The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.

Device Description

The Salvin Tenting Screw System is a set of bone screws and instrumentation. The system consists of a set of screws (one diameter and three lengths) and the driver used to implant these screws. The devices are delivered non-sterile. The screws are made from titanium alloy (Ti-6Al-4V ELI), as described by ASTM F136. The screws come in one diameter – 1.5mm (5.0mm head diameter), and three lengths – 7mm, 8mm, and 9mm. The screws incorporate a 4mm thread length adjacent to a polished neck.

AI/ML Overview

The provided document is a 510(k) summary for the Salvin Tenting Screw System, a medical device. This type of document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a standalone study with acceptance criteria and device performance in the way one might for diagnostic accuracy or clinical outcomes.

Therefore, the information requested regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not applicable or typically found in this type of FDA submission for a Class II fixation device.

However, I can extract the relevant information regarding performance testing and how substantial equivalence was demonstrated:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in a pass/fail table format. Instead, it states that "demonstrated substantial equivalence" to the predicate. The performance data is focused on demonstrating mechanical similarity to the predicate device.

Performance Test	Acceptance Criteria (Implicit)	Reported Device Performance (Salvin Tenting Screw System)
ASTM F543-13 Mechanical Testing	- Torsional Properties: Comparable to Osteogenics Pro-Fix™ device - Drive Torque: Comparable to Osteogenics Pro-Fix™ device - Axial Pullout: Comparable to Osteogenics Pro-Fix™ device - Self-Tapping Force: Comparable to Osteogenics Pro-Fix™ device	"demonstrated substantial equivalence" to the predicate device (Osteogenics Pro-Fix™) leading to the conclusion that "mechanical performance" is equivalent.
Sterilization Validation	Met acceptance criteria (typically defined by AAMI standards for sterility assurance level)	"met the acceptance criteria."
Geometric Comparisons	Comparable geometry to Osteogenics Pro-Fix™ device	"demonstrated substantial equivalence" to the predicate device.

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

Sample Size: Not specified in the document. For mechanical testing per ASTM standards, a statistically significant number of samples would typically be tested, but the exact number isn't provided here.
Data Provenance: The tests are bench tests performed on the physical devices. The country of origin of the data is not specified, but the applicant is Salvin Dental Specialties, Inc. based in Charlotte, NC, USA. The study design is not a clinical study, but rather a materials and mechanical performance comparison.

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

Not applicable as this is a mechanical and material performance comparison, not a diagnostic accuracy study requiring expert ground truth for interpretation.

4. Adjudication method for the test set

Not applicable for mechanical performance testing.

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

Not applicable. This is not an AI/software device or a diagnostic device, and no MRMC study was performed.

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

Not applicable. This is a physical medical device (dental screw), not an algorithm or software.

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

For mechanical properties, the "ground truth" is defined by the relevant ASTM standards (e.g., ASTM F543-13), and the comparison is made against the performance of a legally marketed predicate device.
For sterilization, the "ground truth" is meeting the specified Sterility Assurance Level (SAL) criteria.

8. The sample size for the training set

Not applicable. This is not a machine learning device, so there is no "training set."

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

Not applicable for the reasons mentioned above.

Study Summarized:

The study described is a series of bench tests and geometric comparisons performed on the "Salvin Tenting Screw System" to demonstrate its substantial equivalence to a predicate device, the "Pro-Fix™ Tenting Screw" produced by Osteogenics Biomedical (K093719), and a reference predicate "Salvin Dental Fixation Screw System" (K073342).

The tests performed included:

ASTM F543-13 for mechanical properties (Torsional Properties, Drive Torque, Axial Pullout, Self-Tapping Force).
Sterilization Validation.
Geometric comparisons.

The conclusion was that the Salvin Tenting Screw "is substantially equivalent to the Osteogenics Pro-Fix™ predicate device" based on these performance tests and geometric comparisons, as well as shared indications for use, prescription status, material (Ti-6Al-4V ELI), and non-sterile provision for single-use.

Summary

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Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 28, 2017

Salvin Dental Specialties % John Kapitan CEO Kapstone Medical, LLC Po Box 969 Leicester, North Carolina 28748

Re: K161857

Trade/Device Name: Salvin Tenting Screw System Regulation Number: 21 CFR 872.4880 Regulation Name: Intraosseous Fixation Screw Or Wire Regulatory Class: Class II Product Code: DZL Dated: March 30, 2017 Received: March 31, 2017

Dear John Kapitan:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - John Kapitan

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory,

Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7. Indications for Use Statement

510(k) Number (if known): __ _________________________________________________________________________________________________________________________________________________

Device Name: Salvin Tenting Screw System

Indications for Use:

The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

1. Applicant

Salvin Dental Specialties, Inc. 3450 Latrobe Drive Charlotte, NC 28211

2. Official Correspondent

Kapstone Medical LLC PO Box 969 Leicester, NC 28748

Contact Person:

John Kapitan, CEO Tel: (704) 843-7852 Fax: (704) 831-5316 Email: jkapitan@kapstonemedical.com

3. Date Prepared:

March 30, 2017

4. Device Name

Common/Usual Name:	Tenting Screw System
Classification Name:	Intraosseous Fixation Screw or Wire
Regulation Number:	21CFR 872.4880
Product Code:	DZL
Classification:	II
Panel:	Dental

5. Predicate Devices

The Salvin Tenting Screw System is substantially equivalent to the Pro-Fix™ Tenting Screw produced by Osteogenics Biomedical. The Pro-Fix™ Tenting Screw is the Primary Predicate and the Salvin Fixation Screw System is a Reference Predicate.

