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The A.L.P.S. Small Fragment Plating System is intended for fixation of fractures, osteotomies and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, fibula, particularly in osteopenic bone.

The 100 Degree Tubular Plate is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius, ulna, distal tibia (including intra-articular), fibularly in osteopenic bone.

Washers are intended to be used in conjunction with bone screws.

The A.L.P.S.® Small Fragment System is a titanium alloy (Ti-6Al-4V) plate and screw system that fuses locking screw technology with conventional plating techniques.The subject device consists of plates, The devices are available in sterile and nonsterile options, and vary by sizes and number of holes, making the device suitable for a wide range of patient anatomy and needs.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

This document is a 510(k) premarket notification summary for a medical device called the "A.L.P.S. Small Fragment Plating System." As such, it primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and the results of a specific study designed to "prove" the device meets those criteria in the way a clinical trial for an AI diagnostic might.

Key takeaway: The document confirms that for this type of device (metallic bone fixation system), clinical data and conclusions were not needed. The substantial equivalence is based on technological comparison and non-clinical tests related to MRI compatibility. Therefore, many of the questions related to acceptance criteria for algorithmic performance, sample sizes for test/training sets, expert adjudication, or MRMC studies are not applicable in this context.

Here's the information that can be extracted or inferred from the provided text, with clarifications where questions are not applicable:

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

For this device, the "acceptance criteria" are related to established standards for materials and non-clinical performance, primarily demonstrating MR compatibility and structural integrity through existing test methods. The document doesn't provide specific quantitative acceptance criteria or performance metrics in a table format for this specific device's novel performance. Instead, it states that the device's technological characteristics are similar to predicates and that non-clinical tests were conducted.

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. The submission states: "Clinical data and conclusions were not needed for this device." The tests performed are non-clinical (e.g., MRI compatibility on a device, not on patient data).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

• Not Applicable. As no clinical data or test sets requiring expert ground truth were used for this 510(k) submission.

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

• Not Applicable. As no clinical data or test sets requiring expert adjudication were used for this 510(k) submission.

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 device is a metallic bone fixation system, not an AI diagnostic tool. No MRMC study was conducted.

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

• Not Applicable. This device is a metallic bone fixation system, not an algorithm.

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

• Not Applicable. Clinical ground truth was not required for the non-clinical tests performed. The "ground truth" for the device's properties would be based on engineering specifications, material standards, and physical testing outcomes against those standards.

8. The sample size for the training set

• Not Applicable. This device is a physical medical device, not an AI/ML algorithm. There is no training set in this context.

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

• Not Applicable. This device is a physical medical device, not an AI/ML algorithm. There is no training set or ground truth for such a set in this context.

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The Comprehensive® Segmental Revision System is intended for use in cases of:

• 1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
• 2. Revision where other devices or treatments have failed.
• 3. Correction of functional deformity.
• 4. Oncology applications including bone loss due to tumor resection.

When used in a proximal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral head (shoulder) involvement, which are unmanageable using other treatment methods.

When used as a distal or total humeral replacement, the Comprehensive Segmental Revision System is also intended for:
Treatment of acute or chronic fractures with humeral epicondyle (elbow) involvement, which are unmanageable using other treatment methods.

Biomet Comprehensive Segmental Revision System is indicated for use in a reverse application 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 suited to receive the implants and a functional deltoid muscle is necessary. For the US and Canada only: reverse application is limited to proximal humeral replacement.

The Comprehensive Segmental Revision System is intended for use with or without bone cement in the proximal shoulder.

The Comprehensive Segmental Revision System is intended for use with bone cement in distal humeral applications.

Tissue Attachment Augments provide the option for tissue stabilization and attachment Augments are not available in all markets.

The Comprehensive Segmental Revision System (SRS) is a multi-piece orthopedic implant designed to replace the humerus up to and including the humeral side of the shoulder and elbow joints. The device is designed specifically for use in cases where there is extensive bone loss requiring extramedullary replacement of bone. The Tissue Attachment Augments provide the option for tissue stabilization and attachment.

