(28 days)
The Stryker XCEL Anchor System is intended for use in securing soft tissue to bone in such procedures as:
Shoulder:
Bankart repair
SLAP lesion repair
Rotator cuff repair
Capsular shift repair
Biceps tenodesis
Acromio-clavicular separation
Knee:
Medial collateral ligament repair
Lateral collateral ligament repair
Joint capsule closure to anterior proximal tibia
Posterior oblique ligament or joint capsule to tibia repair
Extra capsular reconstruction/ITB tenodesis
Patellar ligament and tendon avulsion repairs
Elbow:
Biceps tendon reattachment
Foot & Ankle:
Achilles tendon repair/reconstruction
Lateral stabilization
Medial stabilization
The Stryker XCEL Anchor System is intended for single-use only.
The line extension of the Stryker XCEL Anchor System consists of a Poly L-lactic acid (PLLA) anchor pre-threaded with non-absorbable braided polyethylene surgical suture, and pre-assembled on a disposable inserter.
The provided document is a 510(k) summary for the Stryker XCEL Anchor System, a medical device intended for securing soft tissue to bone. It's a "line extension" of an existing device, meaning it's substantially equivalent to a previously cleared product.
Here's the information regarding acceptance criteria and the study, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in terms of performance metrics (e.g., tensile strength, pull-out force with specific thresholds). Instead, the acceptance criterion for this 510(k) "line extension" is primarily substantial equivalence to the predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K023013) | "The line extension of the Stryker XCEL Anchor System is substantially equivalent in material of construction, overall design, intended use, and safety and efficacy to the predicate device. The subject device was shown to have substantially equivalent performance when compared to the predicate device." |
| Sterility (SAL of 10^-6) | "The line extension of the Stryker XCEL Anchor System will be provided sterile for single-use (ASTM 4169)... validated to a sterility assurance level (SAL) of 10−⁶." |
| Biocompatibility (per ISO-10993-1 and G95-1) | "The device is biocompatible per ISO-10993-1 and G95-1." |
| Ethylene Oxide Residuals (limits per ANSI/AAMI/ISO 11135) | "The device will be sterilized by Ethylene Oxide (ANSI/AAMI/ISO 11135), including limits for Ethylene Oxide residuals..." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on specific sample sizes for a test set or the provenance (country of origin, retrospective/prospective) of data used for any specific performance testing. The focus of this 510(k) summary is on demonstrating substantial equivalence rather than presenting detailed raw study data. It implies that performance testing was conducted, but the specifics are not included in this high-level summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe a clinical study with human patients where expert adjudication of outcomes would be required to establish "ground truth." The evaluation here is for a medical device's substantial equivalence to a predicate, not a diagnostic algorithm. Therefore, information about experts for ground truth is not applicable in this context.
4. Adjudication Method for the Test Set
As there's no mention of a clinical study generating a "test set" requiring human interpretation or diagnosis, there's no adjudication method described in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done for this 510(k) application. This type of study is typically for evaluating the impact of an AI-powered diagnostic tool on human reader performance. The Stryker XCEL Anchor System is a physical surgical implant, not a diagnostic AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
N/A. This is not an algorithm or AI device, so the concept of standalone performance does not apply.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established standards and predicate device performance. The type of "ground truth" used for demonstrating substantial equivalence includes:
- Existing Predicate Device Performance: The primary ground truth is the established safety and efficacy profile of the predicate device (Stryker XCEL Anchor System, K023013). The new device is compared against this.
- Industry Standards: Compliance with standards like ASTM 4169 (sterility), ANSI/AAMI/ISO 11135 (EO sterilization and residuals), and ISO-10993-1/G95-1 (biocompatibility) serve as ground truth for specific aspects of the device.
8. The Sample Size for the Training Set
There is no mention of a "training set" as this is not an artificial intelligence or machine learning device. The term "training set" is not applicable.
9. How the Ground Truth for the Training Set was Established
As there is no training set, this question is not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.