FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

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

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.