The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable bone cement flow restrictor for use in the intramedullary canal. This device is not intended for use in the spine.

Device Description

The ImproVise™ Absorbable Cement Flow Restrictor is designed to provide a quick, simple, and effective method of plugging the intramedullary canal with an easy-to-place absorbable foam plug. Based on the size of the reamer used to form the channel, the appropriate size foam plug is selected and is then guided onto the tip of the tool. The ImproVise™ Insertion tool is then used to advance the plug down the canal to the desired depth, using the Cement Restrictor as a guide. The ImproVise™ foam plugs are deformable and bank against the irregular shape of the canal, effectively sealing the canal at the insertion point. The cement restrictors are available in sizes small, medium, large and extra-large (9.5-11 mm, 11-13 mm, 13-15 mm, 15-17.5 mm), both in straight cylindrical and tapered versions. The restrictor can be easily carved with a scalpel at the time of surgery, or press-fit into the bone. The ImproVise™ Absorbable Cement Flow Restrictor is manufactured from a proprietary polylactic acid foam, which is greater than 90% void space.

AI/ML Overview

The provided text describes the regulatory clearance (510(k)) of the ImproVise™ Absorbable Cement Flow Restrictor and presents a comparison to a predicate device, the Resorbaplug™ Bone Plug. However, the document does not contain a study report or detailed acceptance criteria for the ImproVise™ device's performance, nor does it describe a study specifically designed to prove the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed performance study against pre-defined acceptance criteria.

Despite the lack of explicit study details, some information relevant to the request can be extracted or inferred:

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

The only "performance" metric mentioned that resembles acceptance criteria, and for which data is provided for both devices, is:

Acceptance Criteria	Reported Device Performance (ImproVise™)	Reported Device Performance (Resorbaplug™)
Interference fit that provides 100N push-out force:	1.9-2.9 mm	2.5 mm

Note: This is the only direct performance comparison provided in the document. It's listed in the "Performance" row of Table 1 under "Interference fit that provides 100N push-out force." The values (1.9-2.9 mm for ImproVise™ and 2.5 mm for Resorbaplug™) likely refer to the amount of interference fit (compression/diameter difference) required to achieve a 100N push-out force.

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

Sample Size: Not mentioned in the provided text.
Data Provenance: Not mentioned in the provided text (e.g., country of origin, retrospective/prospective). The data appears to be from laboratory testing rather than clinical study.

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

Not applicable. The performance metric (push-out force) is a physical test and does not involve expert interpretation or ground truth establishment in the traditional sense of clinical or diagnostic studies.

4. Adjudication method for the test set

Not applicable, as there is no expert interpretation or consensus involved for this physical performance test.

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 applicable. This device is a physical bone plug, not an AI or diagnostic imaging device, so MRMC studies involving human readers are irrelevant.

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

Not applicable. This device is a physical bone plug.

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

The "ground truth" for the reported performance (interference fit vs. push-out force) would be the objective measurement taken from mechanical testing apparatus. There is no expert consensus, pathology, or outcomes data mentioned in relation to this specific performance metric.

8. The sample size for the training set

Not applicable. This is a physical device, and the context provided does not involve machine learning or a "training set."

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

Not applicable.

Summary of Device Acceptance Criteria and Study (Based on Provided Text):

The provided 510(k) summary (K011943) for the ImproVise™ Absorbable Cement Flow Restrictor focuses on demonstrating substantial equivalence to a predicate device, the Resorbaplug™ Bone Plug (K920118). The core of this submission, concerning "acceptance criteria" and "proof," is the comparison of material, intended use, and a specific physical performance characteristic.

Acceptance Criteria (Inferred from Substantial Equivalence): The implicit acceptance criteria are that the ImproVise™ device performs comparably to the predicate device, the Resorbaplug™, especially regarding its mechanical function as a cement flow restrictor. The key comparable performance metric identified is the "interference fit that provides 100N push-out force."
Study That "Proves" Performance: The document itself is the "study" in the context of a 510(k) summary, as it presents data for the new device and compares it to the predicate. The "study" here is a comparative analysis, likely based on non-clinical (benchtop) testing as opposed to a full-scale clinical trial.
- Evidence: The table (Table 1) directly compares the ImproVise™ to the Resorbaplug™ across various attributes including "Performance: Interference fit that provides 100N push-out force."
- ImproVise™ Performance: 1.9-2.9 mm
- Resorbaplug™ Performance: 2.5 mm
- The close proximity of these values is presented as evidence of substantial equivalence and, by extension, that the ImproVise™ meets the expected performance for its intended use, as established by the predicate device.

Missing Information:

Crucially, the document lacks detailed information on the methodology of the mechanical testing, exact sample sizes for these tests, the precise definition of the "1.9-2.9 mm" range (e.g., mean, range, standard deviation, confidence interval), or the specific test standards followed. This level of detail would typically be found in a full test report, not a 510(k) summary.

