(62 days)
The Solana Surgical LLC, Gaitway Implant System is intended to treat the hyperpronated foot and stabilize the subtalar joint. It is intended to block forward and medial displacement of the talus, thus blocking excessive pronation and the resulting sequela.
The Solana Surgical Gaitway Implant is a one-piece device made of Titanium Alloy intended to be implanted in the Sinus Tarsi of the foot. The implant is available in a range of sizes (5) ranging from 6.5 mm to 11.5 mm. The design of the Solana Surgical implant is similar to the predicate devices. No new materials or processes are used in the production of this implant.
The provided text is for a 510(k) summary for a medical device called the "Gaitway Implant System," a subtalar arthroereisis implant. The primary goal of a 510(k) submission is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove device performance against specific acceptance criteria through a clinical study in the same way a PMA (Pre-Market Approval) study would.
Therefore, many of the typical acceptance criteria and study details for a software-based or diagnostic device are not applicable to this type of submission. This 510(k) focuses on equivalence in material, geometry, and intended use.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This table is not applicable in the traditional sense of a clinical study with performance metrics for diagnosis or treatment efficacy like sensitivity, specificity, or accuracy. The "acceptance criteria" for a 510(k) for an implantable device like this revolved around demonstrating substantial equivalence to predicate devices in terms of:
| Acceptance Criterion (for Substantial Equivalence) | Reported Device Performance (from 510(k)) |
|---|---|
| Material Composition | Identical to Memometal and Instratek predicate devices (Titanium Alloy). |
| Mechanical Strength Characteristics | "Greatly exceeds the mechanical strength characteristics of the Arthrex device" (which is made of PLLA). "Equivalent or greater strength" than predicates. |
| Geometry/Design | Similar to predicate devices; conical shape to fit sinus tarsi. Cannulated. |
| Indications for Use | Intended to treat hyperpronated foot and stabilize the subtalar joint, blocking forward/medial talus displacement and excessive pronation. This matches the function described for predicate devices. |
| Manufacturing/Usage Attributes | One-piece, range of sizes (6.5mm to 11.5mm), single use, surgical implantation longer than 30 days, placed into subtalar sinus tarsi. Consistent with predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. This 510(k) is based on a comparison to predicate devices, not a clinical trial with a "test set" of patients in the way a diagnostic device would have a test set of images or cases. The evaluation is primarily bench testing of material properties and design comparison.
- Data Provenance: Not applicable. There is no patient data involved in demonstrating substantial equivalence in this context. The data comes from engineering specifications and comparisons to existing devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Not applicable. There is no "ground truth" to establish for a test set of patients or data in this type of 510(k) submission. The evaluation is based on engineering principles and regulatory equivalence.
4. Adjudication Method for the Test Set
- Not applicable. No test set or human adjudication process is described or required for this type of submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size.
- No. An MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This is an implantable device, and such a study is not part of its 510(k) pathway.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- No. This is an implantable medical device, not an algorithm or software. Therefore, "standalone performance" in that context is not applicable. The device itself performs its intended function in the body.
7. The Type of Ground Truth Used
- Not applicable. For this 510(k), the "ground truth" equivalent would be established engineering and material science principles, and the regulatory understanding of what constitutes a safe and effective implant based on the performance of legally marketed predicate devices. There's no pathology, expert consensus, or outcomes data used to establish ground truth for a test set in this application.
8. The Sample Size for the Training Set
- Not applicable. This submission does not involve machine learning or AI algorithms with "training sets."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As above, no training set is involved.
Summary of the Study that Proves the Device Meets Acceptance Criteria (Substantial Equivalence):
The "study" described in the 510(k) summary is a comparative analysis of the Solana Surgical Gaitway Implant System against three legally marketed predicate devices:
- Memometal SubFix Arthroereisis Implant (K093820)
- Instratek, INC. Sub-Talar Lok, Model 7-11 mm (K080280)
- Arthrex Pro Stop Plus (K071456)
The primary method of demonstrating that the device meets "acceptance criteria" (i.e., is substantially equivalent) involves:
- Direct Comparison: The applicant explicitly states that "The design of the Solana Surgical implant is similar to the predicate devices."
- Material Equivalence/Superiority: The device is constructed of Titanium Alloy, which is "identical to the Memometal and Instratek devices." It is also stated that it "greatly exceeds the mechanical strength characteristics of the Arthrex device" (which is PLLA).
- Geometric Equivalence: All compared devices (Solana Surgical and predicates) are "conical in shape so as to fit into the anatomy of the sinus tarsi" and are "cannulated to accept a guide wire."
- Indications for Use Equivalence: The indications for use of the Gaitway Implant System are presented, and the summary implies their consistency with the predicate devices: "Each device is placed into the sinus tarsi of the foot, allowing normal subtalar joint motion while blocking excessive pronation."
- Manufacturing and Usage Parameter Equivalence: All devices are for single use, surgical implantation longer than 30 days, and placed into the subtalar sinus tarsi.
The conclusion drawn by the applicant, and presumably accepted by the FDA based on the approval letter, is: "Given the similar geometry and equivalent or greater strength, the Solana Surgical device should not introduce new concerns of safety or effectiveness."
The FDA's letter (K122738) confirms their review and determination that the device is substantially equivalent to legally marketed predicate devices for the stated indications for use. This regulatory determination serves as the "proof" that the device meets the necessary acceptance criteria for market clearance under the 510(k) pathway.
§ 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.