The LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX) is indicated for the softening of bone cement to facilitate the removal of implants, including pedicle screws and other spinal implants, during revision surgery.

Device Description

The USCIX consists of a power module which generates the ultrasonic energy and provides overall control of the device, a reusable implant removal handpiece, a reusable acoustic coupler and a range of single use adaptors. USCIX employs longitudinal mode ultrasound at nominally 29kHz (Range 28.00-30.00kHz) to remove cemented implants for revision.

AI/ML Overview

The provided text describes a 510(k) summary for the LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX). However, it does not contain details about specific acceptance criteria, a study proving performance against those criteria, or the methodology typically associated with such studies (like sample size, ground truth establishment, expert qualifications, or MRMC studies).

The "Testing" section (G) briefly mentions:

"Testing to FCC Part 18 has been carried out at EMC Network (SW) Ltd, Devon UK, refer to Section 17 for data."
"Electrical testing to UL 60601-1 has been successfully carried out by Underwriters Laboratories and the Certificate of Compliance is included in Section 17."

These refer to electrical and electromagnetic compatibility (EMC) safety and performance standards, which are general requirements for medical devices but not specific performance or clinical efficacy metrics for the intended use described (softening bone cement). The document states that "performance testing was carried out for some characteristics" due to descriptive characteristics not being "sufficiently precise to assure substantial equivalence" and that "The data from this testing are available and are presented in this 510(k)." However, the actual performance data, acceptance criteria, or the study details are not present in this excerpt.

Therefore, I cannot fully complete the requested table and answer all questions. I can only provide what little is mentioned about testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific performance criteria for softening bone cement or facilitating implant removal (e.g., time to soften, completeness of removal, safety metrics related to surrounding tissue)	Not provided in the excerpt. The document states "performance testing was carried out for some characteristics" but does not detail the criteria or results of this testing.
Compliance with FCC Part 18	Successfully carried out (data in Section 17, not provided here).
Compliance with UL 60601-1 (Electrical Safety)	Successfully carried out (Certificate of Compliance in Section 17, not provided here).

Missing Information (Not Available in the Provided Text):

2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: 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: Not mentioned. This device is an ultrasonic surgical instrument, not an AI-assisted diagnostic tool, so an MRMC study would generally not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This refers to typical AI/software performance studies, which are not relevant for this type of physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
8. The sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

Conclusion based on the provided text:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and general safety/electrical testing. It explicitly states that "performance testing was carried out for some characteristics" to assure substantial equivalence where descriptive characteristics were not sufficient, and that this data is available in the full 510(k) submission. However, this specific excerpt does not detail the nature of this performance testing, the acceptance criteria, or the results, nor does it describe any clinical or comparative efficacy studies.

Summary

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K 072961

Section 5 510(k) Summary

Reason for Submission	2
Legally Marketed Predicate Device	2
Device Description	2
Intended Use	2
Technological Characteristics	3
Substantial Equivalence Summary	3
Testing	3
Conclusions	3

・

DEC 19 2007

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K072961

510(k) Summary

LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX)

Common Name: Classification Name:

Product Code: Subsequent Class: Sponsor:

Ultrasonic Surgical Instrument Instrument, Surgical, Sonic And Accessory/Attachment JDX LZV SRA Developments Ltd Bremridge House Ashburton Devon TQ13 7JX nK T: +44 1364 652426 F: +44 1364 653589

Contact:

Dr. Michael J.R. Young.

A. REASON FOR SUBMISSION

This 510(k) is being filed to obtain clearance to market the LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX).

B. LEGALLY MARKETED PREDICATE DEVICES

This premarket notification will demonstrate that the LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX) is substantially equivalent to the Orthosonics OSCAR OE3000DB cleared by FDA as K051053.

C. DEVICE DESCRIPTION

D. INTENDED USE

Section 5

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E. TECHNOLOGICAL CHARACTERISTICS

The basic technological characteristics of the USCIX are the same as those of the predicate device. Both systems are designed to use ultrasound to remove an implant from bone cement during revision surgery. The primary difference is that the USCIX system is specifically designed to apply the ultrasound directly to the implant, softening the bone cement encasing it. This approach is particularly advantageous where the access to the bone cement is restricted such as in the spine. The predicate applies the ultrasound to the bone cement via a probe to soften it facilitating the implants removal. The USCIX utilises the same process used by OSCAR when its titanium probe has become accidentally or deliberately embedded in cement. In this case the OSCAR probe is directly equivalent to the USCIX implant (See OSCAR User Manual in Section 13 of this submission).

F. SUBSTANTIAL EQUIVALENCE SUMMARY

USCIX is a medical device, that uses ultrasound to soften bone cement to facilitate the removal of an implant during revision surgery. This is the same function as the predicate device.

USCIX has the same technological characteristics as the predicate devices. However, the descriptive characteristics may not be sufficiently precise to assure substantial equivalence. Therefore, performance testing was carried out for some characteristics. The data from this testing are available and are presented in this 510(k). The data do in fact demonstrate equivalence.

G. TESTING

Testing to FCC Part 18 has been carried out at EMC Network (SW) Ltd, Devon UK, refer to Section 17 for data. Electrical testing to UL 60601-1 has been successfully carried out by Underwriters Laboratories and the Certificate of Compliance is included in Section 17.

H. CONCLUSIONS

This premarket notification has demonstrated substantial equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the center for Devices and Radiological Health.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines forming its body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2007

SRA Developments, Ltd. % Michael J.R. Young, Ph.D. Managing Director Bremridge House Asburton, Devon, TQ13 7JX United Kingdom

Re: K072961

Trade/Device Name: LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX) Regulation Number: 21 CFR 888.4580 Regulation Name: Sonic surgical instrument and accessories/attachment Regulatory Class: II Product Code: JDX Dated: October 11, 2007 Received: October 19, 2007

Dear Dr. Young:

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. Ilisting 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 mav 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

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Page 2 - Michael J.R. Young, Ph.D.

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 Prostmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device acre venine (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 yours.

Mark N. Millerson

Mark N. Melkerson 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): K 072961

Device Name: LOTUS Ultrasonic System for Cemented Implant eXtraction System (USCIX)

Indications For Use:

Prescription Use ✓ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 CFR 801 Subpart C)

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

Regulation Number and Section

§ 888.4580 Sonic surgical instrument and accessories/attachments.

(a)
Identification. A sonic surgical instrument is a hand-held device with various accessories or attachments, such as a cutting tip that vibrates at high frequencies, and is intended for medical purposes to cut bone or other materials, such as acrylic.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 888.9.

Section 5

510(k) Summary

Contents

510(k) Summary

A. REASON FOR SUBMISSION

B. LEGALLY MARKETED PREDICATE DEVICES

C. DEVICE DESCRIPTION

D. INTENDED USE

E. TECHNOLOGICAL CHARACTERISTICS

F. SUBSTANTIAL EQUIVALENCE SUMMARY

G. TESTING

H. CONCLUSIONS

Indications for Use

§ 888.4580 Sonic surgical instrument and accessories/attachments.