The SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope are indicated for use for endoscopic access and visualization in the surgical area of the cervical, thoracic, or lumbar spine and are accessorized with surgical and coagulation tools for interventional spinal procedures such as discectomy, nucleotomy and foraminotomy.

Device Description

The SESS kit is a collection of arthroscopic surgical accessories, including a bipolar RF electrosurgical accessory. The Spine Vu MiniScope is an arthroscope.

AI/ML Overview

The provided text is related to a 510(k) Premarket Notification for the "SpineVu Endoscopic Spine System (SESS)" and "SpineVu MiniScope." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a comparative study with a ground truth, as would typically be described for AI/ML device evaluations.

Therefore, many of the requested elements (acceptance criteria table, sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable or cannot be extracted from this type of regulatory submission. This document describes a medical device, not a software or AI device that would have performance metrics like sensitivity, specificity, or AUC against a ground truth.

However, I can extract information about the types of testing performed to support the substantial equivalence claim.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Note: This 510(k) submission focuses on demonstrating substantial equivalence of a physical medical device (endoscopic spine system) to previously cleared predicate devices, rather than establishing performance against specific acceptance criteria for an AI/ML algorithm or software as commonly described in device performance studies for AI. Therefore, the response will focus on the types of evidence provided to support the substantial equivalence claim.

1. Table of Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" for performance metrics like sensitivity, specificity, or accuracy, as typically found in AI/ML device studies, is not present in this document. Instead, the submission relies on demonstrating substantial equivalence based on intended use, design, and certain testing types.

Category	Description of "Acceptance" / Evidence	Reported Device Performance
Biocompatibility	Compliance with ISO 10993 standards.	"Biocompatibility data demonstrates that the device is in compliance with ISO 10993."
Bench Testing	Compliance with pertinent standards, medical community expectations, and product labeling.	"Bench testing has demonstrated that the device is in compliance with pertinent standards, the medical communities expectations, and the product labeling."
Cadaver Testing	Device can be used as intended in humans.	"Cadaver testing demonstrated that the device can be used as intended in humans."
Substantial Equivalence	Device is substantially equivalent to predicate devices in intended use and design, raising no new safety or efficacy issues.	The document concludes "SpineView concludes that the SESS is substantially equivalent to the predicate arthroscopic surgical kits," and "Spine View concludes that the SpineVu MiniScope is substantially equivalent to the predicate arthroscopes." It further states, "The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy."

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

Sample Size for Test Set: Not applicable in the context of this 510(k) as it's not an AI/ML performance study with a 'test set' of data.
Data Provenance:
- Biocompatibility data and bench testing are laboratory-based.
- Cadaver testing involves human cadavers. Specific country of origin is not mentioned.
- The studies described are for regulatory submission to the FDA, implying they were conducted to support this submission. They are not framed as "retrospective" or "prospective" clinical studies.

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

Not applicable. This submission focuses on the safety and effectiveness of a physical medical device through substantial equivalence, not on the performance of a software or AI algorithm requiring expert-established ground truth. Expert involvement would be in the design, testing, and regulatory review process, but not for "ground truth" calibration for a test set.

4. Adjudication Method

Not applicable. No adjudication method is described as this is not an AI/ML performance study requiring expert consensus on data labels.

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

No. An MRMC comparative effectiveness study is not mentioned or implied because this is a physical medical device, not an AI/ML interpretive or diagnostic aid. The "effectiveness" is primarily demonstrated through the intended use and lack of new safety/efficacy concerns compared to predicates.

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

Not applicable. The device is a physical endoscopic spine system, not an algorithm.

7. Type of Ground Truth Used

Not applicable in the AI/ML sense of labeled data. The "truth" for this submission revolves around:
- Compliance with established standards (ISO 10993 for biocompatibility)
- Functional performance against engineering specifications and clinical expectations (bench testing)
- Feasibility of intended use (cadaver testing)
- Equivalence to predicate devices (demonstrated through comparative analysis of intended use, technology, materials, and safety/performance data).

8. Sample Size for the Training Set

Not applicable. The device is 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 AI/ML training set, there is no ground truth establishment process for it.

Summary

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

Kosios1

SpineView, Inc.

