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

Device Description

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.

AI/ML Overview

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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K Number

K993111

Device Name

ASCENT KNEE SYSTEM

Manufacturer

BIOMET MANUFACTURING, INC.

Date Cleared

1999-10-05

(18 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K936274

Intended Use

The indications for use for Biomet knee joint replacement prostheses include: 1) painful and disabled knee joint resulting from osteoarthritis, theumatoid arthritis, traumatic arthritis where one or more compartments are involved; 2) Correction of varus, valgus, or posttraumatic deformity; and 3) Corrections or revision of unsuccessful osteotomy, arhtrodesis, or failure of previous joint replacement procedure. This device is for use with bone cement

Device Description

The Ascent Closed Box Posterior Stabilized Femoral Component is a stemmable knee component designed for use in cases where extensive ligament damage has occurred. This design is based upon the features of the currently marketed Performance Closed Box Knee Components with certain modifications. There are five sizes available in both right and left configurations. The femoral articulation is the same as the Performance Posterior Stabilized Knee (K936274). The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur. The femoral component has an Interlok finish for use in cemented applications. The Ascent Closed Box PS Femoral Component can be used with either a constrained or PS tibial bearing. The femoral component also has independent posterior and distal augments to correct bone loss deficiencies and can still be used with previously cleared Performance stems and locking screw.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing that this document is an FDA 510(k) summary for a premarket notification, which typically focuses on demonstrating substantial equivalence rather than presenting a detailed performance study with acceptance criteria.

Key Observation: The provided document is an FDA 510(k) notification for the Ascent Knee System. This type of submission primarily aims to demonstrate substantial equivalence to a predicate device already on the market, rather than proving performance against specific acceptance criteria through a de novo clinical study. Therefore, robust performance data tables, detailed study designs, and ground truth methodologies as typically seen in a de novo approval or clinical trial report are not present in this document. The "device performance" described would relate to its similarity to the predicate device.

Description of Acceptance Criteria and Proving Device Meets Criteria

Given the nature of a 510(k) submission, the "acceptance criteria" are implicitly met if the device is found to be "substantially equivalent" to a legally marketed predicate device. The "study" that proves this is the 510(k) review process itself, where the FDA assesses the similarities and differences between the new device and the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (as per 510(k) Summary)
Premarket Review Objective: Substantial Equivalence to a legally marketed predicate device. This includes assessing:	The FDA found the device to be "substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976" (or to reclassified devices).

The Ascent Closed Box Posterior Stabilized Femoral Component is described as:A stemmable knee component.Designed for use in cases of extensive ligament damage.Based on currently marketed Performance Closed Box Knee Components (K936274).Available in five sizes, right and left configurations.Femoral articulation same as Performance Posterior Stabilized Knee (K936274).Anatomic component design to reconstruct anatomic dimensions and kinematics.Interlok finish for cemented applications.Can be used with constrained or PS tibial bearing.Features independent posterior and distal augments for bone loss correction.Compatible with previously cleared Performance stems and locking screw.The document states that the potential risks associated with this device are the same as with any joint replacement device. These include, but are not limited to: reaction to bone cement, deformity of the joint, cardiovascular diseases, fracture of the cement, implant loosening/migration, tissue growth failure, blood vessel damage, soft tissue imbalance, delayed wound healing, metal sensitivity, fracture of the components, nerve damage, bone fracture, infection, hematoma, and dislocation, and excessive wear. |
| 1. Indications for Use: Are the indications for use the same or sufficiently similar to the predicate device? | The stated indications for use are:

painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved;
Correction of varus, valgus, or post-traumatic deformity; and
Corrections or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
The device is for use with bone cement. These indications are standard for knee replacement prostheses. |
| 2. Technological Characteristics: Are the technological characteristics (materials, design, performance) sufficiently similar to the predicate device? Any differences must not raise new questions of safety or effectiveness. | The device is described as being "based upon the features of the currently marketed Performance Closed Box Knee Components with certain modifications." The femoral articulation is "the same as the Performance Posterior Stabilized Knee (K936274)." It uses an "Interlok finish for use in cemented applications." The description implies that the design changes are within the scope of existing, approved technology. The enumerated "Potential Risks" are generic to joint replacement, suggesting no new or unanticipated risks from the design. |
| 3. Performance Data (if applicable): If there are any differences in technological characteristics, does non-clinical or clinical performance data demonstrate safety and effectiveness? (This is often mechanical testing or bench testing for orthopedic implants, not clinical trials in a 510(k)). | The document does not explicitly detail performance data (e.g., mechanical testing reports). However, for a 510(k) for an orthopedic implant, the FDA typically reviews bench testing (e.g., fatigue, wear, strength) to demonstrate that any modifications do not negatively impact the performance compared to the predicate device. The statement that the device is "substantially equivalent" implies that such data, if required, was submitted and found acceptable. |

Detailed Information (Based on 510(k) nature, many points are not applicable or explicitly stated):

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/Not stated. This document does not describe a clinical study with a "test set" of patients. The "testing" for a 510(k) is usually non-clinical (e.g., bench testing or comparison to existing predicate data). If any such testing was done, the sample size (e.g., number of implants tested mechanically) and data provenance are not provided in this summary.

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. As no clinical "test set" and associated "ground truth" determination by experts is described for this 510(k) submission.

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

Not applicable. No clinical test set requiring expert adjudication is described.