Osteoplast Bone Void Filler is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteoplast Bone Void Filler is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Osteoplast provides a bone void filler that resorbs and is replaced with bone during the healing process. Because Osteoplast is biodegradable and biocompatible, it may be used in an infected site.

Device Description

Osteoplast Bone Void Filler is an osteoconductive calcium sulfate di-hydrate implant. Osteoplast is comprised of a pre-measured formulation of calcium sulfate hemi-hydrate powder and accelerating saline solution. The powder and saline are combined to form calcium sulfate di-hydrate pellets, which are then gently packed into bony voids or gaps of the skeletal system. Osteoplast is supplied sterile for single use only. Calcium sulfate is an osteoconductive and biocompatible material which resorbs quickly in the human body as bony ingrowth occurs. The biodegradable, radiopaque material is resorbed in approximately 30-60 days when used according to labeling.

AI/ML Overview

The provided text describes the Osteoplast Bone Void Filler, a medical device. However, it does not contain information about specific acceptance criteria or a study that "proves" the device meets these criteria in the context of diagnostic performance or AI-assisted interpretation, as your detailed questions suggest.

The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a predicate device. The "Testing Summary" section broadly states:

"Dissolution studies demonstrate that Osteoplast has dissolution rates which are substantially equivalent to the predicate device."
"Mechanical testing demonstrates that Osteoplast has compressive characteristics substantially equivalent to the predicate device."
"Testing indicates the product to be non-pyrogenic and non-toxic."

This means the device's physical and biological properties were evaluated against those of an already approved device to show they are comparable. It does not involve AI, human reader studies, or ground truth establishment in the way typically associated with diagnostic device evaluations.

Therefore, I cannot populate the table or answer most of your questions because the provided text does not contain this type of information.

Here's an attempt to address your questions based on what is available in the document, and explicitly stating where information is missing:

1. Table of acceptance criteria and reported device performance

The document does not provide a table of acceptance criteria or specific numerical performance metrics for diagnostic accuracy. Instead, it states that the device's physical and biological characteristics are substantially equivalent to a predicate device.

Acceptance Criteria (e.g., specific dissolution rate, compressive strength range)	Reported Device Performance (Osteoplast Bone Void Filler)
Dissolution Rates: Substantially equivalent to predicate device (Wright Medical's OsteoSet K963587 and K963562)	Demonstrated to have dissolution rates substantially equivalent to the predicate device.
Mechanical Characteristics (Compressive): Substantially equivalent to predicate device	Demonstrated to have compressive characteristics substantially equivalent to the predicate device.
Biocompatibility (Pyrogenicity, Toxicity): Non-pyrogenic, non-toxic	Indicated to be non-pyrogenic and non-toxic.

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

Sample Size (Test Set): Not specified in the document.
Data Provenance (Country of origin, retrospective/prospective): Not specified in the document. The studies mentioned are likely in-vitro or ex-vivo laboratory tests, or possibly animal studies, not studies on human patients with data requiring provenance details like country of origin.

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 not provided. The testing described (dissolution, mechanical, pyrogenicity, toxicity) does not involve human expert interpretation or "ground truth" establishment in the diagnostic sense.

4. Adjudication method for the test set

Not applicable and not provided.

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 not an AI or diagnostic imaging device.

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

No. This is not an AI or diagnostic imaging device.

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

The "ground truth" for this type of device (bone void filler) relates to its intrinsic material properties and biological interactions. The document implies:
- For dissolution rates and mechanical properties: Established laboratory metrics and comparisons to an existing, approved device.
- For biocompatibility: Standardized tests for pyrogenicity and toxicity.

8. The sample size for the training set

Not applicable and not provided. This device does not use an AI algorithm that requires a training set.

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

Not applicable and not provided.

Summary

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AUG 26 1999

K59185'4

510(k) SUMMARY

SUBMITTED BY

Lynn Rodarti Manager, Regulatory Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618

(949) 453-3200

DATE: May 28, 1999

CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME

Classification Name: Filler, Bone Void, Non-Osteoinductive Common/Usual Name: Bone Void Filler, Bone Graft Substitute Product Classification: Unclassified Proprietary Name: Osteoplast Bone Void Filler

PREDICATE DEVICE

Wright Medical's OsteoSet Bone Void Filler 510(k) K963587 and 510(k) K963562.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

INDICATIONS-FOR-USE

DEVICE DESCRIPTION

Osteoplast Bone Void Filler is an osteoconductive calcium sulfate di-hydrate implant.