The provided text describes a medical device, the "Comprehensive Segmental Revision System (SRS)," and its 510(k) premarket notification to the FDA. This document is a regulatory submission for a medical device and thus does not contain information about acceptance criteria or a study proving that a device meets those criteria in the context of an AI-powered diagnostic or predictive system.

The text does mention:

• Non-Clinical Tests/Justification: Coating Characterization, Fatigue Strength Report Flanges, Fatigue Strength Analysis Humeral Stems, Shot Peen Testing Summary, and MRI. These are engineering and material science tests relevant to the physical implant's safety and performance, not a study of an AI system's diagnostic accuracy.
• Clinical Tests: "None provided." This explicitly states that no clinical studies were performed for this specific submission to expand the indications of the device, as substantial equivalence was demonstrated through other means (comparison to predicates, engineering tests).

Therefore, based on the provided text, I cannot answer questions 1 through 9 as they relate to the performance evaluation of an AI device. The document is about a mechanical orthopedic implant, not an AI system.

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The Taperloc® Complete Hip Stems are intended for hip joint arthroplasty.

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 by other techniques.
5. Revision procedures where other treatment or devices have failed
   Porous coated components are intended for uncemented biological fixation.

Taperloc® Complete Hip Stems are an implant device, a porous coated femoral stem intended for uncemented biological fixation. The Taperloc® Complete is a series of hip stems with a bi-planar wedge design, titanium substrate, and proximally circumferential titanium porous plasma sprayed design.

The document provided is a 510(k) premarket notification for the Taperloc® Complete Hip Stems. It describes the device, its intended use, and provides a summary of performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not present:

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

The document does not explicitly present acceptance criteria in a formal table with pass/fail thresholds for the tests conducted. Instead, it states that "All testing passed and met the specifications or comparison testing (as applicable) to the predicate devices." This implies that the acceptance criteria were either established by the referenced ASTM standards or through direct comparison to the performance of the predicate device.

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

• Sample Size for Test Set: The document mentions "samples" for the porous plasma spray coating testing and "samples" for the one-step forging distal pot up/down fatigue testing. However, specific numerical sample sizes are not provided for any of these non-clinical tests.
• Data Provenance: The document states these are "Non-Clinical Tests" performed to support the 510(k) submission. It does not specify the country of origin where the testing was conducted. It is inherently prospective in the sense that the tests were performed specifically for this regulatory submission to evaluate the cumulative changes to the device.

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 a medical device, specifically an orthopedic implant (hip stem), and the performance data is entirely non-clinical (mechanical and material testing). Therefore, there were no human experts involved in establishing ground truth in the traditional sense of clinical or diagnostic studies. The "ground truth" for these engineering tests would be established by the testing protocols and the objective measurements themselves, adhering to the specified ASTM standards.

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

Not applicable. As stated above, these are non-clinical, objective engineering tests, not clinical evaluations requiring expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This document describes a medical device (hip implant), not an AI/software as a medical device (SaMD) that would involve human readers or AI assistance. No MRMC study was performed.

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

Not applicable. This document describes a physical medical device, not an algorithm or AI.

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 objective measurements obtained through adherence to the specified ASTM standards and direct comparison to the predicate device's performance. There is no expert consensus, pathology, or outcomes data used as ground truth for these non-clinical mechanical tests.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device and the studies refer to non-clinical material and manufacturing process changes, not machine learning or AI.

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

Not applicable. As above, there is no training set mentioned or implied.

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Biomet's MAK OSS Femoral Knee Components are intended for use in conjunction with the OSS System for total knee replacement procedures. Specific indications for the OSS System are:

1. Painful and disabled joint resulting from avascular necrosis, osteoarthritis, rheumatoid arthritis, or traumatic arthritis.
2. Correction of varus, valgus or post-traumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
4. Ligament deficiencies.
5. Tumor resections.
6. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques. *
7. Revision of previously failed total joint arthroplasty.
8. Trauma.
   These devices are to be used with bone cement unless a proximal femur is indicated for use (USA).

