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The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is to be press-fit.

The Linear stems without HA coating were cleared for commercial distribution on K974294 and K991325; the Foundation stem on K973302 and K991226; and the The only difference between the devices cleared in the Revelation on K973685. aforementioned submissions and this is the addition of hydroxyapatite to the porous The porous coating is plasma sprayed with coated regions of the proximal bodies. hydroxyapatite (HA).

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for HA Coated Hip Stems. The document is a 510(k) summary and FDA letter, which primarily focuses on establishing substantial equivalence to predicate devices for regulatory clearance, rather than detailing performance studies and specific acceptance criteria.

The information provided only discusses:

• The submitter's name and address
• Device name, common name, and classification name
• Legally marketed predicate devices
• Subject device description and intended use
• Technological characteristics and basis for substantial equivalence to predicate devices.
• The FDA's decision to clear the device for market based on substantial equivalence.

Therefore, I cannot extract the requested information regarding acceptance criteria or a study proving the device meets those criteria from the provided text.

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The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is to be press-fit.

When viewed in the mediolateral plane the Linear™ Porous Coated Hip Stem tapers slightly proximal to distal beginning at the distal border of the porous coating. Proximal to this point the stem flares approximately 6°. The stem has a rectangular cross-sectional geometry to provide rotational stability. The Linear™ Porous Coated Hip Stem is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136 or F620, respectively. The outside surface of the stern is porous coated with commercially pure titanium (ASTM F67 grade 2) to provide a porous surface for enhanced fixation. The stem is intended to be press-fit. The Linear™ Porous Coated Hip Stem is collarless and has a Morse type taper to receive modular heads. This stem is available with a standard head/stem offset and a lateralized version that provides additional lateralization of the patient's femur without increasing leg length. The stem/neck angle is 135°.

The provided text describes a medical device, the Linear™ Porous Coated Hip Stem, and its regulatory approval (K991325). It details the device's characteristics, materials, and intended use. However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of device performance metrics like accuracy, sensitivity, or specificity.

Instead, the document focuses on:

• Device Description: Physical attributes, materials, and manufacturing standards.
• Intended Use/Indications For Use: Clinical conditions for which the device is designed to be used.
• Comparable Features to Predicate Device(s): How it is similar to previously approved devices.
• Test Results (Limited): It mentions "Finite element analysis of the fatigue stem strength and laboratory testing of the Morse type taper was conducted," but provides no specific results, acceptance criteria for these tests, or detailed methodology.

Therefore, I cannot populate the requested table or answer most of the questions because the necessary data is not present in the provided text.

Here's how I would answer based on the absence of the requested information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample size: Not specified. The document mentions "Finite element analysis" and "laboratory testing," but no sample sizes for these tests are provided.
• Data provenance: Not applicable, as there are no detailed test results or clinical data presented to determine provenance (e.g., country of origin, retrospective/prospective). The tests mentioned appear to be mechanical/simulation-based.

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

• Not applicable. The document describes a hip stem, a physical implant. The "ground truth" concept (e.g., for diagnostic algorithms) does not apply here. The "tests" mentioned are mechanical stress analysis and taper quality, which would have engineering standards as their basis, not expert consensus on interpretations.

4. Adjudication method for the test set:

• Not applicable. No adjudication method is mentioned or relevant for the types of tests alluded to (finite element analysis, lab testing of taper).

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. This is a hip implant, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study and AI performance metrics are not relevant or discussed.

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

• No. This is a hip implant, not an algorithm or AI device.

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

• Not applicable in the context of diagnostic AI. For the mechanical tests mentioned, the "ground truth" would be established engineering standards and physical properties of the materials and design, against which the results of the finite element analysis and laboratory testing would be compared. These standards are not detailed.

8. The sample size for the training set:

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable. This is a physical medical device.

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The Linear™ Porous Coated Hip Stem is intended for treatment of patients who are candidates for total hip arthroplasty because the natural femoral head and neck have been affected by osteoarthritis, inflammatory arthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis or femoral neck fracture, and revision arthroplasty where bone loss is minimal.

The indications for use of the total hip replacement prosthesis include: noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis; rheumatoid arthritis; correction of functional deformity; revision procedures where other treatments or devices have failed; and treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement, which is unmanageable using other techniques. This stem is to be press-fit.

When viewed in the mediolateral plane the Linear™ Porous Coated Hip Stem tapers slightly proximal to distal beginning at the distal border of the porous coating. Proximal to this point the stem flares approximately 6°. The stem has a rectangular cross-sectional geometry to provide rotational stability

The Linear™ Porous Coated Hip Stem is fabricated from wrought/forged Ti-6Al-4V that conforms to ASTM F136 or F620, respectively. The outside surface of the stem is porous coated with commercially pure titanium (ASTM F67 grade 2) to provide a porous surface for enhanced fixation The stem is intended to be press-fit.

The Linear™ Porous Coated Hip Stem is collarless and has a Morse type taper to receive modular heads. This stem is available with a standard head/stem offset and a lateralized version that provides additional lateralization of the patient's femur without increasing leg length. The stem/neck angle is 135°.

The provided text is a 510(k) premarket notification for the Linear™ Porous Coated Hip Stem. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through a clinical study. Therefore, the document does not contain information regarding detailed acceptance criteria, a study proving device performance against those criteria, or the other specific elements requested in the prompt (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

The document primarily focuses on:

• Device Description: Material, design, and intended use.
• Predicate Device Comparison: Highlighting features comparable to existing devices.
• Laboratory Testing: Mentioning fatigue stem strength and Morse type taper testing, but without providing acceptance criteria or detailed results.
• FDA Clearance: A letter from the FDA stating that the device is substantially equivalent to predicate devices and can be marketed.
• Indications for Use: The specific conditions for which the hip stem is intended.

Therefore, I cannot provide the requested table and information as it is not present in the provided text. The information requested, such as acceptance criteria, detailed study results, sample sizes, and ground truth methodologies, would typically be found in a more comprehensive clinical trial report or a more detailed technical submission, which is not what this 510(k) summary provides.

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