibility. No new types of safety or effectiveness questions were raised.
Sterility: The device must be sterile and maintain sterility for single-use.	The MILD Tool Kit is labeled sterile, for single-use only. The packaging and contents will be sterilized with gamma irradiation by a validated process to a Sterility Assurance Level (SAL) of 10^-6 per AAMI / ISO 11137 and AAMI TIR 27. (This is the acceptance criterion and the method to achieve it, implying successful validation).
Substantial Equivalence (Overall Safety and Effectiveness): The device must demonstrate substantial equivalence to legally marketed predicate devices in function, technology, and intended use, raising no new questions of safety or effectiveness.	The X-Sten MILD Tool Kit was tested in accordance with 21 CFR 807.87(d-g) to verify substantial equivalence to the predicate devices. The technological comparisons to the predicates support the substantial equivalence. Combined with product performance test results and substantial equivalence discussions, the X-Sten MILD Tool Kit is demonstrated to be substantially equivalent to the predicates. Any differences do not raise new types of safety or effectiveness questions.

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

Sample Size for Test Set: Not specified for the mechanical tests or the cadaver evaluations. The text only states "The X-Sten Mild Tool Kit Retractor and Access instruments passed the designated mechanical test criteria" and "Cadaver evaluations demonstrate that tissue can be simultaneously retracted, grasped and excised."
Data Provenance:
- Mechanical Tests: Likely performed in a controlled laboratory setting (in-house or by a testing service). The country of origin and whether it was retrospective or prospective is not specified, but device testing is typically prospective.
- Cadaver Evaluations: Performed using human cadavers. The country of origin and whether it was retrospective or prospective is not specified, but cadaver studies are inherently prospective for the device evaluation.
- Biocompatibility: Performed according to ISO 10993 and FDA Blue Book Memorandum #G95-1, which are international and US standards, respectively. These tests are prospective.

3. Number of Experts and Qualifications for Ground Truth

Mechanical Tests: No experts are typically used to establish ground truth for mechanical tests; the ground truth is defined by the predetermined engineering specifications and criteria.
Cadaver Evaluations: The text implies observation and assessment by medical professionals involved in the cadaver evaluation for usability and functional performance. However, the number of experts and their specific qualifications are not specified.
Biocompatibility: The ground truth is established by the results of the standardized biological tests per ISO 10993 and G95-1, not by expert consensus on individual cases.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used for studies evaluating subjective medical interpretations or diagnoses (e.g., imaging studies). The types of studies described here (mechanical, cadaver, biocompatibility) do not involve such subjective interpretations and therefore do not indicate an adjudication method. The "ground truth" for these tests is objective measurement against predefined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. The submission focuses on substantial equivalence based on technological characteristics, intended use, and objective performance tests (mechanical, cadaver, biocompatibility) as opposed to a clinical outcome study or reader performance study. The device is a surgical tool, not an interpretive diagnostic aid. Therefore, there is no mention of human readers or AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The X-Sten MILD Tool Kit is a set of physical surgical instruments, not an algorithm or AI-driven system. Therefore, a standalone (algorithm only) performance study was not conducted. The device inherently requires human operation.

7. Type of Ground Truth Used

Mechanical Tests: Engineering specifications and objective measurements (e.g., strength, integrity defined by design parameters).
Cadaver Evaluations: Observational assessment of functional performance (ability to retract, grasp, excise tissue) in a simulated surgical environment. This is a form of empirical functional validation.
Biocompatibility Tests: Laboratory test results against established scientific standards.
Substantial Equivalence: Comparison of technological characteristics, intended use, and performance data to legally marketed predicate devices, with FDA's determination serving as the ultimate ground truth for market approval.

8. Sample Size for the Training Set

Not applicable. The X-Sten MILD Tool Kit is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI or algorithm development.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

{0}------------------------------------------------

MILD Tool Kit - Premarket Notification [510(k)] Submission

X-Sten Corp Page 1 of 3, Tab 5

ko6 2038 Tab 5

Premarket Notification [510(k)] Summary

Trade Name:	X-Sten MILD Tool Kit
Common Name:	Arthroscope and Accessories		DEC 19 2006
Classification /Name:	Class II; 21 CFR, part 888.1100Arthroscope
Device Code:	HRX
Manufacturer's Name:	X-Sten Corp
Address:	2362 Qume Drive, Suite DSan Jose, CA 95131-1841
Corresponding Official:	Timothy M. Reeves
Title:	Director, Regulatory, Quality and Clinical Affairs
Address:	2362 Qume Drive, Suite DSan Jose, CA 95131-1841
Telephone:	408-437-3101
Predicate Devices:	K053267 K022578 K991794 K983144 K052241 K043602 K002931 K041123 K040919 K032473 K002008 K992898	Endius Atavi SystemEndius FlexTip BladeEndius Endoscopic Spinal Access SystemEndius Flexposure RetractorEllman International Disc-Fx SystemMedtronic MAST QUADRANT RetractorMedtronic METRxHydroCision AthroJet Resector XTClarus 21200 Nucleotome Probe SetStryker Dekompressor PercutaneousDiscectomy ProbeSurgical Dynamics Spinal RetractorBright Medical Dilatation Retractor System
Intended Use:	The X-Sten MILD Tool Kit is a set of specialized surgicalinstruments intended to be used to perform percutaneouslumbar decompressive procedures for the treatment ofvarious spinal conditions

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product addressed in this submission may be lawfully market approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including patent infringement, litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent or patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.