Summary

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510(k) Summary

Class II

LZN

Kensey Nash Corporation

55 East Uwchlan Avenue

Exton, PA 19341 USA

Koi194/3

Company: Address:

Phone: Fax:

Proprietary Name: Common Name: Classification Name and Reference: Proposed Regulatory Class: Device Product Code:

610-524-0188 610-524-0265 ImproVise™ Absorbable Cement Flow Restrictor Bone Plug Cement Obturator (reference unknown)

For information, contact:

Robin M. Fatzinger Requlatory Affairs Manager Telephone: (610) 594-7146 Fax: (610) 524-0265 Email: r.fatzinger@kenseynash.com

June 20, 2001

Date Summary Prepared: Device Description:

The ImproVise™ Absorbable Cement Flow Restrictor is designed to provide a quick, simple, The improvise - Absorbable Ochton I tramedullary canal with an easy-to-place absorbable and chective method of playing the reamer used to form the channel, the appropriate size foam plug. "Dased on the Size of the roamid aboth the canal to the desired depth, using the Cement resultion is scieolor and is them garded onto the tip of the tool. The ImproVise™ Improvise - Inscrition tool. I lago will be progular shape of the canal, effectively toam plugs are deformable and bank tans on the it restrictors are available in sizes small, sealing the canar at the motion in point. The sements of 9.5-11 mm, 11-13 mm, 13-15 mm, medium, large and extraight cylindrical and tapered versions. The restrictor can be aria 13-17.5 min), both in struight bylindhour and or a careery or press-fit into the bone. The ImproVise™ easily Carved with a scalper at the time of ourger, or proprietary polylactic acid foam.
Absorbable Cement Flow Restrictor is manufactured from a propriet Absorbance Ocmont How Receivere which is greater than 90% void space.

Intended Use:

The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable The improvise - Absorbable our for use in the intramedullary canal. This device is not intended for use in the spine.

Substantial Equivalence:

Stantial Equivalenoo.
The intended use, material and design of the ImproVise™ Absorbank Flow The liftended use, material and thus substantially equivalent to the Resorbapliug™ Bone Resultion are heany lightlear and this Gabor Danek division of Medtronic, Inc.) (K920118). See Table 1 below for a comparison of the two devices.

Revised December 12, 2001.

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	ImproVise™Absorbable Cement Flow Restrictor(Kensey Nash Corporation)	Resorbaplug™ Bone Plug(Danek Group)
Status	New Device	Predicate
Intended Use	Bone cement flow restrictor for intra-medullary canal	Bone cement flow restrictor forintramedullary canal
Target Population	Patients undergoing orthopedicprocedures (large joint replacementrequiring use of bone cement)	Patients undergoing orthopedicprocedures (large jointreplacement requiring use ofbone cement)
Anatomical Sites of Use	Orthopedic procedures in the long bones	Orthopedic procedures in the longbones
Material	Polylactic acid	Polylactic acid
Architecture	Foam	Foam
Manufacturing Process	Proprietary foaming process	Proprietary foaming process
Shape	Cone, cylinder	Cone, cylinder
Size	Small (9.5-11 mm), medium (11-13 mm),large (13-15 mm), and extra-large (15-17.5 mm)	14, 20 and 26 mm in diameter
Sterilization	Gamma radiation	Gamma radiation
Where Used	Hospital operating room	Hospital operating room
Principle of Operation	Foam plug conforms to shape ofintramedullary canal and is friction fit toproper depth; plug prevents bonecement from migrating deeper into thecanal.	Foam plug conforms to shape ofintramedullary canal and is frictionfit to proper depth; plug preventsbone cement from migratingdeeper into the canal.
PerformanceInterference fit thatprovides 100N push-outforce	1.9-2.9 mm	2.5 mm
Safety Characteristics	Biocompatibility of material,demonstrated push-out forces	Biocompatibility of material,demonstrated push-out forces

Table 1: Substantial Equivalence of ImproVise™ and Resorbaplug™

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Public Health Service

SEP 1 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Julie N. Broderick Vice President of Clinical and Regulatory Affairs Kensey Nash Corporation 55 East Uwchlan Avenue Exton, Pennsylvania 19341

Re: K011943

Trade/Device Name: Impro Vise™ Absorbable Cement Flow Restrictor Regulation Number: 878.3300 Regulation Name: Surgical Mesh Regulatory Class: II Product Code: LZN Dated: June 20, 2001 Received: June 21, 2001

Dear Ms. Broderick:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have leviewed your becaon o r (x) presses 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 encreated of to charactment date of the Medical Device Amendments, or to Commerce proof to May 20, 1978, are cassified in accordance with 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 Tournal controls provisions of the Act include requirements for annual registration, listing of general obliness provided in a sactice, 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 exactined (tional 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 r toase of action and I Draination that your device complies with other requirements of the Act that I Dr has intact a avoid regulations administered by other Federal agencies. You must of any I catal suttated and registments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in also qualis) 25 total provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Julie N. Broderick

This letter will allow you to begin marketing your device as described in your Section 510(k) I ma lotter will and in yourse FDA finding of substantial equivalence of your device to a legally premaince noticate 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Sus-Walk, us

$\infty$

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

Celia M. Witten, Ph.D., M.D.

Enclosure

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INDICATIONS FOR USE

510(K) NUMBER (IF KNOWN):

K011943

DEVICE NAME: ImproVise™ Absorbable Cement Flow Restrictor

INDICATIONS FOR USE:

The ImproVise™ Absorbable Cement Flow Restrictor is intended for use as an absorbable The Inford ISC Ausorbable Coment In the intramedullary canal. This device is not intended for use in the spine.

Please do not write below this line – Use another page if necded

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use I (per 21 CFR 801.109) Over-the-counter Use _________

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K011943

003

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.