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The DePuy RECLAIM Monobloc Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

The subject devices in this line extension to the RECLAIM Monobloc Revision Femoral Stem (previously cleared through Primary Predicate 510(k) K221462 and with MRI Conditional status cleared through 510(k) K231873) include four new Standard length RECLAIM Monobloc Revision Femoral Stems and twenty-three new Short length RECLAIM Monobloc Revision Femoral Stems.

The line extension will extend the DePuy RECLAIM Monobloc Revision Femoral Stems portfolio by twenty-seven product codes.

The Subject Device RECLAIM Monobloc Revision Femoral Stems are revision implants that are intended to treat patients with prior failed hip replacement devices. They are made of Ti6Al4V alloy and present a grit-blasted tapered fluted intramedullary region with splines that are intended to be in interference of the previously reamed femoral cavity and in contact with the cortical bone in the canal in an uncemented use.

The provided text describes a 510(k) clearance letter for the RECLAIM Monobloc Revision Femoral Stem. This is a medical device, specifically a hip joint prosthesis, not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI/SaMD performance criteria, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone algorithm-only performance," "number of experts for ground truth," and "training set size," are not applicable to this submission.

The clearance is for an expansion of the existing RECLAIM Monobloc Revision Femoral Stem (K221462 and K231873) to include additional sizes. The regulatory review focuses on mechanical performance and substantial equivalence to the predicate devices.

Here's the information extracted from the provided text regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for the mechanical tests (Neck Fatigue, MRI Safety, Range of Motion, Stem Fatigue). However, for medical device mechanical testing, typically a representative number of samples (e.g., 3-6 or more) for each configuration are tested according to relevant ISO or ASTM standards.

The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective. As these are physical device tests, they would be conducted in a laboratory setting.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is a physical device, not an AI/SaMD for which expert-established ground truth would be required. The "truth" is determined by mechanical testing against established engineering standards.

4. Adjudication Method for the Test Set

Not applicable. This is a physical device, not an AI/SaMD where adjudications of expert interpretations are relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Not applicable. This is a physical medical device (hip implant), not an AI/SaMD that assists human readers.

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

Not applicable. This is a physical medical device, not an AI/SaMD.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" is established by:

• Engineering Standards: Bench testing against industry-accepted standards (e.g., ISO, ASTM) for fatigue, range of motion, and other mechanical properties.
• Predicate Device Performance: Demonstrating that the subject device performs "as well as" or equivalently to the legally marketed predicate devices, which have already established safety and effectiveness.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/SaMD, therefore a "training set" in the context of machine learning is not relevant.

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

Not applicable. As above, there is no "training set" for this type of device.

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The DePuy RECLAIM Monobloc Revision Femoral Stem is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

The Subject Devices DePuy Reclaim Monobloc Femoral Stems are revision implants that are intended to treat patients with prior failed hip replacement devices. They are made of Ti6Al4V alloy and present a grit-blasted tapered fluted intramedullary region with splines that are intended to be in interference of the previously reamed femoral cavity and in contact with the cortical bone in the canal in an uncemented use.

The design of the Subject Device extramedullary region is based on that of the Predicate Reclaim Modular stem implants which were cleared by the FDA via K102080 in 2010. The extramedullary region has standard and high offset options on a polished neck, with a 12/14 AMT trunnion. The Subject Devices are intended to be inserted into the femoral canal using the Reclaim Monobloc Inserter Instruments.

With the exception of the Subject Device being a one-piece implant versus the Predicate two-piece modular implant, resulting in fewer theoretically possible construct lengths, and the addition of the secondary splines, the Subject and Predicate Devices are identical in intended use, indications for use, materials, sterilization method, and fixation method. The non-modular design, and the addition of the secondary splines do not impact the safety or effectiveness of the Subject Device as compared to the Predicate.

This 510(k) also includes sterilization instrument trays, that, according to FDA guidance document "Medical Device Accessories – Describing Accessories and Classification Pathways, Guidance for Industry and Food and Drug Administration Staff," issued on December 20, 2017, requires clearance under the same product codes as the Subject Device.

