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510(k) Data Aggregation
(187 days)
The Forma Medical Optimal Plating System is intended for fixation of fractures, osteotomies, arthrodeses, and bone reconstructions in adult patients with normal or osteopenic bone. Indications include flat (scapula), long (clavicle, upper and lower extremities including metacarpals, and phalanges), irregular (pelvis, hand, foot) bones and joints (wrist, ankle). The Forma Medical Optimal Plating System is not indicated for ribs, sternum, spine, or the skull.
The Forma Medical Optimal Plating System is designed to hold bones in relative stability for fracture fixation and arthrodesis. The plates and screws are available in multiple sizes based on patient anatomy and clinical application. The screws are manufactured from titanium alloy, cobalt chromium molybdenum alloy, or stainless steel, as specified in ASTM F67, F136, F1537, and F138. The plates are manufactured from titanium, titanium alloy, or stainless steel, as specified in ASTM F67, F136, and F138. The system includes plates, screws and instruments. The system instrumentation is manufactured from stainless steel, aluminum, and other surgical grade materials.
The provided text describes mechanical testing performed to demonstrate substantial equivalence for the Forma Medical Optimal Plating System. It does not contain information about an AI/ML-enabled device or a study involving human readers. Therefore, many of the requested fields are not applicable.
Here's the relevant information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criterion (Test) | Reported Device Performance |
|---|---|
| Screw: Torsional Strength per ASTM F543-23 | Mechanical testing results demonstrated substantial equivalence to predicate system screws. |
| Screw: Insertion/Removal Torque per ASTM F543-23 | Mechanical testing results demonstrated substantial equivalence to predicate system screws. |
| Screw: Pullout Strength | Mechanical testing results demonstrated substantial equivalence per the Chapman analytical formula. |
| Plate: Four-Point Bending per ASTM F382-17 | Mechanical testing results demonstrated substantial equivalence to predicate system plates. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample size (number of screws or plates) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable for mechanical testing of a physical device.
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. Ground truth for mechanical testing is established by engineering standards and measurement, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective assessments, not for objective mechanical testing.
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 physical bone fixation system, not an AI-enabled diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical bone fixation system, not an AI-enabled diagnostic tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for the mechanical testing is based on established engineering standards (ASTM F543-23, ASTM F382-17) and an analytical formula (Chapman analytical formula for pullout strength).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI model.
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(107 days)
Airlock® Centrolock® osteosynthesis implant systems are single-use devices intended for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers and toes.
Examples include:
- Mono or Bi-Cortical osteotomies in the foot or hand
- Distal or Proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Calcaneus/cuboid arthrodesis
- Talar/navicular arthrodesis
The system may be used in adult patients.
Airlock® Centrolock® osteosynthesis implant systems are single-use bone fixation devices intended to be permanently implanted. implant systems are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 2mm cortical screws or 2,5mm locking screws. The drill holes are aligned to make sure there is no risk of conflict between the screws. The implant vary essentially through different curvatures and shapes.
Here's a breakdown of the acceptance criteria and study information for the Airlock® Centrolock® osteosynthesis implant system based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K192356) is a 510(k) summary for a medical device. For such devices, "acceptance criteria" are typically met through performance testing that demonstrates substantial equivalence to a predicate device, rather than specific numerical performance metrics for an AI algorithm. The document emphasizes mechanical and material characteristics.
| Acceptance Criterion (Established through substantially equivalent predicate) | Reported Device Performance (as demonstrated by testing and comparison) |
|---|---|
| Material Composition | Wrought Titanium 6-Aluminum 4-Vanadium Alloy (ISO 5832-3 Fourth edition 2016-10-15) |
| Mechanical Characteristics (Implants) | Similar static and dynamic bending resistance (tested per ASTM-F382-17) to predicate Novastep Airlock® osteosynthesis Plate System. |
| Mechanical Characteristics (Screws) | Similar pull-out strength and torsional resistance (tested per ASTMF543-17 sections A1 A3) to predicate Novastep Airlock® osteosynthesis Plate System. |
| Biocompatibility | Evaluation conducted in accordance with Blue Book Memorandum #G95-1 and ISO 10993-1. |
| Intended Use / Indications for Use | Same as predicate devices: Fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers, and toes in adult patients. |
| Design | Similar technological characteristics in terms of design to predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
This is not an AI/software device submission. The "test set" in this context refers to the samples used for mechanical and biocompatibility testing.
- Sample Size: Not explicitly stated in terms of specific numbers of implants or screws tested for mechanical properties. Biocompatibility would involve various test samples, also not specified numerically.
- Data Provenance: Not applicable in the context of clinical data. The tests are material and mechanical characterization tests conducted in a laboratory setting. No country of origin for clinical data is relevant here as no clinical studies were performed. The tests are prospective in the sense that they were designed and executed for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. This is not an AI device where expert ground truth is typically established. The "ground truth" for mechanical testing is based on established engineering standards (ASTM, ISO).
4. Adjudication Method for the Test Set
Not applicable. This is not an AI device with human expert 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 is a medical implant, not an AI-powered diagnostic or assistive device. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on:
- Engineering Standards: Established international standards for material composition (ISO 5832-3), mechanical testing (ASTM F382-17, ASTM F543-17), and biocompatibility (ISO 10993-1).
- Substantial Equivalence: Comparison to legally marketed predicate devices in terms of intended use, indications for use, material, design, and function. The "truth" is that the new device is as safe and effective as the predicate.
8. The Sample Size for the Training Set
Not applicable. This is not an AI device that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable.
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