The ThRevo™ Suture Anchor with Disposable Driver is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.

Device Description

The ThRevo™ Suture Anchor with Disposable Driver consists of a titanium suture anchor with a self-tapping cutting tip. The design requires no predrilling and can be inserted by hand into the bone with the accompanying disposable driver. The ThRevo™ Suture Anchor with Disposable Driver is substantially equivalent in design, performance specifications, function and intended use to the Super Revo® Suture Anchor. The design of the implant has not been modified.

The only modification to the currently marketed device is the ThRevo™ Suture Anchor with Disposable Driver is preloaded with three (3) nonabsorbable USP size # 2 braided polyester sutures (green, white and green/white striped) instead of two (2) nonabsorbable, USP size # 2 braided polyester sutures (green and white). The surgical technique has been slightly modified to for account for the addition of the third suture.

The implant design has not been modified in any way. The titanium suture anchor implant of the ThRevo™ Suture Anchor with Disposable Driver is the same as for the Super Revo® Suture Anchor (510(k) # K003984). Both are provided preloaded onto a disposable driver with a stainless steel shaft and ABS handle. Also, both the ThRevoTM Suture Anchor with Disposable Driver and Super Revo® Suture Anchor are supplied sterile and single use.

This modification does not affect the device's intended use, fundamental scientific technology or performance specifications.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called the ThRevo™ Suture Anchor with Disposable Driver. It is primarily a declaration of substantial equivalence to a previously marketed device, the Super Revo® Suture Anchor, rather than a study proving the device meets acceptance criteria.

Therefore, many of the requested elements for a study that "proves the device meets the acceptance criteria" are not applicable to this type of submission. However, I can extract the relevant information provided:

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document does not provide specific numerical acceptance criteria or performance metrics in a table format. The core of this 510(k) is to demonstrate substantial equivalence. It states:

Acceptance Criteria Implied: The new device (ThRevo™ Suture Anchor with Disposable Driver) must be substantially equivalent to the predicate device (Super Revo® Suture Anchor) in design, performance specifications, function, and intended use, and not raise new issues regarding safety and effectiveness.
Reported Device Performance: The document explicitly states: "The design of the implant has not been modified." and "The implant design has not been modified in any way. The titanium suture anchor implant of the ThRevo™ Suture Anchor with Disposable Driver is the same as for the Super Revo® Suture Anchor". The only modification is the addition of a third suture.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The document refers to "Testing has been conducted to assure that providing the suture anchor with the additional strand of nonabsorbable USP #2 polyester suture does not raise any new issues regarding safety and effectiveness." However, the details of this testing (sample size, methodology) are not provided in this summary.
Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable/Not specified. This is not a study involving expert assessment of a test set for ground truth establishment.

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

Not applicable/Not specified.

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

No. This is a submission for a physical medical device (suture anchor), not an AI-assisted diagnostic tool.

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

No. Not applicable, as this is not an algorithm.

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

Not applicable. The "ground truth" in this context is the established safety and effectiveness of the predicate device.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not a machine learning model.

9. How the ground truth for the training set was established

Not applicable.

Summary of the Study (or justification for substantial equivalence):

The "study" presented here is a Special 510(k) Summary aiming to demonstrate "substantial equivalence" of the ThRevo™ Suture Anchor with Disposable Driver to a legally marketed predicate device, the Super Revo® Suture Anchor (510(k) # K003984).

Key "Proof" points:

Device Description (E): The titanium suture anchor implant itself has not been modified from the predicate device.
Modification: The only change is the addition of a third non-absorbable USP size #2 braided polyester suture.
Intended Use (F): The intended use (rotator cuff repairs in the shoulder) remains the same.
Substantial Equivalence (G): "The ThRevo™ Suture Anchor with Disposable Driver is substantially equivalent in intended use, scientific technology and design to the Super Revo® Suture Anchor. Testing has been conducted to assure that providing the suture anchor with the additional strand of nonabsorbable USP #2 polyester suture does not raise any new issues regarding safety and effectiveness."
Suture Safety: The additional suture material (Polydek) is from TeleFlex Medical, which is approved for commercial distribution under 510(k) number K021019. The other two sutures are from Surgical Specialties and approved under NDA 80-950.

In essence, the "study" for this 510(k) filing relies on the established safety and effectiveness of the predicate device and the materials used, asserting that the minor modification (addition of a suture) does not alter the fundamental safety or performance profile. No detailed clinical or performance study data is provided in this summary.

