The NeXtra™ arthroscopic pump and shaver system is intended to provide controlled fluid distension and suction, controlled cutting, burring, shaving and abrading of bone and tissue during orthopedic procedures of the knee, shoulder, elbow, wrist, ankle, hip, small joints and temporal mandibular joint (TMJ).

Device Description

The NeXtra™ arthroscopic pump and shaver system is a dual pump system that provides inflow and outflow to and from the joint cavities during arthroscopy. It combines a built in shaver that allows the removal of bone and soft tissue during orthopedic procedures. The NeXtra™ console consists of the following components: A power supply, housing, a motherboard, two peristaltic roller heads, three tube rs power supply, nousing, and a touch screen LCD. The system has a user-friendly cassette load system with an intuitive LCD touch screen. Several asor friendry casbette four pedal and a remote control are available as optional features. The NeXtra™ is to be used exclusively with specific FMS tube sets.

AI/ML Overview

The provided 510(k) summary for the NeXtra™ arthroscopic pump and shaver system does not contain information regarding detailed acceptance criteria or a specific study proving the device meets said criteria in the manner typically expected for AI/ML-driven medical devices.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through similarity in intended use, design, and technological characteristics, and compliance with general electrical safety and quality manufacturing standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about study design elements like sample size, ground truth establishment, or expert qualifications, as this information is not present in the given text.

Here's an analysis based on the provided document, highlighting the absence of the requested information:

Analysis of Acceptance Criteria and Performance Studies for NeXtra™ arthroscopic pump and shaver system (K041824)

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not provided in the submitted 510(k) summary. The document does not specify quantitative or qualitative performance criteria that the NeXtra™ system was intended to meet, nor does it report specific performance outcomes from any dedicated acceptance testing in a format like a table.

2. Sample size used for the test set and the data provenance:

This information is not provided. The submission does not detail any specific test set (for performance evaluation), its sample size, or the provenance of any data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided. The concept of "ground truth" and its establishment by experts is not discussed in the context of device performance testing in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided. As no specific test set or performance evaluation study is detailed, an adjudication method is not mentioned.

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:

This information is not applicable/provided. The NeXtra™ arthroscopic pump and shaver system is a mechanical device, not an AI/ML diagnostic or assistive tool. Therefore, a multi-reader multi-case comparative effectiveness study involving human readers and AI assistance would not be relevant to this type of device and is not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable/provided. The NeXtra™ system is a physical medical device. The concept of an "algorithm only" performance study is not relevant to its nature and is not discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

This information is not provided. Given the nature of the device, "ground truth" in the context of an AI/ML model (e.g., for diagnostic accuracy) is not relevant to this submission. The validation for this type of device would typically involve engineering specifications, safety testing, and functional testing, rather than a diagnostic ground truth.

8. The sample size for the training set:

This information is not applicable/provided. The NeXtra™ system is not an AI/ML-based device that would require a training set in the conventional sense.

9. How the ground truth for the training set was established:
This information is not applicable/provided. As the device is not AI/ML-based, the concept of a "training set" and its associated ground truth is not relevant.

Summary of the Study Proving the Device Meets Acceptance Criteria (as per the document):

The provided 510(k) summary does not describe a specific clinical or performance study designed to prove the device meets pre-defined acceptance criteria in the way a modern AI/ML device submission would.

Instead, the "Performance Data" section (VIII) states:
"The device complies with IEC 60601-1 (electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), CE mark in accordance with the Medical Device Directive 93/42/EEC, manufactured in an ISO 9001 Version 2000 and ISO 13485 facility."

This indicates that the "study" proving the device meets (implicitly defined) acceptance criteria primarily relied on:

Compliance with recognized international standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), and CE mark (Medical Device Directive 93/42/EEC). These standards lay out technical requirements and testing methodologies, and compliance implies meeting their respective thresholds for safety and performance characteristics.
Quality Management System Certification: Manufacturing in an ISO 9001 and ISO 13485 certified facility demonstrates adherence to quality management principles, which include processes for design control, risk management, and product testing, rather than a single "study."

The core argument for marketing clearance is Substantial Equivalence (Section VII). The submission argues that the NeXtra™ system is substantially equivalent to existing predicate devices (K954465, K913028, K932699, K940075) because their "intended use, design and technological characteristics are similar." The minor differences are asserted not to "raise any new issues of safety and effectiveness."

Therefore, for this device, the "proof" the device meets acceptance criteria is primarily tied to:

Demonstrated compliance with relevant safety and manufacturing standards.
Argument of substantial equivalence to legally marketed predicate devices, implying that if the predicates are safe and effective, and the new device is sufficiently similar and meets modern safety standards, it is also safe and effective.

Summary

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510(k) SUMMARY for NeXtra™ arthroscopic pump and shaver system.

