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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.

Device Description

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.

AI/ML Overview

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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K Number

K082525

Device Name

CORIN METAFIX FEMORAL STEM

Manufacturer

CORIN USA

Date Cleared

2010-02-04

(520 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K003666,K992235,K925866,K042992

Intended Use

The indications for the Corin Metafix Hip Stem as a total hip arthroplasty include:

Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
Rheumatoid arthritis
Correction of functional deformity
Treatment of non-union, femoral neck and trochanteric fractures of the proximal femur
DDH/CDH
The Corin Metafix Hip Stem is indicated for cementless use only.

Device Description

The Corin Metafix Hip Stem is a titanium femoral hip stem featuring a 12/14 tapered male trunnion for assembly with modular femoral head components. The stem is manufactured from Titanium (TiAI.V.) alloy for surgical implant applications, conforming to ASTM F136-2 and is coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-88. 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 9 sizes (Size 2 to Size 10), each available in three lateral offsets including standard, lateralized, and Coxa Vara.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Corin Metafix Hip Stem, structured as requested. It's important to note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel device performance against specific, pre-defined acceptance criteria in the way a new drug or high-risk device might.

Acceptance Criteria and Study for Corin Metafix Hip Stem

This document describes a 510(k) submission for the Corin Metafix Hip Stem, asserting its substantial equivalence to a predicate device (Depuy Orthopaedics Corail AMT Hip System). The concept of "acceptance criteria" in this context is primarily focused on demonstrating that the new device performs at least as well as the predicate for its intended use, rather than meeting novel performance thresholds.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criterion	Reported Device Performance (Corin Metafix Hip Stem)
Mechanical Performance / Safety	Fatigue Strength: Device should withstand physiological loading conditions over its intended lifespan without fracture or failure, comparable to the predicate device.	Met Acceptance: Non-clinical testing included "mechanical fatigue testing." The results of this testing, along with static tensile testing and range of motion testing, "show that the Corin Metafix Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." Implicitly, its fatigue performance was found to be comparable and adequate.
	Static Tensile Strength: Device should withstand static tensile forces without deformation or failure, comparable to the predicate device.	Met Acceptance: "Static tensile testing" was performed. Results, along with fatigue and range of motion testing, "show that the Corin Metafix Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." Implicitly, its static tensile performance was found to be comparable and adequate.
	Range of Motion: Device allows for appropriate range of motion when implanted, comparable to the predicate device.	Met Acceptance: "Range of motion testing" was performed. Results, along with fatigue and static tensile testing, "show that the Corin Metafix Hip Stem is expected to be safe and effective for the proposed indications and is substantially equivalent to the predicate device." Implicitly, its range of motion performance was found to be comparable and adequate.
Biocompatibility / Material Safety	Material Conformance: Device materials (Titanium (TiAI.V.) alloy, Hydroxyapatite coating) must conform to established ASTM standards for surgical implant applications.	Met Acceptance: The stem is "manufactured from Titanium (TiAI.V.) alloy for surgical implant applications, conforming to ASTM F136-2" and is "coated with plasma sprayed hydroxyapatite conforming to ASTM F-1185-88." This directly indicates material conformance to the specified standards.
Functional / Design Equivalence	Proximal Horizontal Grooves, Distal Vertical Grooves, Medial Calcar Grooves: Presence and design of these features should be substantially equivalent to the predicate device to ensure comparable seating and stability.	Met Acceptance: The device "has proximal horizontal grooves, distal vertical grooves and medial calcar grooves that are substantially equivalent to those found on the predicate device, the Depuy Corail AMT Hip System." This explicitly states equivalence in these design features.
Indications for Use / Intended Use Equivalence	Matching Indications: The indications for use of the new device must be identical or substantially similar to the predicate device to justify substantial equivalence.	Met Acceptance: "The Corin Metafix Hip Stem has the same intended use and indications... as the predicate." The listed indications for both are: Non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), Rheumatoid arthritis, Correction of functional deformity, Treatment of non-union/femoral neck/trochanteric fractures, and DDH/CDH.
Manufacturing Processes (Implied for 510(k))	While not explicitly listed as an "acceptance criterion" in performance, implicit in a 510(k) is that the manufacturing process ensures consistent quality and adherence to specifications, which is typically demonstrated through a Quality Management System (QMS) as per 21 CFR Part 820.	Met Acceptance: The FDA's substantial equivalence letter reminds the applicant of their responsibility to "comply with all the Act's requirements, including... good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)." This indicates that the expectation is that they meet these unstated but critical criteria.
Clinical Performance (No Specific Criteria for SE)	For a 510(k), explicit prospective clinical performance criteria are typically not required if substantial equivalence can be demonstrated through non-clinical means and similarity to a predicate. The "acceptance criterion" is effectively "clinical testing is not necessary to prove substantial equivalence."	Met Acceptance: "Clinical testing was not necessary to determine substantial equivalence between the Corin Metafix Hip Stem and the predicate device." This implicitly means that based on the non-clinical data and design similarity, the device is presumed to have comparable clinical performance to the predicate.

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

Test Set Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients" in the context of clinical data. The "test set" here refers to the specimens used for the non-clinical mechanical testing (fatigue, static tensile, range of motion). The exact number of hip stems tested for each mechanical evaluation is not provided in this summary.
Data Provenance: The mechanical testing described (fatigue, static tensile, range of motion) is non-clinical. The origin of the data is therefore laboratory-based testing performed by the manufacturer (Corin USA) or a contracted lab. It is prospective in the sense that the tests were conducted specifically for this submission. There is no mention of geographical provenance for the subjects being tested as it's not human data.

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

This information is not applicable as the "test set" described consists of non-clinical mechanical performance tests. Ground truth in this context would be the objective measurement of physical properties, not expert opinion.

4. Adjudication Method for the Test Set

This is not applicable as the "test set" consists of non-clinical mechanical performance tests. No adjudication of expert opinions or interpretations was involved.

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. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is common for AI/imaging devices involving human interpretation, but it is entirely irrelevant for a mechanical orthopedic implant like a hip stem.

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

No. A standalone algorithm performance study was not done. This device is a mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical mechanical tests, the "ground truth" would be the objective, empirically measured physical properties of the device (e.g., force to fracture, cycles to failure, range of motion limits under load). This is based on established engineering principles and ASTM standards for materials and testing.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device being a mechanical implant. AI models have training sets, but this product does not involve AI.

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

This information is not applicable. As there is no "training set," there is no ground truth to establish for it.

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