The XTool™ Device is indicated for spinal discectomy procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.

Device Description

The XTool™ is an orthopedic manual hand held surgical instrument for use in performing discectomy in open and minimally invasive spine procedures. It is composed of an angled cutting head with serrated cutting edges and a distal guard, and a hollow shaft that connects the cutting head to the handle proximal. The handle has a port for connecting to standard hospital wall or pump suction. Two different diameter devices are specified to accommodate the range of disc heights for which a discectomy can be performed, with the smaller diameter for lower height discs, and the larger diameter for larger height disc. Two different tip angles are also specified to facilitate ipsilateral and contralateral disc removal. The finished assembly working length is 22 cm, Tip Angle is 15° or 40° and the cutter head diameter is either 5.2 mm or 6.3 mm.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the XTool™ MIS DISCECTOMY Device:

Based on the provided 510(k) summary (K122861), the device is a manual handheld surgical instrument for discectomy, not an AI/ML-driven device. Therefore, many of the requested elements (like AI-specific performance metrics, reader studies, training/test sets, ground truth establishment methods typical for AI/ML, etc.) are not applicable or not explicitly detailed in the way they would be for an AI/ML device submission.

The acceptance criteria and supporting studies described are typical for traditional medical devices, focusing on safety, performance, and substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Standards (Implied/Stated)	Reported Device Performance
Biocompatibility	In compliance with ISO 10993	Device is in compliance with ISO 10993 for biocompatibility.
Sterilization Validation	In compliance with ISO 11137 standards	Device is in compliance with ISO 11137 standards for product sterility assurance.
Packaging Validation	In compliance with ISO 11607-1	Device is in compliance with ISO 11607-1.
Bench Testing	Compliance with pertinent standards; meets expectations of the medical community and product labeling	Device is in compliance with pertinent standards, expectations of the medical community, and product labeling.
Simulated Use (Cadaver)	Demonstrated ability to be used as intended in humans	Demonstrated that the device can be used as intended in humans.
Substantial Equivalence	Equivalence in intended use and technology to predicate devices (HydroCision Arthrojet/SpineJet, Blackstone Medical Inc. Laparoscopic Disc Removal System)	Achieved substantial equivalence determination by FDA.

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

Sample Size for Test Set: Not explicitly stated for specific tests.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective).
- For biocompatibility, sterilization, and packaging, these are typically laboratory tests performed on device samples.
- Bench testing would also be laboratory-based.
- Simulated use testing was conducted using cadavers, implying a controlled laboratory environment rather than patient data.

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

Not Applicable in the traditional AI/ML sense. The device is a surgical instrument. The "ground truth" for its performance relates to its physical properties, material safety, and functional capability as assessed through engineering testing and cadaver studies. This doesn't involve expert consensus on medical images or diagnoses for a "test set" in the context of an AI/ML algorithm. Instead, it would involve qualified engineers and possibly surgeons (for the cadaver study) assessing the physical performance and safety.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used to resolve disagreements among multiple human readers generating ground truth for AI/ML model evaluation. This device is not an AI/ML diagnostic tool, and its evaluation methods (biocompatibility, sterilization, bench, cadaver studies) don't involve such adjudication processes.

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

No. An MRMC study is typically performed to evaluate the diagnostic performance of a new system (often AI-assisted) compared to human readers, with or without AI assistance. The XTool™ is a surgical instrument; therefore, an MRMC study is not relevant to its stated evaluation.

6. If a Standalone Study (Algorithm-Only Performance) was Done

No. This question is specific to AI/ML algorithms. The XTool™ is a physical surgical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's evaluation is primarily established through:
- Scientific Standards: Compliance with ISO standards (10993, 11137, 11607-1) for material safety, sterility, and packaging.
- Engineering Specifications: Performance metrics derived from bench testing, comparing against established engineering and functional requirements.
- Functional Demonstration: Successful demonstration of the device's intended use and performance in a simulated environment (cadaver testing).
- Predicate Device Comparison: Establishing substantial equivalence based on comparison of intended use and technological characteristics to previously cleared devices.

