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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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The ALLthread PEEK Suture Anchor devices are intended for soft tissue fixation.

The ALLthread PEEK Suture Anchors are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

The ALLthread PEEK Suture Anchors are soft tissue anchors with preloaded nonabsorbable polyethylene surgical sutures used to repair and reattach soft tissue to bone and are supplied in both double and triple loaded suture configurations. The ALLthread PEEK Suture Anchors are designed to reattach soft tissue to bone in procedures in the shoulder.

The purpose of this submission is: To submit a 510(k) for cumulative changes: Line extension including device configurations with 2 or 3 suture options, a white/black suture option, a white/green suture option and a tapered needle option. To update labeling in order to narrow the Indications for Use statements, describe the third suture options, and bring the Instructions for Use up to current practices; To ensure that the all of the instrumentation/accessories for use with this system are appropriately associated with a 510(k).

The provided text describes a 510(k) premarket notification for a medical device called the ALLthread PEEK Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might expect for an AI/algorithm-based diagnostic device.

However, based on the information provided, I can extract details about the performance testing conducted and how it relates to demonstrating the device's safety and effectiveness.

Here's an attempt to structure the information according to your request, adapting it to the nature of the device and the provided document:

Device: ALLthread PEEK Suture Anchor

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for each test. The document mentions "test results indicate that the device modifications..." implying that the tests were conducted on a sample of the ALLthread PEEK Suture Anchors and their components.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). These are non-clinical tests performed in a laboratory setting, not on patient data.

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

• This question is not applicable to this type of device and study. The "ground truth" for the non-clinical tests (like tensile strength or cyclic loading) is based on engineering specifications, industry standards, and established physical properties, not expert consensus on medical images or patient outcomes. The tests verify adherence to pre-defined performance characteristics.

4. Adjudication method for the test set

• This question is not applicable to this type of device and study. Adjudication methods like 2+1 or 3+1 refer to agreement among multiple experts for interpreting medical data, which is not the nature of these mechanical and biological safety 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

• This question is not applicable. This is a physical orthopedic implant (suture anchor), not an AI/algorithm-based diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is involved.

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

• This question is not applicable. This is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used

• The "ground truth" for these performance tests is defined engineering specifications, material properties, and regulatory standards (e.g., tensile strength limits, cyclic loading cycles, endotoxin limits). The tests demonstrate compliance with these objective, measurable standards.

8. The sample size for the training set

• This question is not applicable. This is not an AI/machine learning device that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices.

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

• This question is not applicable as there is no training set for this device.

Summary of the Study:

The document describes a series of non-clinical bench tests (mechanical and biocompatibility) performed on the ALLthread PEEK Suture Anchor. These tests were conducted to verify that specific design modifications (e.g., line extension, new suture options) and accessories do not introduce new risks and that the device maintains comparable performance to its predicate devices. The "study" here is a set of engineering and safety validation tests aimed at demonstrating "substantial equivalence" for regulatory clearance. The acceptance criteria are implicit in the statement that "test results indicate that the device modifications do not introduce any new risks to implant performance" and explicitly stated for the Bacterial Endotoxins Test. No clinical data or human studies were provided.

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Titanium Interference Screws are intended for use in fixation of patellar bone grafts in ACL reconstruction.

Titanium Interference Screws are metallic bone screws used to provide fixation of patellar bone-tendon-bone grafts during anterior cruciate ligament (ACL) repair.

This document is a marketing clearance (510(k)) for a medical device called "Titanium Interference Screws." It establishes substantial equivalence to a predicate device, meaning it's considered as safe and effective as a device already on the market, and therefore does not include detailed studies demonstrating performance against specific acceptance criteria in the way a clinical trial for a novel device would.

The provided document does not contain a study focused on proving the device meets acceptance criteria in a clinical or AI-related context, nor does it provide a table of acceptance criteria and reported device performance relevant to AI/diagnostic efficacy.

Instead, the document focuses on demonstrating substantial equivalence for the Titanium Interference Screws by comparing their characteristics and non-clinical performance to an already legally marketed predicate device. The "acceptance criteria" here refer to the regulatory safety and performance standards for a substantially equivalent device, rather than specific diagnostic metrics.

