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The Titanium Repicci II(® Unicondylar Femoral Knee Components and CoCr Repicci II(8) Unicondylar Knee are indicated for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

These devices are single-use implants intended for implantation with bone cement.

The Titanium Repicci II® Unicondylar Femoral Knee Components are medial or lateral unicondylar knee replacement implants available in six sizes. Each size is anatomical in nature and is available in two configurations - one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM).

The CoCr Repicci II® Unicondylar Knee (K020264) is available in five sizes. Each size is anatomical in nature and is available in two configurations – one for the medial side of right knees and lateral side of left knees (LL/RM), and one for the lateral side of right knees and the medial side of left knees (RL/LM),

Here's an analysis of the provided text regarding the acceptance criteria and study for the device:

Important Note: The provided document is a 510(k) summary for a knee implant, which in many cases, especially for predicate devices, relies heavily on substantial equivalence to already approved devices rather than new clinical trials demonstrating performance against specific clinical acceptance criteria. The information you're asking for (e.g., acceptance criteria, test set details, expert qualifications, HRMC studies) is typically found in the clinical study reports for devices that require extensive new clinical evidence, often for novel devices or those with higher risk classifications.

Based on the provided text, the device is being cleared based on substantial equivalence, meaning it's demonstrated to be as safe and effective as a legally marketed predicate device. This often involves non-clinical testing (e.g., mechanical, materials) and comparison of design and indications for use, rather than extensive human clinical trials with performance metrics.

Analysis of Acceptance Criteria and Study for K063515

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" for the device's performance in the clinical sense are not explicitly stated in terms of specific sensitivity, specificity, accuracy, or similar clinical metrics. Instead, the "acceptance criteria" are implied by demonstrating that the new device is as safe and effective as its predicates.

The "study that proves the device meets the acceptance criteria" largely relies on non-clinical testing and comparison to predicates.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable in the context of a human clinical test set. The evaluation primarily involved non-clinical laboratory testing.
• Data Provenance: Not applicable for clinical data. The non-clinical testing would have been performed in a laboratory setting, likely at Biomet or a contracted facility.

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

• This information is not provided because the submission did not involve a clinical study requiring expert ground truth for a test set in the way a diagnostic AI device would. The "ground truth" for non-clinical testing would be measured physical properties and performance against established engineering standards or predicate device benchmarks.

4. Adjudication Method for the Test Set

• Not applicable as there was no human clinical test set requiring adjudication.

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

• No, an MRMC comparative effectiveness study was explicitly NOT done. The document states: "Clinical Testing: None provided as a basis for substantial equivalence."
• Therefore, there is no effect size reported for human readers with or without AI assistance.

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

• Not applicable. This device is a physical knee implant, not a software algorithm.

7. The Type of Ground Truth Used

• For the non-clinical testing, the "ground truth" would be established engineering specifications, material properties (e.g., tensile strength, fatigue life), and performance metrics (e.g., wear testing, load bearing capacity) as defined by relevant ISO or ASTM standards, and comparative data from the predicate devices. There is no mention of expert consensus, pathology, or outcomes data being used to establish "ground truth" for the new device itself in a clinical context.

8. The Sample Size for the Training Set

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

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

• Not applicable, as there was no training set in the context of machine learning.

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The indications for use for the Repicci II™ Unicondylar Knee System are for painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved; the correction of varus, valgus, or posttraumatic deformity; and the correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. This device is for use with bone cement.

The Repicci II™ Unicondylar Porous Knee is the same as the predicate, the Repicci III™ Unicondylar Knee (K971938), except for the additions of an intermediate sized femoral component -- 51mm and Ti-6Al-4V plasma spray porous coating to the interior of the components.

The provided document is a 510(k) premarket notification for a medical device (Repicci II™ Unicondylar Knee System) and does not contain information about acceptance criteria or a study proving the device meets specific performance criteria.

Instead, it's a submission for substantial equivalence to a legally marketed predicate device. This means the manufacturer is asserting their device is as safe and effective as a device already on the market, rather than presenting novel performance data against predefined criteria.

Here's why the requested information cannot be extracted from this document:

1. No Acceptance Criteria or Reported Device Performance: The document doesn't define any specific performance metrics (e.g., accuracy, sensitivity, specificity, mechanical thresholds) that the device needs to meet, nor does it report any such performance data for the Repicci II™ Unicondylar Knee System.
2. No Clinical Testing Provided as a Basis for Substantial Equivalence: The document explicitly states: "Clinical Testing: No clinical testing was provided as a basis for substantial equivalence."
3. Non-Clinical Testing was a Finite Element Analysis (FEA): The non-clinical testing mentioned was an FEA combined with engineering justification to demonstrate no new risks compared to the predicate device. This is a computational analysis, not a study involving a test set, ground truth, or human readers.

Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, experts, adjudication, MRMC studies, standalone performance, or training set details because this type of information is not present in the provided text.