• Not applicable to Regenerex Ultra Porous Construct titanium knee augment usage (not licensed in Canada), or any other knee component.
  When components of the Orthopedic Salvage System are used with Biomet's Compress Segmental Femoral Replacement System, they are intended for uncemented application and indicated for:

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

The MAK OSS Femoral Knee Components are intended to be used as an optional femoral knee component for use in coniunction with the cleared Orthopedic Salvage System. The MAK OSS Femoral Knee Components include either resurfacing or segmental femoral components that utilize the yoke and axle of the OSS System but limit extension of the knee to limit or prevent hyperextension.

This document is a 510(k) premarket notification for a medical device called "MAK OSS Femoral Knee Components." It focuses on design modifications to a locking pin within the existing device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the test set used in the non-clinical testing. It only states that "Verification testing was conducted."

The data provenance is not explicitly mentioned (e.g., country of origin). Since this is a 510(k) submission to the FDA, it can be inferred that the testing and data generation occurred within a context relevant to US regulatory standards, likely in the US or by a US-based or affiliated entity. The testing was non-clinical, involving mechanical tests, not human subjects.

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

This document describes non-clinical, mechanical testing. Therefore, there were no human experts establishing a "ground truth" in the clinical sense (e.g., diagnosis, outcome assessment). The "ground truth" for this engineering verification would be the objective measurements of insertion and extraction forces against predefined engineering specifications or benchmarks for the predicate device. The experts involved would be biomechanical engineers or test technicians, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

Not applicable. This was non-clinical testing against engineering specifications, not a study involving human interpretation or subjective assessments that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is a 510(k) submission for a mechanical medical device (femoral knee components) and does not involve AI, human readers, or image interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a mechanical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used for the non-clinical testing was based on objective engineering measurements of insertion and extraction forces, compared against predefined specifications or performance of the predicate device.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is not a machine learning or AI-based device. The term "training set" is generally used in the context of supervised learning, where an algorithm learns from labeled data.

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

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

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The Compress® Segmental Humeral Replacement System is intended to replace the resected part of the humerus in cases of severe bone loss in either the proximal or distal humerus. The Compress® Segmental Humeral Replacement System components are intended for uncemented use.

The Compress® Segmental Humeral Replacement System is indicated for:

1. Correction or 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 Humeral Replacement System components are intended for uncemented use.

The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement System are restricted to the Compress® Segmental Humeral Replacement System indications and are intended to be inserted with bone cement.

The Modular Hybrid Glenoid when used in conjunction with the Compress® Segmental Humeral Replacement System is restricted to the Compress® Segmental Humeral Replacement System indications and is intended to be used 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 Compress® Segmental Humeral Replacement System is a metallic segmental fixation system intended to replace the resected part of the humerus in cases of severe bone loss. The design of the Compress® System allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.

The Compress® Segmental Humeral Replacement System is a set of Compliant - Pre-Stress implants that replace the humeral stems that would normally be used during a proximal or distal humeral replacement surgery.

Here's a summary of the acceptance criteria and the study information based on the provided text, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document describes non-clinical (bench) testing only. It does not mention a "test set" in the context of patient data.

• Sample Size for Test Set: Not applicable, as no clinical test set was used.
• Data Provenance: Not applicable, as no clinical data was used.

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

Not applicable. The tests performed are mechanical engineering tests, not clinical evaluations requiring expert consensus on ground truth.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set with ground truth establishment was performed. The non-clinical tests likely followed standardized engineering practices for evaluation.

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

No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The device is a physical medical implant (Compress® Segmental Humeral Replacement System), not an algorithm or AI system. Therefore, a standalone performance study in the context of AI is not relevant.

