The PRO-DENSE™ Core Decompression Procedure Kit, consisting of a bone void filler and manual surgical instruments, is intended to be used during core decompression procedures. The bone void filler component resorbs and is replaced with bone during the healing process. The bone void filler included in the PRO-DENSE™ Core Decompression Procedure Kit is not intended to be used as a load-bearing device.

Device Description

The design features of the PRO-DENSE™ Core Decompression Procedure Kit are substantially equivalent to the design features of the PRO-DENSE Bone Void Filler submission (510(k); K070437). The implant material of the PRO-DENSE™ Core Decompression Procedure Kit is exactly the same as the predicate above. The PRO-DENSE Core Decompression Procedure Kit includes Class I and Class II (premarket notification exempt) instrumentation to facilitate a standard core decompression procedure. A brief description of the PRO-DENSE™ implant is provided below.

PRO-DENSE™ consists of a calcium sulfate - calcium phosphate composite bone void filler consisting of a powder component and an aqueous mixing solution. When the two components are mixed, according to directions, an injectable paste is formed which subsequently hardens via hydration reactions. The paste can be injected and cured in situ or formed into pellets which can be gently packed into bony defects.

AI/ML Overview

The provided text is a 510(k) summary for the PRO-DENSE™ Core Decompression Procedure Kit. It establishes substantial equivalence to a predicate device (PRO-DENSE™ Bone Void Filler, K070437).

However, the document does not describe specific acceptance criteria and a study proving the device meets those criteria in the way you've outlined. This type of regulatory submission (510(k)) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against pre-defined acceptance criteria through a specific clinical study with detailed statistical targets.

Here's an analysis based on the information provided, highlighting why many of your requested items cannot be answered from this document:

Overall Conclusion from the Document:
The PRO-DENSE™ Core Decompression Procedure Kit demonstrated substantial equivalence to the PRO-DENSE™ Bone Void Filler (K070437) based on:

Intended Use: Same.
Type of interface, operating principles, shelf life, and design features: Substantially equivalent.
Implant material: Exactly the same.
Safety and effectiveness: Adequately supported by substantial equivalent information, materials data, and testing results provided within the Premarket Notification (though these specific tests are not detailed in the provided summary).

Therefore, there is no specific performance study described in this document with defined acceptance criteria that would allow me to fill in your requested table and information points. The FDA clearance is based on the comparison to a predicate device, not on meeting new, specified performance thresholds from a clinical trial.

Attempted Answer based on Lack of Information in the Provided Text:

Since the provided document is a 510(k) summary focusing on substantial equivalence, it does not include the detailed clinical study information typically associated with establishing specific performance criteria for AI/ML devices. Therefore, most of your questions cannot be answered from this text.

Here's an attempt to address each point, acknowledging the limitations of the provided document:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as performance metrics in this 510(k) summary. The primary "acceptance criteria" for a 510(k) in this context is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: Not reported in terms of specific clinical outcomes or statistical performance metrics. The document states its safety and effectiveness are "adequately supported by the substantial equivalent information, materials data, and testing results," but does not detail these results or the performance observed.
Performance Metric Acceptance Criteria Reported Device Performance
Not Applicable Not Applicable Not Applicable

Rationale: The 510(k) summary focuses on demonstrating substantial equivalence, not on presenting results from a clinical trial designed against specific performance criteria.
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 mentioned.
- Data Provenance: Not mentioned.
Rationale: This information would typically be part of a clinical study report, which is not included in this high-level 510(k) summary.
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)
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
Rationale: Ground truth establishment is irrelevant in a substantial equivalence filing for a bone void filler where performance is typically assessed through material testing and biological response, not interpretive tasks requiring expert consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned.
Rationale: Same as above. Adjudication is relevant for interpretive tasks, not for material devices like a bone void filler in this regulatory context.
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
- MRMC Study: Not applicable/not mentioned. This device is a bone void filler and surgical instrument kit, not an AI/ML radiology device that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable/not mentioned. This device is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. For "materials data, and testing results" mentioned in the substantial equivalence statement, the "ground truth" would likely refer to established engineering and biocompatibility standards, and possibly animal model or in-vitro test results confirming material properties, resorption rates, and biological response. Clinical "outcomes data" might be part of the predicate device's evidentiary basis, but no new clinical outcomes study for this specific kit is detailed here.
The sample size for the training set
- Sample Size (Training Set): Not applicable/not mentioned. This is a physical device, not an AI/ML model that requires a training set.
How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not applicable/not mentioned.

Performance Metric	Acceptance Criteria	Reported Device Performance
Not Applicable	Not Applicable	Not Applicable

Summary of what the document does provide regarding "performance" and "acceptance":

Acceptance based on Substantial Equivalence: The FDA determined the device is substantially equivalent to the predicate device (K070437). This is the key "acceptance" criterion for a 510(k) pathway.
Basis for Equivalence: The claimed equivalence relies on:
- Identical intended use.
- Substantially equivalent design features, interface, operating principles, and shelf life.
- Exactly the same implant material.
- "Adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification" (which are not detailed in this summary).

In essence, the "study" proving the device meets "acceptance criteria" here is the comparison to the predicate device (K070437) and the underlying data (materials testing, etc., not detailed) that support that comparison. This is a common shortcut for devices deemed to be sufficiently similar to already cleared products.

Summary

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K072597

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

00115 2007

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CRF 807, this information serves as a Summary of Safety and Effectiveness for the use of PRO-DENSE™ Core Decompression Procedure Kit.

Submitted By:	Wright Medical Technology, Inc.
Date:	June 21, 2007
Contact Person:	Ryan M. Belaney
	Regulatory Affairs Specialist II
Proprietary Name:	PRO-DENSE™ Core Decompression Procedure Kit
Common Name:	Bone Void Filler
Classification Name and Reference:	21 CFR 888.3045 -- Resorbable Calcium Salt Bone VoidFiller Device - Class II
Device Product Code and Panel Code:	Orthopedic/87/MQV

DEVICE INFORMATION

A. INTENDED USE

B. DEVICE DESCRIPTION

IMPLANT DESCRIPTION

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C. SUBSTANTIAL EQUIVALENCE INFORMATION

The intended use, type of interface, operating principles, shelf life, and design features of the PRO-DENSE™ Core Decompression Procedure Kit are substantially equivalent to the previously cleared PRO-DENSE™ Bone Void Filler 510(k): K070437. Additionally, the safety and effectiveness of the PRO-DENSE™ Core Decompression Procedure Kit is adequately supported by the substantial equivalent information, materials data, and testing results provided within this Premarket Notification.

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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 & Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Wright Medical Technology, Inc. Mr. Ryan M. Belaney Regulatory Affairs Specialist II 5677 Airline Road Arlington, Tennessee 38002

OCT 1 5 2007

K072597 Re:

Trade/Device Name: PRO-DENSE™ Core Decompression Procedure Kit Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: June 27, 2007 Received: September 14, 2007

Dear Mr. Belaney:

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 - Mr. Ryan M. Belaney

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Barbara Buell ND
for

Mark N. Melk 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

510(k) Number: K072597 Device Name: PRO-DENSE™ Core Decompression Procedure Kit Indications For Use:

Prescription Use V (Per21 CFR 801.109) OR

Over-The Counter Use (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchius fox MKL

(Division Sign-Of Division of General, Restorative, and Neurological Devices

510(k) Number K072597

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.