The core of this submission is establishing substantial equivalence to a predicate device (Repicci II™ Unicondylar Knee, K971938) based on similarities in materials, design, sizing, and indications for use, with the primary difference being an added intermediate sized femoral component and a porous coating, which were justified through non-clinical FEA.

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Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or posttraumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty.

The devices covered by this 510(k) are intended to be used with a Repicci Femoral component.

The device is a single use implant intended for implantation with bone cement.

The Repicci II Unicondylar Knee system consists of a femoral and tibial component. The femoral components have been cleared through a previous 510(k) as have thicker sizes of the all poly tibial component.

The all polvethylene tibial component is universal in geometry so separate components are not necessary for left and right knees. A waffle pattern and recessed holes on the under surface assists in fixation with bone cement. Due to the radiolucency of polyethylene, a wire is molded within the component.

The provided text is a Summary of Safety and Effectiveness for the Biomet Repicci II Unicondylar Knee All Poly Tibial Components, along with an FDA clearance letter. This type of document is a pre-market notification (510(k)) and primarily focuses on demonstrating substantial equivalence to a previously legally marketed device, rather than proving a device meets specific acceptance criteria through a standalone study with detailed performance metrics.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, MRMC studies, and standalone performance is not present in the provided text, as these are typically part of a clinical trial or performance study, which is not the primary purpose of a 510(k) submission for this type of device.

The document states that "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...". This means the FDA found it equivalent to similar devices already on the market based on its intended use, design principles, and materials, without requiring new, independent performance data against specific acceptance criteria like you would find for a novel diagnostic AI algorithm.

However, I can extract information related to the device and its intended use, which are implicitly part of the "acceptance" for market clearance:

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

Since specific quantitative acceptance criteria and performance data from a dedicated study are not presented, I cannot create this table as requested. The "performance" demonstrated for a 510(k) is typically by demonstrating equivalence to a predicate device in terms of materials, design, and intended use, rather than achieving specific numerical performance thresholds in a clinical study for this type of implant.

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

Not applicable. The document does not describe a "test set" or a study designed to evaluate performance metrics. It's a 510(k) submission for substantial equivalence.

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. No "test set" and no related ground truth establishment by experts are described.

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

Not applicable. No "test set" or adjudication method are described.

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 is not an AI diagnostic device, and no MRMC comparative effectiveness study is mentioned.

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

Not applicable. This is a physical implant, not an algorithm.

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

Not applicable. No study requiring ground truth is described.

8. The sample size for the training set:

Not applicable. This is a physical implant, not a machine learning model, so there's no concept of a "training set" in the context of the provided document.

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

Not applicable. There is no training set involved.

Summary of what IS available in the document regarding "acceptance" for market clearance:

• Intended Use (Implicit Acceptance Criteria for Market Clearance): The device is intended for "Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty."
• Design and Materials (Implicit Acceptance Criteria for Market Clearance): The device is an all-polyethylene tibial component, universal in geometry, with a waffle pattern and recessed holes for cement fixation, and a molded wire for radiolucency. It is intended for use with a Repicci Femoral component.
• Safety (Implicit Acceptance Criteria for Market Clearance): The potential risks are acknowledged to be "the same as with any joint replacement device."
• Clinical Performance (Implicit Acceptance Criteria for Market Clearance): The FDA clearance is based on the device being "substantially equivalent" to predicate devices already on the market, implying that its performance is expected to be comparable and acceptable based on the history of those predicate devices. No new clinical performance study is detailed in this document.
• Specific Limitations/Conditions for Market Clearance from the FDA:
  • Thinnest tibial component is nominal 6.5mm, with a minimum polyethylene thickness of 6.5mm.
  • May not be labeled or promoted for non-cemented use.
  • All labeling must prominently state that it is for cemented use only.
  • Non-cemented fixation is considered investigational and requires IDE regulations (21 CFR, Part 812) and IRB/FDA approval.

In conclusion, the document is a 510(k) pre-market notification that demonstrates substantial equivalence, not a clinical study report with detailed performance metrics against specific acceptance criteria.

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Partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity or revision of previous arthroplasty. The device is a single use implant intended for implantation with bone cement.

The Repicci II Unicondylar Knee consists of femoral and tibial components. The femoral component is anatomic in design.to provide coverage of the condyle from posterior to anterior. The anatomic shape of the femoral component necessitates separate left and right configurations. A central keel and post on the back of the device assist in cement fixation. The device is manufactured from cobalt alloy. Two styles of tibial components are available with this system, an all polyethylene component and a modular metal backed component. The all polyethylene component is universal in geometry. A waffle pattern on the under surface assists in initial fixation. A modular tibial component consists of a metal tray and a polyethylene bearing which is snap fit into the tray by the surgeon.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria. The document is a 510(k) premarket notification approval letter for the Repicci II Unicondylar Knee, which primarily addresses the device's substantial equivalence to a predicate device and outlines limitations and regulatory requirements. It does not include details on performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to the specific questions asked.

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