(395 days)
The InSpace™ Subacromial Tissue Spacer System is indicated for the treatment of patients with massive. irreparable full-thickness torn rotator cuff tendons due to trauma or degradation with mild to moderate gleno-humeral osteoarthritis in patients greater than or equal to 65 years of age whose clinical conditions would benefit from treatment with a shorter surgical time compared to partial rotator cuff repair.
The InSpace™ Subacromial Tissue Spacer System (Figure 1) is a prescription-use device that is comprised of a biodegradable implant provided pre-loaded on a deployer. The deployer is designed for deployment, inflation, sealing, and detachment of the implant in the subacromial space between the humeral head and the acromion. The system is single-use, supplied sterile, and ready for use in the operating room upon removal from the package. Once positioned in the subacromial space, the implant is filled with sterile saline (0.9%, not provided) to the pre-defined volume, sealed, and released from the deployer. Following implantation, it is designed to biodegrade over approximately one year.
The implant is supplied pre-folded within the cylindrical protective tube of the deployer to facilitate insertion into the subacromial space and achieves its final shape by subsequent unfolding via inflation with sterile saling, and detachment. It is supplied in three sizes to accommodate individual anatomical variations (Small, Medium, or Large). The InSpace implant is designed to reduce pain and restore function to the gleno-humeral joint by acting as a temporary spacer between the humeral head and acromion, enabling smooth gliding between the bones and reducing acromio-humeral contact pressure while depressing the humeral head to a more central anatomical position on the glenoid, similar to that of a shoulder with an intact rotator cuff.
This document describes the InSpace™ Subacromial Tissue Spacer System, a resorbable shoulder spacer intended for patients with massive, irreparable full-thickness torn rotator cuff tendons. The acceptance criteria and the study proving the device meets these criteria are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the InSpace™ Subacromial Tissue Spacer System are derived from the primary composite endpoint of the pivotal clinical trial and the special controls outlined.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Comments |
|---|---|---|---|
| Clinical Performance (Effectiveness) | Non-inferiority compared to partial repair in improving shoulder function (WORC ≥275 pts, ASES >6.4 pts) and reducing symptoms, with no subsequent secondary surgical interventions (SSSI) or Serious Adverse Device Effects (SADEs) at 24 months, specifically for patients ≥65 years of age. | Achieved (for ≥65 years): |
- For patients ≥65 years: Non-inferiority established (p=0.01) with 87.8% success rate (InSpace™) vs. 88.1% (Partial Repair), within 10% margin.
- WORC improvement (InSpace™): -1083.37 at Month 24, ASES improvement (InSpace™): 46.22 at Month 24. These represent improvements over baseline similar to or numerically greater than Partial Repair.
- Similar SSSI rates for both groups.
- No serious device-related adverse effects observed. | Non-inferiority was not statistically achieved for the overall population (p=0.06) or for patients
§ 888.3630 Resorbable shoulder spacer.
(a)
Identification. A resorbable shoulder spacer is intended to act as a temporary spacer, creating a physical barrier between tissues in the shoulder, for the treatment of massive irreparable rotator cuff tears.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Evaluation of improvement of shoulder function and reduction of symptoms (
e.g., pain and function) for the indications for use; and(ii) Evaluation of relevant adverse events.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and include the following:
(i) Integrity testing of the device, including mechanical and chemical stability; and
(ii) Characterization of the device degradation profile.
(3) Animal performance testing must include evaluation of the following:
(i) Adverse effects, including gross necropsy and histopathology; and
(ii) Device degradation to verify in vitro versus in vivo degradation correlation.
(4) All patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Performance data must support the sterility and pyrogenicity of the device components intended to be sterile.
(6) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life.
(7) Labeling must include the following:
(i) Instruction for use, including specific instructions regarding device selection and placement;
(ii) A detailed summary of the clinical performance testing with the device, including procedure- and device-related complications or adverse events; and
(iii) A shelf life.