However, based on the non-clinical tests described, we can infer some "acceptance criteria" as they relate to the mechanical performance of the device.

Here's an analysis based on the information provided, inferring what could be considered "acceptance criteria" for this type of device and what was done to support its clearance:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a physical medical device (Titanium Interference Screws) and not an AI or diagnostic device, the "acceptance criteria" are related to its mechanical and biological safety, not diagnostic performance. The document states that the test results "indicate the device and the modifications do not introduce any new risks to the device performance" and "the testing indicates that the device performs within the intended use and did not raise any new safety and efficacy issues."

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

• Sample Size: Not explicitly stated for each non-clinical test. The document mentions "Cyclic loading testing of Titanium Interference Screws," "Failure torque testing of Titanium Interference Screws," etc., which implies a sample of devices were tested. Typical mechanical testing involves a statistically significant number of samples, but the exact count is not disclosed here.
• Data Provenance: The tests are non-clinical, likely performed in an engineering lab environment. The country of origin of the data is not specified beyond being part of the submission from "Biomet Inc." in "Warsaw, Indiana" to the FDA. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission to demonstrate performance, but they are in vitro (bench testing) rather than in vivo data.

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

This question is not applicable to this type of device clearance. "Ground truth" in the context of expert consensus is typically relevant for diagnostic or AI-driven devices where human interpretation provides a reference standard. For a mechanical implant device, the "ground truth" is defined by established engineering and biological safety standards (e.g., ASTM standards for mechanical properties, USP standards for endotoxins) and the expert interpretation is embedded within the test methodologies and regulatory review process.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic decisions. For mechanical testing, results are quantitative and either meet or do not meet pre-defined criteria; expert adjudication of test results is not typically part of the process, though expert interpretation of the implications of the results is part of the regulatory review.

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. This is a clearance for a physical orthopedic implant (Titanium Interference Screws), not an AI or imaging device that would involve human readers or diagnostic interpretation.

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

Not applicable. This device is an orthopedic implant, not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests described, the "ground truth" is derived from:

• Established engineering standards: For cyclic loading, failure torque, insertion torque, and pull-out strength, these likely refer to industry-accepted mechanical testing standards (e.g., ISO, ASTM standards for orthopedic implants). The "ground truth" is the established performance benchmarks or thresholds for these mechanical properties that ensure safety and effectiveness for the intended use.
• Biological safety standards: For Bacterial Endotoxins, the "ground truth" is the regulatory limit of ≤20 Endotoxin units (EU)/Device per USP41-NF36 Chapter .

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm, so there is no training set in the machine learning sense.

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

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

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WIN Flexible Nail System

WIN Nails (for use in pediatric patients) are to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

This device is intended for osteosynthesis.

The WIN Flexible Nail System is to be used for treatment of long-bone fractures including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, distal third fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures.

The subject WIN Flexible Nail System is made of titanium alloy, which has been continuously made commercially available since the 1950s. This device is to be implanted by insertion into long bones for fixation of fractures.

This document is a 510(k) premarket notification for the "WIN Flexible Nail System" and focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of AI/software performance.

Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, ground truth, and MRMC studies is not applicable to this type of submission.

Here's an analysis based on the provided document:

1. Table of acceptance criteria and the reported device performance

• Not Applicable. This document does not describe performance metrics for a diagnostic or AI device with specific acceptance criteria. It's for a physical medical device (bone fixation nails) and focuses on mechanical properties and material equivalence to a predicate.

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

• Not Applicable. No test set or data provenance details are relevant for this type of device submission. The submission relies on demonstrating equivalence through comparison of materials, design features, and intended use, rather than a clinical performance study.

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. There is no "ground truth" establishment in the context of an AI/diagnostic device performance study mentioned in this document.

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

• Not Applicable. No adjudication method for a test set is discussed.

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. This is not an AI/software device, so no MRMC study was conducted or is relevant.

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

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

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

• Not Applicable. There is no ground truth concept as defined for AI/diagnostic devices in this submission. The "ground truth" in this context is established by the known properties and clinical history of the predicate device and the materials used.