{1}------------------------------------------------

Device Description:

The X-Sten MILD Tool Kit is a set of specialized surgical tools for retracting, grasping and excising tissue in the lumbar spine. The kit consists of the following components:

MILD Tissue Retractor Cobra Device 8.5 Gauge, 8.5" working length .
MILD Trocars and Handles- 7 Gauge, 6.5" working length ●
MILD Portals 6 Gauge, 6.5" working length ●
Surgical Clamp 14" length .

The Trocars, Portals (cannula) and Retractor devices contain stainless steel shafts and plastic handle components. The radiopaque tip and pistol-grip handle aid the user in the Minimally Invasive Lumbar Decompression (MILD) Retractor device positioning and Under fluoroscopic imaging guidance, the MILD Retractor device is advancement. inserted through the Portal into the posterior lumbar spine to retract and grasp tissue. An accessory Clamp can be used to position the Portal and allow handling outside of the fluoroscopic imaging field. A cutting mechanism on the MILD Retractor is advanced by depressing a handle trigger. Excised tissue is removed using an integrated member.

Attributes	X-Sten	ClarusMed	Stryker	Hydro-Cision	EllmanInt'l	BrightMed	SurgicalDynamic	Medtronic	Endius
IntendedUse	Minimally invasive image-guided tissue resection during decompressive surgery within thelumbar spine.
TargetPopulation	Products are used for various procedures in patients indicated for spinal decompressive surgery.
DeviceClass			Arthroscope			Retractor		Arthroscope; Retractor
Approach			Percutaneous				Minimally Invasive Portal
TargetAnatomy		Spine /Lumbar		Spine / Disc				Spine / Lumbar
Imaging			Fluoroscope			Endoscope			Endoscope /Fluoroscope
Materials			Stainless Steel Shafts and Plastic Handles (metaldiscectomy probes for Stryker)				Stainless Steel Cannula, Dilatators and/orTissue Resectors
Action	RetractGraspCut		Cut /Aspirate		AblateCoagulate		AccessRetract		RetractGraspCut
Labeling			Sterile Kit, Single-use				Non-sterile, Re-use		Sterile& Non-sterile

Comparison Table of the X-Sten MILD Tool Kit to the Predicates

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product addressed in this submission may be lawfully marketed without premarket approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including patent infringement, litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a pagentability perspective, from any of the other devices referenced in this filing

{2}------------------------------------------------

X-Sten Corp Page 3 of 3, Tab 5

Performance Testing

The X-Sten Mild Tool Kit Retractor and Access instruments passed the designated mechanical test criteria established for the product assemblies. The tests verified the devices have the adequate strength and integrity to safely and effectively perform the stated intended use. Cadaver evaluations demonstrate that tissue can be simultaneously retracted, grasped and excised from the posterior lumbar spine using image guided techniques.

Biocompatibility

The patient contacting stainless steel materials used in the X-Sten MILD Tool Kit were tested for "Externally Communicating Devices, Tissue/Dentin/Bone, Limited Contact", less than 24 hours, as described in ISO 10993 and the FDA Blue Book Memorandum #G95-1. The biocompatibility is substantially equivalent to the predicate devices. The documentation substantiates that the X-Sten MILD Tool Kit Retractor and Access Instruments' patient contacting components fulfill the acceptance criteria for biocompatibility. These results are equivalent to those claimed of the predicates and there were no new types of safety or effectiveness questions.

Sterilization

The MILD Tool Kit is labeled sterile, for single-use only. The packaging and contents will be sterilized with gamma irradiation by a validated process to a Sterility Assurance Level (SAL) of 10th per AAMI / ISO 11137 and AAMI TIR 27.

Substantial Equivalence

The X-Sten MILD Tool Kit is substantially equivalent in function, technology and intended use to commercially available predicate devices for image guided lumbar spinal decompression procedures. Applicable predicates are identified in the provided comparison table. These include devices for minimally invasive surgery and percutaneous discectomy.

The X-Sten MILD Tool Kit was tested in accordance with 21 CFR 807.87(d - g) to verify substantial equivalence to the predicate devices. The technological comparisons to the predicates support the substantial equivalence of the MILD Tool Kit for its intended use. Combined with the product performance test results and the substantial equivalence discussions, the X-Sten MILD Tool Kit is demonstrated to be substantially equivalent to the predicates. The MILD Tool Kit has the same intended use and similar technological characteristics as the predicate devices. Any differences between the MILD devices and the predicates do not raise any new types of safety or effectiveness questions.

Any statement regarding "substantial equivalence" made in this submission only relates to whether the product addressed in this submission may be lawfully market approval or reclassification, and is not intended to be interpreted as an admission or any other type of evidence in any patent proceeding, including patent infringement, litigation or proceeding before any Patent Office. The present submission and statements therein therefore should not be construed as affecting or relating to the scope of any patent application, or to whether the product addressed in this submission, or its use, may be considered indistinct, from a patentability perspective, from any of the other devices referenced in this filing.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

X-Sten Corporation % Mr. Timothy M. Reeves Director of Regulatory, Quality and Clinical Affairs 2362 Qume Drive, Suite D San Jose, California 95131-1841

DEC 1 9 2006

Re: K062038

Trade/Device Name: X-Sten MILD Tool Kit Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: November 27, 2006 Received: November 28, 2006

Dear Mr. Reeves:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

{4}------------------------------------------------

Page 2 - Mr. Timothy M. Reeves

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for

Mark N. Mellon

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known): _ KO62038

Device Name: X-Sten MILD Tool Kit

Indications for Use:

The X-Sten MILD Tool Kit is a set of specialized surgical instruments intended to be File A bled MILL - Fourneous lumbar decompressive procedures for the treatment of various spinal conditions.

x_____________________________________________________________________________________________________________________________________________________________________________ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number	14062038

Page 1 of 1

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.