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Biomet Metal-On-Metal Total hip replacement components are intended for either cemented or uncemented use to replace the articulating portions of the hip during total hip arthroplasty.

Indications For Use:

1. Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. (a) Revision procedures where other treatment or devices have failed (M2a-Taper™ and M2a-RinglocTM).
   (b) Revision of previously failed total hip arthroplasty (M2a-Magnum™ and M2a-38™).
5. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.

The components of the M2a-Magnum™ system were also cleared for diastrophic variant, fracture of the pelvis, fused hip, Legg Perthes, slipped capital epiphysis, subcaptial fractures, and traumatic arthritis indications. The M2a-Taper™ Metal-on-Metal Hip Joint Replacement Prosthesis are intended for use in cemented and non-cemented primary and revision hip joint arthroplastic procedures.

Metal-On-Metal Hip prosthesis components provide for total hip replacement with a direct metal to metal articulation. They consist of a series of metal femoral head prostheses (either monolithic or modular) that articulate with highly congruent mating acetabular components without the need for a ceramic or polyethylene liner.

This submission is intended to notify FDA that Biomet has included additional Contraindications to the labeling for Metal-On-Metal total hip prosthesis components to assure the safe and effective use of Biomet Metal-On-Metal components for the appropriate patient populations. These changes are incorporated into one IFU that will be applicable for all Metal-On-Metal components currently cleared by FDA.

The provided text is a 510(k) summary for a medical device. It explicitly states that no non-clinical or clinical testing was performed or included to support substantial equivalence. The submission is solely for updating the labeling (specifically, adding contraindications) for previously cleared metal-on-metal hip prosthesis components.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, ground truth, and expert involvement cannot be extracted from this document, as no such studies were conducted for this particular 510(k) submission.

The document indicates:

• "Non-Clinical mechanical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices."
• "Clinical testing is not included to support a substantial equivalence determination since this submission is intended only to update labeling for previously cleared medical devices."

As a result, a table of acceptance criteria and reported device performance cannot be generated, nor can any details about studies, sample sizes, experts, or ground truth.

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1. Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.
   The ArComXL™ Active Articulation Head is a single-use implant, intended for uncemented applications.

The ArComXL™ Active Articulation belongs to the family of dual mobility acetabular implants: the presence of two articulating surfaces in the same joint device. The ArComXL™ Active Articulation Head fits over a femoral modular head, which articulates within the ArComXL™ Head. The resultant assembly then articulates within the acetabular metal shell. The ArComXL™ Head is designed to be used with several styles of acetabular shells that have been cleared in previous submissions: M²a Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and M²a 38™ Flared Cups and Non-Flared Cups (K011110).
The ArComXL™ Active Articulation Heads are available in sizes 44-66mm (Note: Size 44-66mm references O.D. of mating shell; the actual head sizes are 38-60mm.) and are manufactured from highly cross-linked polyethylene, conforming to ASTM F648. ArComXL™ is not a new material; the material and manufacturing process were cleared in K042051, ArComXL™ Polyethylene Liners, as well as subsequent submissions. The ArComXL™ Active Articulation is designed for both primary and total revision surgeries, where all device components associated with the wear couple are removed and replaced. The system is intended for uncemented applications.

This document describes the Biomet ArComXL™ Active Articulation Head, a hip replacement component. This submission is for a material change from the predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Push-In and Lever-Out: Six samples.
  • Wear Testing: Not explicitly stated, but typically multiple samples are used in ISO 14242 testing. The document states "the ArComXL™ Active Articulation heads were tested".
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing conducted by Biomet Manufacturing Corp. (the submitter). These are non-clinical tests.

3. Number of Experts and Qualifications for Ground Truth of Test Set

Not applicable. The reported studies are non-clinical mechanical tests (Push-In and Lever-Out, Wear Testing), not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method for Test Set

Not applicable. This section relates to clinical studies and expert review, which were not performed for the determination of substantial equivalence for this device.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No clinical studies were conducted, and therefore, no MRMC studies comparing human readers with and without AI assistance were performed. The device is a medical implant, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a physical implant, not an algorithm or software. The performance studies are non-clinical hardware tests.

7. Type of Ground Truth Used

• Push-In and Lever-Out: Comparison to the performance of a legally marketed predicate device (K991990), establishing functional equivalence.
• Wear Testing: Comparison to the wear rates of a legally marketed predicate device, ArCom™ 36mm liners (K032396), as per ISO 14242 standards.