JAN - 7 2005

Date of submission: July 4th 2004

510k #: K041824

1/2

I. Submitter:

Owner / Operator:	Future Medical Systems, SA.
Address:	265 Route de la Baronne, ST. Jeannet 06640 France
Phone:	011-33-4-92-12-32-56
Fax:	011-33-4-92-12-04-75
Contact:	Patrick Janin

Official correspondent:

Company:	Future Medical Systems, Inc.
Address:	504 McCormick Drive, Glen Burnie, MD 21061
Phone:	410 761 9411 ext. 11
Fax:	410 760 9422
Contact:	Mr. Steve Janin

II. Device Names:

Classification name:	Arthroscope and Accessories
Common name:	Arthroscopic pump and shaver (debridement) system and accessories.
Proprietary name:	NeXtraTM arthroscopic pump and shaver system.

III. Classification:

Class II. Product code is HRX. This device is described in 21 C.F.R § 888.1100

IV. Predicate devices:

K954465: FMS DUO (pump and shaver), Future Medical Systems K913028: Arthro-Flow Irrigation system (pump), Davol (BARD) K932699: ARTHREX AR-8200 SHAVER SYSTEM (Arthrex) K940075: SHAVER BLADE SET (Arthrex)

V. Intended use:

VI. Device Description:

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K64 1824 2/2 510(k) SUMMARY for NeXtra™ arthroscopic pump and shaver system.

A power supply, housing, a motherboard, two peristaltic roller heads, three tube rs power supply, nousing, and a touch screen LCD. The system has a user-friendly cassette load system with an intuitive LCD touch screen. Several asor friendry casbette four pedal and a remote control are available as optional features. The NeXtra™ is to be used exclusively with specific FMS tube sets.

VII. Substantial Equivalence:

The device and its accessories described in this notification are similar in intended use, design and technological characteristics as the K954465: FMS DUO (pump and shaver), Future Medical Systems, the K913028: Arthro-Flow Irrigation system (pump), Davol (BARD) and the K932699: Arthrex AR-8200 Shaver System and K940075: Shaver blade set, Arthrex.

The predicate devices and the NeXtra™ are both intended to provide inflow and outflow during arthroscopic surgery. The shaver systems are both intended to remove bone and soft tissue during arthroscopic surgery.

We believe the NeXtra™ is substantially equivalent to these predicate devices since the basic features; specifications, design and intended uses are similar. The minor differences do not raise any new issues of safety and effectiveness.

VIII. Performance Data:

The device complies with IEC 60601-1 (electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), CE mark in accordance with the Medical Device Directive 93/42/EEC, manufactured in an ISO 9001 Version 2000 and ISO 13485 facility.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

Mr. Patrick Janin Manager Future Medical Systems 265, Route de la Baronne 06640 Saint-Jeannet France

Re: K041824

K041824
Trade/Device Name: NeXtra™ arthroscopic pump and shaver system Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: November 29, 2004 Received: December 1, 2004

Dear Mr. Janin:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premaited is substantially equivalent (for the indications
referenced above and have determined the devices marketed in interstate referenced above and have delemined the devices marketed predicate devices marketed in interstate for use stated in the enclosure) to regally manced promoted provice Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior to May 26, 1970, the encentials with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act and Cosmetic Act (Act) that do not require approvate controls provisions of the Act. The Act. The You may, merelore, market the device, basjoct to the ...
general controls provisions of the Act include requirements michreading and general controls provisions of the receined requirement
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 If your device is classified (see above) mis chaires and many of the strecting your device can
may be subject to such additional controls. Existing major regulations all pro may be subject to such adultional controller. Extrang major of to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts of Research be found in the Code of Poderal Regarmers
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 Please be advised that FDA s issualice of a subscribe with other requirements of the Act
that FDA has made a determination that your device of a complies. You must that FDA has made a determination that your as roo over Federal agencies. You must or any Federal statures and regulations administered of registration and listing (2)
comply with all the Act's requirements, including, but not limited to: ret comply with an the Act 3 requirements, mo; good manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electron CFR Part 807); labeling (21 CFR Pat 001); good and frapplicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, 11 CFR 1000 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000

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Page 2 - Mr. Patrick Janin

This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin makeming your antial equivalence of your device to a legally premarket notification. The PDA midning of backannel of 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 If you desire specific advice for Joan as (240) 276-0115. Also, please note the regulation entitled, Collier the Office of Computine at (210) 216-215 Part 807.97). You may obtain "Misoralluling by relefence to promance as promance the Act from the Division of Small
on and information on your responsibilities under the Act from the Division of Small other general information on your respenses is its toll-free number (800) 638-2041 or Manufacturers, International and Ochss.http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K041824

Device Name: NeXtra™ arthroscopic pump and shaver system.

Indications For Use:

The NeXtra™ arthroscopic pump and shaver system is intended to provide controlled The Nextra ™ arthroscopic pump and sharer Jording, shaving and abrading of bone
fluid distension and suction, controlled cutting, blank, wrist, ankle, wrist, ankle, bi fluid disension and Suction, continued outfilly, burning and one of the survive, ankle, hip,
and tissue during orthopedic procedures of the Kree, shoulder, elbow, wrist, ankl and tissue danny enporal mandibular joint (TMJ).

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)

Miriam C Provost
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices	Page 1 of 1
510(k) Number	K041824

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.