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The indications for the Patient-Specific Vanguard™ Femoral Components are as follows:

• l . Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• Correction of varus, valgus or posttraumatic deformity. 2.
• 3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
     These devices are single-use implants intended for cemented applications.

The Patient-Specific Vanguard™ Femoral Components are comprised of a series of CoCrMo femoral components with each size offering an envelope of acceptable dimensions to allow for a fit that is specific to each patient, while still maintaining the Vanguard" design. These components are intended for primary knee arthroplasty.

This document is a 510(k) premarket notification for a medical device called "Patient-Specific Vanguard™ Femoral Components." It describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Specifically:

• No acceptance criteria or device performance table: The document does not provide a table outlining specific acceptance criteria (e.g., performance metrics, thresholds) for the device.
• No study proving acceptance criteria are met: The document explicitly states under "Clinical Testing" that "None provided as a basis for substantial equivalence." Non-clinical testing was performed, and the results indicated the device is "functional within its intended use," but this is a general statement and not a detailed study proving specific acceptance criteria are met.
• No information on test set sample size, data provenance, ground truth establishment, or adjudication method: Since no clinical study or formal test set evaluation is presented in the document, these details are not available.
• No MRMC comparative effectiveness study: The document does not describe any study involving human readers and AI assistance.
• No standalone (algorithm only) performance study: The device is a physical femoral component, not an algorithm. Therefore, a standalone algorithm performance study is not applicable.
• Type of ground truth: Not applicable as no clinical study or performance evaluation with ground truth is described.
• Training set sample size: Not applicable as this is a physical device, not an AI/algorithm-based product requiring a training set in the conventional sense.
• How ground truth for training set was established: Not applicable for the same reason mentioned above.

In summary, this document is a regulatory submission for a physical medical device and does not contain the type of information requested regarding acceptance criteria and performance studies typically associated with AI/algorithmic medical devices.

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Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure. Cemented and uncemented applications. The Regenerex™ femoral augments are indicated for use with the Vanguard™ Total Knee System. The Regenerex™ tibial augments are indicated for use with standard and offset Biomet® Tibial Trays.

Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis. Correction of varus, valgus, or posttraumatic deformity. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement. Ligament deficiencies. Tumor Resection. Revision of previously failed total joint arthroplasty. Trauma. These are single use implants. These devices are for cemented use only.

The Regenerex™ Ultra Porous Construct- Titanium Knee Augments are designed for attachment to selected commercially available Biomet® tibial base plates and femoral components using bolts, cement or a combination of both (depending on the augment). The augments are manufactured to interface with selected femoral and tibial Biomet® components. The femoral augments come in nine (9) different sizes that correspond with the sizes of the femoral components. The thickness options for the femoral augments vary from 5mm to 15mm. The tibial augments are available in 10° wedge and block form. The block augments are available in three (3) thicknesses for nine (9) tibial sizes. The OSS femoral augments are available in a 3,5mm thick anterior flange augment. The OSS tibial augments are available in monoblock and block form. The monoblocks are only available in 10mm thicknesses for three tibial sizes, while the block augments are available in 10mm and 20 mm sizes for three tibial sizes.

The provided document is a 510(k) premarket notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments. The content primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than providing a detailed study proving the device meets specific performance acceptance criteria.

Therefore, many of the requested details about acceptance criteria, specific study design, and performance metrics are not present in this document. The document states:

"Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." (Page 1)
"Clinical Testing: None provided as a basis for substantial equivalence." (Page 1)

This means the submission relies on non-clinical testing and comparison to predicates, not specific clinical performance studies with detailed acceptance criteria as one might find for a novel device requiring more extensive validation.

Given the information provided, here's what can be inferred and what cannot:

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

Missing: Specific quantifiable acceptance criteria (e.g., tensile strength, fatigue life, wear rate thresholds) and the exact numerical performance results for these criteria. The document only provides a general statement of functionality.

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

Not provided. The document mentions "non-clinical laboratory testing" but does not specify the sample size, type of test specimens, or the provenance of any data used for these tests. It is implied these were laboratory tests on the device itself, not patient data.

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

Not applicable/Not provided. Since the testing was non-clinical and no clinical data was presented, there was no "ground truth" derived from expert review of patient data in the context of this 510(k) submission.

