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The indications for the MiniHip Stem as a total hip arthroplasty include:

• · Non-inflammatory degenerative joint discase including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• · Correction of functional deformity
• · Development dysplasia of the hip (DDI-I) and congenital dysplasia of the hip (CDH)

The MiniHip Stem is indicated for cementless use only.

The MiniHip Stern is a titanium femoral hip stem featuring a 12/14 tapered male trumion for assembly with modular femoral head components. The MiniHip Stem uses a short stem philosophy to provide a bone-conserving option to the use of a standard total hip prosthesis. The stem is manufactured from Titanium (TiAI6V4) alloy and is proximally coated with plasma sprayed hydroxyapatite, conforming to ASTM F-1185-03(2009), over plasma sprayed purc titanium. The Corin MiniHip Stem is available in 7 sizes marked 3 through 9. The Corin MiniHip Stem was originally cleared in K083312 and K111046.

Modular CoCrMo Femoral Heads are available in a diameter of 28mm with -3.5mm (short), 0.0mm (standard) and, +3.5mm (long) offsets and diameter of 32mm, 36mm and 40mm heads with offsets of -4mm (short), 0mm (standard) and +4mm (long) as previously cleared in K093472 and K110087 submissions. The 32mm with +7mm offset (extra-long), and the 36mm and +0mm with +8mm offset (extra-long), were added to the range of heads available in K130343.

Modular BIOLOX detta™ Ceramic Femoral Heads are available in a diameter of 28mm with -3.5mm (short), 0mm (standard) and, +3.5mm (long) offsets and diameters of 32mm, 36mm and 40mm heads with offsets of -4mm (short), 0mm (standard) +4mm (long) as previously cleared in K103120 and K110087 submissions. The 32mm with +7mm offset (extra-long), and the 36mm and 40mm with +8mm offset (extra-long), were added to the range of heads available in K130343.

The Corin MiniHip Stem was originally cleared in K083312 and K111046 and as clearced compatible with short, standard and long offsets modular femoral heads. The purpose of this submission is to modify the labeling for the Corin MiniHip Stem to include an additional size of the compatible femoral heads. The addition is for three offsets in the CoCrMo and Ceramic extra-long heads, 32mm (+7mm), 36mm (+8mm) and 40mm (+8mm).

The provided text describes a 510(k) premarket notification for a medical device (Corin MiniHip Stem) and explicitly states that clinical testing was not necessary to determine substantial equivalence.

Therefore, the following information regarding acceptance criteria, study details, expert involvement, and ground truth establishment cannot be extracted from the given document as no such study was performed or required for this submission.

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. No clinical study was performed, thus no acceptance criteria or corresponding device performance from such a study are reported.

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

• Not applicable. No clinical study was performed.

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

• Not applicable. No clinical study was performed.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical study was performed.

5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:

• No. An MRMC study was not performed. The submission explicitly states "Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices."

6. Standalone Performance Study:

• No. A standalone performance study (algorithm only) was not performed as this is a physical medical device, not an AI algorithm.

7. Type of Ground Truth Used:

• Not applicable. No clinical study was performed.

8. Sample Size for the Training Set:

• Not applicable. No training set for an algorithm was used as this is a physical medical device.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. No training set for an algorithm was used.

Summary of the Device Submission:

The submission for the Corin MiniHip Stem (K131986) was focused on modifying the labeling to include additional compatible modular femoral heads (32mm with +7mm, 36mm with +8mm, and 40mm with +8mm offsets). The device itself (MiniHip Stem) was already cleared in previous submissions (K083312 and K111046). The "substantial equivalence" claim was based on the fact that the MiniHip Stems in this submission are identical to predicate devices, and the additional compatible components are identical in material, intended use, and indications to components of an already cleared predicate device (Trinity Acetabular System with XL Heads, K130343). Therefore, no new clinical or performance studies were required.

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