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Osteoplast is comprised of a pre-measured formulation of calcium sulfate hemi-hydrate powder and accelerating saline solution. The powder and saline are combined to form calcium sulfate di-hydrate pellets, which are then gently packed into bony voids or gaps of the skeletal system. Osteoplast is supplied sterile for single use only. Calcium sulfate is an osteoconductive and biocompatible material which resorbs quickly in the human body as bony ingrowth occurs. The biodegradable, radiopaque material is resorbed in approximately 30-60 days when used according to labeling.

Osteoplast is an osteoconductive device. There are three prerequisites for osteoconduction and new bone formation to consistently occur:

1. There must be direct apposition of the implant to surrounding host bone. The implant must be within one to two millimeters of the host bone at all contact points. This is because bone cannot bridge a gap greater than one to two millimeters.
1. The host bone must be viable. That is, it must be normally functioning bone that is fully vascularized.
1. The interface between the host bone and implant must be stable, without macromotion,

These conditions are met when the defect is carefully reconstructed using Osteoplast, when the implant material is in direct apposition to viable bone, and when macromotion is minimized through the use of rigid fixation.

COMPARISON TO THE PREDICATE DEVICE

Osteoplast Bone Void Filler is substantially equivalent to the predicate device as a filler for non-loadbearing bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). In general, Osteoplast and OsteoSet are substantially equivalent in that they have identical Indications-For-Use. In addition, both are:

Manufactured from Calcium sulfate .
Radiopaque .
Available sterile, off-the-shelf ●
Inorganic/Synthetic
Biocompatible .
Resorbable ●
Used with rigid fixation
Osteoconductive
Osteophyllic ●
Non toxic .

In addition, both devices have similar mechanical compaction characteristics and both have similar use and handling characteristics.

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CONTRAINDICATIONS, WARNINGS, PRECAUTIONS AND COMPLICATIONS

1. Contraindications:
  This product is not intended to provide structural support during the healing process, therefore, Osteoplast is contraindicated where the device is intended as structural support in the skeletal system. Conditions representing relative contraindications include:
Severe vascular or neurological disease .
Uncontrolled diabetes .
Severe degenerative disease .
. Pregnancy
. Uncooperative patients who will not or cannot follow postoperative instruction. including individuals who abuse drugs and/or alcohol.
Hypercalcemia .
1. Warnings and Precautions:

Osteoplast Bone Void Filler should not be mixed with other mixing solutions. To do so will alter the material's setting time and performance characteristics.

As with any surgical procedure, care should be exercised in treating individuals with preexisting conditions that may affect the success of the surgical procedure. This includes individuals with bleeding disorders of any etiology, long-term steroidal therapy, or immunosuppressive therapy or high dosage radiation therapy.

It is recommended that the treatment site be as dry and blood-free as possible. Gentle blotting with sterile gauze around, but not on, the treatment site may help to absorb excess blood or wetness. It is not recommended to use Osteoplast Bone Void Filler where severe bleeding is present. Severe bleeding may dislodge the material.

Osteoplast is radiopaque until resorbed. Radiopacity may mask underlying pathological Radiopacity may also make it difficult to radiographically assess the conditions. ingrowth of new bone.

Do not use this device if the ampule is cracked or broken.

1. Complications:
  Possible adverse effects include but are not limited to:
Wound complications including hematoma, site drainage, bone fracture, infection, . and other complication that are possible with any surgery
Fracture or extrusion of the Osteoplast pellets, with or without generation of . particulate debris
. Deformity of the bone at the site

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Incomplete, or lack of osseous ingrowth into bone void, as is possible with any bone . void filler

TESTING SUMMARY

Dissolution studies demonstrate that Osteoplast has dissolution rates which are substantially equivalent to the predicate device. Mechanical testing demonstrates that Osteoplast has compressive characteristics substantially equivalent to the predicate device. Testing indicates the product to be non-pyrogenic and non-toxic.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake entwined around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 26 1999

Ms. Lynn Rodarti Manager, Regulatory and Clinical Affairs Interpore Cross International 181 Technology Drive Irvine, California 92618-2402

Re: K991854 Trade Name: Osteoplast, Model POP200 Regulatory Class: Unclassified Product Code: MQV Dated: May 28, 1999 Received: June 1, 1999

Dear Ms. Rodarti:

We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general control provisions of the Act. The general control 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820), and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Lynn Rodarti

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely vours,

Mark M. Milkinson

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ¥99 / 854

Device Name: Osteoplast

Indications-For-Use:

Osteoplast Pellets are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. Osteoplast Pellets are indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The Pellets provide a bone void filler that resorbs and is replaced with bone during the healing process. Because the Pellets are biodegradable and biocompatible, it may be used at an infected site.

Mark N. Melkerson

for
cmw
(Di
Div
51

evices

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(PER 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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.