(61 days)
Patient Contoured Mesh (PCM) is intended to replace bony voids in mandibular, maxillofacial or craniofacial skeleton.
Patient Contoured Mesh (PCM) is a custom shaped titanium panel that is pre-shaped to fit the anatomy of the patient using a CT based model of the patient. Patient Contoured Mesh (PCM) is fixated using standard KLS Martin's 1.5mm titanium screws (K971297)
The provided text is a 510(k) summary for the KLS-Martin Patient Contoured Mesh (PCM) device, focusing on its substantial equivalence to predicate devices rather than a detailed study demonstrating quantitative performance against specific acceptance criteria. Therefore, most of the requested information cannot be found in the provided document.
Here's a breakdown of what can and cannot be extracted:
Acceptance Criteria and Study Information
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., strength, fit accuracy in a numerical range). The approval is based on "substantial equivalence" to predicate devices regarding materials and intended use.
- Reported Device Performance: No specific quantitative performance data (e.g., mechanical test results, clinical outcomes data with specific metrics) is provided. The document highlights similarities in 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. This is a 510(k) submission based on substantial equivalence, not a clinical trial or performance study with a test set of data.
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 mention of a test set with ground truth established by experts.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable.
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 not an AI/software device, and no MRMC study or AI assistance is mentioned.
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.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable.
8. The sample size for the training set
- Not applicable. There is no mention of a training set as this is not a machine learning device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of what is available from the document:
- Device Name: Patient Contoured Mesh (PCM)
- Intended Use: To replace bony voids in mandibular, maxillofacial or craniofacial skeleton.
- Basis for Approval: Substantial equivalence to predicate devices (K052871, K053199, K033868, K944565, K971297).
- Technological Characteristics (Similarities):
- Manufactured from titanium (similar to Stryker Custom TI Implant, Synthes Patient Specific Cranial/Craniofacial Implant).
- Materials and intended use for reconstructive procedures of the mandibular, maxillofacial or craniofacial skeleton (identical to KLS-Martin Micro Osteosynthesis System).
- Technological Characteristics (Differences):
- PCM is manufactured from CP Titanium, whereas some predicate devices (Synthes Patient Specific Cranial/Craniofacial Implant) are manufactured from titanium and PEEK.
§ 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).