(98 days)
ExsoMed ArcPhix and ArrowPhix are indicated for use in the surgical fixation of small bones, bone fragments, and osteotomies. The devices are not indicated for soft tissue fixation.
The Exsomed Small Screw system are stainless steel compression bone screws contained in sterile procedure kits. The ArcPhix screws are offered in two lengths, 28mm or 36mm by 3.2mm with an 18-degree bend. The ArrowPhix is a straight screw 26mm by 2.5mm. Implantation is facilitated by use of accessories provided in a sterile kit: • Implant • K-wire used as a guide Drill to prepare the bones to receive the implant Hexalobe driver for insertion of the bone screw
The provided text is a 510(k) summary for the ExsoMed ArcPhix and ExsoMed ArrowPhix small bone screw system. It details the device's intended use, indications for use, and a comparison to a predicate device. However, it does not contain information related to a study that uses a machine learning algorithm or AI, nor does it discuss acceptance criteria and device performance in the context of AI/ML or a clinical study with human readers.
The "Non-Clinical Performance Testing" section describes bench testing studies, which are standard for orthopedic implants, to demonstrate the performance of the devices against the predicate. These tests evaluate mechanical properties like torsional properties, driving torque, pullout strength, and self-tapping performance, as well as an engineering analysis comparing torsional and bending strength.
Therefore, I cannot fulfill the request to provide information about the acceptance criteria and a study proving the device meets those criteria, specifically concerning AI/ML performance, human reader improvement with AI, or standalone algorithm performance, as these elements are not present in the provided document.
Here's a breakdown of what is available regarding testing and comparison, tailored to the table format as much as possible, acknowledging the lack of AI/ML-specific details:
Acceptance Criteria and Device Performance (Non-AI/ML Product)
Device Name: ExsoMed ArcPhix and ExsoMed ArrowPhix
| Acceptance Criteria Category (for Mechanical Performance) | Reported Device Performance |
|---|---|
| Torsional Properties (per ASTM F543-13 Annex 1) | Bench testing conducted. (Specific metric values for torsional strength are not provided in the summary, but the conclusion states "demonstrated that the ArcPhix and ArrowPhix perform in a substantially equivalent manner to the predicate device" and that "engineering analysis has been conducted demonstrating that the subject devices outperform the SBI Autofix screws in torsional and bending strength.") |
| Driving Torque Testing (per ASTM F543-13 Annex 2) | Bench testing conducted. (Specific metric values are not provided.) |
| Pullout (per ASTM F543-13 Annex 3) | Bench testing conducted. (Specific metric values are not provided.) |
| Self-Tapping Performance (per ASTM F543-13 Annex 4) | Bench testing conducted (for SpikeScrew only, though the document refers to ArcPhix and ArrowPhix). (Specific metric values are not provided.) |
| Bending Strength (Engineering Analysis) | Engineering analysis demonstrated the subject devices outperform the predicate (SBI Autofix screws) in bending strength. (Specific metric values are not provided.) |
| Endotoxin Testing | Testing completed. (Results not specified but implicitly met required standards for sterile implants.) |
Additional Study Details (Not applicable to AI/ML or comparative effectiveness with human readers)
The provided document describes non-clinical performance testing for the ExsoMed ArcPhix and ExsoMed ArrowPhix small bone screw system, an orthopedic implant. It does not involve a study with a machine learning algorithm, AI, or human readers.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" described refers to physical devices undergoing bench testing. The document does not specify the number of devices tested for each mechanical performance criterion. Data provenance is implied to be from laboratory bench testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical properties is established by standardized test methods (ASTM standards) and engineering analysis, not by human expert interpretation in this context.
- Adjudication method for the test set: Not applicable. Performance is measured against engineering standards and compared to a predicate device, not adjudicated by experts in the context of diagnostic interpretation.
- 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 document does not describe an AI/ML device or a study involving human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not describe an AI/ML algorithm.
- The type of ground truth used: For mechanical performance, the "ground truth" is derived from established engineering principles and ASTM standards for medical device testing.
- The sample size for the training set: Not applicable. No AI/ML training set is mentioned as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable. No AI/ML 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.