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The Headless Compression Screw System Micro-2.8 screw fasteners are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include, but are not limited to scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

The Headless Compression Screw System Mini-3.9 screw fasteners are intended for fixation of small bones and small bone fragments, such as fractures of the metatarsals, arthrodeses of the carpals and phalanges, steochondritis dissecans, and ligament fixation.

The screw fasteners are intended for single use only and may not be reused under any circumstances.

The system drills and guide wires are single use instruments.

The OsteoCentric Extremities Headless Compression Screw System within the product line of SMV Scientific Cannulated Screws consists of cannulated screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The screws are provided nonsterile. The subject headless compression screws are manufactured from Titanium per ASTM F136. The Headless Compression Screw System fasteners are offered in diameters of Ø2.8mm or Ø3.9mm and lengths from 12mm to 50mm.

This document describes a 510(k) premarket notification for a medical device, specifically the "Headless Compression Screw System." It does not contain information about software, AI, or diagnostic performance studies that would involve acceptance criteria, test sets, expert ground truth, or statistical analyses typically associated with AI/ML medical devices.

Therefore, I cannot provide the requested information, which includes:

1. A table of acceptance criteria and the reported device performance.
2. Sample sizes used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method for the test set.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document focuses on the substantial equivalence of a physical medical device (screws) to legally marketed predicate devices based on identical or nearly identical technological characteristics, materials, principles of operation, and indications for use. Performance testing summarized here relates to mechanical testing (e.g., to ensure modifications introduce no new worst-case scenarios for mechanical performance), not diagnostic or interpretative performance.

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The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The screws are available in 11 length configurations between 10mm - 30mm, with increments of 2mm. The system is provided non-sterile and is sterilized in the user facility.

This document describes the Skeletal Dynamics Headless Compression Screw System, a device for bone fixation. However, the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance.

Instead, the document is a 510(k) premarket notification to the FDA for a medical device. The "performance testing" mentioned refers to mechanical testing of the hardware itself (compression and ASTM F543 testing), not the performance of an AI/ML algorithm or system.

Therefore, I cannot provide the requested information for an AI/ML device. The document explicitly states:

• "Compression testing and ASTM F543 testing were performed to demonstrate conformance to the requirements."
• "The substantial equivalence of the Skeletal Dynamics Headless Compression Screw System to the predicate device is demonstrated by similarities in intended use, indications for use, materials, design (fundamental scientific technology), performance, sterility and packaging, and does not present any new issues of safety or effectiveness."

This indicates a traditional medical device submission based on substantial equivalence for physical properties and intended use, not an AI/ML diagnostic or assistive device.

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The Skeletal Dynamics Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw. Examples include: Scaphoid fractures, lunate fractures, capitate fractures, trapezial fractures, metacarpal and metatarsal fractures, phalangeal fractures, radial head fractures, ulnar styloid fractures, osteo-chondral fractures, small joint fusions, carpal fractures and non-unions, capitellum fractures, distal radius fractures, humeral head fractures, glenoid fractures, intercarpal fusions, interphalangeal fractures, metatarsal osteotomies, tarsal fusions, malleolar fractures, patellar fractures, odontoid fractures, and mandibular fractures.

The Skeletal Dynamics Headless Compression Screw System consists of 2.5mm and 3.5mm cannulated titanium screws and specialized instrumentation. The 2.5mm screw is available in 7 length configurations between 12mm - 24mm, with increments of 2mm. The 3.5mm screw is available in 7 length configurations between 14mm - 26mm, with increments of 2mm. The system is provided non-sterile and is sterilized in the user facility.

The provided 510(k) summary for the Skeletal Dynamics Headless Compression Screw System describes a medical device (bone screw), not an AI/ML powered device or diagnostic software. Therefore, many of the requested criteria, such as "number of experts used to establish ground truth," "adjudication method," "MRMC study," and "training set sample size," are not applicable to this type of device and submission.

The acceptance criteria and study described pertain to proving substantial equivalence to a predicate device based on mechanical performance.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not explicitly stated. The document mentions "Preclinical compressive force testing," implying a laboratory-based study on physical samples of the screws.
• Data Provenance: The data is generated from preclinical, laboratory-based mechanical testing of the device itself. This is not patient data from a specific country, nor is it retrospective or prospective in the clinical sense.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not Applicable. For a medical device like a bone screw, "ground truth" is typically defined by engineering specifications and material properties, validated through standardized mechanical testing methods, rather than expert interpretation of data.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods are typically used in studies involving human interpretation or subjective assessments, which is not the case for mechanical performance testing of bone screws.

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 a hardware medical device; it does not involve human readers or AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This is a hardware medical device; there is no algorithm involved.

7. The Type of Ground Truth Used:

• The "ground truth" for this type of device is the mechanical performance (e.g., compressive strength) of the screws as measured in a laboratory setting, compared against a predicate device. This is based on engineering specifications and established mechanical testing standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established:

• Not Applicable. There is no "training set" or corresponding ground truth establishment process for this type of device.

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