(132 days)
The ULTRATINE TransBleph™ is intended for use in subperiosteal browplasty fixation. The ULTRATINE TransBleph is specifically indicated for use to fixate the subdermis to the frontal bone.
The ULTRATINE TransBleph™ consists of a bioabsorbable implant. This device is supplied sterile for single use only.
The provided text describes a 510(k) premarket notification for the ULTRATINE TransBleph™ Device, which is intended for subperiosteal browplasty fixation. However, the document does not contain a study that proves the device meets specific acceptance criteria through performance metrics. Instead, it relies on demonstrating substantial equivalence to predicate devices.
Therefore, many of the requested elements for a study proving device performance against acceptance criteria cannot be extracted from this document.
Here's what can be gathered based on the provided text, and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | The document states: "The ULTRATINE TransBleph™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications." However, no specific performance data or quantitative acceptance criteria are provided. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. No ground truth establishment by experts for a test set is described.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study is mentioned. The document focuses on demonstrating substantial equivalence rather than comparative effectiveness with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This device is a bioabsorbable implant, not an AI algorithm, so an "algorithm only" performance study is irrelevant.
7. Type of Ground Truth Used:
- Not applicable. No ground truth is described as the basis for performance evaluation in the context of a study. The evaluation appears to be based on adherence to "applicable standards" and "user specifications" in direct comparison to predicate devices.
8. Sample Size for the Training Set:
- Not applicable. This device is a physical implant, not an AI model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established:
- Not applicable for the same reason as above.
Summary of what the document does state regarding performance, without providing specific data:
- Substantial Equivalence: The primary method of demonstrating safety and effectiveness is by claiming substantial equivalence to legally marketed predicate devices (ENDOTINE TransBleph™ and Vicryl suture).
- Performance Claim: "The ULTRATINE TransBleph™ performance data meet the applicable standards and fulfill the device requirements as defined in the user specifications." However, these "applicable standards" and "user specifications" are not detailed, nor are the specific "performance data" presented.
- Differences: "The differences between the ULTRATINE TransBleph™ and the predicate devices do not affect the safety and effectiveness of the ULTRATINE TransBleph™." And, "Any differences between the ULTRATINE TransBleph™ and the predicate devices are minor and do not raise issues regarding safety or effectiveness."
In conclusion, while the document asserts that performance data meets requirements and supports substantial equivalence, it does not provide the details of a specific study with defined acceptance criteria and quantitative performance results that would allow for the complete answer to your detailed request. The focus of this 510(k) summary is on demonstrating equivalence rather than presenting an independent performance study.
§ 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.