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests was based on engineering specifications and predefined performance thresholds for mechanical properties (fatigue life, pull-off strength). This is a form of objective physical measurement against a standard.

8. The Sample Size for the Training Set

Not applicable. The device is a physical medical implant, not an AI or machine learning model that requires a training set.

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

Not applicable, as there was no training set for an AI/ML model.

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1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
2. Correction of varus, valgus, or posttraumatic deformity.
3. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

For cemented and un-cemented use.

The E-Poly™ Tibial Bearings are provided in five sizes. Each size comes in five thicknesses. (There are five basic styles of the E-Poly™ Bearings which are intended to be unsel with previously cleared Biomet knee products.)

The E-Poly™ UHMWPE tibial bearings are highly-crosslinked to improve wear resistance, and infused with vitamin E to stabilize free-radicals and prevent oxidative degradation.

The provided text does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving the device met such criteria. This document is a 510(k) summary for the E-Poly™ Tibial Bearings, which focuses on demonstrating substantial equivalence to legally marketed predicate devices for the purpose of market clearance.

Here's what the document does state:

• Non-Clinical Testing: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This generally refers to bench testing for mechanical properties, wear resistance, etc., but specific acceptance criteria or detailed results are not provided.
• Clinical Testing: "None provided as a basis for substantial equivalence." This explicitly states that no clinical studies were performed or submitted for this 510(k) application to establish substantial equivalence.

Therefore, I cannot provide the requested information in the table format or answer the specific questions related to acceptance criteria and performance studies because this data is not present in the provided document.

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The InnerVue™ Diagnostic Scope System is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening. Examples of generic surgical use include the visualization of joints within the body. These joints can include, joints located in the torso/trunk, upper/lower extremities, and the temporomandibular joint.

The InnerVue™ Diagnostic Scope System consists of five (5) main parts: hardware, software, instrumentation and procedural kit(s).

Hardware: The hardware consists of the following components: Monitor, keyboard, image processor, Xenon light source, camera unit, power supply, printer, handpiece (which incorporates the camera head and light cable), a slide-out working surface and a storage drawer.

Software: The software enhances the image from the scope to remove fiber optic pixilation without adding distortion. The software allows the operator to record and print still images as well as record and archive audio and video information recorded during the procedure.

Scope: A rigid fiber optic scope designed for one-time use.

Supplementary Instruments: Supplementary instruments consist of four (4) pieces that can be used interchangeably throughout the procedure. The four components are a cannula, a trocar, and a cannula plug. Both disposable supplementary instruments are available with the system.

Procedural Kits: Supplementary items to assist in the surgical procedure.

The provided text states, "Clinical Testing: None provided as a basis for substantial equivalence." This means that no clinical study was conducted to prove the device meets acceptance criteria specific to its diagnostic or operational performance related to medical outcomes.

Instead, the device's substantial equivalence and performance are based on compliance with electrical safety and general medical equipment standards.

Here's the breakdown of the information requested, based on the provided text:

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)

Not applicable. No clinical testing with a test set was conducted for substantial equivalence. The performance assessment was based on compliance with electrical and safety standards, not clinical data or patient samples.

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

Not applicable. No clinical testing was performed, so no experts were used to establish ground truth for a test set.

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

Not applicable. No clinical testing was performed.

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 mentioned or conducted, as the device is not an AI-assisted diagnostic tool and no clinical testing was performed for substantial equivalence.

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

Not applicable. No standalone algorithm performance was assessed as this is a medical device for visualization and illumination, not an AI or algorithm-based diagnostic tool. The performance was assessed against safety and electrical standards.

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

Not applicable. Ground truth in a clinical sense was not established as no clinical testing was performed. The "ground truth" for compliance was the requirements outlined in the specified electrical and medical device safety standards.

8. The sample size for the training set

Not applicable. No training set was used as this device does not involve machine learning or AI that requires a training set.

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

Not applicable. No training set was used.

