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Kirschner Wires are used for;
· As guide pins for insertion of other implants
· Bone reconstructions
· Fixation of bone fractures and osteotomies
· Implanted through the skin for traction applied to the skeletal system

Biomet Inc manufactures a variety of internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. Biomet Kirschner Wires (K-wires) are rigid yet malleable wires with penetrating tips such that they may be inserted through tissue and into bone to alow for traction of bone fragments as desired or for alignment quides for other bone fixation implants. These wires are available in multiple diameters, same length and unthreaded (smooth) versions.
Biomet Kirschner Wires are single use and provided in both sterile configurations. Unless supplied sterile, metallic internal fixation devices must be sterilized prior to surgical use.

The provided text describes a 510(k) premarket notification for Biomet Kirschner Wires (K-Wires). It states that the device is substantially equivalent to a predicate device based on its indications for use, technological characteristics, and conformance to specific standards.

However, the document does not contain the detailed information requested regarding the acceptance criteria and the study that proves the device meets those criteria, specifically concerning data provenance, sample sizes for test and training sets, expert qualifications, ground truth establishment, or multi-reader multi-case studies, as these aspects are typically relevant for AI/ML-driven medical devices or diagnostic tools. The Biomet Kirschner Wires are described as "rigid yet malleable wires with penetrating tips," implying they are a physical medical device, not a software-based or AI-enabled device.

Therefore, many of the requested categories are not applicable to the information provided in the given text.

Here's a breakdown of the available information based on your request:

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

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

• Sample Size for Test Set: Not specified. Testing for conformance to ASTM standards typically involves a defined sample size as per the specific standard, but this detail is not present in the document.
• Data Provenance: Not applicable in the context of device conformance to ASTM physical/mechanical standards.

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

• Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. Conformance to ASTM standards is typically evaluated by technical testing against predefined specifications.

4. Adjudication method for the test set

• Not applicable. Conformance to ASTM standards involves objective measurement and comparison against specified limits, not expert adjudication.

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

• Not applicable. This is a physical bone fixation device, not a diagnostic imaging or AI-assisted diagnostic tool.

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

• Not applicable. This device is not an algorithm.

7. The type of ground truth used

• Ground Truth Type: Conformance to established industry standards (ASTM F138-19 for mechanical properties and ASTM F366-17 for dimensional properties). These standards themselves define the "ground truth" or acceptable parameters for such devices.

8. The sample size for the training set

• Not applicable. This device does not involve a "training set" in the context of machine learning or algorithms. Its design and manufacturing are based on established engineering principles and materials science.

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

• Not applicable. Since there is no training set for an algorithm, the method for establishing its ground truth is irrelevant. The "ground truth" for the device's characteristics is inherently defined by the ASTM standards it aims to meet.

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StageOne™ Select Hip Cement Spacer Molds with stainless steel reinforcement stems, adapters and inserts are indicated for use to mold a temporary hemi-hip replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin Bone Cement R, assembled and inserted into the femoral medullary cavity following removal of the existing femoral and acetabular replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The hemi-hip prosthesis made from the StageOne™ Select Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-hip prosthesis material (Refobacin Bone Cement R), the temporary hemi-hip prosthesis is only indicated for patients who will consistently use traditional mobility assist devices (e.g. crutches, walkers) throughout the implant period.

The StageOne™ Select Hip Cement Spacer Molds are sterile, single use medical devices made of silicone with a stainless steel reinforcement stem, head insert and neck length adapter. The device is used to create a temporary hip implant component made from antibiotic bone cement, Refobacin® Bone Cement R by injecting with a dispenser/gun into the mold. After removal of the initial femoral and acetabular implants, the prepared cement spacers are assembled using the neck length adapter and placed into the femoral joint space using Refobacin® Bone Cement R as the first stage of a two-stage revision surgical procedure. The temporary hemi-hip prosthesis remains in place (180 days or less) until the second stage of the two-stage revision procedure is performed to implant a conventional hip joint prosthesis.

