(17 days)
The aap AcroPlate is intended for use on:
- Acromioclavicular dislocations Type Tossi III and Type Rockwood III-V
- Extremely lateral fractures of the clavicula
The qqp AcroPlate is manufactured of Titanium Alloy (Ti Al6 V4 E.L.), and 316 L Stainless Steel. The agp AcroPlate is available with 3 or 4 holes.
This 510(k) submission describes the aap AcroPlate, a metallic bone fixation appliance.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or detailed device performance metrics from a clinical study. Instead, it relies on substantial equivalence to a predicate device and adherence to general manufacturing and quality standards.
| Acceptance Criteria Category | Specific Criteria (as implied or stated) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Device must be substantially equivalent to a legally marketed predicate device (K915315 aap Bone Plate) in technological characteristics and materials. | "The agp AcroPlate is substantially equivalent to the predicate devices with respect to physical/technical and material characteristics." |
| Material Composition | Must be manufactured from Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136) or 316L Stainless Steel (ASTM F 138). | "The agp AcroPlate is manufactured of Titanium Alloy (Ti 6Al 4V E.L.I. = ASTM F136), and 316L Stainless Steel (ASTM F 138)" |
| Later stated as "Titanium Alloy (Ti Al6 V4 E.L.) and 316 L Stainless Steel." (Minor difference in Ti alloy notation, likely a typo or alternative designation). | ||
| Manufacturing Standards | Manufactured according to cGMPs, applicable ASTM requirements, ISO 9001 / EN 46001. | "Devices are manufactured according to cGMP's, applicable ASTM requirements, and applicable harmonised standards ISO 9001 / EN 46001." |
| Sterilization Process | Recommendations for sterilization provided, users sterilize according to AAMI Guideline "Good Hospital Practice: Steam Sterilisation and Sterility Assurance" and ANSI/AAMI/ISO 11737 to achieve acceptable Sterility Assurance Level (SAL). | "The devices are distributed in non sterile, recommendations for sterilization are contained in package insert. Note: These devices are sterilised by end users utilizing the approved/outlines found in the AAMI Guideline "Good Hospital Practice: Steam Sterilisation and Sterility Assurance" and in ANSI/AAMI/ISO 11737 guidelines to achieve the acceptable Sterility Assurance Level (SAL)." |
| Intended Use | For healing AC-joint injury of Tossi III and Rockwood III-V (3 holes) and lateral clavicle fractures (4 holes). | The device's design (3 or 4 holes) corresponds to the specified indications for use. |
Conclusion on Acceptance Criteria: The primary "acceptance criteria" presented in this 510(k) are based on demonstrating substantial equivalence to a predicate device and adherence to recognized material and manufacturing standards, rather than specific performance targets from a clinical trial.
2. Sample size used for the test set and the data provenance
The document does not describe a test set or data provenance in the context of clinical performance evaluation. The submission relies on comparative effectiveness to a predicate device, material specifications, and manufacturing standards. There is no mention of a clinical study with a "test set" of patients or data from a specific country or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. As no clinical "test set" is described for performance evaluation, there is no mention of experts establishing ground truth for such a set.
4. Adjudication method for the test set
Not applicable. No "test set" for performance evaluation 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 metallic bone fixation plate, not an AI/software device. Therefore, MRMC studies involving human readers and AI assistance are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this type of device (metallic bone fixation plate), the "ground truth" for demonstrating safety and effectiveness typically revolves around:
- Material properties: Verified against ASTM standards (e.g., ASTM F136, ASTM F138).
- Biocompatibility: Inferred from the use of well-established, biocompatible materials like medical-grade titanium alloy and stainless steel.
- Mechanical performance: Often demonstrated through preclinical bench testing (e.g., fatigue, static strength) to ensure the device can withstand physiological loads. While not detailed in this summary, such tests would have been part of the technical documentation.
- Clinical outcomes (by reference): The predicate device (K915315 aap Bone Plate) would have established its safety and effectiveness based on prior clinical use or direct studies, and the current device leverages this by demonstrating substantial equivalence.
The document itself does not explicitly detail these 'ground truths' but implies their existence through adherence to standards and comparison to a predicate.
8. The sample size for the training set
Not applicable. This device is a physical medical device, not an algorithm or AI system that requires a training set.
9. How the ground truth for the training set was established
Not applicable. No training set is used for this type of device.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.