HEALOS® Bone Graft Material (“HEALOS”), combined with autogenous bone marrow, is intended for use in filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural healing process.

Device Description

HEALOS® Bone Graft Material (HEALOS) is a mineralized collagen matrix processed into lyophilized strips or pads for surgical implantation. The principal components of HEALOS are Type I bovine collagen and hydroxyapatite. HEALOS is approximately 30% mineral by weight. The collagen is processed prior to mineralization using aqueous and organic purification steps to reduce lipids, salts, and endotoxins. Hydroxyapatite coats the surface of the collagen fibers by the controlled addition of calcium chloride, sodium phosphate, and sodium hydroxide. The mineralized collagen fibers are fixed into a three dimensional, open-cell matrix. HEALOS is provided as a sterile, dry material that must be hydrated with autogenous bone marrow at the point of use. HEALOS can be cut into shapes optimized for a specific population and is designed to retain its shape and physical integrity following specific population and is designed to simily resorbed during the natural process of bone formation and remodeling.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (HEALOS® Bone Graft Material) and describes its characteristics, intended use, and substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or the details of a study designed to prove the device meets those criteria, especially in the context of performance metrics like accuracy, sensitivity, or specificity that would be relevant for a diagnostic or algorithmic device.

The document outlines testing that was done, including material characterization, performance testing (pH measurement, solubility, in vivo testing in animal models, and clinical testing), but it does not provide the results of these tests against predefined numerical acceptance criteria. It only concludes that these tests "support the substantial equivalence of HEALOS Bone Graft Material to the predicate devices."

Therefore, based solely on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide information on sample sizes, ground truth establishment, or multi-reader studies for a device performance evaluation in the way requested for an algorithmic/AI device.

Here's what can be extracted based on the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

Cannot provide. The document does not specify numerical acceptance criteria for various performance metrics (e.g., bone growth rate, resorption rate within a specific range, mechanical strength thresholds, etc.) nor does it report the device's performance against such criteria. It states that tests were performed (material characterization, in vivo, clinical) but only offers a general conclusion of "substantial equivalence."

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

Test Set Sample Size: Cannot be determined from the document. The general mention of "in vivo testing (rabbit radial defect model, spinal fusion in any and fision solubinty, and in VIVO testing (intracutaneous toxicity; systemic toxicity; genotoxicity; cytotoxicity; sensitization; and bone implantation); and clinical testing" does not provide specific sample sizes for these studies.
Data Provenance: The document implies in-house testing by Orquest, Inc. and references in vivo animal models (rabbit, "any" likely a typo for another animal or general reference) and "clinical testing", but no details on countries of origin or whether clinical data was retrospective or prospective.

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

Cannot provide. The document does not describe the establishment of ground truth for any performance evaluation in terms of expert consensus or qualifications.

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

Cannot provide. This information is typically relevant for studies involving human interpretation or subjective assessment, which is not detailed here for performance evaluation.

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 type of study is entirely irrelevant for a bone graft material. It's applicable to diagnostic or AI-assisted interpretation devices.

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

No. This is not an algorithmic device.

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

For the in vivo animal studies and clinical testing (general mention), the ground truth for evaluating the bone graft material would typically involve histological analysis (pathology) of new bone formation, radiographic assessment of defect healing, and possibly biomechanical testing or other clinical outcomes (e.g., patient reported outcomes, fusion rates for spinal applications). However, the document does not specify which of these were used or how they were established.

8. The sample size for the training set:

N/A. This is not an AI/ML device, so there is no training set in the context of machine learning.

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

N/A. Not an AI/ML device.

Summary

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NOV 1 4 2001

510(k) SUMMARY

Name of 510(k) sponsor:	Orquest, Inc.
Address:	365 Ravendale DriveMountain View, CA 94043Telephone: 650 237.4800Fax: 650 903.1903
Contact information:	Kristine F. LahmanTelephone: 650-237-4852Fax: 650-903-0157
Date summary prepared:	August 15, 2001
Proprietary name of device:	HEALOS® Bone Graft Material
Generic/classification name:	Bone void filler
Product code (classification):	MQV (not classified)

Legally Marketed Predicate Devices:

Vitoss Scaffold Synthetic Cancellous Bone Void Filler (K994337); Pro Osteon Implant 500R Resorbable Bone Graft Filler/Bone Graft Material; 200R Resorbable Bone Graft Material (K980817, K990131, K0000515); Bio-Oss Collagen (K974399); and Collagen Periodontal Membrane (K003339) Collagraft Strip Bone Graft Matrix (K000122)

Device Description:

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HEALOS is provided as a sterile, dry material that must be hydrated with autogenous bone marrow at the point of use. HEALOS can be cut into shapes optimized for a specific population and is designed to retain its shape and physical integrity following specific population and is designed to simily resorbed during the natural process of bone formation and remodeling.

