(49 days)
The ENDOTINE TransBlephTM Device is intended for use in subperiosteal browplasty fixation. The ENDOTINE TransBlephTM is specifically indicated for use to fixate the sub-dermis to the frontal bone.
The ENDOTINE TransBleph™ Device kit consists of the brow implant with inscrtion tool and a drill bit. The TransBleph device along with its insertion tool and drill bit are supplied sterile for single use only.
The provided 510(k) summary for the ENDOTINE TransBleph™ Device does not contain the typical information associated with studies that establish acceptance criteria and prove a device meets them through clinical or performance evaluations in the way a diagnostic algorithm or a complex interventional device would.
This document describes a fastener (an implantable device) and focuses on demonstrating substantial equivalence to predicate devices based on design, materials, function, intended use, and performance evaluations. The "performance summary" refers primarily to mechanical testing and anecdotal feedback rather than a formal clinical study with quantifiable acceptance criteria.
Here's an analysis of the provided text in relation to your request, highlighting what's missing and what can be inferred:
1. A table of acceptance criteria and the reported device performance
This information is not explicitly stated in the provided document in the format of specific, measurable acceptance criteria with corresponding performance results.
The "Performance Summary" section (K04 0748, page 3) states:
- "Design performance studies that included cadaveric evaluation, and strength and compression testing results that exceeded specifications."
- "Feedback and user observation from several leading surgeons."
- "The ENDOTINE TransBleph™ performance data meet the applicable standards and fulfill the device requirements as defined in the design specifications."
While it mentions "exceeded specifications" and "meet applicable standards and fulfill device requirements," the specific numerical specifications, acceptance criteria, and the exact results are not detailed. For example, it doesn't state "tensile strength X N, acceptance criteria > Y N, device achieved Z N."
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document mentions "cadaveric evaluation" and "feedback and user observation from several leading surgeons." This suggests a small, unspecified number of cadavers and surgeons were involved.
- Data Provenance: Not specified. "Cadaveric evaluation" implies laboratory-based testing, not human clinical trial data. The "feedback and user observation" would likely be from surgeons practicing where the company operates or sponsored evaluations, but no country or specific setting is mentioned.
- Retrospective/Prospective: Not applicable in a formal sense, as no clinical trial is described. Mechanical testing of cadavers would be a prospective experiment. Surgeon feedback would be descriptive observation, not a structured clinical study.
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 concept of "ground truth" as it applies to diagnostic algorithms or complex outcome measures is not relevant or described for this type of device submission. The device is a bone fixation fastener. The "experts" mentioned are "several leading surgeons" who provided "feedback and user observation." Their number and specific qualifications beyond being "leading surgeons" are not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable/Not mentioned. There was no formal adjudication process described, as there was no study producing ambiguous results requiring expert consensus.
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
No, an MRMC comparative effectiveness study was not conducted or described. This type of study is relevant for diagnostic AI devices, not for a bone fixation fastener.
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 (expert consensus, pathology, outcomes data, etc.)
As noted in point 3, the concept of "ground truth" in the context of diagnostic performance is not applicable. The "ground truth" for this device's performance would be its mechanical integrity (strength, compression) and its ability to achieve its intended surgical function (fixate subdermis to frontal bone) in a cadaveric setting. This is evaluated by mechanical testing results "exceeding specifications" and "user observation," not through pathology or outcomes data from a clinical trial.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of developing this physical medical device. The device design is based on engineering principles, materials science, and presumably iterative design and testing.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study (as described in the 510(k)) and its Basis for Clearance:
The clearance for the ENDOTINE TransBleph™ Device was based on the following, rather than a formal clinical study with detailed acceptance criteria:
- Substantial Equivalence: The primary strategy was to demonstrate that the device is substantially equivalent in design, materials, function, and intended use to already legally marketed predicate devices (ENDOTINE Forehead™, Lactosorb® Panels, ENDOTINE Chin™ 3.5 Device).
- Performance Testing (Non-Clinical):
- Cadaveric evaluation: This involved testing the device's function in cadaver models. Although details are scant, this would assess its ability to be implanted and secure tissue as intended.
- Strength and compression testing: Mechanical tests to ensure the device can withstand the forces it will encounter in vivo. The document states these "exceeded specifications," implying internal design requirements were met.
- User Observation/Feedback: Input from "several leading surgeons" regarding their experience or observations.
- Material Safety: Reliance on the established safety profile of the device materials (likely the bioabsorbable material used in the predicate devices) in both the forehead and other craniofacial sites.
Conclusion:
The provided 510(k) summary does not describe a clinical study in the format typically used for diagnostic or more complex interventional devices, where quantitative acceptance criteria and detailed study designs (sample sizes, ground truth establishment, expert adjudication, MRMC studies) are paramount. Instead, the clearance was sought through a demonstration of substantial equivalence supported by non-clinical performance testing (mechanical and cadaveric) and anecdotal expert feedback. The acceptance criteria were implied to be the fulfillment of "design specifications" and "applicable standards" regarding mechanical performance, rather than clinical efficacy metrics.
§ 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.