The provided text is related to an FDA 510(k) premarket notification for a medical device called "StageOne™ Select Hip Cement Spacer Molds." It details the device's purpose, indications for use, and a comparison to predicate and reference devices to establish substantial equivalence.

However, the document DOES NOT contain information about acceptance criteria or a study that proves the device meets specific performance metrics in the context of an AI/ML medical device submission. This document pertains to a physical medical device (cement molds) and the testing described is non-clinical (biocompatibility, packaging, shelf-life, sterilization, MRI analysis, fatigue performance, antibiotic elution, BET, and pyrogenicity testing) and does not involve AI/ML performance evaluation.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving device performance in the context of AI/ML, as the provided text does not contain such information.

If you have a different document related to an AI/ML medical device, please provide it, and I will be happy to assist.

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StageOne™ Shoulder Cement Spacer Molds are indicated for use to mold a temporary hemi-shoulder replacement for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the humeral medullary canal and glenoidal cavity following removal of the existing total shoulder replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The hemi-shoulder prosthesis made from StageOne™ Shoulder Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment performed (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the hemi-shoulder prosthesis material (Refobacin® Bone Cement R), the temporary hemi-shoulder prosthesis is only indicated for patients who will consistently follow activity limitations throughout the implant period.

The subject device is a sterile, single use device made of silicone and is used to create a temporary hemi-shoulder implant component made from antibiotic bone cement, Refobacin® Bone Cement R. After removal of the initial implant the prepared cement spacer is placed into the glenohumeral

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "StageOne™ Shoulder Cement Spacer Molds." It describes the device's intended use, indications for use, and a summary of performance data (nonclinical).

However, the document does not contain information about:

• Acceptance criteria for an AI/ML device.
• A study that proves the device meets AI/ML acceptance criteria.
• Details about the test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types, training set size, or training ground truth establishment.

The document explicitly states that Clinical Testing was deemed not necessary to establish substantial equivalence for the proposed device modifications, and the focus was on non-clinical performance testing for a physical medical device (molds for bone cement).

Therefore, based on the provided text, I cannot describe the acceptance criteria or a study proving an AI/ML device meets those criteria because this document does not pertain to an AI/ML device.

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StageOne™ Knee Cement Spacer Molds are indicated for use to mold a temporary total knee replacement (TKR) for skeletally mature patients undergoing a two-stage revision procedure due to a septic process. The temporary prosthesis is molded using Refobacin® Bone Cement R and inserted into the joint space following removal of the existing total knee replacement implants and debridement. The device is intended for use in conjunction with systemic antimicrobial antibiotic therapy (standard treatment approach to an infection).

The knee prosthesis made from the StageOne™ Knee Cement Spacer Molds is not intended for use more than 180 days, at which time it must be explanted and permanent devices implanted or another appropriate treatment (e.g. resection arthroplasty, fusion, etc.).

Due to the inherent mechanical limitations of the knee prosthesis material (Refobacin® Bone Cement R), the temporary knee prosthesis is only indicated for patients who will consistently use traditional mobility devices (e.g. crutches, walkers) throughout the implant period.

The subject device is a sterile, single use device made of silicone and is used to create temporary tibial and femoral implant components made from antibiotic bone cement, Refobacin® Bone Cement R. After removal of the initial implant the prepared cement spacers are placed into the tibiofemoral joint space using Refobacin® Bone Cement R as the first stage of a two-stage revision surgical procedure. The temporary spacers remain in place (180 days or less) until the second stage of the two-stage revision procedure is performed to implant a conventional knee joint prosthesis.

This document describes the StageOne™ Knee Cement Spacer Molds, a device used to mold temporary total knee replacements in a two-stage revision procedure due to a septic process.

Here's an analysis based on your request:

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

The provided text does not contain a specific table of acceptance criteria with corresponding performance results. Instead, it lists various non-clinical performance tests conducted to support the modifications and establish substantial equivalence to a predicate device. The underlying assumption is that the device met the acceptance criteria for these tests, as the FDA concluded substantial equivalence.