Predicate	510(k) Number	Device	Manufacturer
Primary	K093719	Pro-Fix™ Tenting Screw	Osteogenics Biomedical
Reference	K073342	Salvin Dental Fixation Screw System	Salvin Dental Specialties

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6. Description of the Device

The screws come in one diameter – 1.5mm (5.0mm head diameter), and three lengths – 7mm, 8mm, and 9mm. The screws incorporate a 4mm thread length adjacent to a polished neck.

7. Indications for Use

The Salvin Tenting Screw System is used to stabilize, fixate, and/or support bone grafts, bone filling materials and /or barrier membranes used for regeneration of bone in the oral cavity.

8. Summary of Technological Similarities and Differences

The Salvin Tenting Screw is substantially equivalent to the primary predicate – the Osteogenics Pro-Fix™ Tenting Screw in terms of material, geometry, and mechanical performance. The Salvin Fixation Screw is a reference predicate with technological similarities in terms of material, geometry, and manufacturing processing.

Applicant	Salvin Dental	Osteogenics	Salvin Dental
	SUBJECT DEVICE	PRIMARY PREDICATE	REFERENCE PREDICATE
Product Name	Tenting Screw	Pro-Fix™	Fixation Screw
510(k) Number	K161857	K093719	K073342
Product Code	DZL	DZL	HWC
Regulation #	21CFR 872.4880	21CFR 872.4880	21CFR 888.3040
Class	II	II	II
Prescription or O-T-C?	Prescription	Prescription	Prescription
Provided Sterile orNon-sterile?	Non-sterile	Non-sterile	Non-sterile
Indications for Use	The Salvin Tenting Screwis used to stabilize, fixate,and/or support bonegrafts, bone fillingmaterials and /or barriermembranes used forregeneration of bone inthe oral cavity.	The Pro-Fix™ PrecisionFixation System is used tostabilize, fixate, and/orsupport bone grafts, bonefilling materials and /orbarrier membranes used forregeneration of bone in theoral cavity.	The Salvin FixationScrew is intended foruse in internal fixationof small bones includingthe craniofacial andmaxillofacial skeletonaffected by trauma, orfor reconstruction.
Components andSize(s)	Diameter: 1.5mmLengths: 7, 8, and 9mm	Diameter: 1.5mmLengths: 7, 8, and 9mm	Diameters: 1.5 and2.0mmLengths: 4, 6, 8, 10, 13,15, 17mm

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Applicant	Salvin Dental	Osteogenics	Salvin Dental
	SUBJECT DEVICE	PRIMARY PREDICATE	REFERENCE PREDICATE
Product Name	Tenting Screw	Pro-Fix™	Fixation Screw
Device/ImplantMaterials	Ti-6Al-4V ELI per ASTMF136	Ti-6Al-4V ELI per ASTMF136	Ti-6Al-4V ELI per ASTMF136
Manufacturing &Cleaning	Proprietary ProcessShared with SalvinFixation Screw	Unknown	Proprietary ProcessShared with SalvinTenting Screw
SterilizationMethodology	Steam	Steam	Steam

9. Summary of Performance Data

Specific Tests Performed:

· ASTM F543-13
- ଚ୍ଚ Torsional Properties
- Drive Torque
- ► Axial Pullout
- Self-Tapping Force
- Sterilization Validation

Bench testing including axial pullout and torque to failure, as well as geometric comparisons of the Salvin Tenting Screw device to the Osteogenics Pro-Fix™ device demonstrated substantial equivalence. The results for Sterile Validation met the acceptance criteria.

10. Conclusion

The Salvin Tenting Screw is substantially equivalent to the Osteogenics Pro-Fix™ predicate device (Primary Predicate - K093719). In addition to conclusions from performance testing and geometric comparisons, the devices have the same "Indications for Use," are available by prescription only, utilize Ti-6Al-4V ELI material, and are provided non-sterile for single-use only. It can be concluded that the Salvin Tenting Screw is substantially equivalent to the predicate device.

Regulation Number and Section

§ 872.4880 Intraosseous fixation screw or wire.

(a)
Identification. An intraosseous fixation screw or wire is a metal device intended to be inserted into fractured jaw bone segments to prevent their movement.(b)
Classification. Class II.