(25 days)
The ENDOTINE device is intended for use in browplasty surgery. The ENDOTINE device is specifically intended for use to fixate the sub-dermis to the cranial bone in browplasty procedures.
The ENDOTINE system includes the bioabsorbable ENDOTINE Implant, a stainless steel step drill-bit intended to be used in conjunction with the drill handle, and the ENDOTINE installation instrument and a sterilization tray.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Coapt Systems ENDOTINE Device, based on the information available:
This 510(k) submission (K023922) is for a substantially equivalent device, not a novel device requiring extensive clinical trials to establish new performance criteria. The core of this submission is to demonstrate that the revised ENDOTINE device (with a material change) is as safe and effective as the previously cleared ENDOTINE device (K014153). Therefore, the provided text does not contain the kind of detailed clinical study information a de novo device submission would.
Based on the provided text, here's what can be inferred or explicitly stated regarding your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a modification to an already cleared device, primarily a material change. Therefore, specific performance metrics (e.g., tensile strength, fixation stability) would have been used to demonstrate equivalence to the predicate device, rather than patient-focused clinical acceptance criteria. The document does not explicitly state numerical acceptance criteria or performance results (e.g., "The device demonstrated a fixation strength of X N, meeting the acceptance criterion of >Y N"). Instead, it relies on the concept of "substantial equivalence" across various attributes.
| Acceptance Criteria (Inferred from Substantial Equivalence Claim) | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Similar intended use | Intended use remains unchanged (browplasty surgery, fixation of subdermis to cranial bone). |
| Similar fundamental scientific technology | Technology is considered similar. |
| Similar labeling | Labeling is considered similar. |
| Similar design | Design is considered similar. |
| Similar dimensional specification | Dimensional specifications are considered similar. |
| Similar performance specification | Performance specifications are considered similar to the predicate, demonstrating equivalence despite material change. |
| Similar ergonomics of the patient-user interface | Ergonomics are considered similar. |
| Similar packaging and expiration dates | Packaging and expiration dates are considered similar. |
| Similar sterilization methods | Sterilization methods are considered similar. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not describe a clinical "test set" in the sense of patient data. The basis of equivalence is likely through bench testing and possibly animal studies to compare the performance characteristics of the new material variant to the predicate device. The document does not specify the number of samples or specimens used in such tests, nor does it mention any clinical data provenance (country, retrospective/prospective) for a test set. This is typical for a 510(k) based on substantial equivalence for a material change.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable and not provided. The "ground truth" here would relate to the performance characteristics of the device itself (e.g., mechanical properties, biocompatibility), established through engineering tests and scientific principles, not clinical expert consensus on patient outcomes.
4. Adjudication Method for the Test Set
This information is not applicable and not provided for the reasons stated above. Adjudication methods like 2+1 or 3+1 typically refer to clinical outcome assessment by multiple experts, which is not the primary focus of this "substantial equivalence" submission for a material change.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging devices where human readers interpret medical images with or without AI assistance. The ENDOTINE device is a surgical fixation device.
6. If a Standalone (Algorithm Only) Performance Study Was Done
No, this is a surgical fixation device, not an algorithm. Standalone performance studies are for AI/ML-based algorithms.
7. The Type of Ground Truth Used
For this 510(k) submission, the "ground truth" would be established through:
- Bench Test Results: Mechanical properties (e.g., strength, degradation profile, pull-out force), biocompatibility, and possibly sterile barrier integrity testing.
- Scientific Principles: Demonstrating that the new material (bioabsorbable) meets the functional requirements and safety profile of the predicate device.
- Historical Data from Predicate Device (K014153): The successful clinical use and safety record of the predicate device serve as the ultimate "ground truth" for the intended use and performance.
8. The Sample Size for the Training Set
Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable.
In summary, this 510(k) submission (K023922) focuses on demonstrating substantial equivalence to a previously cleared device (K014153) due to a change in material. It is not a submission for a new device requiring extensive clinical trials to establish de novo safety and effectiveness or algorithm performance. The "acceptance criteria" are implicitly met by demonstrating that the device with the new material performs equivalently to the predicate device across various non-clinical and design attributes. The provided text outlines the declaration of substantial equivalence but does not detail the specific test results or clinical studies that would support such a claim beyond stating similarity in fundamental scientific technology, design, and performance specification.
§ 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.