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510(k) Data Aggregation
(237 days)
The AmorChem 3.8 mm Headless Porous Titanium Compression Screw is used for fixation of bone fractures, bone reconstruction, and fixation of osteotomies.
The AmorChem Porous Titanium Fixation Device is a 3.8mm, 15mm long variable pitch, fully threaded, cannulated, and headless compression screw. The AmorChem screw is designed to be inserted into a pre-drilled hole that can be guided with a standard k-wire or Allen-drive k-wire. The headless design is intended to be seated flush with the surface of bone. The device is 40% titanium with interconnected porosity. The AmorChem device is provided clean, not sterile, and is single-use only.
The AmorChem Porous Titanium Fixation Device is a medical device designed for bone fixation. The provided document is a 510(k) summary, which evaluates the device's substantial equivalence to legally marketed predicate devices rather than proving its performance against pre-defined acceptance criteria in a clinical study. Therefore, comprehensive information regarding acceptance criteria, sample sizes for test sets, expert consensus, adjudication methods, MRMC studies, or training sets for an AI device is not applicable to this document.
However, the document does contain information about performance testing conducted to demonstrate substantial equivalence to predicate devices. Below is a summary of the performance characteristics and comparative results:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission demonstrating substantial equivalence, explicit "acceptance criteria" in the sense of predefined thresholds for clinical efficacy or diagnostic accuracy are not presented. Instead, the device's performance was compared to established predicate devices using in-vitro and in-vivo biomechanical and biocompatibility tests. The "reported device performance" reflects these comparative results.
| Test Category | Acceptance Criteria (Implicit: Comparable or Superior to Predicates) | Reported AmorChem Porous Titanium Fixation Device Performance |
|---|---|---|
| Biomechanical (In-vitro) | ||
| Torsional Properties, Torque-in, Torque-out, Holding Strength (ASTM F 543 and F 2502) | Comparable or superior to Acumed predicate device (for torque-in/out), superior holding power to k-wire primary-predicate device. | - Possessed similar torque-in and -out properties as the Acumed predicate device. |
| - Demonstrated superior holding power to the k-wire primary-predicate device. | ||
| Static and Fatigue 3-Point Bend Testing (ASTM F1264 and F1541) | Substantially stronger than the primary-predicate k-wire device. | - Found to be substantially stronger in 3-point bending than the primary-predicate k-wire device. |
| Biocompatibility (In-vitro & In-vivo) | ||
| Chemical Characterization and Risk Assessment (ISO 10993-1, -5, -6, -12, -17, -18, ISO 14971: 2012, FDA G-95-1, USP Physiochemical Tests) | Levels of residual compounds below detectable levels or presenting no risk of safety. Locally, no adverse effects. | - Chemical analysis showed levels of residual compounds to be below detectable levels, or presenting no risk of safety. |
| - ISO 10993-6 evaluation showed no adverse effects. | ||
| Assessed suitability for permanent implantation. | - The porous titanium material and subject device were found to be biocompatible for permanent implantation. | |
| Biological Fixation (Ovine model at 6- and 12-weeks post-op) | Biological fixation via interconnected porous structure and cannula. | - The subject device was shown to be biologically fixed via the interconnected porous structure and cannula of the device at 6- and 12-weeks post-op. |
Detailed Information (Not Applicable or Extracted where possible):
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated for specific tests (e.g., number of devices tested for mechanical properties, number of animals in ovine model). The document refers to "in-vitro" and "in-vivo laboratory testing."
- Data Provenance: Not specified regarding country of origin. The in-vivo testing involved an "ovine model," which implies prospective animal studies. In-vitro testing is laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable as this is not a study requiring expert readers/interpreters in the described clinical context for a "ground truth" establishment. The ground truth (or assessment) for mechanical properties comes from lab measurements, and for biocompatibility and biological fixation, it comes from standard histological and toxicological analyses conducted by specialized labs (NAMSA, AccelLAB).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human interpretation or adjudication.
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 document pertains to a physical medical device (bone fixation screw) and its substantial equivalence, not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithmic or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Biomechanical Tests: Measured physical properties based on standardized laboratory methods (ASTM F 543, F 2502, F1264, F1541) and comparison to predicate device measurements.
- For Biocompatibility: Chemical analysis results (leachables/extractables, toxicological risk assessment), and histological evaluation (local tissue effects) as per ISO 10993 standards.
- For Biological Fixation: Histological and potentially imaging assessments from the ovine model at 6- and 12-weeks post-op, demonstrating tissue ingrowth into the porous structure.
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
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