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

The document focuses on non-clinical performance testing. Therefore, there is no patient-specific test set sample size or provenance information (country of origin, retrospective/prospective) for clinical data provided. The testing relates to the physical and chemical properties of the device and its molded cement.

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)

Since this is a non-clinical device, there were no clinical experts used to establish ground truth for a test set in the traditional sense (e.g., radiologists interpreting images). The "ground truth" for the non-clinical tests would have been based on established standards, protocols, and scientific principles followed by engineers, material scientists, and microbiologists involved in the testing. The document does not specify the number or specific qualifications of these individuals, but it's understood that qualified personnel would conduct such tests.

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

No adjudication method was used for a test set because this was entirely non-clinical testing. Adjudication methods are typically relevant for clinical studies involving human interpretation or decision-making.

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 MRMC comparative effectiveness study was done. This device is a cement spacer mold, not an AI or imaging-related device that would involve human readers or AI assistance.

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

No standalone algorithm performance study was done. This device is a physical medical device, not a software algorithm.

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

For the non-clinical tests, the "ground truth" was established by recognized industry standards, scientific principles, and internal specifications for biocompatibility, packaging, sterilization, wear, and antibiotic elution. For example, biocompatibility testing would adhere to ISO 10993 standards, and sterilization validation would follow established guidelines to ensure a certain sterility assurance level (SAL).

8. The sample size for the training set

There is no "training set" as this is a physical medical device and not a machine learning model.

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

As there is no training set, this question is not applicable.

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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

The subject devices, Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeves, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.

This submission proposes a new bioburden reduction manufacturing process that includes a new contact material for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve.

The provided document is a 510(k) summary for the Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that a device meets specific acceptance criteria through a study with performance metrics in the way one might expect for a diagnostic AI or imaging device.

Therefore, the requested information, particularly regarding acceptance criteria performance, sample sizes for test/training sets, expert consensus, adjudication methods, MRMC studies, standalone performance, and ground truth types and establishment, is not applicable to this type of submission. This submission is for a physical medical device (a hip prosthesis component) and its substantial equivalence is based on technological characteristics and biocompatibility.

Here's a breakdown of what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" are not reported as specific performance metrics (e.g., sensitivity, specificity). Instead, they are implied by demonstrating substantial equivalence to a predicate device (K193546 Distal Centralizers). The criteria revolve around showing that the new device shares similar technological characteristics (intended use, indications for use, materials, design features, sterilization) and biocompatibility with the predicate.
• Reported Device Performance:
  • Non-Clinical Tests: A biocompatibility assessment was performed in accordance with ISO 10993-1. The data confirmed the biocompatibility of the candidate manufacturing process flow for the device in long-term contact with patient bone and tissues. No specific numerical performance metrics are provided, as this is a qualitative assessment of biocompatibility.
  • Clinical Tests: None were provided for this submission.

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

• Not Applicable. This submission does not involve a "test set" in the context of evaluating an algorithm or AI. The biocompatibility assessment is a laboratory test on device materials, not a study on a human subject population with a test set of data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. Ground truth in the context of expert consensus for diagnostics is not relevant here. Biocompatibility assessment relies on standardized testing procedures and interpretation by qualified laboratory personnel.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or expert adjudication is involved.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• Not Applicable. This is a physical device, not an AI or diagnostic tool that would involve human readers.

6. If a Standalone Performance (Algorithm Only) Was Done

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

7. The Type of Ground Truth Used

• Not Applicable. For the biocompatibility assessment, "ground truth" would be established by the results of the ISO 10993-1 tests themselves, interpreted against the standard's requirements. This is not "expert consensus," "pathology," or "outcomes data" in the typical sense applied to diagnostic performance.

8. The Sample Size for the Training Set

• Not Applicable. No training set is involved as this is not an AI/algorithm submission.

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

• Not Applicable. No training set is involved.