8. The Sample Size for the Training Set

Not Applicable. This device is a manual surgical instrument, not an AI/ML algorithm that requires a training set.

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

Not Applicable. As there is no training set for an AI/ML algorithm, there is no ground truth established for one.

Summary

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K/22861

Section 5: 510(k) Summary

DEC 0 7 2012

Category	Comments
Sponsor:	Ouroboros Medical, Inc.47757 Fremont Blvd.,Fremont, CA 94538
Correspondent ContactInformation:	Shelley TrimmConsultant, Regulatory AffairsOuroboros Medical, Inc.47757 Fremont Blvd.,Fremont, CA 94538Tel: 510 933-3441Fax: (866) 931-5422Email:shelleytrimm@sbcglobal.net
Device Common Name:	Arthroscope and Accessories
Device Classification &Code:	Arthroscope: Class II, HRXArthroscope Accessories: Class I, NBH
Device ClassificationName:	21 CFR § 888.1100 Arthroscope andAccessories
Device Proprietary Name:	XTool™ MIS DISCECTOMY

Predicate Device Information:

Predicate Devices:	Arthrojet/SpineJet	Laparoscopic Disc RemovalSystem
Predicate DeviceManufacturers:	HydroCision	Blackstone Medical Inc.
K#s	041233	972768
Predicate Device CommonName:	Arthroscope and Accessories	Arthroscope and Accessories
Predicate DeviceClassification:	21 CFR § 888.1100	21 CFR § 888.1100
Predicate DeviceClassification & Code:	Arthroscope: Class II, HRX	Arthroscope: Class II, HRX

b. Date Summary Prepared

September 1, 2012

Description of Device C.

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Indications for Use

The XTool™ Device is indicated for spinal discectomy, procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.

Comparison to Predicate Device e.

The Ouroboros Medical XTool™ MIS DISCECTOMY Device is substantially equivalent in intended use and technology to the currently marketed predicate devices the HydroCision Arthrojet/SpineJet handpiece (K041233) and the Blackstone Medical Inc. Laparoscopic Disc Removal System (K972768). Both the Application device and the predicate devices provide a means to cut soft tissue, remove cartilage, and aspirate tissue through a stainless steel tube in spinal surgeries. The Arthrojet/SpineJet has a cutting blade () at the tip and a tip orifice that draw tissue in to be aspirated through the collection tube. The XTool™ Device also has a cutting blade at the tip with a tip opening for drawing in tissue to be aspirated through a stainless steel tube. The Blackstone Laparoscopic Disc Removal System also has cutting edges around an opening at the tip that draws tissue in using suction to be aspirated through the stainless steel tube.

f. Summary of Supporting Data

Biocompatibility testing demonstrates that the device is in compliance with ISO 10993 for biocompatibility of the product.

Sterilization Validation has demonstrated that the device is in compliance with ISO 11137 standards for product sterility assurance.

Packaging Validation has demonstrated that the device is in compliance with ISO 11607-1.

Bench testing has demonstrated that the device is in compliance with the pertinent standards, the expectations of the medical community and the product labeling.

Simulated use cadaver testing demonstrated that the device can be used as intended in humans.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

December 7, 2012

Ouroboros Medical % Ms. Shelley Trimm Consultant, Regulatory Affairs 47757 Fremont Boulevard Fremont, California 94538

Re: K122861

Trade/Device Name: XTool™ MIS DISCECTOMY Device Regulation Number: 21 CFR 888.1100 · Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: October 18, 2012 Received: October 19, 2012

Dear Ms. Trimm:

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

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Page 2 -- Ms. Shelley Trimm

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 vours.

Peter D. Rumm -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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Section 4: Indications for Use Statement

510(k) Number (if known): K122861

Device Name: XTool™ MIS DISCECTOMY Device

Indications For Use: The XTool™ Device is indicated for spinal discectomy procedures for the cutting and removal of soft and hard tissue in open and minimally invasive spinal surgeries.

AND/OR Prescription Use X (Part 21 CFR 801 Subpart D)

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)

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Neil R Ogden 2012.12.03 11:56:08 -05'00'

(Division Sign-off) Division of Surgical Devices 510(k) Number

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.