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The Sterile Bioplate ZIP® Craniotomy Fixation System is intended to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure. The device is used to align and stabilize bony tissue while normal healing occurs. Each device is intended for single use only and may be combined only with other titanium and titanium alloy implants.

The Bioplate ZIP® Craniotomy Fixation System consists of two circular caps, in a parallel configuration that is connected by an internal, serrated post. The devices will be available in several sizes with cap diameters in the range of 12mm to 20mm to be used for varying cranial closure techniques. The device will be packaged and provided Sterile ( by gamma radiation)

This document describes a 510(k) premarket notification for a modified design of the Bioplate ZIP® Craniotomy Fixation System. It does not contain information about acceptance criteria or a study proving that the device meets such criteria in the context of device performance as one might expect for a diagnostic or AI-based device. Instead, this is a traditional medical device submission focused on substantial equivalence to predicate devices for regulatory clearance.

Therefore, many of the requested categories about acceptance criteria, study design, and ground truth are not applicable to this type of submission. The provided text does not contain any performance data from a clinical or analytical study in the way these questions are typically posed for AI/diagnostic devices.

Here's an assessment based on the provided text, indicating where information is present versus where it's absent or not applicable:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for performance metrics. The underlying acceptance criterion for this type of submission is "substantial equivalence" to predicate devices regarding safety and efficacy.
• Reported Device Performance: No performance metrics (e.g., accuracy, precision, sensitivity, specificity) are reported. The submission focuses on demonstrating that the modified design's technical characteristics are "substantially equivalent" to predicate devices and raise "no new issues of safety and efficacy."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable. There is no mention of a "test set" or data provenance in the context of device performance evaluation. The submission relies on a comparison of technical characteristics and intended use.

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 "ground truth" establishment in the context of a performance study for this device type within this document. Regulatory review is done by FDA reviewers.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No test set or expert adjudication process is described for performance evaluation.

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 implant (craniotomy fixation system), not an AI or diagnostic tool involving "human readers" or "AI assistance."

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. As there's no performance evaluation in the traditional sense, there's no "ground truth" specified for such an evaluation. The "truth" for this submission is that the device's technical characteristics and intended use are similar enough to previously cleared devices.

8. The sample size for the training set

• Not applicable. There is no "training set" for this type of physical device submission.

9. How the ground truth for the training set was established

• Not applicable.

Summary based on the provided text:

This 510(k) submission (K082175) for the modified Bioplate ZIP® Craniotomy Fixation System describes a physical device intended to reattach a cranial bone flap. The "study" (or rather, the regulatory approach) detailed here is a demonstration of substantial equivalence to predicate devices (K070901, K013050, K020088).

The "acceptance criteria" and "study" are implicitly tied to the FDA's declaration of substantial equivalence. The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that the provided information regarding the device's technological characteristics and intended use adequately demonstrated that it did not raise new questions of safety or efficacy compared to the predicate devices.

The document does not elaborate on specific engineering tests or biocompatibility assessments that would typically be part of such a submission, only that the "technical characteristics are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." These underlying tests would form the basis for proving that the device itself meets its design specifications and is safe, but the submission summary does not provide their details.

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