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The Herbert Ulnar Head Prosthesis System is indicated for ulnar head and stem replacement necessitated by: 1) Failed operative procedures such as Darrach, Bowers, or Sauve-Kapandji, 2) Primary osteoarthritis, 3) Post -traumatic osteoarthritis as a result of radial fractures, TFCC tears, ulnar impingement, 4) Rheumatoid arthritis, and 5) Tumors.

The Herbert Ulnar Head Prosthesis System consists of an intramedullary ulnar stem made of titanium, a Co/Cr or Zirconia ulnar head, and a surgical instrumentation set.

The provided text describes a 510(k) premarket notification for the "Herbert Ulnar Head Prosthesis System." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics against those criteria. Therefore, much of the requested information regarding detailed acceptance criteria and a study proving device performance in the context of AI/software device evaluation is not directly applicable to this document.

However, I can extract the relevant information from the document to address as many of your points as possible within the context of a 510(k) submission for a physical medical device.

1. A table of acceptance criteria and the reported device performance

For a 510(k) for a physical implant, "acceptance criteria" are typically related to meeting recognized standards and demonstrating equivalence to a predicate device in terms of design, materials, and intended use. Performance is demonstrated through comparison with the predicate and compliance with these standards.

• ISO 5832-2:1999 (Unalloyed Titanium)
• ISO 5832-3:1996 (Wrought titanium 6-aluminium 4-vanadium alloy)
• ISO 5832-12:1996 (Wrought cobalt-chromium-molybdenum alloy)
• ISO 7153-1:1991/Amd. 1:1999 (Surgical instruments Metallic materials - Stainless steel)
• ASTM F899 95 (Stainless Steel Billet, Bar and Wire for Surgical Instruments)
• ASTM F138 97 (Wrought 18 Chromium-14 Nickel-2.5 Molybdenum Stainless Steel Bar and Wire for Surgical Implants) |
  | Sterilization Process Compliance: Ensure the sterilization method meets recognized standards. | The device complies with:
• AAMI/ANSI/ ISO 11134:1993 (Sterilization of health care products - industrial moist heat sterilization)
• AAMI/ANSI ST46:2002 (Steam Sterilization and Sterility Assurance in Health Care Facilities) |
  | Technological Equivalence to Predicate Device: Demonstrate that the design and features are substantially equivalent to a legally marketed predicate device. | An "8-point comparison of technological characteristics" was performed between the Herbert Ulnar Head Prosthesis System and the predicate device (uHead Ulnar Implant System, K010786). The devices were found to be substantially equivalent based on this comparison. |
  | Intended Use Equivalence: Ensure the indications for use are the same or subset of the predicate device. | The indications for use match the predicate: for ulnar head and stem replacement necessitated by: 1) Failed operative procedures (Darrach, Bowers, Sauve-Kapandji), 2) Primary osteoarthritis, 3) Post-traumatic osteoarthritis, 4) Rheumatoid arthritis, and 5) Tumors. |
  | Manufacturing Standards: Adherence to good manufacturing practices. | The device "will be manufactured per specifications using good manufacturing practices that ensure the device is safe and effective for its intended use." |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable to this 510(k) submission. A test set in the context of device performance studies (like for AI/software) was not used. The clearance is based on comparison to a predicate device and adherence to recognized standards for materials and manufacturing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no "test set" and thus no ground truth established by experts in the sense of a clinical performance study for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No test set requiring adjudication was used.

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 for a physical prosthetic implant, not an AI/software medical device.

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

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device.

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

Not applicable. For this 510(k), the "ground truth" for clearance is the established performance and safety of the legally marketed predicate device and the recognized standards for materials and manufacturing, not a clinical ground truth established for a test set.

8. The sample size for the training set

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device that uses a training set.

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

Not applicable. This is for a physical prosthetic implant, not an AI/software medical device that uses a training set.

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