In summary, the provided document is a regulatory submission for a physical medical device, not a diagnostic or AI product. Therefore, most of the requested information about "acceptance criteria" and "studies" related to performance metrics, test/training sets, and expert evaluations is not applicable to this specific type of device and submission.

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1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Correction of functional deformity.
4. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
5. Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
   Optional use in revision: in some medical conditions (e.g. revision when healthy and good bone stock exists), the surgeon may opt to use primary implants in a revision procedure.
   Humeral components with a MacroBond® Surface Coating are indicated for either cemented or uncemented press-fit applications.
   Humeral components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
   The Comprehensive® Modular Hybrid® Glenoid is intended to be implanted with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
   The Comprehensive Humeral Positioning Sleeves are for cemented use only and are intended for use with the Comprehensive Fracture Stem.
   The Versa-Dial Humeral Head Prosthesis is intended for use only with the Comprehensive Shoulder Stems (Fracture, Primary and Revision), and the glenoid components of the Comprehensive Shoulder System.
   The Titanium Versa-Dial Humeral Head Prosthesis is indicated for patients with suspected cobalt alloy sensitivity. The wear properties of Titanium and Titanium alloys are inferior to that of cobalt alloy. A Titanium humeral head is not recommended for patients who lack suspected material sensitivity to cobalt alloy.

The Comprehensive Humeral Fracture Positioning Sleeves is composed of Polymethylmethacrylate (PMMA) and is used in conjunction with the Comprehensive Humeral Fracture System. The device is a sleeve that fits over the distal tapered end of the Comprehensive Humeral Fracture Stem and stops at a point below the fins of the stem.

The provided text is a 510(k) summary for a medical device (Comprehensive Humeral Fracture Positioning Sleeves) seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as one would expect for an AI algorithm or a diagnostic device.

Instead, this document focuses on demonstrating that the device, after a change in its bioburden reduction process, still has identical characteristics and performance to the previously cleared predicate devices. The "Summary of Performance Data (Nonclinical and/or Clinical)" section explicitly states:

• Non-Clinical Tests: "Testing was completed to demonstrate that the change in bioburden reduction process using REVOX technology does not have any impact on sterilization, shelf life, or biocompatibility of the device."
• Clinical Tests: "None provided"

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number/qualifications of experts for ground truth.
• Adjudication method.
• MRMC comparative effectiveness study or effect size.
• Standalone AI performance.
• Type of ground truth used.
• Training set sample size or ground truth establishment for the training set.

The document describes a submission for a physical medical device (positioning sleeves) where the primary change being evaluated is a manufacturing process change (bioburden reduction). It is not a software device or an AI/ML diagnostic system that would typically have the types of performance studies and acceptance criteria you are asking about.

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The A.L.P.S. Clavicle Plating System is indicated for fixation of fractures, osteotomies and nonunions of the clavice including osteopenic bone.

The A.L.P.S. Clavicle Plating System is designed to address fractures of the clavicle. The system is comprised of plates, screws, and instruments to facilitate the installation of the implants.

The provided text is a 510(k) summary for the A.L.P.S. Clavicle Plating System. This document is related to a medical device (bone fixation appliance), not an AI/Software as a Medical Device (SaMD) or a diagnostic device.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/SaMD performance metrics (like sensitivity, specificity, AUC), "test sets," "ground truth by experts," "MRMC studies," etc., as requested in your prompt, are not applicable to this submission.

This 510(k) focuses on demonstrating substantial equivalence to a predicate device (K173767, also an A.L.P.S. Clavicle Plating System by Biomet Inc.) based on:

• Identical intended use and indications for use.
• Similar technological characteristics (materials, design features, sterilization).
• Non-clinical tests (Guide Comparison, Drilling Test) to validate a design change to a soft tissue guide, aimed at improving safety and effectiveness without altering the fundamental mode of action or indications.

The document explicitly states "Clinical Tests: NA" (Not Applicable). This further confirms that there were no human subject studies or performance evaluations in the way one would typically assess an AI/SaMD.

