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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.

Device Description

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.

AI/ML Overview

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 <65 years (p=0.93), highlighting an age-specific effectiveness profile.
Clinical Performance (Safety)	Acceptable Adverse Event (AE) profile.	Acceptable despite higher risk: - Increased relative risk of total AEs of the index shoulder (RR 1.47; 95% CI 1.02, 2.10) for InSpace™ vs. Partial Repair. - Increased relative risk for medication use for AEs (RR 1.44). - Increased relative risk for serious AEs related to the index shoulder (e.g., open opioid prescriptions, reverse total shoulder arthroplasty). - Majority of AEs (93% InSpace™, 90% Partial Repair) were mild or moderate. - No serious device-related adverse effects.	Despite higher risk ratios, the overall benefit-risk determination was positive, noting the mild-to-moderate nature of most AEs and no serious device-related events.
Clinical Performance (Surgical Time)	Shorter surgical time compared to partial rotator cuff repair.	Achieved: - Duration in Operating Room: 84 minutes (InSpace™) vs. 113 minutes (Partial Repair). - Duration of Anesthesia: 91 minutes (InSpace™) vs. 121 minutes (Partial Repair). - Duration of Procedure: 45 minutes (InSpace™) vs. 71 minutes (Partial Repair).	Significant advantage in surgical time for InSpace™.
MRI Safety and Device Integrity	Device inflation and location within the subacromial space.	Partially met, concern noted: - Core Imaging Lab assessment at Week 6: Inflation success 88% (28/32), Location success 84% (27/32), Combined success 72% (23/32). - FDA Independent Musculoskeletal Radiologist assessment at Week 6: Inflation success 78% (25/32), Location success 63% (20/32), Combined success 47% (15/32). - Migration or collapse/rupture identified in 28% to 53% of cases at 6 weeks.	FDA's more stringent criteria showed lower success rates for inflation and location, and a higher rate of migration/collapse/rupture. This was acknowledged as a risk in the benefit-risk determination.
Non-Clinical Performance (Integrity & Degradation)	Integrity (mechanical and chemical stability) and characterization of degradation profile.	Achieved: - In vitro degradation: Mostly degraded at (b)(4) weeks, via hydrolysis. - In vitro vs. in vivo degradation: Correlation demonstrated in molecular weight and viscosity, meeting criteria. - Fatigue testing (inflated implants): Average weight loss after (b)(4) days of cyclic testing was (b)(4), meeting acceptance criteria (<(b)(4) weight loss). No degradation/failure visually. - Resistance to external loads: Average max load at failure was (b)(4) (range: (b)(4)-(b)(4)), surpassing criterion of ≥(b)(4) (2x max expected force).	All bench testing results suggested adequate performance against simulated conditions.
Biocompatibility	All patient-contacting components must be biocompatible.	Achieved: - Evaluated per ISO 10993-1. Cytotoxicity, intracutaneous irritation, systemic sub-acute and chronic toxicity, sensitization, material-mediated pyrogenicity, chemical characterization, and toxicological risk assessment were conducted. - Exhaustive extraction showed no concerning extract concentrations. - Declared biocompatible.	Comprehensive testing indicated no biocompatibility concerns.
Sterility/Packaging/Shelf Life/Pyrogenicity	Sterility (SAL 10-6), packaging integrity, shelf life, and pyrogenicity (EU <20 per device) must be supported.	Achieved: - Sterilized by ethylene oxide to SAL 10-6 per ISO 11135:2008. - Packaging validated per ISO 11607-1:2006 and ISO 11607-2:2006. - Shelf life of 3 years determined via real-time and accelerated aging, with functionality tests passed. - Pyrogenicity testing demonstrated acceptable levels (<20 EU per device). Endotoxin monitoring plan in place.	All aspects met established standards.

2. Sample Sizes and Data Provenance

Test Set (Clinical Study):
- Sample Size: 184 subjects (93 investigational: 91 control were enrolled and randomized).
- Data Provenance: Prospective, multicenter, randomized, single-blinded controlled study conducted at 22 sites (19 in the US, 3 in Canada).
MRI Reassessment Test Set (Subset of Clinical Study):
- Sample Size: 32 patients with evaluable MRIs out of 93 subjects in the InSpace™ group at Week 6. A total of 171 MR images (89 InSpace™, 82 Partial Repair) were assessed at Month 12 for residuals.
- Data Provenance: Retrospective analysis of MRI data collected prospectively during the clinical trial (US and Canada).

3. Number and Qualifications of Experts for Ground Truth (Clinical Study)

The document does not explicitly state the number or specific qualifications of experts used to establish the ground truth for the clinical study outcomes (WORC, ASES, SSSI, SADEs). These are typically patient-reported outcomes or clinically documented events adjudicated by study investigators and/or independent committees.
For MRI Reassessment Ground Truth: An "FDA Independent Musculoskeletal Radiologist" performed an independent assessment. The qualifications (e.g., years of experience) are not specified beyond the specialty. A "Core Imaging Lab" also conducted assessments.

4. Adjudication Method for the Test Set (Clinical Study)

The document does not explicitly detail the adjudication method (e.g., 2+1, 3+1) for the clinical outcomes (WORC, ASES scores, SSSI, SADEs). These outcomes are typically collected directly or via validated questionnaires and reviewed by study personnel.
For the MRI Reassessment, two independent assessments were performed: one by a "Core Imaging Lab" and another by an "FDA Independent Musculoskeletal Radiologist." Their findings were compared. This represents a form of independent review rather than an explicit adjudication process like 2+1, but serves to validate the imaging findings.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study evaluating human reader improvement with AI assistance was performed. This study evaluated a medical device (spacer), not an AI algorithm for diagnostic assistance. The clinical trial was a direct comparison between the InSpace™ device and partial rotator cuff repair.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical medical implant, not an algorithm.

7. Type of Ground Truth Used

Clinical Study:
- Effectiveness Endpoints: Primarily patient-reported outcomes (Western Ontario Rotator Cuff - WORC, American Shoulder and Elbow Surgeons - ASES, VAS Pain, EQ-5D-5L), clinician-assessed range of motion (ROM), and documented surgical interventions (SSSI) and adverse events (SADEs).
- Safety Endpoints: Clinically documented adverse events adjudicated by study investigators and reported.
MRI Reassessment: Imaging findings (implant inflation, location, presence of residuals, condition of tissues) as interpreted by a Core Imaging Lab and an FDA Independent Musculoskeletal Radiologist.

8. Sample Size for the Training Set

Not applicable. This study pertains to a physical medical device. There is no mention of an AI model or training set in the context of device performance of the InSpace™ system itself. The clinical trial and bench studies serve as the "training" data in a broader sense for regulatory approval, but not as a machine learning training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As there is no AI model or training set, this question is not relevant to the provided text. The "training" to demonstrate safety and effectiveness was achieved through the described bench, animal, and clinical studies, with ground truth established by the methods outlined in point 7.

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