The provided document is a 510(k) summary for the DePuy Reclaim Monobloc Revision Femoral Stem. It describes the device, its indications for use, and how it demonstrates substantial equivalence to a predicate device.

Crucially, this document is for a medical device (hip stem prosthesis), not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of a "test set" for AI models, "ground truth" established by experts, "multi-reader multi-case (MRMC) studies," "training set," or "adjudication methods" are not applicable to the information presented in this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to engineering and biocompatibility testing for a physical implant, not the performance of an AI algorithm.

Here's a breakdown of the requested information based on what is relevant and present in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes non-clinical performance benchmarks and biocompatibility tests. The "acceptance criteria" are implied to be "Pass" for each test, indicating the device met the pre-defined standards for that specific test.

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

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of stems tested) for each non-clinical performance test. It simply states that "All testing was performed on final sterile devices."
• Data Provenance: The tests are laboratory-based, non-clinical tests performed on the physical device. There's no "country of origin of the data" or "retrospective/prospective" distinction in the way it applies to clinical data or AI
  studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. This is a physical device, and its performance is evaluated through engineering and material science tests, not by expert interpretation of images or other data for ground truth establishment.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication is relevant for consensus-based ground truth establishment in AI/clinical studies, not for objective engineering tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• No. An MRMC study is designed for evaluating human performance, often with and without AI assistance, in interpreting medical images or data. This document describes a physical medical implant. No such study was performed or is relevant here.
• Effect Size of Human Improvement with AI: Not Applicable.

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

• Not Applicable. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Engineering/Physical Test Standards. The "ground truth" here is the adherence of the device's physical properties and performance to established, industry-recognized standards (e.g., ISO standards for fatigue, biocompatibility testing protocols).

8. The Sample Size for the Training Set

• Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not Applicable. As there is no training set.

In summary: The provided document is a regulatory submission for a physical medical device. The concepts and terminology surrounding AI/SaMD performance evaluation do not apply to this context. The "acceptance criteria" were met through a series of non-clinical, bench-top engineering and biocompatibility tests designed to demonstrate the physical and material safety and effectiveness of the hip stem prosthesis.

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Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The Revision Femoral Stem consists of a femoral stem and a modular neck, assembled together through a taper coupling stabilized by means of a safety screw. When used in total hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with modular femoral heads and compatible acetabular cups. When used in partial hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with a Lock Bipolar Head.

The stem is made of Ti6Al4V (ASTM F1472 – ISO 5832-3). The stem is straight, with a tapered profile, round finned section and a rounded tip to facilitate insertion. The external surface of the stem features a macro-roughened finishing obtained by sandblasting. Diameters ranging from 14 to 26 mm, with increases of 1 mm, for a total of 13 diameters are available. Two lengths (140 or 200 mm) for each diameter of the stem are available.

The neck is made of Ti6A14V (ASTM F1472 – ISO 5832-3). The same material is also used for the safety screw, which also has a small pin made of UHMWPE (ISO 5834-2, ASTM F648) to help prevent loosening of the safety screw. Two (2) versions of the neck are available , one with a CCD angle of 131° and another with a CCD angle of 135°. Both the neck versions are available in 7 different heights. Distally, the external surface of the neck component features a macro-roughened finishing obtained by sandblasting; proximally, the surface of the neck component is polished to reduce the chance of polyethylene wear particles if the neck accidentally rubs against the polyethylene of the acetabular component.

This document is a 510(k) premarket notification for a medical device called "Revision Femoral Stem." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria. Therefore, the information requested may not be fully available in this document.

Based on the provided text, here's what can be extracted and what is explicitly stated as not applicable or not provided:

1. A table of acceptance criteria and the reported device performance:

The document describes non-clinical testing designed to demonstrate substantial equivalence, not to meet specific performance acceptance criteria for a new clinical indication. The tests performed are those commonly used for implantable orthopedic devices.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample size for test set: The document refers to "non-clinical testing" (mechanical and LAL testing), which typically involves a number of physical samples rather than biological test sets. The specific number of mechanical test samples for each test (e.g., how many stems were fatigued) is not provided.
• Data provenance: As this is non-clinical testing, there isn't a "country of origin of the data" in the sense of patient data. The manufacturer is Limacorporate S.p.A. in Italy, suggesting the testing likely occurred in a facility associated with the manufacturer or a contract testing laboratory.
• Retrospective or prospective: This concept is not applicable to non-clinical mechanical or LAL testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

This is not applicable as the document describes non-clinical mechanical and LAL testing, not studies requiring expert interpretation of clinical data to establish a ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable as the document describes non-clinical mechanical and LAL testing.