In summary, your prompt's questions are designed for AI/SaMD products, and this 510(k) submission is for a physical orthopedic implant. As such, I cannot extract the information you are requesting from this document.

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Soft tissue fixation to bone, specifically during ligament reconstructive procedures.
Small Cannulated Screws (4.0mm and smaller diameter) are intended for use in:

1. Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow.
2. Arthrodesis of the foot, wrist and elbow.
3. Small and long bone osteotomies.
4. Fracture fixation of small bones, small bone fragments and long bones.
   Large Cannulated Screws (5mm and larger in diameter) are intended for use in:
5. Fixation of fractures in long bones and long bone fragments.
6. Long bone osteotomies (femur, tibia, foot, ankle, olecranon).
7. Arthrodesis, and fracture fixation of the foot and ankle, such as Jones fractures of the fifth metatarsal, and Calcaneal fractures.
   Large Cannulated Screws (6.5mm and larger in diameter) are intended for use in:
8. Slipped capital femoral epiphysis
9. Pediatric femoral neck fractures
10. Tibial plateau fractures
11. SI joint disruptions
12. Intercondylar femur fractures
13. Subtalar arthrodesis
14. Fixation of pelvis and iliosacral joint.
    The Biomet Headless Compression Screws and Twist-Off Screws are indicated for fixation of bone fractures, fusion of a joint (arthrodesis) or bone reconstruction (osteotomy) of the mid-foot bones, metatarsal and phalanges of the foot or the phalanges, metacarpals and carpals of the hand. In the foot, these include procedures to correct Hallux Valgus (bunions), Hallux Varus and Hallux Rigidus, Hammer toe, Claw toe and Mallet toe.

The WasherLoc™ and No-Profile Screw and Washer Systems are internal soft tissue fixation devices that aid in arthroscopic and orthopedic reconstructive procedures. The system includes instrumentation allowing for proper preparation and placement of the soft tissue fixation device.
The No-Profile Screw and Washer System includes titanium alloy (Ti-6A1-4V) screws and washers in various lengths/sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 70mm are available. The No-Profile Washers are available in 14mm, 16mm, and 18mm diameters with and without spikes. The spikes on the washers are not intended for additional fixation as used with the No-Profile screws.
The WasherLoc™ Tibial Fixation System includes titanium alloy (Ti-6Al-4V) screws and washers in various lengths and sizes. Both 4.5mm and 6.0mm diameter screws in lengths from 24mm to 60mm are available. The WasherLoc™ Washers are available in 14mm, 16mm, and 18mm diameters with spikes intended for additional fixation.
The Biomet Cannulated Screw System is designed for a variety of internal fixation, aiding in the alignment, stabilization, and healing of fractures or osteotomies to the skeletal system. The Biomet Cannulated Screw System has multiple variants included which fluctuate in screw diameters and lengths, and include the associated essential instruments that aid in fracture fixation.
The Biomet Cannulated Screw System consists of screw variants, which are available in diameters of 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm. Each screw diameter is accompanied by instruments that are designed specifically for a given diameter. Washers are also part of the Biomet Cannulated Screw System and are sized 3.0mm, 4.0mm, 5.0mm, 6.5mm, and 8.0mm to specifically match each screw diameter. The washers are provided to add additional support under the head of the screw in situations where the bone quality is poor. Washers are also utilized for more surface area contact with the bone which needed in order to maintain proper fixation of the fracture or osteotomy.
The Biomet Headless Compression and Twist-Off Screws are used for fixation of bone fractures, fusion of a joint, or bone reconstruction, osteotomies of the mid-foot bones, metatarsals and phalanges of the foot and metacarpals, phalanges and carpals of the hand. The Ti-6Al-4V alloy Biomet Headless Compression and Twist-Off Screws have multiple lengths and diameters associated with the different screws ranging from 2.0 to 3.0mm in diameter and lengths from 8 to 40mm. Both sets of screws will be available in sterile and non-sterile configurations. The screws include the associated essential instruments that aid in fracture fixation.
The Biomet Headless Compression Screw is a cannulated headless screw which is inserted below the bone surface. This feature helps to minimize soft tissue irritation by sitting recessed and provides compression due to a dual thread design in the shaft and head.
The Biomet Twist-Off Screw is a solid one-piece screw that has a drive shaft that has the ability to connect to a drill or large diameter pin driver. In addition, the screw incorporates a breakaway zone between the head and direct connection that allows the screw to break-off cleanly upon insertion. The Biomet Twist-Off Screw also has compression capabilities with a thread-free segment that achieves compression at the osteotomy site.

