The Kensey Nash Bone Void Filler is intended to be gently packed into the bony voids or gaps of the extremities and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of these autogenous blood products does not alter the performance of the device.

Device Description

Kensey Nash Bone Void Filler is a mixture of beta tricalcium phosphate, polylactic acid and Type I bovine collagen. The product will be provided gamma sterilized for one-time use in a variety of shapes ranging from pre-formed cylinders, granules, cubes and blocks with sizes ranging up to 25 mm in diameter and up to 30 cc in volume.

AI/ML Overview

The provided 510(k) summary for the Kensey Nash Bone Void Filler describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices, focusing on safety and effectiveness. However, it does not provide explicit acceptance criteria or detailed study results with specific performance metrics such as accuracy, sensitivity, or specificity.

The document states: "Results of in vivo and in vitro comparison testing demonstrate that Kensey Nash BVF is substantially equivalent to PolyGraft™ BGS." This implies that the device's performance was compared to a predicate device, and the results were found to be comparable enough to satisfy the substantial equivalence requirements for 510(k) clearance.

Here's an attempt to answer your request based on the available information, highlighting where specific details are missing:

Acceptance Criteria and Device Performance

The 510(k) summary does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., specific thresholds for biocompatibility, compressive strength, or bone healing rates). Instead, the "acceptance criteria" appear to be implicit in demonstrating "substantial equivalence" to a predicate device through various non-clinical tests.

The reported device performance is generally stated as achieving substantial equivalence.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility comparable to predicate device	Testing included biocompatibility. (Results not detailed, but implied to be acceptable for SE)
Physical properties comparable to predicate device	Testing included physical properties testing. (Results not detailed, but implied to be acceptable for SE)
Compressive strength comparable to predicate device	Testing included compressive strength. (Results not detailed, but implied to be acceptable for SE)
In vivo performance (resorption and bone replacement) comparable to predicate device	An animal study was conducted. (Results not detailed, but stated to demonstrate substantial equivalence to PolyGraft™ BGS)
In vitro performance comparable to predicate device	In vitro comparison testing was conducted. (Results not detailed, but stated to demonstrate substantial equivalence to PolyGraft™ BGS)
Overall safety and effectiveness for intended use	Non-clinical testing provides reasonable assurance of safety and effectiveness for its intended use.

Study Details

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Test Set): Not specified in the provided summary. The summary mentions "an animal study" but does not give the number of animals or specific experimental groups.
- Data Provenance: Not specified. The studies are non-clinical (biocompatibility, physical properties, compressive strength, in vitro, and animal study). The location where these studies were conducted or whether they are considered "retrospective" or "prospective" in a clinical sense is not applicable or stated for non-clinical testing.
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. This device is a bone void filler, and the testing described is non-clinical (in vitro, animal study). There is no mention of human expert-established ground truth for visual assessment or diagnosis that would typically be associated with medical imaging or diagnostic devices.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As per point 2, this type of adjudication is not relevant for the non-clinical testing described.
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 medical device (bone void filler), not an AI-assisted diagnostic or imaging device. Therefore, a MRMC comparative effectiveness study involving human readers and AI assistance would not be applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical implant device, not an algorithm or software. "Standalone performance" in this context would refer to the device's inherent physical and biological performance, which was assessed through non-clinical testing.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth for Non-Clinical Studies:
  - Biocompatibility: Likely assessed against ISO standards (e.g., ISO 10993 series) which define acceptable biological responses in various tests (cytotoxicity, sensitization, irritation, etc.). The "ground truth" would be compliance with these biological response criteria.
  - Physical Properties/Compressive Strength: Determined by engineering and materials science standards and measurements. The "ground truth" is the objective measurement of these properties.
  - In vivo (Animal Study): Likely involved histological analysis to assess bone formation, resorption rates, and tissue integration. The "ground truth" would be pathological assessment of tissue samples and potentially radiographic evaluation of bone healing in the animal models.
The sample size for the training set
- Not Applicable. This is a physical medical device, not a machine learning or AI algorithm, so there is no concept of a "training set" in the context of data used to train an algorithm. "Training set" is typically used for AI/ML models.
How the ground truth for the training set was established
- Not Applicable. As per point 7, there is no "training set" for this type of medical device.

In summary, the provided 510(k) pertains to a physical bone void filler and demonstrates substantial equivalence through a series of non-clinical tests (biocompatibility, physical properties, compressive strength, in vitro, and an animal study). The document does not contain the detailed quantitative performance metrics or study designs typically associated with diagnostic or AI-powered devices, which would involve concepts like acceptance criteria for sensitivity/specificity, expert ground truth, or training/test sets.

Summary

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K0600917

510(k) Summary

SEP 2 2 2006

Submitted by: Kensey Nash Corporation 735 Pennsylvania Drive Exton, PA 19341 Contact Person: Jennifer J. Bosley, MBA, RAC Regulatory Affairs Specialist Ph: (484) 713-2173 Fax: (484) 713-2903 Date Prepared: September 14, 2006 510(k) #: K060917 Device Trade Name: Kensey Nash Bone Void Filler Common/Usual Name: Bone Void Filler Proposed Classification: Resorbable Calcium Salt Bone Void Filler Device 21CFR8888.3045 Class II, MQV-87Orthopedics

Device Description:

Intended Use:

Predicate Devices:

MANUFACTURER	DEVICE	510(k) #
OsteoBiologics	PolyGraft™ BGS	K040047
OsteoBiologics	PolyGraft™ TCP	K033707
Kensey Nash [Centerpulse Spine-Tech]	CopiOs™ Bone Void Filler	K033679
Medtronic	MasterGraft® Putty	K051386

Substantial Equivalence:

Kensey Nash BVF is substantially equivalent to the legally marketed predicate devices with regard to intended use, materials, physical structure, principle of operation and technological characteristics. Results of in vivo and in viro comparison testing demonstrate that Kensey Nash BVF is substantially equivalent to PolyGrafi™ BGS.

Non-Clinical Testing:

Kensey Nash BVF has undergone non-clinical testing that provides reasonable assurance of safety and effectiveness for its intended use. Testing included biocompatibility, physical properties testing, compressive strength and an animal study.

1-800-524-1984

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and health.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 2 2006

Kensey Nash Corporation % Ms. Jennifer J. Bosley Regulatory Affairs Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19341

Re: K060917

Trade/Device Name: Kensey Nash Bone Void Filler Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 21, 2006 Received: August 22, 2006

Dear Ms. Bosley:

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, listing 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 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 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 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.

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Page 2 - Ms. Jennifer Bosley

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 Office of Compliance at 240-276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Houracturers; International and Consumer-Assistance at its toll-free-number (809)-638-2011 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Joulau Bucheno

Mark N. Melkerso 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 Statement

K060917 510(k) Number:

Kensey Nash Bone Void Filler Device Name:

Indications For Use:

The Kensey Nash Bone Void Filler is intended to be gently packed into the bony voids or - and gape of the extremities and pelvis that are caused by trauma or surgery-and are not intrinsic to the stability of the bony structure. These defects may be created from traumatic injury to the bone or surgically created osseous defects for the harvest of bone. The device provides a bone void filler that resorbs and is replaced with bone during the healing process. The device may be combined with sterile fluids such as saline or autogenous blood products such as blood or bone marrow aspirate. The addition of these autogenous products does not alter the performance of the device.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (Per 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Burchum for mkm

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

510(k) Number K0140917

Page 1 of 1

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.