SHARPOINT LUKENS BONE WAX by SURGICAL SPECIALTIES CORP.

The provided documents for K050292 do not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically seen for AI/ML-driven medical devices. This submission pertains to a traditional medical device (bone wax) and its clearance is based on substantial equivalence to predicate devices, rather than performance against pre-defined metrics in a clinical study with a test set, ground truth, or expert readers.

Therefore, many of the requested categories are not applicable to this 510(k) summary. I will address the applicable points based on the information provided, explicitly stating where information is not available or not relevant to this type of device submission.

Acceptance Criteria and Reported Device Performance

For a traditional medical device like Sharpoint Lukens® Bone Wax, the "acceptance criteria" for FDA clearance primarily revolve around demonstrating substantial equivalence to a legally marketed predicate device. This means showing that the device has the same intended use, is made of the same materials, operates by the same technological characteristics, and raises no new issues of safety or effectiveness when compared to the predicate device. Performance is largely inferred from the predicate device's established safety and effectiveness.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as described in the 510(k) Summary)
Same intended use as predicate devices	"The Sharpoint Lukens® Bone Wax for control of bleeding from the bone surface during surgical operations." This matches the predicate devices.
Same technological characteristics as predicate devices	"Bone Wax is commonly used in medical applications to control bleeding. The characteristics are the same for the proposed Sharpoint Lukens® Bone Wax as the Ethicon's Bone wax as described in this submission."
Same components as predicate devices	"The components of Sharpoint Lukens® Bone Wax, Ethicon Bone Wax and CP Medical Bone wax are the same..."
Raises no new issues of safety and efficacy	"...raise no new issues of safety and efficacy."

Study Details (Not Applicable for this specific 510(k) submission type)

The following information is typically relevant for AI/ML device submissions or devices requiring clinical performance studies to establish safety and effectiveness. This 510(k) submission for bone wax relies on substantial equivalence to existing devices, not a new performance study.

Sample size used for the test set and the data provenance: Not applicable. No test set or clinical performance study described.
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. No test set or ground truth described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set 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: Not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. Ground truth for performance metrics is not established for this type of submission.
The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.

In summary: The K050292 submission for Sharpoint Lukens® Bone Wax is a traditional 510(k) submission based on demonstrating substantial equivalence to predicate devices (Ethicon Bone Wax and CP Medical Bone Wax). It does not involve a clinical performance study with defined acceptance criteria, a test set, ground truth determination, or AI/ML components as detailed in your request. The "study" proving the device meets criteria is the comparison and analysis of its materials, intended use, and technological characteristics against already cleared devices, which found them to be "the same" and raising "no new issues of safety and efficacy."

Summary

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K050292 page 1/3

MAR 9 - 2005

Image /page/0/Picture/2 description: The image shows the logo for Surgical Specialties Corporation. The logo features the company name in a stylized font, with the words "Surgical Specialties" stacked on top of "Corporation." To the right of the company name is a black triangle pointing to the right. Below the company name is the tagline "Incision & Healing Technologies" in a smaller font.

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter:	Surgical Specialties Corporation
Address:	100 Dennis DriveReading, PA 19606
Telephone:	610 404 1000, ext. 2231
Contact Person:	Elizabeth LazaroRegulatory Affairs Specialist
Date Prepared:	February 1, 2005

Name of Device:	Sharpoint Lukens® Bone Wax
Common / UsualClassification Name:	MTJBone Wax

Predicate Devices:	Ethicon, Inc. Bone WaxCP Medical, Inc. Bone Wax
Indications For Use:	The Sharpoint Lukens® Bone Wax for control ofbleeding from the bone surface during surgicaloperations.

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Device Description

The Sharpoint Lukens® Bone Wax is a sterile mixture of beeswax, paraffin, and isopropyl palmitate. It has a waxy ordor.

Technological Characteristics:	Bone Wax is commonly used in medical applications to control bleeding. The characteristics are the same for the proposed Sharpoint Lukens® Bone Wax as the Ethicon's Bone wax as described in this submission.
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K050292 Page 3/3

Image /page/2/Picture/1 description: The image shows the logo for Surgical Specialties Corporation. The logo is in black and white and features the company name in a stylized font. A black triangle is to the right of the company name. Below the company name is the word "CORPORATION" in a smaller font.

510(k) SUMMARY OF SAFETY AND EFFECTIV

Substantial Equivalence

The Sharpoint Lukens® Bone Wax is equivalent in the intended use to the predicate devices, Ethicon Bone Wax and CP Medical Bone Wax. The Done was arracteristics have been demonstrated to be equivalent. The components of Sharpoint Lukens® Bone Wax, Ethicon Bone Wax and CP Medical Bone wax are the same and raise no new issues of safety and efficacy.

Sharpoint Lukens® Bone Wax Surgical Specialties Corporation

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/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 stripes forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle. The text is in all capital letters and is evenly spaced around the curve.

Public Health Service

MAR 9 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Elizabeth Lazaro Regulatory Affairs Specialist Surgical Specialties Corporation 100 Dennis Drive Reading, Pennsylvania 19606

Re: K050292

Trade/Device Name: Sharpoint Lukens® Bone Wax Regulatory Class: Unclassified Product Code: MTJ Dated: February 24, 2005 Received: February 25, 2005

Dear Ms. Lazaro:

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 reframerice 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 docs 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. Elizabeth Lazaro

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) 276-0115. 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 Manufacturers, International and Consumer Assistance at its toll-frec number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/indcx.html.

Sincercly yours.

Miriam C. Provost, Ph.D. Acting 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

510(k) Number (if known):

Device Name: Sharpoint Lukens® Bone Wax

Indications For Use:

Sharpoint Lukens® bone wax is indicated for use for control of bleeding from bone surface during surgical operations.

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

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

Page 1 of

510(k) Number K050292

Regulation Number and Section

N/A