(67 days)
Interspace Shoulder is indicated for temporary use (maximum of 180 days) as a shoulder replacement (SR) in skeletally mature patients undergoing a two-stage procedure due to a septic process. The head and stem are inserted into the glenoideal cavity and the humeral medullary canal, respectively, following removal of the existing implant and radical debridement. The device is intended for use in conjunction with systemic antibiotic therapy (standard treatment approach to an infection). Interspace Shoulder is not intended for use for more than 180 days, at which time it must be explanted and a permanent device implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion etc.).
The Interspace Shoulder devices is a temporary device composed of fully formed PMMA bone cement with gentamicin and an inner stainless steel metal core. The design mimics a hemi-shoulder prosthesis.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Tecres Interspace Shoulder Temporary Shoulder Prosthesis:
Based on the provided 510(k) summary (K112983), this submission is for a modified medical device, not a new AI/software-as-a-medical-device (SaMD) or diagnostic device. As such, the typical "acceptance criteria" and "study" questions you'd ask for an AI model's performance metrics (like sensitivity, specificity, AUC) are not directly applicable in this context.
Instead, the "acceptance criteria" here refer to production specifications and performance adequate for in vivo application under temporary conditions of use, and the "study" is a performance testing conducted to demonstrate substantial equivalence to a previously cleared device.
Here's the breakdown of the information as requested, translated into the context of this medical device submission:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Material Properties | Mechanical properties matching predicate device and suitable for use. | Evaluated and found to support substantial equivalence. |
| Drug Release Profile | Gentamicin release consistent with intended therapeutic effect. | Evaluated and found to support substantial equivalence. |
| Stability | Device stability for temporary use (up to 180 days). | Evaluated and found to support substantial equivalence. |
| Manufacturing Standards | Meeting production specifications. | Evaluated and found to support substantial equivalence. |
| Biocompatibility | Suitable for in vivo application. | Implicitly covered by substantial equivalence to predicate. |
| Indications for Use | Same as predicate device (temporary shoulder replacement for septic process, up to 180 days). | Confirmed as the same, thus meeting this "performance" criterion. |
Note: The document states that the performance testing was to verify that the implant performance "continues to meet the production specifications and be adequate for in vivo application under the temporary conditions of use." The primary "acceptance criteria" seem to be demonstrating that the modified device is substantially equivalent to its predicate (K060535) despite the addition of a metal reinforcing structure and a new material supplier.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated. The "performance testing" described is likely mechanical and chemical testing of the device itself and its components, rather than a clinical trial with patient data. Therefore, the "test set" would refer to the number of devices or material samples subjected to laboratory tests (e.g., fatigue testing, tensile strength, gentamicin elution studies). Without further documentation, the exact number cannot be determined from this summary.
- Data Provenance: Not applicable in the sense of patient data. The testing would have been conducted in a laboratory setting by the manufacturer (Tecres S.p.A.).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. For material and mechanical performance testing, "ground truth" is established through standardized engineering and chemical testing methods, not expert consensus on clinical cases.
- Qualifications of Experts: Not applicable. The testing would be performed by qualified engineers, chemists, and technicians following established protocols.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. This type of testing involves objective measurements against predefined specifications, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
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MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI diagnostic tool on human reader performance, which is not the nature of this device.
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Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: Not applicable. This device is an implanted prosthesis, not an algorithm or a software device.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the performance testing, the "ground truth" would be established by:
- Engineering specifications and standards: For mechanical properties (e.g., ISO standards for implant materials, internal design specifications for strength and durability).
- Chemical analysis standards: For gentamicin release and stability (e.g., pharmacopeial methods, validated analytical chemistry techniques).
- Comparison to predicate device's established performance: To demonstrate substantial equivalence.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI/machine learning device. The device itself is the product. The term "training set" is not relevant here.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no "training set."
Summary of the 510(k) Submission's Core Argument:
The K112983 submission for the Interspace Shoulder Temporary Shoulder Prosthesis argues for substantial equivalence to its own previously cleared version (K060535). The key modifications are the introduction of a metal reinforcing structure and a new material supplier. The manufacturer conducted performance testing (mechanical properties, gentamicin release, and stability data) to demonstrate that these changes did not negatively impact the device's ability to meet its production specifications and remain adequate for its temporary in vivo application. The FDA's clearance indicates that they found this demonstration of substantial equivalence sufficient without requiring complex clinical trials or new performance metrics beyond what was presented for the predicate device.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.