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:

This is not applicable. The device is an orthopedic implant (femoral stem), not an AI algorithm or an imaging diagnostic tool that would involve human readers or AI assistance.

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

This is not applicable as the device is an orthopedic implant.

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

For the non-clinical tests, the "ground truth" is defined by the standards themselves (e.g., ISO 7206-4, ISO 7206-6, ISO 21535) and the physical properties and performance characteristics measured against those standards. For LAL testing, the ground truth is the specified endotoxin limit (20EU/device).

8. The sample size for the training set:

This is not applicable as the document describes non-clinical mechanical and LAL testing for an orthopedic implant, not an AI algorithm or a clinical study that would have a "training set."

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

This is not applicable for the reasons stated above.

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Revision Femoral Stem is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur. It is intended for cementless revision hip arthroplasty on both uncemented and cemented femoral implants.

The Revision Femoral Stem consists of a femoral stem and a modular neck, assembled together through a taper coupling stabilized by means of a safety screw. When used in total hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with modular femoral heads and compatible acetabular cups. When used in partial hip arthroplasty, the Revision Femoral Stem prosthesis is intended for use with a Lock Bipolar Head. The stem is made of Ti6Al4V (ASTM F1472 – ISO 5832-3). The stem is straight, with a tapered profile, round finned section and a rounded tip to facilitate insertion. The external surface of the stem features a macro-roughened finishing obtained by sandblasting. Diameters ranging from 14 to 24 mm, with increases of 2 mm, for a total of 6 diameters are available. Two lengths (140 or 200 mm) for each diameter of the stem are available. The neck is made of Ti6A14V (ASTM F1472 – ISO 5832-3). The same material is also used for the safety screw. which also has a small pin made of UHMWPE (ISO 5834-2. ASTM F648) to help prevent loosening of the safety screw. Two (2) versions of the neck are available , one with a CCD angle of 131° and another with a CCD angle of 135°. Both the neck versions are available in 7 different heights. Distally, the external surface of the neck component features a macro-roughened finishing obtained by sandblasting: proximally, the surface of the neck component is polished to reduce the chance of polyethylene wear particles if the neck accidentally rubs against the polyethylene of the acetabular component.

This document is an FDA 510(k) clearance letter for a medical device (Revision Femoral Stem). It primarily focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing. Therefore, it does not contain information about the performance of a device that relies on AI/ML or require extensive clinical efficacy studies typically needed for new technologies or those without clear predicates.

Consequently, I cannot provide the detailed information requested in the prompt, as the document explicitly states:

• "Clinical Testing: Clinical testing was not necessary to demonstrate substantial equivalence of Revision Femoral Stem to the predicate devices."

This means there's no data in this document for acceptance criteria related to AI/ML performance, no test set, no ground truth establishment, no human expert involvement for adjudication, no MRMC study, and no standalone algorithm performance.

The document discusses non-clinical testing such as fatigue testing and fretting evaluation, but these are for the mechanical properties of the hip implant itself, not for an AI/ML algorithm's performance.

If you have a document about an AI/ML medical device, I would be happy to analyze it against your criteria.

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The Ascent Knee Revision Femoral Stem is indicated for use in:

• 1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved
• 2. Correction of varus, valgus or posttraumatic deformity
• 3. Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
     This device is for Cemented Use Only

The Ascent Knee Revision Stems are similar to the previously cleared Performance Posterior Stabilized (PS) Total Knee System (K936274) used to ensure component placement and stability. The modifications made add a larger and smaller diameter size, decrease the slot width, and change the stem material. The distal diameter on stems sized 10 - 16 were also increased. Minor modifications were also made to the femoral locking screw.
There are sixteen new wrought titanium alloy (Ti-6Al-4v) Ascent Revision Stems available. Twelve of these sixteen have the same diameter and length as the previously cleared Performance PS Total Knee System (K936274). The larger diameter revision stem has been added to fit within larger canals. The smaller diameter revision stem has been added to fit within smaller canals.

