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510(k) Data Aggregation
(428 days)
Aesculap's PEEK CranioFix is intended for fixation of cranial bone flaps.
Aesculap's PEEK CranioFix consists of two absorbable discs connected by a suture loop.
Here's a breakdown of the acceptance criteria and study information for the Aesculap PEEK CranioFix, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific performance standards promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. | The device was evaluated and performs in accordance with ASTM F452/ASTM F2026. The subject device was found to be similar in performance to previously cleared spinal systems with similar indications. (Note: The provided text does not specify quantitative acceptance criteria (e.g., specific force, torque, or displacement values). The acceptance appears to be based on adherence to these ASTM standards and comparative performance to similar, cleared devices.) |
| Biocompatibility of materials for implants. | All materials used (PEEK) are well recognized in their use as being biocompatible materials for implants and have been used in surgical procedures for many years. These materials have been accepted in previously cleared submissions. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided text does not contain any information regarding a "test set" in the context of clinical or image-based evaluations. The performance data section refers to engineering and material standards. Therefore, information on sample size for a test set and data provenance (country of origin, retrospective/prospective) is not available.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
As there is no mention of a "test set" involving expert review or clinical images, this information is not applicable and therefore not available.
4. Adjudication Method for the Test Set:
Given the type of device and the information provided, there was no "test set" and no adjudication method for a clinical or image-based evaluation. The evaluation was based on material properties and mechanical performance.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No information about a multi-reader multi-case (MRMC) comparative effectiveness study is present in the provided text. The device is a physical implant, not a diagnostic imaging AI tool.
6. Standalone (Algorithm Only) Performance Study:
No standalone performance study for an algorithm was conducted or reported, as this device is a physical craniofix and not an artificial intelligence algorithm.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is based on established engineering standards (ASTM F452/ASTM F2026) and comparison to the mechanical and biological performance of previously cleared devices/materials. It is not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic device.
8. Sample Size for the Training Set:
This information is not applicable as the device is not an AI algorithm requiring a training set. The "training" for the device refers to its design based on established engineering principles and material science, and the manufacturing processes.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the device is not an AI algorithm with a "training set" in the computational sense. The "ground truth" for the device's development (if conceptualized that way) would be established through scientific understanding of material properties, biomechanics, and safety/efficacy requirements for similar medical implants, drawing upon extensive prior research and regulatory precedents for materials like PEEK and the predicate device.
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