This document describes the FDA's decision regarding the 510(k) premarket notification for several orthopedic screw systems (WasherLoc™ and No-Profile Screw and Washer Systems, Biomet Cannulated Screw System, and Biomet Headless Compression and Twist-Off Screws). The core of this submission is not about a novel AI/ML device or a device that performs diagnostic or prognostic functions based on data analysis. Instead, it's about a change in the manufacturing process (bioburden reduction) for existing, already cleared devices.

Therefore, the requested information categories related to acceptance criteria for AI performance, clinical studies, sample sizes for test/training sets, expert ground truth, adjudication methods, and MRMC studies are not applicable to this document. This submission focuses on demonstrating that a manufacturing process change does not alter the safety or effectiveness of physical medical devices.

However, I can extract the relevant information regarding the rationale for substantial equivalence:

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

Since this is a submission for a manufacturing process change for physical medical devices, acceptance criteria are generally related to the physical and biological properties of the devices after the new process, and the ability to maintain the same performance as the predicate devices. The document explicitly states:

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. This submission is not a clinical study to assess diagnostic or prognostic performance of an AI model. The "tests" mentioned are non-clinical, laboratory-based tests on the physical devices.
• The document implies that the tests performed (e.g., cytotoxicity, analytical testing, bioburden reduction, sterilization validation, BET) were conducted on the subject devices that underwent the new REVOX bioburden reduction process. No specific sample sizes for these in-vitro/bench tests are reported 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. No ground truth in the context of expert review of data is established for this type of submission. The "ground truth" for non-clinical tests would be defined by validated laboratory standards and methodologies.

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

• Not Applicable. No adjudication method for medical image interpretation or similar data is mentioned as this is a device modification submission, not a diagnostic AI clearance.

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. No MRMC study was performed as this is not an AI/ML diagnostic or assistive device.

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

• Not Applicable. This is not an AI algorithm.

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

• Not Applicable. For the non-clinical tests conducted, the "ground truth" is defined by established scientific and engineering principles, material science standards, and biological safety testing protocols (e.g., sterility assurance level (SAL), pyrogenicity limits, material composition standards).

8. The sample size for the training set:

• Not Applicable. No training set exists as this is not an AI/ML device.

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

• Not Applicable. No training set or associated ground truth.

In summary, this FDA clearance is for a change in the manufacturing process (bioburden reduction) of existing orthopedic screws, not for a new AI/ML medical device. Therefore, most of the requested information regarding AI performance criteria and studies is not relevant to this document. The "study" referenced is a series of non-clinical, laboratory-based tests to ensure the REVOX process does not negatively impact the safety and performance characteristics of the devices compared to their previously cleared versions.

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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.

The subject devices, Distal Centralizers, are cylindrical components designed to slide onto the distal end of a cemented femoral stem prior to insertion into the femoral canal.

The provided text describes a 510(k) premarket notification for "Distal Centralizers" (K193546). This document is primarily focused on demonstrating substantial equivalence to a predicate device, specifically regarding a change in the bioburden reduction process. It is not a study proving device performance against acceptance criteria in the typical sense of a human-AI comparative study or a standalone algorithm performance study.

Therefore, many of the requested fields cannot be answered directly from this document because it's not a study about AI or human reader performance.

Here's an analysis based on the information available:

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 document does not specify the sample size for the "Non-Clinical Tests" performed, nor does it provide information on data provenance. The tests are focused on the device itself (sterilization, shelf life, biocompatibility, geometry), not data from patients or users.