This document discusses a 510(k) premarket notification for the "Ascent Knee Revision Femoral Stem." Due to the nature of 510(k) submissions, the data provided focuses on demonstrating substantial equivalence to a predicate device rather than detailing a specific study with acceptance criteria and performance metrics in the way one might find for a novel device with clinical trial data.

Based on the provided text, a direct table of acceptance criteria and reported device performance, or a detailed study proving the device meets specific acceptance criteria, is not present. The submission relies on demonstrating substantial equivalence to an existing, legally marketed device.

Here's an analysis of the provided information in the context of your request:

1. A table of acceptance criteria and the reported device performance

• Not Applicable in this context. The document is a 510(k) summary, which is a premarket notification aiming to demonstrate "substantial equivalence" to a predicate device rather than fulfilling specific, pre-defined acceptance criteria through a novel clinical study. The "performance" described is in comparison to the predicate, and detailed success/failure rates or specific outcome metrics against pre-set thresholds are not typically part of this type of submission.
• Implied "Acceptance Criteria": The implicit acceptance criterion for a 510(k) is that the new device is "as safe and effective" as a legally marketed predicate device. This is primarily demonstrated by showing that the new device has the same intended use, similar technological characteristics, and any differences do not raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

• Not Applicable/Provided. Since this is a 510(k) submission focused on substantial equivalence, there is no mention of a "test set" in the context of a prospective clinical study involving patients. The "test" is more about comparing the device's design, materials, and intended use to the predicate. The document describes modifications to an existing device (Performance P/S Knee femoral stem) and states the new stems "have the same diameter and length" or represent "larger and smaller diameter size" modifications. This implies engineering analysis and possibly bench testing, but not a patient-based test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable/Provided. As there is no clinical test set with patient data being evaluated for "ground truth," there is no mention of experts establishing such a truth. The regulatory review process involves FDA experts evaluating the submission.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable/Provided. No clinical test set with patient data is described, so no adjudication method is relevant here.

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

• Not Applicable. The device is a knee revision femoral stem, a physical implant, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

• Not Applicable. The device is a physical implant. This question relates to AI/software performance, which is not relevant for this medical device.

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

• Not Applicable in the traditional sense. For a 510(k) for a physical implant, "ground truth" often refers to well-established engineering principles, material science data, and performance characteristics (e.g., wear, fatigue strength) compared to the predicate device, which has a proven track record of safety and effectiveness (its "ground truth" being its historical clinical outcomes). The clinical performance data of the predicate device (Performance P/S Knee femoral stem - K936274) serves as the "ground truth" that the new device is being compared against for substantial equivalence in safety and effectiveness.

8. The sample size for the training set

• Not Applicable/Provided. There is no "training set" in the context of machine learning or a clinical trial for this type of device submission.

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

• Not Applicable/Provided. As there's no training set, this question is irrelevant.

In summary:

The provided document is a 510(k) notification for a knee revision femoral stem. This regulatory pathway primarily involves demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing detailed clinical study results against specific acceptance criteria. The information you're asking for (acceptance criteria table, study sample sizes, expert ground truth, MRMC studies, etc.) is typically found in submissions for novel devices requiring clinical trials (e.g., PMA applications) or for AI/software as a medical device (SaMD). For this device, the "study" is the comparison against the predicate device through engineering analysis, material testing, and confirmation of similar intended use.

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The Partnership Revision Femoral Stems consist of a family of Titanium femoral stems with Titanium plasma spray coating that are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary and revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth.

