(171 days)
The Patient Contoured Implant - PEEK (PCI-PEEK) is intended to replace bony voids in the cranial skeleton.
The Patient Contoured Implant – PEEK (PCI-PEEK) is a preformed implant manufactured from PEEK material. The implant is pre-shaped to fit the anatomy of the patient using a CT-based model of the patient's skull. The PCI-PEEK is fixated to native bone using previously cleared KLS Martin titanium plates and screws.
The purpose of this premarket notification is to offer the implants sterile.
This document is a 510(k) premarket notification for the KLS Martin L.P. Patient Contoured Implant - PEEK (PCI-PEEK). However, it does not contain acceptance criteria for device performance or a study demonstrating that the device meets such criteria.
Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device (Patient Contoured Mesh - PEEK (PCM-P) [K072707]). This means the submission argues that the new device is as safe and effective as the predicate device because it shares similar characteristics and intended use.
Here's a breakdown of the information provided, specifically addressing your request:
1. A table of acceptance criteria and the reported device performance
- Not provided. This document does not specify performance acceptance criteria in terms of metrics like accuracy, reliability, or specific functional outputs. The focus is on demonstrating equivalence in design, materials, and intended use.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for performance testing. There is no "test set" in the context of typical AI/software performance evaluation. The substantial equivalence argument relies on comparing the characteristics of the new device to the predicate.
- Biocompatibility testing: The document mentions LAL endotoxin testing. While a "sample size" isn't explicitly stated for this, it's typically performed on batches of devices. Data provenance is not specified beyond "LAL endotoxin testing demonstrates...".
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. There is no "test set" requiring ground truth established by experts for performance evaluation in this type of submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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
- No. This is a hardware implant, not an AI or software device. Therefore, no MRMC study or AI-related effectiveness study was conducted or is applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. See point 3. The "ground truth" for this submission revolves around established safety and effectiveness of the predicate device, and the biocompatibility of the material.
8. The sample size for the training set
- Not applicable. This is a hardware implant, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
Information provided related to "acceptance criteria" and "study" (in the context of substantial equivalence):
The document primarily discusses biocompatibility testing as the relevant "study" for the new device.
- Biocompatibility Testing:
- The evaluation was conducted in accordance with FDA Blue Book Memorandum #G95-1 and International Standard ISO 10993-1.
- The patient-contacting material (PEEK) is the same as the predicate device (K072707), with identical chemical composition, manufacturing processes, and permanent body contact duration.
- Specific performance finding: LAL endotoxin testing demonstrated that the sterile PEEK implant conforms to the required **
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).