8. Sample Size for Training Set

Not applicable. This device is a physical implant; there is no "training set" in the context of an algorithm or AI model development.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this device.

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1. Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.
6. Dislocation risks.

The E1™ Avantage™ Head is a single-use implant, intended for uncemented applications.

The E1 Active Articulation™ belongs to the family of dual mobility acetabular implants; the presence of two articulating surfaces in the same joint device. The E1 Active Articulation™ Head fits over a femoral modular head, which articulates within the E1™ Head. The resultant assembly then articulates within the acetabular metal shell. The E1™ Head is designed to be used with several styles of acetabular shells that have been cleared in previous submissions: Ma Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and Mra 38™ Flared Cups and Non-Flared Cups (K01110). The E1 Active Articulation™ Heads are available in sizes 44-66mm and are manufactured from 100 kGy E1™, which is the same 100 kGy E-Poly™ material cleared in K070364, The claims based on small punch testing for the K070364 E-Poly™ (E1™) material were cleared previously in K100048 and are applicable to the identical E-Poly™ (E1™) subject material. The E1™ Active Articulation is designed for both primary and total revision surgeries, where all device components associated with the wear couple are removed and replaced. The system is intended for uncemented applications.

The provided text describes a 510(k) premarket notification for a medical device, the E1™ Avantage™ Head (a.k.a. E1™ Active Articulation), which is an artificial hip replacement component. The submission focuses on demonstrating substantial equivalence to predicate devices and detailing the characteristics of the E1™ Antioxidant Infused Technology material used in the device.

However, the document does not describe an acceptance criteria table for device performance against specific metrics in the way that would typically apply to software or AI-based devices. Instead, it details a series of claims for the material's performance based on non-clinical (bench) testing, comparing the E1™ material to control materials.

Therefore, the following information will be structured to address the spirit of the request based on the available data, acknowledging that it's a materials-based product and not a diagnostic AI device.

Acceptance Criteria and Study for the E1™ Avantage™ Head Device Material

The acceptance criteria are derived from the performance claims and test results for the E1™ Antioxidant Infused Technology material, which is a key component of the E1™ Avantage™ Head. The studies conducted are non-clinical (bench) tests comparing the E1™ material to various control or predicate materials.

1. Table of Acceptance Criteria and Reported Device Performance (Material Performance)

• Ultimate load: 97.2 ± 6.4 N (before) vs. 100.0 ± 5.0 N (after aging, P>0.05).
• Ultimate tensile strength: 45.8 ± 1.6 MPa (before) vs. 46.1 ± 2.9 MPa (after aging, P>0.05).
• Yield strength: 22.6 ± 0.2 MPa (before) vs. 22.8 ± 0.3 MPa (after aging, P>0.05).
  E1™ Hip Material:
• Ultimate load: 105.0 ± 5.5 N (before) vs. 115.0 ± 3.2 N (after aging, P>0.05).
• Ultimate tensile strength: 43.1 ± 1.3 MPa (before) vs. 43.1 ± 1.2 MPa (after aging, P>0.05).
• Yield strength: 24.2 ± 0.2 MPa (before) vs. 24.4 ± 0.2 MPa (after aging, P>0.05).
  No significant decrease in these mechanical properties after accelerated aging for both hip and knee E1™ materials (P>0.05). |

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

The document does not explicitly state numerical sample sizes (e.g., number of specimens tested) for each specific test. However, it indicates multiple test specimens were used for each comparison (e.g., "E1™ specimens showed no evidence...", "GUR1050 E1™ specimens ran head to head...", "multiple samples for statistical analysis implicitly through the use of "±" notation for standard deviations).

• Provenance: All data appears to be from bench testing conducted in a laboratory setting, not from human or animal studies. The studies reference a literature source (Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684) and ASTM standards (F2183, D638, F2003). The location of the testing laboratories is not specified, but the applicant is based in Warsaw, Indiana, USA.

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

This request is not applicable to this submission. The device is a physical orthopaedic implant component, and the "ground truth" for its material properties is established through standardized laboratory testing methods and measurements, not through expert human interpretation or consensus of observational data.

4. Adjudication Method for the Test Set

This request is not applicable. As above, the "test set" consists of material specimens undergoing physical and chemical characterization, not subjective assessments requiring adjudication. The results are quantitative measurements against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This request is not applicable. An MRMC study is relevant for diagnostic devices that involve multiple human readers interpreting medical images or data. The E1™ Avantage™ Head is a physical implant, and its performance is evaluated through bench testing of its material properties and mechanical characteristics, not through human interpretation of cases.

