(132 days)
The ULTRATINE Forehead™ is intended for use in subperiosteal browplasty surgery. The ULTRATINE Forehead is specifically indicated for use to fixate the subdermis to the cranial bone in browplasty.
The ULTRATINE Forehead™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.
The provided document is a 510(k) Premarket Notification for the ULTRATINE Forehead™ device. It describes the device's intended use and claims substantial equivalence to predicate devices. However, this type of regulatory document does not typically include detailed acceptance criteria or the results of a formal study with statistical performance values.
510(k) submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through comprehensive studies with specific performance metrics. The document states that "The ULTRATINE Forehead™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications," but it does not provide those specific acceptance criteria or the study data itself.
Therefore, I cannot provide the requested information regarding detailed acceptance criteria, device performance, sample sizes, ground truth establishment, or specific study results for the ULTRATINE Forehead™ device from the given text.
Based on the provided information, I can offer the following:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document. The document refers to "applicable standards and fulfill the device requirements as defined in the user specifications," but these specifications are not included.
- Reported Device Performance: Not numerically reported in the document. The document generally states that "The ULTRATINE Forehead™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications." This is a general claim rather than specific performance data.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not provided.
- Data Provenance: Not provided. The document mentions "performance evaluations and comparison testing to the predicate devices" but does not detail the nature or source of this data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document does not describe a study involving expert-established ground truth.
4. Adjudication method for the test set:
- Not applicable. The document does not describe a study involving adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and 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 bioabsorbable implant for surgical fixation, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study related to AI assistance is not relevant to this product.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used:
- Not applicable. The document does not describe a study that would require a ground truth as typically defined for diagnostic or AI-based devices. The "performance data" likely refers to biomechanical testing, material properties, and biocompatibility, which are assessed against engineering standards rather than a clinical "ground truth."
8. The sample size for the training set:
- Not applicable. This is not an AI/algorithm-based device and would not have a training set in that context.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
In summary, the provided 510(k) document is for a medical device that demonstrates substantial equivalence based on design, materials, function, and intended use, rather than presenting detailed clinical performance data against specific acceptance criteria in the manner one would expect for an AI or diagnostic device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.