(90 days)
Synthes Hydroxyapatite (HA) Coated Schanz Screws are intended for use with an external fixation system for fracture fixation (open and closed); pseudoarthrosis or non-union of long bones; limb lengthening by epiphyseal or metaphyseal distraction; correction of bony or soft tissue deformity; correction of segmental bony or soft tissue defects; and joint arthrodesis.
Synthes HA Coated Schanz Screws are available as self-drilling and non-self-drilling designs. The HA Coated Schanz Screws are available in a variety of diameters and lengths. The threaded portion of the schanz screw is coated with a very thin plasma sprayed coating of HA.
The provided document describes a medical device, the Synthes Hydroxyapatite (HA) Coated Schanz Screws, and its 510(k) premarket notification (K040701). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive clinical studies to prove performance against specific acceptance criteria in the manner typically seen for novel diagnostic algorithms or AI devices.
Therefore, the document does not contain information about acceptance criteria and a study to prove a device meets acceptance criteria in the context of diagnostic performance (e.g., sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence based on material, design, and indications for use.
Here's an analysis based on the information provided, highlighting why many of your requested points are not applicable to this type of device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
This table is not applicable in the context of a 510(k) for a medical implant like a Schanz screw, which relies on substantial equivalence to existing devices rather than a performance study with diagnostic metrics. The "performance" for such a device is demonstrated through its similarity to legally marketed predicate devices, implying comparable safety and effectiveness for the stated indications.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not applicable for this type of device in a 510(k) submission based on substantial equivalence. | Demonstrated substantial equivalence to predicate devices (Synthes Schanz Screws and Smith & Nephew Jet-X Half Pin) for material, design, and indications for use. |
Explanation: In a 510(k) for devices like bone fixation fasteners, "acceptance criteria" are generally related to demonstrating equivalence in aspects such as:
- Intended Use: Identical or very similar.
- Technological Characteristics: Similar materials, design, operating principles.
- Performance Data: Often non-clinical (e.g., mechanical testing, biocompatibility) to show that any differences in technological characteristics do not raise new questions of safety or effectiveness.
The document states: "Documentation is provided which demonstrates that the Synthes HA Coated Schanz Screws is substantially equivalent* to other legally marketed devices." This is the core "performance" claim for a 510(k).
Additional Notes on Acceptance Criteria (Hypothetical for a similar device if performance data were required):
If this were a novel device requiring performance testing, acceptance criteria would typically involve:
- Biocompatibility: Meeting ISO standards for material compatibility with human tissue.
- Mechanical Strength: Withstanding specified forces (e.g., tensile, torsional, bending strength) without failure compared to predicate or physiological loads.
- Fatigue Life: Demonstrating durability under cyclic loading.
- Corrosion Resistance: Meeting standards for material degradation.
- HA Coating Adhesion/Integrity: Demonstrating the coating remains intact and performs as intended.
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable. This 510(k) submission does not describe a clinical "test set" or a study designed to evaluate diagnostic performance against a ground truth. The substantial equivalence relies on comparing the device's design, materials, and indications to existing predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no "test set" or "ground truth" to be established by experts in the context of this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No test set for diagnostic performance or expert 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 device is a bone fixation fastener, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth for diagnostic or clinical performance is mentioned as this is a substantial equivalence submission for a surgical implant.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no training set or associated ground truth.
Summary of the K040701 Submission:
The Synthes Hydroxyapatite (HA) Coated Schanz Screws received 510(k) clearance (K040701) by demonstrating substantial equivalence to existing, legally marketed predicate devices: Synthes Schanz Screws and Smith & Nephew Jet-X Half Pin. This means the FDA concluded that the device is as safe and effective as the predicate devices, based on comparable:
- Indications for Use: External fixation for fracture fixation, pseudoarthrosis/non-union, limb lengthening, deformity correction, and joint arthrodesis.
- Technological Characteristics: Made of titanium and stainless steel, with a plasma-sprayed HA coating. Available in self-drilling and non-self-drilling designs, and various diameters and lengths.
The 510(k) process for this type of device typically involves submitting non-clinical data (e.g., mechanical testing, biocompatibility reports) to compare the new device to its predicates, rather than conducting new clinical trials with "acceptance criteria" and "ground truth" as you would for diagnostic software.
§ 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.