(134 days)
The HammerLock® is indicated for: Small bone reconstruction and fusion such as inter-digital fusion of fingers and toes.
The Hammerlock is a nitinol implant that comes in a range of sizes to provide intramedullary fixation for fingers and toes. The Hammerlock device is situated in the intramedullary space and the prongs extending into the cancellous bone. When the device is warmed by body temperature. the prongs deflect outward to create an anchoring force. This configuration change for the Hammerlock involves minor configuration changes and adding new sizes to the product line for surgeon choice to better conform to patient anatomy.
The provided text describes a 510(k) premarket notification for a medical device called HammerLock. This is a regulatory submission for a medical device seeking clearance to market, demonstrating substantial equivalence to a legally marketed predicate device. This type of submission does not typically include detailed studies proving device performance against specific acceptance criteria in the way a clinical trial for a new drug or a novel AI software would.
Instead, the "study" mentioned here is primarily bench testing to demonstrate that the upgraded device maintains the same mechanical and material properties as its predicate.
Therefore, many of the requested fields (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, or ground truth for training) are not applicable to this type of regulatory submission as they pertain to clinical or AI performance evaluations, which are not detailed here.
Here's a breakdown based on the information provided:
Acceptance Criteria and Reported Device Performance
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Mechanical Bend Test | Substantially equivalent to predicate K091951 Hammerlock for stiffness and strength (as per ASTM F382-99). | All new Hammerlock designs were found to be substantially equivalent to the stiffness and strength of the predicate. |
| Corrosion Resistance | Adequate according to technical literature and substantially equivalent to predicate SmartToes devices (K070598), as per ASTM F2129-08. | The Hammerlock corrosion resistance was found to be adequate according to technical literature and substantially equivalent to that of the SmartToe (K070598). |
| Material Composition | Nitinol, per ASTM F2063-05. | Nitinol, per ASTM F2063-05. (Matches predicate) |
| Heat Source | Fully transformed at body temperature. | Fully transformed at body temperature. (Matches predicate) |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified for the bench tests. Typically, these involve a small number of representative samples for mechanical and material testing.
- Data Provenance: Not applicable. The "data" here refers to physical properties measured in a laboratory setting, not patient data.
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):
- Not Applicable. Bench testing does not involve human experts establishing ground truth in the clinical sense. The "ground truth" is defined by the objective physical properties and standards (ASTM F382-99, ASTM F2129-08).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for subjective human assessments, not direct physical measurements in bench testing.
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. This is a physical medical implant, not an AI or imaging device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For mechanical and corrosion resistance: Objective physical measurements against established ASTM standards and comparison to predicate devices' measured properties.
8. The sample size for the training set:
- Not Applicable. This device did not involve a "training set" in the context of machine learning or clinical trials. Bench testing does not have a training phase; it's a direct evaluation of manufactured samples.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set mentioned, this question is not relevant.
§ 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.