SpineVu Endoscopic Spine System (SESS) Premarket Notification

ਨੂੰ

1 of

Section 5: 510(k) Summary

Device Information:

AUG - 7 2008

Device Information:
Category	Comments
Sponsor:	Roy ChinPresident & CEOSpineView, Inc48541 Warm Springs Blvd.Suite 507Fremont, CA 94539Tel: 510-377-0898
Correspondent ContactInformation:	Craig CoombsCoombs Medical Device Consulting1193 Sherman StreetAlameda, CA 94501Tel: 510-337-0140Fax: 510-337-0416
Device Common Name:	Arthroscopic Intervention Kit
Device Classification &Code:	Arthroscope: Class II, HRXArthroscope Accessories: Class I, NBHElectrosurgical Accessory: Class II, GEI
Device ClassificationName:	21CFR888.1100: Arthroscope &Accessories21CFR878.4400: Electrosurgical Cutting& Coagulation Device and Accessories
Device Proprietary Name:	SpineVu Endoscopic Spine System (SESS)SpineVu MiniScope

Predicate Device Information:

Predicate Devices:	Kess Instrumentset	Disc-FX System	Perc-D SpineWand
Predicate DeviceManufacturers:	Richard WolfMedicalInstruments	EllmanInternational	ArthroCare
K#s	K000046	K052241	K010811
Predicate DeviceCommon Name:	Arthroscope &accessories	Arthroscope &accessories;electrosurgicalaccessories	Arthroscope &accessories;electrosurgicalaccessories
Predicate DeviceClassification:	21CFR888.1100:Arthroscope &Accessories	21CFR888.1100:Arthroscope &Accessories21CFR878.4400:ElectrosurgicalCutting &CoagulationDevice andAccessories	21CFR888.1100:Arthroscope &Accessories21CFR878.4400:ElectrosurgicalCutting &CoagulationDevice andAccessories

CONFIDENTIAL

Page 1

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

K061051

SpineView, Inc.

SpineVu Endoscopic Spine System (SESS) Premarket Notification

Predicate DeviceClassification &Code:	Class 2, HRX	Class 2, HRX &GEI	Class 2, HRX &GEI
-----------------------------------------------	--------------	-----------------------	-----------------------

Predicate Device Information, continued:

Predicate Devices:	KineticsInterchangeableSpine System	Atavi System
Predicate DeviceManufacturers:	Arthro Kinetics	Endius
K#s	K061246	K061345
Predicate DeviceCommon Name:	Arthroscope &accessories	Arthroscope &accessories
Predicate DeviceClassification:	21CFR888.1100:Arthroscope &Accessories	21CFR888.1100:Arthroscope &Accessories
Predicate DeviceClassification &Code:	Class 2, HRX	Class 2, HRX

b. Date Summary Prepared

10 April 2008

c. Description of Device

The SESS kit is a collection of arthroscopic surgical accessories, including a bipolar RF electrosurgical accessory. The Spine Vu MiniScope is an arthroscope.

d. Intended Use

e. Comparison to Predicate Device

SESS Kit

Nearly all of the components of the SESS kit are Class I exempt (NBH) as Arthroscope accessories (21CFR888.1100). The only exception is the SpineVu CoagProbe. The CoagProbe is a Class II electrosurgical accessory (21CFR878.4440, GEI).

The SpineVu CoagProbe is substantially equivalent in intended use as the coagulation probes found in the Arthrocare Perc-D Spine Wand (K010811) and the Ellman Disc-FX Systems (K052241). Each is used for the ablation and coagulation of intervertebral disc material. The designs of the probes are similar in that all are intended to be used under direct visualization via an endoscope. All of the probes are bipolar and use RF energy to ablate and coagulate the disc material.

SpineView concludes that the SESS is substantially equivalent to the predicate arthroscopic surgical kits.

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

SpineView, Inc.

SpineVu Endoscopic Spine System (SESS) Premarket Notification

SpineVu MiniScope

The Spine Vu MiniScope is substantially equivalent in intended use and design as the arthroscopes in the "Kess" instrument set (K000046), the Arthro Kinetics Spine System (K061246) and the Endius Atavi System (K061345). All are fiber-optic illumination and visualization systems for percutaneous evaluation of intervertebral spaces in the spinal column.

Spinc View concludes that the SpineVu MiniScope is substantially equivalent to the predicate arthroscopes.

The testing described below demonstrates that the differences in the devices do not raise any unresolved issues of safety or efficacy.

SpineView concludes that the devices are substantially equivalent.

f. Summary of Supporting Data

Biocompatibility data demonstrates that the device is in compliance with ISO 10993.

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

Cadaver testing demonstrated that the device can be used as intended in humans

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

Image /page/3/Picture/12 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 7 2008

Spine View, Inc. % Coombs Medical Device Consulting, Inc. Mr. Craig Coombs 1193 Sherman Street Alameda, California 94501

Re: K081051

Trade/Device Name: SpineVu Endoscopic Spine System (SESS™) and SpineVu MiniScope Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX, GEI Dated: July 18, 2008 Received: July 22, 2008

Dear Mr. Coombs:

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

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

Page 2 - Mr. Craig Coombs

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.

Mark M. Mulhausen

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

Enclosure

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

SpineView, Inc.

Section 4: Indications for Use Statement

510(k) Number (if known):

SpineVu Endoscopic Spine System (SESS™) and SpineVu Device Name: MiniScope

Indications For Use:

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(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)	Page 1 of 1
Division of General, Restorative, and Neurological Devices
CONFIDENTIAL	Section 4
510(k) Number	K041051

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.