(29 days)
The intended use of the I.T.S. Hand Locking Plates System - HLS is to draw two or more aligned bone fragments together to facilitate healing in an adult patient.
The I.T.S. Hand Locking Plates System - HLS is indicated for use in fracture fixation of:
- the phalanges,
- the metacarpal bones,
- the carpal bones,
- for arthrodesis,
- for corrective osteotomies, and
- for subcapital radial head fractures.
The I.T.S. Hand Locking Plates System is not for spinal use.
The I.T.S. Hand Locking Plates System -- HLS consists of Predicate small bone trauma implant components commonly found with large companies with orthopedic markets in the United States. The I.T.S. HLS System consists of 1.0 and 1.5mm thick plates in Straight, T-Shape, Y-Shape, L-Shape (Left & Right), Extended and Square Plate configurations (with multiple hole sizing) that utilize both Locking and Non-Locking self-tapping Screws in 1.5mm, 1.8mm and 2.3mm sizes in various lengths. A 2.0mm Headless Compression Screw in various lengths is also available.
All small plate components are manufactured from Commercialy Pure (CP) Titanium material to ASTM F67 and allow for minor intra-operative forming/contouring by the surgeon to fit the small bone anatomy. All screws consist of a 6-4 Alloyed Titanium material to ASTM F136. All I.T.S. small plates and screws are processed with an anodize DOTIZE surface treatment. The low-profile and contoured small plate design minimizes soft-tissue irritation for the patient. Associated instrumentation such as Plate Holder, Drills, Drill Guides, Depth Guage, Countersink Reamers, Guide Wire and ancillary instrumentation is available. All small plates and screws are provided Non-Sterile.
This document is a 510(k) summary for the I.T.S. Hand Locking Plates System - HLS, a metallic bone fixation device. It outlines the regulatory classification, device description, intended use, and claims of substantial equivalence to predicate devices. However, it explicitly states that no nonclinical testing was used in the determination of Substantial Equivalence (SE).
Therefore, based on the provided text, there is no study described that proves the device meets specific performance acceptance criteria. The document relies on a comparison to existing predicate devices already on the market through a claim of "Substantial Equivalence."
Here's an analysis based on your requested information, noting that most of the requested details are not present in this type of regulatory submission because an actual performance study was not conducted as part of this specific 510(k) application:
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A table of acceptance criteria and the reported device performance:
- Not provided. This document does not present acceptance criteria for device performance (e.g., mechanical strength, fatigue life, biological compatibility) nor does it report performance data from any conducted studies against such criteria. The basis for clearance is Substantial Equivalence to predicate devices.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. No test set or data provenance is mentioned because no non-clinical testing was used for the determination of substantial equivalence.
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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 experts were used to establish ground truth for a test set as no performance study was conducted.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method is mentioned.
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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 a bone fixation device, not an AI-based diagnostic tool. No MRMC study was conducted or is relevant.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a bone fixation device, not an algorithm. No standalone performance evaluation was conducted.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. No ground truth was established as no performance study was conducted.
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The sample size for the training set:
- Not applicable. There is no training set mentioned or implied as no algorithm or machine learning component is involved.
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How the ground truth for the training set was established:
- Not applicable. There is no training set or associated ground truth establishment process mentioned.
Summary based on the document:
The device, I.T.S. Hand Locking Plates System - HLS, obtained FDA clearance based on Substantial Equivalence (SE) to legally marketed predicate devices (Stryker - Hand Plating System, Synthes - LCP Compact Hand 1.5, Biomet/DePuy - ALPS Small Bone Locked Plating System, I.T.S. GmbH - Extremity Fixation Systems). The key statement providing this information is:
"The I.T.S. GmbH Hand Locking Plates System - HLS is Substantially Equivalent (SE) to the Stryker, Synthes, Biomet/DePuy and I.T.S. GmbH bone plate/screw systems. No nonclinical testing was used in the determination of Substantial Equivalence (SE)."
This means the device's acceptance was based on its similarity in material, geometry, design, and indications for use to already cleared devices, rather than on new performance data demonstrating its ability to meet specific acceptance criteria.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.