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Total hip components are indicated for uncemented use in individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma, inflammatory joint disease such as rheumatoid arthritis, or noninflammatory degenerative joint disease (NIDJD) or any of its composite diagnoses such as osteoarthritis; avascular necrosis; traumatic arthritis; slipped capital epiphysis; fused hip; fracture of the pelvis; diastrophic variant; old, remote osteomyelitis with an extended drainage-free period; nonunion, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; femoral osteotomy, or Girdlestone resection; fracture dislocation of the hip; and correction of deformity. Smith & Nephew Modular Hip components are for single use only.

The Smith & Nephew Modular Hip consists of primary and revision stems used with porous and HA coated modular sleeves. The stems feature a 12/14 taper and are used with existing Smith & Nephew femoral heads and acetabular components. Modular hip stems and sleeves are manufactured from Ti-6Al-4V conforming to ASTM F 1472 or ASTM F 136.

This document is a 510(k) premarket notification for a hip implant, which primarily focuses on establishing substantial equivalence to previously approved devices based on design, materials, and mechanical testing. It does not contain the kind of detailed clinical study data, acceptance criteria, or performance metrics typically seen in AI/software device submissions. Therefore, I cannot provide information for many of the requested fields.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable for this submission type. The submission relies on mechanical test data and substantial equivalence to predicate devices, rather than clinical performance metrics with pre-defined acceptance criteria for accuracy, sensitivity, or specificity.

2. Sample size used for the test set and the data provenance

No test set of clinical data is described or used in this submission. The "test" mentioned refers to mechanical testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. No clinical ground truth was established for a test set.

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

Not applicable.

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 not an AI/software device submission.

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

Not applicable. This is not an AI/software device submission.

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

Not applicable for clinical performance. For mechanical performance, the "ground truth" would be the engineering specifications and established test methods for hip implants.

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable.

Summary of Relevant Information from the Document:

• Acceptance Criteria (Implicit for mechanical testing): The device is "capable of withstanding expected in vivo loading without failure" and is "equivalent to devices currently used clinically." This is a general statement about mechanical integrity, not specific quantitative performance metrics.
• Study Proving Acceptance: "A review of the mechanical test data indicated that the Smith & Nephew Modular Hip is equivalent to devices currently used clinically and is capable of withstanding expected in vivo loading without failure."
• Sample Size for Mechanical Testing: Not explicitly stated, but mechanical testing of medical devices typically involves a specific number of samples tested to failure or for a specified number of cycles according to relevant ASTM or ISO standards. The document does not provide these details.
• Data Provenance (Mechanical Testing): The mechanical testing would have been conducted by the manufacturer, Smith & Nephew, Inc.
• Ground Truth (Mechanical Testing): Established through engineering specifications and industry-standard mechanical test protocols (e.g., ASTM F1472, ASTM F136 mentioned for materials).
• Substantial Equivalence: The primary "study" for this submission is a comparison to predicate devices, demonstrating similarity in "indications for use, design features, operational principles, and material composition."

In conclusion, this document describes a traditional medical device submission (hip implant) that relies on mechanical testing and substantial equivalence to predicate devices, not clinical studies with acceptance criteria relevant to AI or software performance.

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The S-ROM Zirconia Ceramic Femoral Head is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, posttraumatic arthritis, collagen disorders, avascular necrosis, and non-union of femoral fractures. Use of the prosthesis is also indicated for revision of previous hip arthroplasty and for patients with congenital hip dysplasia, protrusio acetabuli, slipped femoral epiphysis, and disability due to previous fusion.

The S-ROM Zirconia Ceramic femoral head is manufactured of either Yttrium Stabilized Zirconium Oxide (Zirconia), also known as PROZYR® or ZYRANOX™ zirconia ceramic. The S-ROM ceramic femoral head is designed to be used with 11/13 Morse-taper femoral stems composed of either titanium alloy or cobalt-chromium alloy.

This document, K980081, is a 510(k) premarket notification for the S-ROM Zirconia Ceramic Femoral Head. It is not a study report that describes acceptance criteria and device performance based on a study. Instead, it is a submission to the FDA demonstrating substantial equivalence to a predicate device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies cannot be extracted from this document.

The document states:

• "The S-ROM Zirconia Ceramic Femoral Head is identical in design (drawing specifications) to the S-ROM Zirconia Ceramic Femoral Head cleared for marketing under premarket notification K973307 (November 20, 1997) for use with titanium alloy femoral components."
• "The S-ROM Zirconia Ceramic Femoral Head is identical in material (PROZYR® or ZYRANOX™) to the S-ROM Zirconia Ceramic Femoral Head cleared for marketing under premarket notifications K973307 and K921111."
• "The subject device is to be utilized with the same 11/13 Morse-taper femoral components as the predicate device mentioned above (S-ROM Zirconia Ceramic Femoral Head). The difference between the femoral stems which will be utilized is the material composition of either titanium or cobalt-chromium alloy."

This indicates that the manufacturer is asserting equivalence based on design and material similarity to previously cleared devices, rather than presenting a new study with specific acceptance criteria and performance data for this particular submission. The FDA's letter confirms substantial equivalence without requiring a new clinical performance study.

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