(14 days)
Indications for the OSStaple" are fixation of unloaded craniofacial bone fractures and The OSStaple™ is contraindicated for craniofacial patients with a skull cranioplasty. thickness less than the selected prong length.
The BioWarm™ represents a modification to the Warmsystem currently in use with the OSStaple" bone staple system. The BioWarm" has an on/off switch and two user adjusted controls. A user adjusted current and user adjusted time controls are on the front of the console. The controls are set to the requirements of a specific staple size and configuration. The BioWarm™ gives both visual and audible indications of current delivery and an audible signal upon automatic completion of current delivery. The BioWarm", on the electrode handle, also provides visual indication of positive contact between the electrode and staple to be heated and visual indication of actual current flow. Current is activated with a button switch on the handle of the BioWarm" electrode and will cease if the button is released prior to the automatic cessation by the circuitry
This document (K023488) focuses on the BioWarm™ Product, a device modification to an existing system, the Warmsystem, used to heat shape memory Nitinol staples (OSStaple™) for compression. The document primarily discusses the substantial equivalence of this modification to previously approved devices, rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested elements for a performance study are not present in this submission.
Here's an analysis based on the provided text, highlighting the information that is present and noting what is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The submission is a 510(k) summary for a device modification (BioWarm™), arguing for substantial equivalence rather than presenting an independent performance study with defined acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided. As this is a 510(k) for a modification (BioWarm™) deemed substantially equivalent to a predicate, a new dedicated clinical performance study with a test set is not described.
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)
This information is not provided. This typically applies to studies evaluating diagnostic accuracy against an expert-established ground truth, which is not the nature of this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided.
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
There is no indication that an MRMC comparative effectiveness study was done. This document describes a medical device for heating staples, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
This is not applicable as the device is a physical instrument (heater) and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not relevant in the context of this 510(k) submission for a device modification. The device heats staples; its "performance" would likely be around temperature control, heating time, and safety, not diagnostic accuracy against a ground truth.
8. The sample size for the training set
This information is not provided. This is not a machine learning or AI device that would have a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
Summary of what the document does provide regarding the BioWarm™ Product:
- Intended Use: The BioWarm™ is a modification to the Warmsystem, which is used to heat shape memory Nitinol staples (OSStaple™) to achieve compression.
- Indications for Use (for OSStaple™): Fixation of unloaded craniofacial bone fractures and cranioplasty.
- Contraindications (for OSStaple™): Craniofacial patients with a skull thickness less than the selected prong length.
- Device Description:
- Has an on/off switch.
- Two user-adjusted controls: current and time, set according to staple size/configuration.
- Provides visual and audible indications of current delivery.
- Audible signal upon automatic completion of current delivery.
- Electrode handle provides visual indication of positive contact and actual current flow.
- Current is activated by a button on the handle and stops if released or automatically.
- Substantial Equivalence: The BioWarm™ is presented as a modification to the Warmsystem, previously approved via 510(k)s K993714, 001219, 001353, and 001354. No fundamental technology changes are claimed.
In essence, this 510(k) submission argues that the BioWarm™ modification does not introduce new questions of safety or effectiveness when compared to the original Warmsystem, thus negating the need for new, extensive performance studies with detailed acceptance criteria typically associated with novel devices. The "proof" is the demonstration of substantial equivalence to already approved predicate devices.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.