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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

Not Found

This document is a 510(k) clearance letter from the FDA for the HBS Headless Bone Screw. It does not contain any information about acceptance criteria or a study proving device performance in relation to such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and lists its intended indications for use.

Therefore, I cannot provide the requested information.

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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.

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.

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