Intended Use

HEALOS, combined with autogenous bone marrow, is intended for use in filling bony voids on gaps that are not intrinsic to the stability of the bony structure. These defects may be surgically gaps mat are not maniste to the backey or usulting from traumatic injury to the bone. HEALOS
created osseous defects or osseous defects resulting from traumatic injury to the should not be used to treat large defects that in the surgeon's opinion would fail to heal should not oc used to treat targe delects that in that is resorbed and remodeled into new bone as part of the natural healing process.

Technological Characteristics

The intended use, product design, composition, physical stucture, and target population of a The miended use, product design, occipotiates pay leared and legally marketed predicate devices named in the chart below as follows.

HEALOS and the predicate devices, Vitoss (K994337) and Pro Osteon (K980817, . K990131, and K000515) are intended for the same use and target populations.
HEALOS and the predicate devices are sterile and are all matrices that provide an � environment for new bone ingrowth.
Like Collagraft (K000122) and Bio-Oss Collagen (K974399), HEALOS is a . combination of collagen and bone mineral. Although Bio-Oss has a smaller confortion of collagen than HEALOS (10% vs. 70%), there are other dental bone filling augmentation materials that are comprised entirely of collagen (i.e., the named predicate device, Collagen Periodontal Membrane, K00339).
HEALOS and the predicate devices are resorbed following implantation. The . extent and rate of absorption differ between HEALOS and the predicate devices and across predicate devices. These differences in resorption rate do not present safety or efficacy issues because HEALOS is intended to fill bony gaps and defects and not to impart mechanical strength to osseous defects.
Although HEALOS differs from Vitoss, Pro Osteon, and Bio-Oss with regard to . form (strips vs. granules), it is similar in form to the Collagen Periodontal Membrane.

Testing

HEALOS has undergone material characterization testing (calcium and sodium content; mineral III.ALOS mas under gone material texide content; mechanical stability of hydroxyapatite coating;

KO12751

Q OF 3

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K012751
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X-ray diffraction; and mercury porosimetry); performance testing (pH measurement; in יוֹנִי מַ solubility; and in vivo testing (rabbit radial defect model, spinal fusion in any and fision solubinty, and in VIVO testing (intracutaneous toxicity; systemic toxicity; genotoxicity; cytotoxicity; sensitization; and bone implantation); and clinical testing.

Conclusions

The results from these tests support the substantial equivalence of HEALOS Bone Graft Material to the predicate devices.

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Image /page/3/Picture/12 description: The image shows a logo for the National Institute of Health. The logo consists of a stylized depiction of a human figure with three curved lines representing the body and head. To the left of the figure, the text "NATIONAL INSTITUTE OF HEALTH" is arranged in a semi-circular fashion, following the curve of the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 4 2001

Ms. Kristine F Lahman Orquest, Inc. 365 Ravendale Drive Mountain View, California 94043

Re: K012751

Trade/Device Name: HEALOS® Bone Graft Material Regulatory Class: Unclassified Product Code: MOV and LYC Dated: August 15, 2001 Received: August 16, 2001

Dear Ms. Lahman:

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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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 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,

Mark M Mckesson

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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INDICATIONS FOR USE STATEMENT

NOV	1 4 2001
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Applicant:	Orquest, Inc.
510(k) Number:	K012751
Device Name:	HEALOS® Bone Graft Material
Indications for Use:	HEALOS® Bone Graft Material (“HEALOS”), combined with autogenous bone marrow, is intended for use in filling bony voids of the skeletal system (i.e., the extremities, spine and pelvis) that ar pony shunature These defects may be

are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. HEALOS should not be used to treat large defects that in the surgeon's opinion would fail to heal spontaneously. The product provides a bone void filler that is resorbed and remodeled into new bone as part of the natural healing process.

or gaps

(PLEASE DO NOT WRITE BELOW THIS LINE)

Concurrence of CDRH, Office of Device Evaluation (ODE)

~~Participation~~ Use ✓
Prescription

Over-the Counter Use

for Mark n Milkerson

(Division Sign-Off)
Div. (Dental) Restorative
and Surgical Devices

510(k) Number K012757

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.