Search Results

The Orthosphere® Ceramic Spherical Implant is indicated for use in cases of isolated carpometacarpal (CMC) or 4th/5th tarsometatarsal (TMT) joint involvement from either degenerative or post-traumatic arthritis presenting:

• Decreased motion
• X-ray evidence of arthritic changes and/or subluxation of the carpometacometacarpal or tarsometatarsal joints
• Localized pain and palpable crepitation during circumduction movement with axial compression of the involved thumb ("grind test")
• Associated unstable, stiff or painful distal joints
• Decreased pinch and grip strength
• Degenerative joint disease of the midfoot associated with gout or pseudogout

Only sizes 9mm-12mm are indicated for use in the 4th/5th tarsometatarsal joints. Sizes 9mm-14mm are indicated for use in the carpometacarpal (CMC) joints.

The Orthosphere® Ceramic Spherical Implant is for single use only.

The design features of the Orthosphere® Ceramic Spherical Implant previously submitted and cleared are summarized below:

• Manufactured from zirconia ceramic
• Highly polished surface finish
• Acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities
• Will rest in a spherical cavity and articulate directly on bone

Here's an analysis of the provided text regarding the Orthosphere® Spherical Implant, focusing on acceptance criteria and the supporting study information:

Summary of Acceptance Criteria and Device Performance for the Orthosphere® Ceramic Spherical Implant

Based on the provided K030319 510(k) Summary, the device's acceptance criteria and demonstrated performance are primarily centered on substantial equivalence to predicate devices, rather than a direct performance study with quantitative metrics reported against specific acceptance criteria.

The key acceptance criteria appear to be alignment with the intended use, design features, material, and type of interface of already cleared predicate devices. The "performance" is implicitly deemed acceptable by meeting these equivalence standards.

1. Table of Acceptance Criteria and Reported Device Performance

• Extended indication for TMT joints: "substantially equivalent to the indications for use of the Swanson Titanium Great Toe previously submitted and cleared." Both predicate and the Orthosphere articulate on bone, act as a spacer, and allow capsuloligamentous reconstruction. |
  | Design Features | - Manufactured from zirconia ceramic. | - Identical to predicate: "The design features of the Orthosphere® Ceramic Spherical Implant are identical to the Ceramic Spherical CMC Implant." Also, "Manufactured from zirconia ceramic." |
  | | - Highly polished surface finish. | - "Highly polished surface finish." (Implicitly identical to predicate) |
  | | - Acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction. | - "Acts as a spacer to preserve joint relationship and allow appropriate capsuloligamentous reconstruction to correct deformities." (Implicitly identical to predicate) |
  | | - Rests in a spherical cavity and articulates directly on bone. | - "Will rest in a spherical cavity and articulate directly on bone." (Implicitly identical to predicate) |
  | Material | | - Substantially equivalent to predicates: "The material... of the Orthosphere® Ceramic Spherical Implant are substantially equivalent to the Ceramic Spherical CMC Implant and the Swanson Titanium Great Toe Implant." |
  | Type of Interface | | - Substantially equivalent to predicates: "The... type of interface of the Orthosphere® Ceramic Spherical Implant are substantially equivalent to the Ceramic Spherical CMC Implant and the Swanson Titanium Great Toe Implant." |
  | Safety and Effectiveness | Adequately supported by substantial equivalence information and materials data (implicit acceptance criteria for a 510(k) submission). | - "Adequately supported by the substantial equivalence information and materials data provided within this Premarket Notification." The FDA's clearance letter confirms "the device is substantially equivalent... to legally marketed predicate devices." |

2. Sample Size Used for the Test Set and Data Provenance

• No specific "test set" in the conventional sense (e.g., patient data, image dataset) is described for evaluating the Orthosphere® Ceramic Spherical Implant.
• The study relies on substantial equivalence to existing predicate devices (Ceramic Spherical CMC Implant and Swanson Titanium Great Toe Implant).
• Data provenance: Not applicable in the context of a comparative performance study. The "data" consists of design specifications, material properties, and intended uses compared against predicate devices, which would be based on data generated during the development and regulatory clearance of those predicate devices.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

• Not applicable. This submission doesn't describe a study where ground truth was established by human experts for a test set. The "ground truth" for the submission is the regulatory clearance and established safety/effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No test set or expert adjudication process is described.

5. 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 medical device submission for an implant, not an AI/software device that would involve human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

• Not applicable. This is a medical device submission for an implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this submission is the established safety and efficacy of the predicate devices, as determined through their prior FDA clearance processes. This would have involved a combination of materials testing, mechanical testing, clinical data (if required for the predicate), and ultimately, regulatory review and approval.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

• Not applicable. There is no training set mentioned.

Ask a specific question about this device