8. The sample size for the training set

• Not Applicable. No training set is involved as this is not a machine learning/AI device.

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

• Not Applicable. No training set or ground truth for it is relevant.

Information provided in the document related to the device and its assessment:

• Device Name: WIN Flexible Nail System
• Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories
• Regulatory Class: Class II
• Product Code: JDS
• Indications for Use: To be used for treatment of long-bone fractures (including non-comminuted and comminuted mid-shaft fractures, subtrochanteric fractures, combination fractures of the shaft and neck, intertrochanteric fractures, combination intertrochanteric and subtrochanteric fractures) in pediatric patients.
• Predicate Device: Pediatric Fixation Rods (K000764) and 2mm Pediatric Flex Nail (K022531)
• Basis for Substantial Equivalence:
  • Intended Use: Identical to predicate
  • Indications for Use: Identical to predicate
  • Materials: Identical to predicate (titanium alloy, commercially available since the 1950s)
  • Design Features: Similar to predicate
  • Sterilization: Identical to predicate
• Non-Clinical Tests: "None provided" - The document explicitly states no non-clinical tests were provided in this section of the summary. This implies reliance on the equivalence to the predicate and the established properties of the materials.
• Clinical Tests: "None provided" - No clinical tests were provided for this submission.

Conclusion from document: The submission concludes that the differences between the subject device and the predicate do not raise new questions of safety and effectiveness, and the subject device is at least as safe and effective as the legally marketed predicate devices. This is a common approach for Class II devices demonstrating substantial equivalence.

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The ALLthread™ Titanium Suture Anchor devices are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.

The ALLthread Titanium Suture Anchor is a non-resorbable suture anchor used to provide soft tissue fixation to bone during healing.

This document is a 510(k) premarket notification for the ALLthread™ Titanium Suture Anchor, a medical device for soft tissue reattachment, and not a study describing the acceptance criteria and performance of an AI product. Therefore, I cannot extract the requested information. The document focuses on establishing substantial equivalence to predicate devices based on non-clinical testing of mechanical properties and sterility.

Here's why the requested information cannot be found:

• No AI component: The device described is a physical medical implant (suture anchor), not an AI-powered diagnostic or assistive tool.
• Non-clinical testing: The "Summary of Performance Data" details non-clinical tests (cyclic loading, static loading, insertion torque, failure torque, needle attachment strength, suture tensile strength, bacterial endotoxins). These tests assess the physical properties and safety of the anchor itself, not the performance of an algorithm.
• No "acceptance criteria" in the AI sense: The document's closest equivalent to "acceptance criteria" are the performance levels achieved in the non-clinical tests, indicating the device performs "within the intended use" and does "not raise any new risks to device performance." These are not acceptance criteria for an AI model's accuracy, sensitivity, specificity, etc.
• No ground truth, training data, or expert adjudication: Since there's no AI algorithm, there's no concept of ground truth, training set, test set, expert readers, or adjudication methods as they relate to AI performance evaluation.
• No MRMC study: A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is specific to evaluating AI's impact on human performance, which is not applicable here.

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To provide fixation of soft-tissue grafts within the tibial tunnel during anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) reconstruction.

The TunneLoc Tibial Fixation Devices are an implant and inserter instrument system that offers components for treatment of patients that require fixation of soft tissue to bone.

This document (K193092) is a 510(k) Premarket Notification for the TunneLoc® Tibial Fixation Device. It is not for an AI-powered medical device, but rather a mechanical orthopedic device. Therefore, the information requested (acceptance criteria, test set details, expert qualifications, MRMC studies, standalone performance, training set details) related to the performance of an AI/algorithm is not applicable to this document.

The document describes the device, its intended use, and substantial equivalence to existing predicate devices. The performance data provided is non-clinical (mechanical testing, FEA, bacterial endotoxins) to demonstrate the safety and effectiveness of design modifications to the device (specifically the inserter and its yoke) and updated labeling. No clinical studies were conducted or provided.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, adjudication methods, expert qualifications, or MRMC studies for an AI device, as this information is not present in the provided document.

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