6. Standalone (Algorithm Only) Performance Study

This request is not applicable. This is not an algorithm or AI-based device. The "performance" described is the material performance of the polyethylene, not an algorithm's output.

7. Type of Ground Truth Used

The "ground truth" for the material performance claims is established through standardized physical and chemical measurements obtained from controlled bench tests. This includes:

• Observations of environmental stress cracking (absence/presence).
• Infrared spectroscopy for oxidation indices.
• Small punch testing (ASTM F2183) for ultimate load.
• Tensile testing (ASTM D638) for ultimate tensile strength and yield strength.
• Accelerated aging protocols (ASTM F2003).

These methods provide objective, quantitative data about the material's properties.

8. Sample Size for the Training Set

This request is not applicable. There is no "training set" in the context of this device. The described studies are non-clinical performance evaluation tests of a manufactured material, not a machine learning model. The material itself is a result of a manufacturing process using specific raw materials and treatments (e.g., GUR1020/GUR1050 UHMWPE, 100 kGy gamma irradiation, vitamin E infusion, gamma sterilization).

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

This request is not applicable. As there is no training set, there is no ground truth established for it in this context.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision of previously failed total hip arthroplasty.

Cemented and Uncemented Applications

Biomet Manufacturing Corp. is adding additional sizes and designs to the predicate ArComXL™ Acetabular Liners (K042051). The same manufacturing process used in the predicate results in a higher cross-linked polyethylene that Biomet will herein refer to as ArComXL™ . The femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from -6mm to +9mm made from CoCrMo.

The provided document is a 510(k) Summary for a medical device (ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads). It describes the device, its intended use, and claims substantial equivalence to predicate devices. Crucially, it states: "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, a study proving the device meets acceptance criteria as typically understood for AI/diagnostic devices (e.g., performance metrics, ground truth, expert adjudication, MRMC studies) was not conducted for this submission, as it is a medical device, not a diagnostic or AI product.

However, given the request's structure which assumes such a study, I can only extract information related to "Non-Clinical Testing" which serves a similar purpose of validating the device.

Here's a breakdown based on the provided text, primarily addressing the "Non-Clinical Testing" section since clinical trials were not performed.

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document does not specify the exact "standards or guidelines" or quantitative performance metrics, only that they were met or exceeded.)

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

The document does not detail specific sample sizes for non-clinical testing. It simply states "Verification activities were performed on ArComXL™ liners." There is no mention of a "test set" in the context of clinical or diagnostic data, as this is a physical medical implant. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the way it would be for a diagnostic study.

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

This section is not applicable. Since no clinical or diagnostic study was performed, there was no "ground truth" to establish in the context of expert review of data/images. The "ground truth" for non-clinical testing of a physical implant would typically involve engineering specifications, material properties, and mechanical test results against established benchmarks or regulatory standards, which are not detailed here.

4. Adjudication method for the test set

This section is not applicable. No test set requiring adjudication by experts was utilized as no clinical or diagnostic study was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

This section is not applicable. The device is a physical medical implant (hip replacement components), not an algorithm or AI product.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be related to engineering specifications, material science properties, and established regulatory/industry standards for medical implants (e.g., ASTM F-648 for UHMWPE). The document confirms that the device characteristics were "identical to the predicate (K042051)" and met "current standards or guidelines."

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of an AI/algorithm for this device.

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

This section is not applicable. There is no "training set" or corresponding ground truth establishment in the context of an AI/algorithm for this device. The "ground truth" for the manufacturing materials and processes would be based on validated scientific and engineering principles and quality control measures.

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The Triage® Panel for Drugs of Abuse plus Trycyclic Antidepressants - Oplates 2000 (and other forms of the product) The mage Faller of Drugs of Audie plus Tryoyano of the major metabolites of drugs of also Phencyclidine, Benzodiazepines, Cocain Metabolite, Amphetamines, THC, Opiates, Barbiturates, and Tricyclic Antideoressants in urine,

This test provides only a preliminary test result. A more specific atternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatographylmass spectrometry (GCMS) is the preferred Clinical consideration and Other chemical confirmation methods are available. confirmatory method. professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used.

