(87 days)
Headless bone screw system for the fixation of osseous fragments or fractures including:
HBS - MINI: Scaphoid fractures, Lunate fractures, Capitate, Trapezial fractures, Metacarpal and metatarsal fractures, Phalangeal fractures, Radial head fractures, Ulnar styloid fractures, Osteo-chrondral, Small joint fusions
HBS - STANDARD: Scaphoid fractures, Carpal fractures & non-unions, Capitellum fractures, Metacarpal fractures, Phalangeal fractures, Distal radial fractures, Radial head fractures, Ulnar styloid fractures, Small joint fusions, Humeral head fractures, Glenoid fractures, Intercarpal fusions, Interphalangeal fractures, Metatarsal osteotomies, Tarsal fusions, Malleolar fractures, Patellar fractures, Osteo-chrondral fractures, Odontoid fractures, Mandibular fractures
The HBS™ (Headless Bone Screw) and the mini HBS™ are supplied as two series of cannulated bone screws varying in length and diameter. Both systems are intended for small bone applications and are thus considered a single system. Indeed, both systems are intended for use primarily in the hands and feet. The systems may be used for selected fractures elsewhere in the body so long as medically indicated and bone mass compatible.
Available screws and instrumentation are available as two individually boxed sets offered in the following sizes:
MINI HBS™: 1.5mm shaft diameter, 3.2mm proximal thread diameter, 2.5mm distal thread diameter. 10mm through 30mm length in one millimeter increments.
STANDARD HBS™: 3.0mm shaft diameter, 4.7mm proximal thread diameter, 4.0mm distal thread diameter. 10mm through 30mm length in one millimeter increments.
The screws are made from titanium alloy.
The provided document is a 510(k) Premarket Notification Summary for the HBS™ Headless Bone Screw. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not available in these documents.
Here's a breakdown of the information that can be extracted or deduced from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify formal acceptance criteria for device performance in the context of a clinical study, as it's a 510(k) for substantial equivalence. The "performance" discussed is primarily in terms of biomechanical properties and material specifications, which are compared to predicate devices for equivalence.
| Feature/Characteristic | Acceptance Criteria (Not explicitly stated as such, but implied for equivalence) | Reported Device Performance |
|---|---|---|
| Biomechanical Testing | Not explicitly stated (implied to be similar to or better than predicate devices) | High Compression Mode: > 200N (in excess of values obtained with similar devices) Standard Compression Mode: 165N (in excess of values obtained with similar devices) |
| Material Compliance | ISO 5832-3:1996(E) | Device materials meet ISO 5832-3:1996(E). |
| Manufacturing Quality | ISO 9001-2000 regulations | Device produced according to ISO 9001-2000 regulations. |
| Sterilization Assurance Level (SAL) | At least 10^-6 for recommended cycle | Use of recommended sterilization cycle produces an SAL of at least 10^-6. |
| Intended Use | Substantially equivalent to predicate devices (Zimmer HBS™, Onyx Navicular) | Broader indications for use than Onyx device, but shares many with Zimmer HBS™. (See table in original document for full comparison). |
| Design | Substantially equivalent to predicate devices | Headless, threaded both ends, similar lengths and diameters to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical "test set" for performance evaluation in the way one would for an AI/diagnostic device. The biomechanical testing mentioned is likely laboratory-based. No patient-specific data or data provenance (country of origin, retrospective/prospective) is provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study assessing diagnostic performance or requiring expert ground truth in that sense. The "ground truth" for biomechanical performance would be the experimental measurements themselves.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
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 not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a surgical implant, not an algorithm.
7. The Type of Ground Truth Used
For the biomechanical testing, the "ground truth" is the empirically measured force values (e.g., 200N, 165N) obtained from testing the screws. For material and manufacturing, the ground truth is compliance with relevant ISO standards.
8. The Sample Size for the Training Set
Not applicable. No training set for an algorithm is mentioned in this document.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set is mentioned.
§ 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.