The Partnership Revision Femoral Components consist of a family of Titanium femoral stems with Titanium plasma spray coating. The stems are intended to be used with Howmedica V40™ femoral heads, Howmedica Unipolar and Bipolar components, and Howmedica acetabular components in primary and revision total hip arthroplasty. These femoral stems are designed to be press fit into the proximal femur. They do not achieve fixation by biological ingrowth. These femoral components will be made available in two substrate alloys: 1) Ti-6Al-4V, which meets the requirements of ASTM specification F 136; or 2) TMZF alloy (Ti-11.5 Mo-6Zr-2 Fe). The TMZF alloy is the subject of draft ASTM specification F 1813. The Titanium plasma spray coating is CP titanium, which conforms to ASTM specification F 1580.

The provided document is a 510(k) summary for a medical device, specifically the "Partnership Revision Femoral Components" (hip prostheses). While it states that "Testing has demonstrated that the fatigue load carrying capacity of the Partnership Revision Femoral stems exceeds the minimum ISO load requirements," it does not provide explicit acceptance criteria, detailed study results, or the other specific information requested about a device performance study as it relates to software or AI.

The document is primarily a regulatory submission for premarket notification (510(k)) to establish substantial equivalence to existing devices. It focuses on device description, materials, intended use, and substantial equivalence to predicates, rather than on the detailed results of a performance study with acceptance criteria in the manner requested for a modern AI/software device.

Furthermore, the document is from 1997, predating the widespread use of AI in medical devices and the typical methodologies for AI/software device studies. The information requested, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are standard for AI/software device submissions today but are not typically found in 510(k) summaries for mechanical implants from that era.

Therefore,Based on the provided document (K972893 510(k) Summary for Partnership Revision Femoral Components), the detailed information regarding acceptance criteria and a study proving device adherence to these criteria, as typically understood for an AI/software device, is not available.

The document is for a mechanical orthopedic implant (hip prosthesis) from 1997, and its "study" information is limited to demonstrating compliance with mechanical engineering standards rather than clinical performance metrics in the context of AI.

However, I can extract and infer some related information:

1. A table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance: Not applicable/not provided for a clinical performance study in the context of an AI device. The fatigue testing is likely an engineering bench test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not provided. Mechanical testing does not typically involve expert ground truth establishment in this manner.

4. Adjudication method (e.g., 2+1, 3+1, none) 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: Not applicable. This device is a mechanical implant, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to the stated fatigue testing. For a hip prosthesis, the "ground truth" for its function would ultimately be patient outcomes and implant longevity, which is why the FDA required a postmarket surveillance study.

8. The sample size for the training set: Not applicable. This is a mechanical device, not an AI algorithm requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to performance and post-market study:

• Device Type: Mechanical orthopedic implant (femoral stems for hip arthroplasty).
• Performance Claim: "Testing has demonstrated that the fatigue load carrying capacity of the Partnership Revision Femoral stems exceeds the minimum ISO load requirements."
• Rationale for Postmarket Surveillance (Section 522(a)(1)(C)): Due to the lack of long-term (nine years and greater) clinical safety and effectiveness information for plasma-sprayed porous coatings, particularly regarding potential issues like metal debris, coating spalling, or coating delamination. This indicates that while bench testing met immediate mechanical standards, the long-term biological and clinical performance was an area of concern requiring real-world data.
• Postmarket Surveillance Study Requirements:
  • Objective: To monitor for premature failures due to the concerns mentioned above.
  • Duration: Over a nine-year period.
  • Sample Size (Anticipated): "Several hundred patients" in whom the device was implanted.
  • Endpoints: Actuarial survivorship analysis (proportion of hips revised), patient self-assessment of function, patient deaths, losses to follow-up.
  • Data Collection: Stratification by revision of acetabular/femoral components, baseline variables (device configuration, diagnosis, pre-implantation Harris Hip Score).
  • Purpose: To act as an early warning system for late-occurring effectiveness and safety problems.

In conclusion, the document details a mechanical performance test (fatigue load carrying capacity) which the device passed against ISO requirements. However, it does not provide detailed metrics or performance data for that test within the 510(k) summary. Significantly, the FDA mandated a post-market surveillance study precisely because a clinical long-term performance study with sufficient sample size and duration regarding the plasma-spray coating was lacking at the time of clearance. The criteria and methodology for this post-market study are outlined but represent future data collection rather than pre-market proof.

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