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OSS INDICATIONS

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, or traumatic arthritis.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-unions, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques. *
7. Revision of previously failed total joint arthroplasty.
8. Trauma.

These devices are to be used with bone cement unless composed of OsseoTi (titanium alloy, not licensed in Canada) or a proximal femur is indicated for use (USA).

Biomet OSS Reduced size (RS) components offers a variety of component options for treatment in small adults and adolescents (12-21 years) that require proximal femoral, total femur, or proximal tibial replacement as well as, resurfacing components for the proximal tibia and distal femur (USA).

*Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.

COMPRESS INDICATIONS
The Compress Segmental Femoral Replacement System is indicated for:

• 1. Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
• 2. Tumor resections.
• 3. Revision of previously failed total joint arthroplasty.
• 4. Trauma.

The Compress Segmental Femoral Replacement System components are intended for uncemented use. When components of the Orthopaedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, the user should refer to the package insert contained with the Compress components for full prescription information.

EXPANDABLE INDICATIONS
The Biomet Side Access Distal Femoral Expandable offers a treatment requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly turnor resection but could also involve osteoarthritis; theumatoid arthritis; correction of deformity; and correction of unsuccessful osteotomy, arthrodesis or previous joint replacement.

The devices are single use implants intended for implantation with Biomet Compress.

The OSS/Arcos IM Total Femur Rod is, in simplest terms, a metal rod that is inserted into the IM canal of a femur and connects a proximal femoral component to a distal femoral component. The aforementioned femoral components are secured to the rod by both a Morse taper and a screw; the proximal end features an "Arcos" taper while the distal end is an "OSS" taper. The Arcos taper is the same as that utilized by the devices in K090757 while the OSS taper is identical to that utilized by the predicate device.

The rods are slightly bowed to mimic the natural femur and find appropriate alignment. All rods have a diameter of 14 mm and are available in 1 cm length increments from 20 cm to 30 cm.

The device is compatible with Biomet's Arcos proximal bodies and OSS distal femoral components.

Here's a breakdown of the requested information based on the provided document, noting that this document is a 510(k) summary for a medical device and not a study report on device performance with acceptance criteria in the typical sense of a diagnostic or AI algorithm:

This document is a 510(k) Premarket Notification for a medical device (OSS/Arcos IM Total Femur Rod), not a study demonstrating the performance of a diagnostic or AI algorithm against specific acceptance criteria. Therefore, most of the requested fields are not directly applicable in the terms usually associated with AI/diagnostic studies.

The "acceptance criteria" for a 510(k) submission are primarily demonstrating substantial equivalence to a legally marketed predicate device, meaning it is as safe and effective as the predicate and does not raise new questions of safety or effectiveness. The "study" here is a mechanical testing comparison, not a clinical trial.

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

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

This information is not provided in the document. The document refers to "mechanical testing" and "worst-case Arcos constructs" from a previous submission (K090757), but details on sample size for these mechanical tests are omitted. "Data provenance" such as country of origin or retrospective/prospective is not relevant to mechanical engineering tests of this nature.

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. This submission is for a physical orthopedic implant, not a diagnostic device requiring expert interpretation of images or clinical data for ground truth establishment. Mechanical testing relies on engineering standards and measurements, not expert consensus on qualitative data.

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

This is not applicable. Adjudication methods are used to resolve discrepancies in expert interpretation, which is not relevant for mechanical 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. This is not an AI or diagnostic device that involves human readers.

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

This is not applicable. This is not an algorithm or AI device.

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

The "ground truth" for the assessment of this device is based on mechanical engineering standards and physical measurements obtained from testing "worst-case Arcos constructs" as performed in a previous submission (K090757). It's not based on biological or clinical "ground truth" like pathology or outcomes data in the usual sense for diagnostic devices.

8. The sample size for the training set

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

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

This is not applicable. This device is not an AI/ML algorithm that requires a training set or its associated ground truth.

Summary of the "Study" (Mechanical Testing discussed):

The "study" cited in the document to support substantial equivalence is mechanical testing that was previously performed and supplied in a prior 510(k) submission (K090757). This testing was conducted on "worst-case Arcos constructs" to evaluate the performance of the Arcos taper and proximal screw. The current submission argues that since the OSS/Arcos IM Total Femur Rod does not introduce a new worst-case scenario compared to the previously tested Arcos constructs, this existing mechanical testing is sufficient to demonstrate the safety and effectiveness of the new device's modifications. No new mechanical testing data is presented in this specific 510(k) document.

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The proposed device system is an orthopaedic joint intended to replace the damaged or diseased natural hip joint in total hip or hemi hip arthroplasty to provide pain relief and restore function. The hip system is modular in design, consisting of the subject monolithic, femoral stem along with previously cleared, legally marketed compatible Biomet modular heads and/or acetabular components for total hip or hemi hip arthroplasty.

Indications for use:

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

Porous coated components are intended for uncemented, biological fixation.

The Echo Bi-Metric Microplasty Hip System consists of the subject Echo Bi-Metric Microplasty Hip stem component and legally marketed Biomet modular heads and/or acetabular components for total hip or hemi hip arthroplasty. The subject hip stem combines the design features of the standard length Echo Bi-Metric Press-Fit Stems but offers a shortened stem length design within the legally marketed shortened stem lengths using the same previously cleared materials.

Patient contacting, reusable implant specific instruments are manufactured from stainless steel and include an aluminum titanium nitride (AlTiN) PVD or titanium nitride (TiN) PVD coating.

The Echo Bi-Metric Microplasty Hip Stems are proximally fitting, porous coated shortened stems for uncemented, biological fixation. Stem lengths are within the range of legally marketed short stems also cleared for biological fixation. The subject femoral stem utilizes the identical manufacturing processes as the predicates. The subject stem substrate and plasma spray coating are identical to that of K070274 and K090757.

The provided text describes the regulatory clearance (510(k)) for the Echo Bi-Metric Microplasty Hip System. This document does not contain the acceptance criteria or a study proving the device meets those criteria for software or algorithms. Instead, it focuses on the substantial equivalence of a physical medical device (a hip implant).

Therefore, I cannot extract the information required for your request for the following reasons:

• No Acceptance Criteria for AI/Software: The document discusses the performance of a physical hip implant. Acceptance criteria in this context would relate to mechanical strength, fatigue, material properties, and biocompatibility, not to the performance of a software or AI device.
• No Study for AI/Software Performance: The "Performance Data" section explicitly states "No clinical testing was necessary for a determination of substantial equivalence." and lists non-clinical tests like "Range of Motion," "Femoral Stem Proximal Fatigue," "Femoral Stem Distal Fatigue," and "Biocompatibility (Implant Specific Instrument material)." These are tests for the physical characteristics of the hip implant, not for an AI or software component.
• No AI/Software Component Described: The device description is for a hip implant: "The Echo Bi-Metric Microplasty Hip System consists of the subject Echo Bi-Metric Microplasty Hip stem component and legally marketed Biomet modular heads and/or acetabular components for total hip or hemi hip arthroplasty." There is no mention of an AI or software element that would require the kind of data you're asking for (test set, ground truth, MRMC study, etc.).

In summary, the provided document is for a physical medical device (hip implant) and does not contain any information related to the acceptance criteria or performance study of an AI or software device.

Ask a specific question about this device