The tricyclic test is a qualitative screening test. A negative result does not ellminate the possibility of the presence of tricyclic antidepressants in the urine specimen at concentrations lower than 1000 ng/ml. Should confirmation of the test result for the parent compound or the metabolites be desired, an alternative method that is capable of identification and quantification should be used, e.g. HPLC, GC or GC/MS. A positive screening result may be due to the reactivity of the parent tricyclic antidepressant and the various metabolites of the respective compound.

Not Found

The provided document describes a 510(k) premarket notification for a device called "Triage® Panel for Drugs of Abuse plus Trycyclic Antidepressants and Opiates 2000" (and related variations). While the document lists the "Indications for Use" and the "cut off concentrations" for various drugs, it primarily focuses on the FDA's substantial equivalence determination and regulatory aspects.

The document does NOT contain information about specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment that would typically be reported in a study proving the device meets acceptance criteria.

The section titled "The above products have the screening cut-off concentrations as outlined below:" and the subsequent table define the performance specifications or target concentrations at which the device is expected to detect the drugs. These are not the acceptance criteria for a study proving performance, but rather the operational thresholds of the device.

Without the actual study report, it's impossible to fully answer your request. However, I can infer the acceptance criteria based on the information provided (the cut-off concentrations) and explain what kind of study would typically be done for such a device, and what information would ideally be in a study report.

Inference of Acceptance Criteria and a Hypothetical Study Description:

Based on the nature of the device (a rapid immunoassay for drugs of abuse), the acceptance criteria would typically relate to its ability to correctly identify the presence or absence of drugs at or above the specified cut-off concentrations.

1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical):

Since the document only provides the target cut-off concentrations, the acceptance criteria would likely be defined around sensitivity and specificity at these concentrations.

Note: The actual acceptance criteria might also include parameters like agreement within a certain percentage of the cut-off, or detection within a certain analytical range.

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

• Sample Size: The document does not specify the sample size for the test set. For a multi-analyte immunoassay, studies typically involve hundreds to thousands of samples, often stratified to include concentrations near the cut-off, well above the cut-off, and negative samples, as well as samples with potential cross-reactants.
• Data Provenance: Not specified in the document. For such devices, clinical samples from various populations (e.g., diverse demographics, different geographic locations to capture varying drug use patterns) would be ideal. Whether retrospective or prospective is also not mentioned. Prospective collection would be preferred for avoiding bias.

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

• Number of Experts: Not specified.
• Qualifications of Experts: For drug of abuse testing, "experts" in the context of ground truth would typically refer to the highly trained laboratory personnel performing the gold standard confirmatory tests, not necessarily clinical experts. The ground truth method (GC/MS) is intrinsically the "expert" here.

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

• Adjudication Method: Not specified. For analytical studies, a formal adjudication process like 2+1/3+1 is usually not directly applicable. The "adjudication" is inherent in the confirmatory method's results. If multiple runs of the confirmatory method were done, then a consensus approach might be employed, but it's not medical expert adjudication.

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:

• MRMC Study: This device is a diagnostic test kit for drugs of abuse. It is not an AI-assisted diagnostic imaging device. Therefore, an MRMC study or AI assistance is not applicable to this type of device. The "reader" is typically a laboratory technician interpreting a color change or a machine reading it.

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

• Standalone Performance: Yes, the fundamental performance evaluation of such a device is its standalone performance. The document implies this through the cut-off concentrations. The device itself (the panel) yields a result based on chemical reactions. The "algorithm" here is the chemical reactivity. Its performance is measured against confirmatory methods (GC/MS).

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

• Ground Truth Type: As explicitly stated in the document: "A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GCMS) is the preferred confirmatory method. Other chemical confirmation methods are available."
  • Therefore, the ground truth is established by Gas Chromatography/Mass Spectrometry (GC/MS) or other validated chemical confirmation methods. This is the gold standard for drug detection and quantification in urine.

8. The sample size for the training set:

• Sample Size for Training Set: The document makes no mention of a "training set" in the context of machine learning or AI. For an immunoassay, the "training" phase involves optimizing the assay reagents and conditions during development to achieve the desired sensitivity, specificity, and cut-off levels. This isn't typically quantified as a distinct "training set size" in the same way as an AI model.

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

• Ground Truth for Training Set: Not applicable in the AI sense. During the development and optimization of the immunoassay, various spiked and clinical samples would be tested, and their true concentrations (ground truth) would be established using a similar, highly accurate analytical method like GC/MS to guide the optimization of the immunoassay's performance characteristics.

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