PliaFX® Flo is indicated for bony voids or gaps that are not intrinsic to the bony structure. It is indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product provides a bone void filler that remodels into the recipient's skeletal system.

Device Description

PliaFX® Flo Flowable Demineralized Fibers is a sterile, freeze-dried, human bone allograft product consisting of demineralized bone matrix fibers combined with USP grade glycerol/glycerin. The subject device is pre-filled in a 3cc or 14cc delivery syringe based on product volume. The 3cc syringe configuration also includes an optional female luer cap.

AI/ML Overview

This appears to be a 510(k) summary for a medical device called PliaFX Flo, a resorbable calcium salt bone void filler. The document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study to prove performance against specific acceptance criteria.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the way typically found for software-based medical devices or diagnostic tools.

Instead, the summary focuses on non-clinical performance testing to demonstrate that the delivery syringe (a change from the predicate device) is capable of storing and delivering the bone void filler and does not raise different questions of safety or effectiveness.

Therefore, I cannot fulfill all parts of your request with the provided input. However, I can extract the relevant information regarding the non-clinical testing performed and the conclusions drawn:

Information available from the provided text:

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

The document doesn't explicitly define acceptance criteria in a table format with corresponding performance results in the context of a clinical or functional performance study for the bone void filler itself. Instead, it describes general non-clinical performance testing for the delivery syringe.

Acceptance Criteria (Implied for Delivery Syringe)	Reported Device Performance
Capability of storing bone void filler	Confirmed
Capability of delivering bone void filler	Confirmed
Mechanical extrusion	Included in testing
Leak testing	Included in testing
Verification of plunger fit in barrel	Included in testing
Formative evaluation of extrusion force	Included in testing
Formative evaluation of unscrewing torque	Included in testing
Formative evaluation of delivered volume	Included in testing

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

This information is not provided in the document. The document refers to "non-clinical performance testing" but does not detail the sample sizes or the origin of any data used for these tests.

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

This information is not applicable and therefore not provided. The document describes non-clinical engineering/mechanical testing of a delivery system, not a study requiring expert-established ground truth for clinical or diagnostic performance.

4. Adjudication method for the test set:

This information is not applicable and therefore not provided. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the case for the described non-clinical testing.

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 and therefore not provided. This device is a bone void filler and delivery system, not an AI-assisted diagnostic tool.

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

This information is not applicable and therefore not provided. This device is not an algorithm.

7. The type of ground truth used:

This information is not applicable in the usual sense of clinical ground truth (e.g., pathology, expert consensus). The "ground truth" for the described non-clinical tests would be defined by engineering specifications and physical measurements for mechanical properties (e.g., proper extrusion force, no leaks, correct delivered volume).

8. The sample size for the training set:

This information is not applicable and therefore not provided. There is no mention of a training set as this is not an AI/machine learning device.

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

This information is not applicable and therefore not provided. See point 8.

In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence. The "study" mentioned is "non-clinical performance testing" of the device's delivery system (the syringe) to ensure it stores and delivers the bone void filler safely and effectively, and does not relate to the performance of the bone void filler itself in a clinical setting against specific acceptance criteria.

Summary

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November 21, 2024

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

LifeNet Health Brittany Beasley Sr. Manager, Global Regulatory Affairs 1864 Concert Drive Virginia Beach, Virginia 23453

Re: K242799

Trade/Device Name: PliaFX Flo Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MBP, MOV Dated: September 16, 2024 Received: September 17, 2024

Dear Brittany Beasley:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Digitally signed by JESSE JESSE MUIR -S Date: 2024.11.21 14:18:01 -05'00'

Jesse Muir, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair, and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K242799

Device Name PliaFX® Flo

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for LifeNet Health. The logo consists of a blue and green circular graphic to the left of the company name. The words "LifeNet" are in dark blue, while the word "Health" is in light green. There is a registered trademark symbol to the right of the word "Health".

510(k) Summary

Submitter Information:

Company:	LifeNet Health
Address:	1864 Concert Drive
	Virginia Beach, Virginia 23453
Contact:	Brittany Beasley
	Sr. Manager, Global Regulatory Affairs
Phone:	(757) 609-4201
Email:	brittany_beasley@lifenethealth.org
Date Prepared:	November 20, 2024
Device Information:
Trade Name:	PliaFX® Flo
Common Name:	Flowable Demineralized Fibers
Regulation Number:	21 CFR 888.3045
Regulation Name:	Resorbable calcium salt bone void filler device
Regulatory Class:	Class II
Product Code:	MBP; MQV
Proposed Panel:	Orthopedic
Predicate Device:

Name:

K053098, Optium DBM

Device Description:

Indications for Use:

PliaFX® Flo is indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. It is indicated to be placed into the bony voids or gaps of the skeletal system (e.g., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. This product provides a bone void filler that remodels into the recipient's skeletal system.

Comparison of Technological Characteristics with the Predicate:

The subject device is similar in materials, composition, packaging system configuration, and sterility to the predicate device. The differences in technological characteristics requiring 510(k) clearance include a change to the immediate container from a PETG jar to a pre-filled syringe,

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Image /page/5/Picture/0 description: The image shows the logo for LifeNet Health. The logo consists of a blue and green circular graphic to the left of the company name. The words "LifeNet" are in blue, while the word "Health" is in green, and there is a registered trademark symbol to the right of the word "Health".

minor differences in packaging, and a smaller product volume option. The biocompatibility and non-clinical performance testing included in this submission, including mechanical extrusion testing, leak testing, verification of plunger fit in barrel, and formative evaluation of extrusion force, unscrewing torque, and delivered volume, confirm that the proposed device does not raise different questions of safety or effectiveness.

Conclusions:

The submitted data demonstrates that the delivery syringe is capable of storing and delivering the bone void filler. Any differences between the subject device and the predicate device are minor and do not raise different questions concerning safety or effectiveness. Based on the indications for use, technological characteristics, and non-clinical data submitted, LifeNet Health has determined that the proposed device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 888.3045 Resorbable calcium salt bone void filler device.

(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.