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The 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 stabilized 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 disks, in a parallel configuration, that are connected by an internal, serrated post. The devices will be available in several sizes with disk diameters in the range of 10mm to 18mm to be used for varying cranial closure techniques. The implant devices will be manufactured from 6AI4V titanium alloy material.

The provided text is a 510(k) summary for the Bioplate® ZIP™ Craniotomy Fixation System. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving new safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets them in the way a clinical trial would.

Instead, the document focuses on:

• Device Description and Intended Use: The Bioplate® ZIP™ Craniotomy Fixation System is described as consisting of two circular disks connected by an internal, serrated post, made from 6AI4V titanium alloy. Its intended use is to reattach a cranial bone flap to the surrounding cranium after a craniotomy procedure.
• Predicate Devices: Several predicate devices are listed, including systems from Stryker Instruments, Synthes (USA), Walter Lorenz Surgical, Ikonos Corp., and Aesculap, Inc., as well as a previous Bioplate® ZIP™ system (K013050).
• Substantial Equivalence: The core argument of the 510(k) is that the new system has the "same indications for use as the predicate devices" and that "all of 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."

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies, as this information is not present in the provided 510(k) summary. The FDA's letter explicitly states that they "reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... to devices marketed in interstate commerce prior to May 28, 1976." This implies a comparison to existing devices rather than a de novo clinical study to meet predefined acceptance criteria for novel safety or efficacy claims.

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The 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 stabilized bony tissue while normal healing on the site is achieved. Each device is intended for single use only and only in conjunction with other titanium and titanium alloy implants.

The Bioplate® ZIP™ Craniotomy Fixation System consists of two circular disks, in a parallel configuration, that are connected by an internal, serrated post. The devices will be available in several sizes with disk diameters in the range of 10mm to 18mm to be used for varying cranial closure techniques. The implant devices will be manufactured from 6Al4V titanium allov material.

This looks like a 510(k) premarket notification for a medical device called "The Bioplate® ZIP™ Craniotomy Fixation System." This document primarily focuses on demonstrating substantial equivalence to predicate devices, not on a clinical study proving that the device meets specific performance acceptance criteria through quantitative metrics like accuracy, sensitivity, or specificity.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this type of regulatory submission. This document aims to show that the new device is as safe and effective as devices already on the market, rather than conducting a de novo performance study with specific statistical endpoints typically found in AI/diagnostic device submissions.

Here's a breakdown of the information that can be extracted from the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated in a quantitative, metric-based manner. For a 510(k) for a mechanical implant, the "acceptance criteria" usually revolve around demonstrating that the device has similar technological characteristics, intended use, and performs at least as well as predicate devices, without raising new safety or effectiveness concerns. This is qualitative rather than quantitative.
• Reported Device Performance: The document states: "All of the technical characteristics of The Bioplate® ZIP™ Craniotomy Fixation System are substantially equivalent to the corresponding characteristics of the predicate devices, and any minor differences raise no new issues of safety and efficacy." This is the core "performance" claim for a 510(k), asserting equivalence. No specific quantitative performance metrics (e.g., tensile strength, fatigue life with specific values) are provided in this summary. Such data would typically be in supporting documentation that isn't part of this public summary.

2. Sample size used for the test set and the data provenance:

• Not Applicable. This document does not describe a test set or data provenance in the context of a performance study with human or image data. It pertains to a physical implant.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. Ground truth, in this context, does not refer to expert-derived medical interpretations. It refers to engineering specifications and clinical outcomes related to surgical implants, which are assessed through engineering tests and clinical experience, not typical "expert consensus" on diagnostic data.

4. Adjudication method 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 is a hardware implant, not an AI or diagnostic device that involves human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not Applicable. This is a hardware implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

• For this type of device, "ground truth" would be established through:
  • Engineering specifications and standards: Confirming material properties, dimensions, and mechanical performance (e.g., strength, biocompatibility) against established standards for medical implants.
  • Clinical experience with predicate devices: Relying on the long-standing safe and effective use of similar devices.
  • Pre-clinical testing: Biocompatibility testing, potentially some in-vitro mechanical testing.
• The document implies that the "ground truth" is that the predicate devices are safe and effective, and the new device shares sufficient characteristics not to raise new concerns.

8. The sample size for the training set:

• Not Applicable. No training set as this is not a machine learning device.

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

• Not Applicable.

In summary, based only on the provided text, a detailed response to your questions regarding acceptance criteria and performance studies in the context of diagnostic/AI devices cannot be fully generated because this document is a 510(k) summary for a physical medical implant, which follows a different regulatory pathway and relies on different types of evidence (primarily substantial equivalence to predicate devices and engineering/biocompatibility testing) rather than a clinical performance study with statistical endpoints for diagnostic accuracy.

The core "proof" in this document is the assertion of substantial equivalence to already legally marketed devices, as stated in the letter from the FDA: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..."

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