(197 days)
The Spiralok Anchor is intended for: Shoulder: Rotator cuff repair.
The SpiraLok Anchor, like the current BioFastin RC Anchor, is a PLA threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of two strands of suture to bone. Ethibond non-absorbable suture, the Panacryl absorbable suture and the Orthocord composite suture options may include tapered needles to facilitate suture passage through tissue. The attached suture is then used to reattach soft tissue back to bone where it reconnects through the healing process.
The provided document is a 510(k) summary for a medical device (Spiralok Anchor) and focuses on demonstrating substantial equivalence to a predicate device (BioFastin RC Anchor). It does not contain information about clinical studies with acceptance criteria, device performance metrics, or study design details in the way typically required for AI/software-as-a-medical-device (SaMD) clearances.
Therefore, the requested information cannot be fully provided from the given text. Here's a breakdown of what can and cannot be extracted:
Acceptance Criteria and Device Performance (Not Applicable/Not Provided for this Type of Device)
This 510(k) pertains to a physical medical device (suture anchor), not an AI/SaMD. The "acceptance criteria" here are based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical laboratory testing and by showing that dimensional and material changes do not affect safety or effectiveness. Specific performance metrics like sensitivity, specificity, or F1-score, which are common for AI/SaMD, are not relevant or provided for this type of device.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria (Implicitly Met for Substantial Equivalence) | Reported Device Performance / Evidence |
|---|---|---|
| Material Safety | Biocompatibility, appropriate material properties for absorbable fixation (PLA) | Non-clinical laboratory testing (implied to match or be equivalent to predicate) |
| Dimensional Equivalence | Minor variations from predicate not impacting safety/effectiveness | Description of minor dimensional changes (detailed in Section 2, but not provided in extract) |
| Suture Option Safety | Inclusion of composite Orthocord suture does not compromise safety/effectiveness | Orthocord previously cleared by FDA (K040004) for general soft tissue approximation, including orthopedic surgeries. |
| Intended Use Equivalence | Device maintains the same intended use as the predicate | Stated that changes do not alter intended use (Shoulder: Rotator cuff repair). |
| Fundamental Scientific Technology Equivalence | Device operates on the same core principles as the predicate | Stated that changes do not alter fundamental scientific technology. |
1. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Information Not Provided: The document mentions "Non-clinical laboratory testing was performed," but does not detail sample sizes, specific test protocols, or data provenance for these non-clinical tests. This is a physical device, and these would likely be engineering or bench tests rather than clinical studies with patient data.
2. 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: For a physical device undergoing non-clinical laboratory testing, "ground truth" and expert consensus in the context of diagnostic interpretation (like for AI/SaMD) are not relevant. Testing would involve engineering measurements and material property assessments against established standards or predicate device performance.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are typically associated with human interpretation of data in clinical studies, not non-clinical laboratory testing of a physical implant.
4. 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 physical medical implant, not an AI/SaMD. MRMC studies or human reader improvement with AI assistance are not relevant.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is a physical medical implant, not an algorithm or SaMD.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the traditional sense: For non-clinical lab testing of a physical implant, "ground truth" would be established by validated measurement techniques, material specifications, and engineering principles, often by comparison to the established performance of the predicate device under simulated conditions.
7. The sample size for the training set
- Not Applicable: This device is not an AI/SaMD and does not involve "training sets" in the context of machine learning.
8. How the ground truth for the training set was established
- Not Applicable: As there is no training set for an AI/SaMD, this question is not relevant.
Summary of the Study that Proves the Device Meets Acceptance Criteria (from the provided text):
The document states that the determination of substantial equivalence was based on a detailed device description and changes made to currently marketed devices. "Non-clinical laboratory testing was performed demonstrating that the device is safe and performs as intended."
The core of the "study" demonstrating the Spiralok Anchor met the criteria for substantial equivalence involved showing that:
- Dimensional changes from the predicate BioFastin RC Anchor were minor and did not affect safety or effectiveness.
- Material changes (specifically the inclusion of the Orthocord suture option) were safe, as Orthocord was previously cleared by the FDA (K040004) for orthopedic surgeries.
- These changes did not alter the intended use, safety, effectiveness, or fundamental scientific technology of the predicate device.
The specific details of the "non-clinical laboratory testing" (e.g., specific tests, precise methodologies, number of units tested, results in terms of strength, degradation, etc.) are not included in this 510(k) summary, but are implicitly assumed to have been robust enough to satisfy the FDA's requirements for substantial equivalence.
§ 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.