Summary

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K050227

MAR 2 - 2005

1/3

LINVATEC CORPORATION

February 07, 2005

510(k) SUMMARY

Summary of Safety and Effectiveness

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the Special 510(k) Summary of Safety and Effectiveness for the ThRevo™ Suture Anchor with Disposable Driver 510(k) Number _

A. Submitter

Linvatec Corporation l 1311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

B. Company Contact

Elizabeth Paul Manager, Regulatory Affairs (727) 399-5234 Telephone (727) 399-5264 FAX

C. Device Name

Trade Name:	ThRevo™ Suture Anchor with DisposableDriver
Common Name:	Suture Anchor
Classification Names:	Screw, Fastener, Fixation, Nondegradable,Soft Tissue, 21 CFR 888.3040
Proposed Class/Device:	Class II
Product Code:	MBI

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KOSO227

LINVATEC CORPORATION

510(k) Summary (Continued)

ThRevo™ Suture Anchor with Disposable Driver 510(k) # February 07, 2005

Predicate/Legally Marketed Devices D.

510(k) # K003984 Super Revo® Suture Anchor Linvatec Corporation

Device Description E.

This modification does not affect the device's intended use, fundamental scientific technology or performance specifications.

F. Intended Use

The ThRevo™ Suture Anchor with Disposable Driver is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.

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K050227

- LINVATEC CORPORATION

510(k) Summary (Continued) ThRevo™ Suture Anchor with Disposable Driver 510(k) # February 07, 2005

Substantial Equivalence G.

The ThRevo™ Suture Anchor with Disposable Driver is substantially equivalent in intended use, scientific technology and design to the Super Revo® Suture Anchor. Testing has been conducted to assure that providing the suture anchor with the additional strand of nonabsorbable USP #2 polyester suture does not raise any new issues regarding safety and effectiveness.

Surgical Specialties, Redding, Pennsylvania, supplies two (2) non-absorbable USP #2 Silicone coated polyester braided sutures (Polyviolene), which are approved under NDA 80-950

TeleFlex Medical, Coventry, Connecticut, supplies the additional third nonabsorbable USP #2 PTFE coated polyester braided suture (Polydek) which is approved for commercial distribution in the U.S. under 510(k) number K021019.

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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 - 2005

Ms. Elizabeth Paul Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773

Re: K050227

Trade/Device Name: ThRevo™ Suture Anchor with Disposable Driver Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: MBI Dated: January 24, 2005 Received: February 1, 2005

Dear Ms. Paul:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your bection of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cherosure) to regary manated to the Medical Device Americans, or to commerce prior to May 20, 1978, the enaordance with the provisions of the Federal Food, Drug. devices mar nave been rochasined in assic approval of a premarket approval application (PMA). and Cosmetic Act (71ct) that do not required to the general controls provisions of the Act. The 1 ou may, dicierore, mance and as requirements for annual registration, listing of general controls provisions 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 abor of the tixisting major regulations affecting your device can may be subject to subli additional controller Links - 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 r lease oc advised that i Dr overan that your device complies with other requirements of the Act that IDA has made a dolorimistered by other Federal agencies: You must or any I edetar statutes and seeginements, including, but not limited to: registration and listing (21 Comply with an the Act 8 requirements)01); good manufacturing practice requirements as set CI IC rail 6077, adoling (21 (QS) regulation (21 CFR Part 820); and if applicable, the electronic rolum in the quality bysellions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Elizabeth Paul

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 marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of thus, premarket nothication. The PDA midning of backanda vijas
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 If you desire specific advice for your as note the regulation of the regulation entitled, comaci the Office of Compunance at (21 t restarted in (21CFR Part 807.97). You may obtain " Misbranding by responsibilities to premance noutheanswill in the Division of Small other general information on your responsibility to the states and on the manufacturers were workinders by by block Manufacturers, international and Consultip://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

iriam 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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PROPRIETARY INFORMATION - LINVATEC CORPORATION

January 10, 2005

510(k) Number (if known):

K050227

Device Name: ThRevo™ Suture Anchor with Disposable Driver

Indications for Use: The ThRevo™ Suture Anchor with Disposable Driver is intended to be used for rotator cuff repairs in the shoulder either arthroscopically or in a mini-open technique.

Over-the-Counter Use Prescription Use_X_ OR (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)

iriam C. Provost

(Division Sign-6 Division of General. Restorative. and Neurological Devi

510(k) Number K650227

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.