(90 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence in compressive force testing to predicate device (HBS Headless Bone Screw (K030302)). | Preclinical compressive force testing demonstrated that the Skeletal Dynamics Headless Compression Screw is substantially equivalent to the predicate device. |
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.