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Indications for use include:

1. noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis;
2. rheumatoid arthritis;
3. correction of functional deformity;
4. revision procedures where other treatments or devices have failed; and,
5. nonunions, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Secur-Fit Advanced Hip Stems with compatible Howmedica Osteonics Constrained Liners:

1. When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Secur-Fit Advanced Hip Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Howmedica Osteonics is introducing the Novel Fit and Fill Hip Stem (aka Secur-Fit Advanced), a tapered non-porous coated femoral stem intended for cementless, press-fit application. The basic design of the Secur-Fit Advanced is similar to other total hip stems that have been commercially distributed such as the Accolade II, Secur-Fit and Rejuvenate Monolithic Hip Stems. The Novel Fit and Fill and the Accolade II stem are both made from the same material combinations. The subject device is similar in design to Secur-Fit and Rejuvenate Monolithic as they are straight stems with a normalization pattern. Three dimensional simulations have shown the normalizations on the anterior and posterior aspects of the proximal end of the stem to facilitate press-fit stability and load transmission in the proximal region of the femur. These normalizations are designed to convert medial and lateral shear stresses to compressive forces, which may facilitate proximal loading.

The stem is manufactured from a Ti-6Al-4V substrate material, Commerically Pure (CP) Titanium coating and Purefix hydroxylapatite (HA) coating identical to the previously cleared Accolade II Hip Stem (K103479, K120578).

The Secur-Fit Advanced Hip Stem has a shot peened neck and includes 16 implant sizes 4-12 (nine 132° stems & seven 127° stems) that provide dual head offsets. The stem is designed only for use with compatible Howmedica Osteonics' femoral heads and acetabular components.

The provided document describes the K122853 510(k) submission for the Secur-Fit Advanced Hip Stem, which is a medical device. This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical acceptance criteria in the manner one might find for a software or AI device.

Therefore, the requested information geared towards AI/software device studies (like sample size for test sets, data provenance, ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable to this submission. This is a traditional mechanical medical device submission.

Here's the information derived from the document, tailored to the context of a mechanical medical device:

Acceptance Criteria and Device Performance (Mechanical Device)

Study Details (Mechanical Device)

1. Sample size used for the test set and the data provenance:

   • The document refers to "mechanical testing" (Distal Stem Fatigue Testing and Neck Fatigue Testing). For such tests, the "sample size" would typically refer to the number of physical device units tested according to the specified ISO standards. This specific number is not provided in the summary.
   • Data provenance: Not explicitly stated, but mechanical testing is generally performed in a laboratory setting by the manufacturer or a contracted lab. This is standard pre-market testing for mechanical medical devices. It is not retrospective or prospective in a clinical sense.

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

   • Not applicable. For mechanical device testing, the "ground truth" is adherence to predefined engineering specifications and performance standards (e.g., ISO 7206-4, ISO 7206-6). Expert clinical consensus is not typically used to establish this type of ground truth.

3. Adjudication method for the test set:

   • Not applicable. Test results are typically compared directly against the pass/fail criteria of the specified international standards. There is no "adjudication" in the sense of reconciling human reader opinions.

4. 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 mechanical hip stem, not an AI or software device. MRMC studies are for assessment of reader performance, typically with imaging or diagnostic devices.

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

   • Not applicable. This is a mechanical hip stem, not an AI or software device.

6. The type of ground truth used:

   • Compliance with international mechanical testing standards (ISO 7206-4 and ISO 7206-6) and demonstration of material and design equivalence to legally marketed predicate devices.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable.

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