The TITANIUM HARTSHILL SYSTEM consists of the following items:
REF SIZE
HTR 4025 - 4mm x 25mm
HTR 4035 - 4mm x 35mm
HTR 4045 - 4mm x 45mm
HTR 4065 - 4mm x 65mm
HTR 4075 - 4mm x 75mm
HTR 4085 - 4mm x 85mm
Surgical instruments designed to implant the device are also available.
Fixation Wire and Braided Fixation Cable are available in both stainless steel and titanium alloy for use with the appropriate implant type.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for the TITANIUM HARTSHILL SYSTEM, a spinal implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed acceptance criteria and a study dedicated to proving performance against those criteria. Therefore, much of the requested information regarding acceptance criteria, specific device performance, sample sizes for test/training sets, expert adjudication, and MRMC studies is not present in this document, as it is not typically required for a 510(k) submission for this type of device.

However, I can extract information related to the device's comparison to its predicate and the basis for its safety and effectiveness.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" and "reported device performance" in the traditional sense of a clinical trial. Instead, the "acceptance criteria" can be inferred as being substantially equivalent in terms of intended use, indications for use, materials, surgical approach, and method of attachment to the predicate device. The "reported device performance" is the demonstration that these equivalencies hold.

Feature	Inferred Acceptance Criteria (Substantial Equivalence to Predicate)	Reported Device Performance (TITANIUM HARTSHILL SYSTEM)
Intended Use	Surgical stabilization and fusion of the cervical spine for the correction of spinal deficiencies (same as predicate)	Surgical stabilization and fusion of the cervical spine for the correction of spinal deficiencies
Indications For Use	Spinal deformity, Spinal tumors, Spinal fracture, Dislocations, Subluxations, Spondylolisthesis (same as predicate)	Spinal deformity, Spinal tumors, Spinal fracture, Dislocations, Subluxations, Spondylolisthesis
Materials	Similar to predicate, meeting BS, ISO, ASTM standards (predicate is Stainless steel)	Titanium and stainless steel (predicate is Stainless steel)
Surgical Approach	Posterior (same as predicate)	Posterior
Method of Attachment	Wires/cable to posterior arches (same as predicate)	Wires/cable to posterior arches
Safety and Effectiveness	Demonstrated through long-established engineering/design principles and comparison to predicate mechanical test data	"Testing and clinical performance demonstrate that TITANIUM HARTSHILL SYSTEM will perform substantially the same as the stainless steel Hartshill Spinal Fixation System"

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

Sample Size: Not applicable/not provided. This submission relies on demonstrating substantial equivalence through design and material comparison, and a review of existing literature and mechanical test data, rather than a prospective clinical "test set" for performance evaluation.
Data Provenance: The document mentions "review of peer literature concerning physiological loading of the cervical spine" and "available mechanical test data comparing the Titanium Hartshill SysTEM to the literature and the substantially equivalent predicate device." This suggests a combination of retrospective literature review and mechanical (bench) testing. No specific country of origin for this data is provided, but the manufacturer is based in England.

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

Not applicable/not provided. As there's no clinical "test set" and a formal "ground truth" derived from expert consensus for device performance in the context of this 510(k) submission, this information is not included. The FDA's review committee (Orthopaedics and rehabilitation devices panel) serves as the expert body reviewing the submission.

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

Not applicable/not provided. This pertains to a clinical study design that is not part of this 510(k) submission.

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/not provided. The device described is a physical spinal implant, not an AI-assisted diagnostic tool.

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

Not applicable/not provided. This is a physical medical device, not an algorithm.

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

For the demonstration of substantial equivalence, the "ground truth" is primarily based on established engineering and design principles, materials standards (BS, ISO, ASTM), and the performance history of the predicate device (Stainless steel Hartshill Spinal Fixation System - K853033). The statement "Testing and clinical performance demonstrate that TITANIUM HARTSHILL SYSTEM will perform substantially the same as the stainless steel Hartshill Spinal Fixation System" implies reliance on prior clinical evidence for the predicate and mechanical testing for the new device.

8. The sample size for the training set:

Not applicable/not provided. This refers to machine learning, which is not relevant to this device.

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

Not applicable/not provided. This refers to machine learning, which is not relevant to this device.

In summary: The provided document is a 510(k) notification for a spinal implant. Its primary purpose is to establish substantial equivalence to an existing marketed device. Therefore, it does not contain the detailed information typically found in a clinical study report that establishes performance against specific acceptance criteria for a novel device or AI-based system. The "study" referenced is largely a comparison to mechanical test data and a review of existing peer literature to support the claim of substantial equivalence and safety/effectiveness based on the predicate's history.

Summary

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SURGICRAFT, LIMITED	I the TITANIUM HARTSHILL SYSTEM

Safe Medical Devices Act of 1990, 21 CFR 807.92 Requlatory Authority:

1. Device Name:

TRADE NAME:	TITANIUM HARTSHILL SYSTEM
Common Name:	Spinal implant
Classification Name:	Appliance, Fixation, Spinal Interlaminar

2. Establishment Name & Registration Number:

Name: Surgicraft, Ltd.

Number: 8020712

3. Classification:

§ 888.3050 Spinal interlaminal fixation orthosis. (a) Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome. (b) Classification. Class II.

Product Code: 87KWP

Device Class: Class II

Classification Panel: Orthopaedics and rehabilitation devices panel

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K-991662 2 84

5. Contact Person:

Mr. Simon Fitzer SURGICRAFT, LIMITED Redditch, Worcestershire B97 6HF, England VOICE: FAX : E-MAIL: 1067362743@COMPUSERVE.COM

6. Special Controls:

Special controls have not been established for this device.

