(126 days)
The SAMBA™ Screw System is intended for fixation of sacroiliac joint disruptions. This fixation device is to only be used in skeletally mature patients.
The SAMBA screw is a cannulated metallic bone screw designed to stabilize the sacroiliac (SI) joint. The SAMBA screw is composed of implant-grade Titanium, Ti-6Al-4V ELI, conforming to ASTM F-136. The SAMBA screw is 9 mm in diameter and offered in 25-50 mm lengths with multiple longitudinal slots on its shaft. Each slot set consists of four (4) holes oriented 90 degrees apart around the circumference of the screw at specified axial location. It will be provided as sterile, single units packaged in a sealed tray and pouch. The screw is a single use device and is not intended to be resterilized.
This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study with acceptance criteria in the way a diagnostic AI product might. Therefore, many of the requested categories (like sample size for test set, number of experts for ground truth, MRMC study, ground truth for training set) are not applicable or not provided in this type of document.
The document primarily describes mechanical testing for the device's functional and performance requirements.
Here's a breakdown of the information that can be extracted or noted as not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional & Performance Requirements | Device design meets functional and performance requirements. | Representative samples underwent mechanical testing. The results imply that the device met these requirements, as the conclusion states substantial equivalence. Specific thresholds are not listed in this summary. |
| Static Axial Pull Out Strength | Measured in accordance with ASTM F2193-02 (2007) and F543-07. | Testing was performed as per ASTM F2193-02 (2007) and ASTM F543-07. Specific numerical results are not provided in this summary. |
| Static Torsion | Measured in accordance with ASTM F2193-02 (2007) and F543-07. | Testing was performed as per ASTM F2193-02 (2007) and ASTM F543-07. Specific numerical results are not provided in this summary. |
| Static Cantilever Bending | Measured in accordance with ASTM F2193-02 (2007) and F543-07. | Testing was performed as per ASTM F2193-02 (2007) and ASTM F543-07. Specific numerical results are not provided in this summary. |
| Dynamic Cantilever Bending | Measured in accordance with ASTM F2193-02 (2007) and F543-07. | Testing was performed as per ASTM F2193-02 (2007) and ASTM F543-07. Specific numerical results are not provided in this summary. |
| Material Composition | Implant-grade Titanium, Ti-6Al-4V ELI, conforming to ASTM F-136. | The SAMBA screw is composed of implant-grade Titanium, Ti-6Al-4V ELI, conforming to ASTM F-136. |
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 mechanical testing, but refers to "representative samples." This document does not describe a clinical "test set" in the context of an AI/diagnostic device.
- Data Provenance: The mechanical testing is laboratory-based, not patient-data based.
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: This is a hardware device (bone screw) undergoing mechanical testing, not a diagnostic AI product requiring expert-established ground truth from images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As above, this is mechanical testing, not a diagnostic study with a test set requiring adjudication.
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: This is a hardware implant, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable: This is a hardware implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (in the clinical/diagnostic sense): For this device, the "ground truth" for compliance would be the established engineering and materials standards (ASTM F2193-02, ASTM F543-07, ASTM F-136) that the device must meet through mechanical testing.
8. The sample size for the training set
- Not Applicable: There is no "training set" in the context of a hardware device undergoing mechanical testing.
9. How the ground truth for the training set was established
- Not Applicable: There is no "training set" for this type of device submission.
§ 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.