(230 days)
SURESHOT™ TAN Nails are indicated for fractures of the femur including simple long bone fractures, severely comminuted, spiral, large oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; and for fixation of fractures that occur in and between the proximal third and distal fourth of the femur.
In addition, SURESHOT™ TAN Nails contain holes/slots proximally to accept screws that thread into the femoral head for compression and rotational stability and are indicated for the following: subtrochanteric fractures; intertrochanteric fractures; ipsilateral femoral shaft/neck fractures; and intracapsular fractures.
SURESHOT™ TAN Nails and Accessories are for single use only.
The subject devices are comprised of intramedullary nails and accessories such as lag screws, compression screws and set screws for use in the femur. All described components are manufactured from titanium material. The subject devices are available in the following size ranges:
| Device Type | Available Range of Diameters | Available Length Range |
|---|---|---|
| Nails | 9mm - 13mm | 32cm - 42cm |
| Lag Screws | 8.64mm (one diameter only) | 70mm - 125mm |
| Compression Screws | 6.22mm (one diameter only) | 30mm - 120mm |
| Set Screws | 6.6mm (one diameter only) | 25.4mm - 39.3mm |
The provided 510(k) summary for the SURESHOT™ TAN Nails and Accessories describes a medical device for femoral fracture treatment. However, it does not include information about acceptance criteria or a study designed to prove the device meets specific performance metrics in the way that an AI/software device would.
This document pertains to a Class II medical device (intramedullary nails and accessories), which typically undergo different types of testing and approval processes compared to AI/ML-driven software as a medical device (SaMD). The evaluation for such devices often focuses on:
- Substantial Equivalence: Demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is primarily done through comparisons of indications for use, material composition, and technological design characteristics.
- Pre-clinical Testing: Mechanical testing (e.g., fatigue, pullout strength) to ensure the device can withstand the physiological loads it will experience.
- Biocompatibility Testing: Ensuring the materials are safe for implantation.
Therefore, the specific questions regarding acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, and standalone performance are not applicable to this type of device accordingment to the provided text.
Here is a summary of the information that is available in relation to your questions, highlighting what is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (N/A for this device type) | Reported Device Performance (N/A for this device type) |
|---|---|
| Not defined in the provided document. | Not defined in the provided document. |
- Explanation: The document does not specify quantitative acceptance criteria for clinical performance metrics (like sensitivity, specificity) as would be expected for a diagnostic or AI device. The "performance" discussed is primarily related to mechanical properties and comparison to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This type of information (sample size, data provenance, retrospective/prospective) is typically relevant for clinical studies or AI algorithm validation. For this orthopedic implant, the "testing" involved pre-clinical mechanical evaluations. The document does not mention any clinical test sets with human subjects or associated data provenance.
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: Ground truth establishment by experts is not described, as there is no clinical test set or diagnostic task presented in the 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: No clinical test set or adjudication method is described.
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
- Not Applicable: MRMC studies are used for evaluating diagnostic performance, often with AI assistance. This is an orthopedic implant, and no such study is mentioned or relevant to its 510(k) clearance process described here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: There is no algorithm or AI component in this device, so standalone performance is irrelevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable: As there is no diagnostic or AI component, the concept of "ground truth" for classification or diagnosis is not discussed. For mechanical testing, the "ground truth" would be the engineering specifications and material properties against which the device's physical performance (e.g., fatigue life, pullout strength) is measured, often by comparison to predicate devices.
8. The sample size for the training set
- Not Applicable: There is no AI/ML model described that would require a training set.
9. How the ground truth for the training set was established
- Not Applicable: No training set or associated ground truth establishment is mentioned.
Summary of the Study that Proves the Device Meets the Acceptance Criteria (Based on Provided Document):
The "study" described in the 510(k) summary to establish substantial equivalence (which serves as the "acceptance criteria" for this type of device) primarily consisted of:
- Comparison to Predicate Devices: The SURESHOT™ TAN Nails and Accessories were compared to several legally marketed predicate devices (TriGen™ Titanium Intramedullary Nail System, TriGen™ InterTAN Nail, TriGen™ Trochanteric Antegrade Nail, TriGen™ Meta-Nails Retrograde Femoral and Tibia Nails, Asian Intramedullary Hip Screw (IMHS), T2 Femoral Nail). The comparison focused on:
- Overall indications for use: The new device shares "very similar indications" with predicates.
- Material composition: Manufactured from identical titanium material as predicates.
- Technological design characteristics: Incorporated "very similar technological design characteristics" to predicates.
- Pre-clinical Testing: To further support substantial equivalence, the following pre-clinical tests were conducted:
- Finite Element Analysis (FEA): A computational method to predict how a product reacts to real-world forces, vibration, heat, fluid flow, and other physical effects.
- Construct Fatigue Testing: Evaluation of a nail construct with appropriate accessory devices to determine its resistance to cyclic loading over time, simulating physiological conditions.
- Axial Pullout Testing: Assessment of the force required to pull out the lag screw from an appropriate test medium, indicating fixation strength.
The document states that substantial equivalence was based on these similarities and pre-clinical tests, implying that the results of these tests demonstrated comparable performance to the predicate devices and met general engineering and safety standards for such implants. The specific numerical results or detailed acceptance thresholds for these pre-clinical tests are not provided in this summary.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.