7. Device Description:

The TITANIUM HARTSHILL SYSTEM consists of the following items:

REF SIZE

HTR 4025 - 4mm x 25mm HTR 4035 - 4mm x 35mm HTR 4045 - 4mm x 45mm HTR 4065 - 4mm x 65mm HTR 4075 - 4mm x 75mm HTR 4085 - 4mm x 85mm

Surgical instruments designed to implant the device are also available.

Fixation Wire and Braided Fixation Cable are available in both stainless steel and titanium alloy for use with the appropriate implant type.

8. Substantially Equivalent Device(s):

The TITANIUM HARTSHILL SYSTEM is substantially equivalent to the following device:

1. Stainless steel Hartshill Spinal Fixation System - K853033

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9. Comparison to Predicate Device(s):

Surgicraft, Ltd. currently manufactures a legally marketed device for the same indications called the stainless steel Hartshill Spinal Fixation System. The United States Food and Drug Administration previously reviewed a 510(k) submission for the Hartshill device (K853033). The FDA agreed that the Hartshill device was substantially equivalent to other preamendment spinal fixation systems and cleared it for marketing. The TITANIUM HARTSHILL SYSTEM intended for the identical indications cleared for the Hartshill device.

Both the stainless steel Hartshill Spinal Fixation System and the TITANIUM HARTSHILL SysTEM are posterior attachment surgical approach systems. Both are used to treat the same medical conditions. Both have essentially the same cautions and contraindications for use. Both are basic spinal rod, crosslink and sublaminar wire systems. Both systems may be attached via bore holes wires.

The use of long established engineering and design principles (sublaminar wires and contoured rods) which most physicians are already experienced. should contribute to the expected safety and effectiveness performance of the TITANIUM HARTSHILL SYSTEM System. The TITANIUM HARTSHILL SYSTEM utilizes similar implant materials meeting various BS, ISO and ASTM standards.

Testing and clinical performance demonstrate that TITANIUM HARTSHILL SYSTEM will perform substantially the same as the stainless steel Hartshill Spinal Fixation System (K853033).

10. Clinical Experience:

Summary and Conclusions: A review of peer literature concerning physiological loading of the cervical spine, together with the available mechanical test data comparing the Titanium Hartshill SysTEM to the literature and the substantially equivalent predicate device give an assurance that the Titanium Hartshill SYSTEM is both safe and effective when used for the indications given.

11.Packaging:

All implants and instruments are supplied packaged in industry standard medical grade packaging suitable for surgical implants and instruments. Shippers and boxes are of suitable design and materials to ensure protection and identification during shipping and storage.

12. Sterilization/Re-sterilization:

All implants are supplied sterile by gamma irradiation to an SAL of 10°. Instruments are supplied non-sterile. Implants are processed to remove manufacturing residue

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and debris. All implants and instruments should be removed from shipping and packing materials then washed and rinsed thoroughly before sterilization.

The labelling of the implants & instruments clearly indicates their status. The package insert found in Appendix I specifies the recommended sterlillzation/resterilization cycle.

The recommended sterilization method, time and temperature for the implants is gravity steam sterilization for 45 minutes at 121° C (250° F). The Sterility Assurance Level (SAL) of the recommended sterilization cycle is 10° (SAL 10°). Validation of the recommended cycle has been conducted by qualified commercial laboratories. The validation method used is known as the overkill method.

The recommended storilization method is based on Health Industry Manufacturers Association (HIMA) & Association of Operating Room Nurses (AORN) protocols. Only the recommended sterilization cycle was validated.

13. Conclusion:

Based on the materials, intended uses, design, and effectiveness, the TITANIUM HARTSHILL SYSTEM" unit is substantially equivalent to the referenced legally marketed Stainless steel Hartshill Spinal Fixation System. The feature comparison chart below graphically demonstrates this equivalence.

FEATURE	TITANIUM HARTSHILL SYSTEM	Stainless steel Hartshill SpinalFixation System	SE?
Intended Use:	Surgical ctabilization and fusion of thecervical spine for the correction ofspinal deficiencies.	Same cervical Intended use.	Yes
Indications ForUse:	Spinal deformitySpinal tumorsSpinal fractureDislocationsSubluxationsSpondylolisthesis	Same cervical indications for use.	Yes
Materiale:	Titanium and stainless steel	Stainless steel	Yes
SurgicalApproach:	Posterior	Posterior	Yes
Method ofAttachment:	Wires /cable to posterior arches	Wires to posterior arches	Yes
K-Number	NA	K853033	Yes
Manufacturer:	Surgicraft, Ltd.	Surgicraft, Ltd.	Yes

14. Comparison Table:

SURGICRAFT 10/26/99

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 1999

Mr. A. J. Fennell Commercial Director Surgicraft, Limited Fishing Line Road Redditch, Worcestershire B97 6HF, England

Re: K991662 Trade Name: Titanium Hartshill System Regulatory Class: II Product Code: KWP Dated: September 27, 1999 Received: September 30, 1999

Dear Mr. Fennell:

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 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 (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. ਜੋ 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 requlation may result in requlatory 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 - Mr. A. J. Fennell

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 yours,

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): _ K 99 | 662

Titanium Hartshill System™ Device Name:

Intended Use:

Surgical stabilization and fusion of the cervical spine for the correction of spinal deficiencies.

Indications For Use:

1. Spinal deformity
1. Spinal tumors
1. Spinal fracture
1. Dislocations
1. Subluxations
1. Spondylolisthesis

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY

Concurrence of CDRH, Office of Device Evaluation (ODE)

colles

(Division Sign-Off)
Division of General Restorative Devices K991662
510(k) Number

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109) SURGICRAFT 27/09/99

(Optional format 1-2-96)

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.