4. Adjudication method for the test set

Not applicable/Not provided. No clinical test set requiring adjudication by experts was presented.

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 device is a medical implant (knee augments), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is entirely irrelevant to this submission.

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

No. As mentioned above, this is a physical implant, not an algorithm.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be established by standard engineering and material science specifications, predicate device performance data, and regulatory standards for mechanical and material properties of implants. However, the document does not detail these specific standards or how the device's performance compared against them. It only states it was "functional within its intended use."

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" in the context of this 510(k) submission as it is not a machine learning/AI device.

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

Not applicable/Not provided. As above, no training set was involved.

In summary: The provided 510(k) notification for the Regenerex™ Ultra Porous Construct- Titanium Knee Augments relies heavily on a comparison to predicate devices and general non-clinical laboratory testing to assert substantial equivalence. It does not contain the detailed performance data, acceptance criteria, sample sizes for patient data, or expert review methodologies that would be typical for clinical studies validating a new diagnostic or AI-driven device. The statement "Clinical Testing: None provided as a basis for substantial equivalence" is key in understanding the limited scope of detailed performance data in this particular document.

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• Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
• Correction of varus, valgus, or posttraumatic deformity.
• Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
  The device is a single use implant intended for use with bone cement.

Vanguard™ Removable Molded Polyethylene Tibia is intended to replace the tibial articulating surface in a joint replacement along with femoral components that were cleared in K023546. There are three parts to the Vanguard™ Removable Molded Polyethylene Tibia component: the tibial tray, tibial bearing, and an insert.

The I-beam profile of the tibial tray is identical to that of the Maxim® tibial tray cleared in the following submissions K984623 and K991753. The articulating surface is identical to the surface cleared in K023546.

The provided document is a 510(k) summary for a medical device called the "Vanguard™ Removable Molded Polyethylene Tibia (Pop-Top)". This type of document is for premarket notification of a medical device and aims to demonstrate substantial equivalence to a predicate device already on the market. It does not typically include detailed studies with acceptance criteria, sample sizes, expert-established ground truth, or multi-reader multi-case studies as would be found in a clinical trial report for AI/CAD devices.

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

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or a direct performance table as would be expected for an AI/CAD device. Instead, the "acceptance" is based on demonstrating substantial equivalence through non-clinical testing.

Study Details

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

   • No test set for clinical performance is mentioned. The assessment was based on non-clinical laboratory testing.

2. 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 clinical ground truth was established from experts for a device performance test set.

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

   • Not applicable. No clinical test set or adjudication process is described.

4. 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: None provided as a basis for substantial equivalence." This type of study is not relevant for this device's submission.

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

   • Not applicable. This is a physical implantable device, not an algorithm.

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

   • For the non-clinical testing, the "ground truth" would be established by engineering standards and specifications for material properties, mechanical performance, and design adherence to the predicate device. The document does not detail the specific ground truth methods for these non-clinical tests, but implies they were sufficient for substantial equivalence.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set.

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

   • Not applicable. This is not an AI/ML device that requires a training set.

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The Vanguard™ PS Open Box Porous Femoral Components are indicated for cemented or non-cemented use in cases of:

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. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
   The device is a single use implant.

The Vanguard™ PS Open Box Porous Femoral Components described in this submission have the same articulating surface as the predicate Maxim® Accel (Vanguard™) posterior stabilized (PS) Interlok® femoral components and the cruciate retaining (CR) porous femoral components cleared in K023546 and feature the exact same porous-coated inner surface as the cruciate retaining (CR) porous design cleared in K023546 and K033489.

The provided 510(k) summary for the Biomet Vanguard™ PS Open Box Porous Femoral Components explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, based on the provided document, the device did not undergo clinical testing to demonstrate its performance against specific acceptance criteria. Instead, it relied on an engineering justification including a Finite Element Comparison to show it was "functional within its intended use" and claimed substantial equivalence to legally marketed predicate devices (Maxim® Accel Knee System K023546 and Non-Cemented Porous Coated Knees K033489).

As such, I cannot provide information on acceptance criteria, a study proving the device meets those criteria, or details regarding ground truth, sample sizes, expert qualifications, or adjudication methods, as these elements are typically part of a clinical study.

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