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. This is not a study requiring expert interpretation of results or establishment of ground truth in a clinical sense. The "ground truth" (or rather, the reference standards) for sterilization, biocompatibility, and geometric evaluations would be established through established scientific and engineering principles and testing protocols.

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

Not applicable. There is no mention of adjudication as this is not a study involving human interpretation or subjective assessment of clinical data.

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. An MRMC comparative effectiveness study was not done. The device (Distal Centralizers) is a physical medical implant, not an AI or imaging system.

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

Not applicable. This is not an algorithm or AI device. The "standalone" performance here would refer to the physical and material performance of the centralizers themselves under the new manufacturing process, which was evaluated through non-clinical testing.

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

For the non-clinical tests described:

• Sterilization: Ground truth is established by validated sterilization protocols and tests (e.g., sterility testing, bioburden reduction validation) that adhere to international standards.
• Shelf life: Ground truth is established by accelerated aging or real-time shelf life studies using accepted methodologies.
• Biocompatibility: Ground truth is established by standard biocompatibility testing protocols (e.g., ISO 10993 series) against a known safe biological response.
• Geometric Evaluation: Ground truth is established by engineering specifications and design tolerances.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

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These devices are intended for shoulder joint arthroplasty.
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
Interlok® finish humeral stems are intended for cemented use and the MacroBond® coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.

The Comprehensive® Reverse Shoulder (CRS) is a total shoulder replacement system in a reverse configuration. The CRS was designed to provide a complete, seamless system based on the Comprehensive Shoulder platform by avoiding the need to remove a well-fixed humeral stem associated with a prior anatomical shoulder arthroplasty for conversion to reverse shoulder arthroplasty. This is made possible because the CRS can utilize any of the existing Comprehensive stems, including primary, revision, or fracture stems in cemented or uncemented applications. The CRS performs its function by replacing the damaged or diseased articular surfaces of the native shoulder with artificial surfaces with the intent to improve shoulder function and/or reduce shoulder pain.

The provided document is a 510(k) premarket notification for the Biomet Comprehensive® Reverse Shoulder. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a standalone study. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not directly applicable or explicitly stated in this document in the way it would be for a de novo submission or a product with novel technology requiring extensive clinical trials to establish safety and effectiveness.

However, based on the non-clinical tests described, we can infer the acceptance criteria and the "study" (non-clinical testing) that supports the device's performance relative to these criteria.

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

Information not available or not applicable based on the provided document:

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

• Sample Size: Not specified for the fatigue strength or ROM testing. Non-clinical mechanical tests typically use a smaller number of samples sufficient to demonstrate statistical significance or meet a deterministic threshold.
• Data Provenance: The fatigue testing was "performed in the Zimmer Fatigue and Fracture Mechanics Laboratory (Warsaw, IN)". This indicates a U.S.-based, internal laboratory setting for the non-clinical tests. The tests themselves are prospective for the specific design changes.

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 question is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or clinical data requiring expert ground truth establishment. The "ground truth" for these tests is the physical performance under controlled conditions.

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

• This question is not applicable for the same reason as point 3. Adjudication methods are relevant for subjective data interpretation, not for objective mechanical performance tests.

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 MRMC study was done. This is a mechanical implant, not an AI-powered diagnostic device. The document explicitly states "Clinical Tests: None provided."

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

• This question is not applicable as it pertains to AI/software performance. The device is a surgical implant, not an algorithm.

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

• For the non-clinical tests: The "ground truth" is defined by the physical and mechanical properties of the device as measured under controlled laboratory conditions, against established engineering standards (e.g., ASTM F1378-12) and internal test requirements. It's an objective measurement of material and design performance.
• For the overall submission: The primary "ground truth" or basis for clearance is substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as existing ones.

8. The sample size for the training set

• This question is not applicable as the document describes a mechanical implant, not a machine learning model. There is no concept of a "training set" in this context.

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

• This question is not applicable for the same reason as point 8.

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