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

• Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
• Rheumatoid arthritis
• Correction of functional deformity
• DDH/CDH
• Revision procedures where other treatments or devices have failed
• Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  The MiniHip Stem is indicated for cementless use only.

The MiniHip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion 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 (TiAIsV4) alloy and is proximally coated with plasma sprayed hydroxyapatite over plasma sprayed pure titanium in order to enhance primary fixation. The stem is designed to be used in conjunction with Corin Eurocone CoCr modular femoral heads (K003666) and Corin Zyranox Zirconia Ceramic modular femoral heads (K992235), both of which mate with Corin Cenator Acetabular Cups (K925866). The stem is available in six sizes, each with the provision of a 130° CCD (Caput-Collum-Diaphysis) neck angle with a polished distal section for guidance and to minimize distal fixation and reduce proximal stress-shielding.

The provided text describes a 510(k) premarket notification for the MiniHip Stem, a femoral hip stem. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, the document does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics such as accuracy, sensitivity, or specificity.

The "Non-Clinical Testing" section mentions "mechanical fatigue testing, range of motion testing and coating characterization," and states that "The results of this testing show that the MiniHip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." However, it does not provide the quantitative acceptance criteria for these tests, nor the reported performance data from these tests.

The "Clinical Testing" section explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices." This means no human-based clinical studies, including those for the purpose of demonstrating clinical performance or comparative effectiveness (MRMC studies), were conducted or submitted for this 510(k).

As a result, I cannot populate the requested table or answer most of your specific questions related to acceptance criteria and device performance studies because the information is not present in the provided text.

Here's a summary of what can be extracted or directly inferred:

1. Table of Acceptance Criteria and Reported Device Performance

• Cannot be provided. The document states that non-clinical testing (mechanical fatigue, range of motion, coating characterization) was performed, and the results showed the device is "expected to be safe and effective" and "substantially equivalent." However, it does not list specific quantitative acceptance criteria (e.g., "fatigue strength must exceed X N at Y cycles") or the device's measured performance against those criteria.

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

• Not applicable / Not provided. No clinical or standalone device performance testing data on a "test set" (in the context of AI/diagnostic device evaluation) is presented. The non-clinical tests would have used physical device samples, but details on their quantity or "data provenance" are not given.

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

• Not applicable / Not provided. No test set or ground truth establishment by experts is mentioned.

4. Adjudication method for the test set

• Not applicable / Not provided.

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

• No. The document explicitly states: "Clinical testing was not necessary to determine substantial equivalence between the MiniHip Stem and the predicate devices." This includes MRMC studies.

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

• No. The device is a physical medical implant (femoral hip stem), not an algorithm or diagnostic software that operates in a "standalone" mode.

7. The type of ground truth used

• Not applicable / Not provided. In the context of a hip stem, "ground truth" would typically relate to mechanical properties, biocompatibility, and clinical outcomes. The document relies on non-clinical testing for mechanical and material properties, and substantial equivalence to predicate devices for clinical safety and effectiveness rather than direct clinical ground truth generation.

8. The sample size for the training set

• Not applicable / Not provided. The device is a physical implant, not an AI model that requires a "training set."

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

• Not applicable / Not provided.

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