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Indications for the LactoScrew™ Screw Anchors include use in soft tissue reattachment procedures in the shoulder, wrist/hand, ankle/foot, elbow, and knee. Specific indications are as follows:

Shoulder: Bankart repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tendodesis, deltoid repair. Wrist/Hand: Scapholunate ligament reconstruction, ulnar/radial collateral ligament reconstruction.

Ankle/Foot: Lateral stabilization, medial stabilization, Achilles tendon repair/reconstruction, halluxvalgus reconstruction, mid- and forefoot reconstruction.

Elbow: Tennis elbow repair, ulnar or radial collateral ligament reconstruction, biceps tendon reconstruction.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, joint capsule closure, iliotibial band tendodesis, and patellar ligament/ tendon repair.

This device is a screw anchor used to provide a means for attaching soft tissue to bone during healing. The device consists of a screw portion and a head portion. The screw portion engages the bone while the head portion provides a means to drive the anchor in and a means to attach the suture to the anchor. These anchors are comprised of 85% L-Lactide/15% Glycolide and are available in 3.5 mm and 5.5 mm diameter sizes.

The provided text is a 510(k) summary for the Biomet LactoScrew™ Screw Anchor, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a new study with acceptance criteria and performance metrics.

Therefore, the document explicitly states:

• Non-Clinical Testing: "Mechanical testing was performed to establish substantial equivalence to the predicate devices."
• Clinical Testing: "Clinical testing was not used to establish substantial equivalence to predicate devices."

Due to this, the questions regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment for a study proving acceptance criteria cannot be answered directly from the provided text.

The 510(k) process for this device relies on demonstrating that its technological characteristics (material and design) are similar to existing, legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The "acceptance criteria" here would relate to the successful demonstration of substantial equivalence, primarily through non-clinical mechanical testing, rather than performance against pre-defined clinical metrics.

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Calcigen™ PSI bone graft substitute is indicated for bony voids or gaps of the skeletal system (i.e., the extremities, spine and pelvis) that are not intrinsic to the stability of the bony structure. These defects may be surgically created osseous defects or osseous defects created from disease or traumatic injury to the bone. Calcigen™ PSI bone graft substitute can be combined with autogeneous bone marrow aspirate or autogenous blood. Calcigen™ PSI resorbs and is replaced with bone during the healing process.

Calcigen™ PSI bone graft substitute is a resorbable osteoconductive scaffold composed of 60% hydroxyapatite (HA) and 40% tri-calcium phosphate (TCP). The device is available as granules, cubes, or cylinders. Calcigen™ PSI is porous with multidirectional interconnected pores resembling that of cancellous bone.

The provided text describes the 510(k) summary for the Calcigen™ PSI Bone Graft Substitute. Based on the information provided, here's a breakdown of the requested details:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This indicates that no clinical studies (and therefore no test set) were conducted with the Calcigen™ PSI device itself for this 510(k) submission. Substantial equivalence was claimed based on comparison to legally marketed predicate devices and non-clinical testing/literature review.

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

Since no clinical testing was performed for the Calcigen™ PSI device in this submission, there was no test set requiring expert ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable, as no clinical testing and test set were used.

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

No MRMC study was performed or referenced for this 510(k) submission. The document states "Clinical Testing: None provided as a basis for substantial equivalence."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a bone graft substitute, not an algorithm, and its performance is not assessed in a standalone algorithmic manner.

7. Type of Ground Truth Used

For the Calcigen™ PSI device itself, no specific "ground truth" was established via clinical studies for this 510(k). Instead, the substantial equivalence relied on:

• Comparison of technological characteristics (materials, design, indications) to legally marketed predicate devices.
• Non-clinical laboratory testing and literature review, which would implicitly draw on established scientific understanding and historical data regarding bone graft substitutes.

8. Sample Size for the Training Set

Not applicable. This document pertains to a medical device (bone graft substitute), not an AI/algorithm-based device that would require a 'training set'.

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

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

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