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Hip Arthroplasty Indications:
· Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
• · Correction of functional deformity
  · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
· When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
· When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks

Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

Restoration Modular 115mm Conical Distal Stem Indications for Use:

• · Noninflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
  · Rheumatoid arthritis;
• · Correction of functional deformity;
• · Revision procedures where other treatments or devices have failed; and,
  · Nonunions, femoral neck fractures, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.
  · Primary and revision total hip arthroplasty as well as in the presence of severe proximal bone loss. These femoral stems are designed to be press-fit into the proximal femur.

The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepared femoral canal for either primary or revision total or hemi hip arthroplasty.
The Insignia Hip Stem includes 12 sizes ranging from Size 0 through 11. Each stem size is offered in a Standard Offset and a High Offset option at a single 132 degree neck angle. The stem is designed only for use with compatible V40 Howmedica Osteonics' femoral heads, sleeves and acetabular components.
The Insignia Hip Stem is manufactured from Ti6Al4V ELI alloy and the device features hydroxyapatite coating over a commercially pure titanium plasma sprayed surface for cementless fixation.

The subject Restoration Modular 115mm Conical Distal Stem is a part of the Restoration Modular Hip System. The Restoration Modular Hip System is a modular femoral replacement system comprised of three main components: the Restoration Modular Proximal Femoral Body, the Restoration Modular Distal Stem, and the Locking Bolt. Each of these components feature unique design iterations and are offered in a range of sizes, allowing for independent sizing of the proximal femoral body and the distal stem. The distal stem addresses fixation and stability, and the proximal femoral geometry allows for adjustments to anteversion, height, and offset. The Restoration Modular Hip System is designed to attain fixation and restore hip biomechanics.
The subject device is a sterile, single-use device designed to be press-fit into a prepared femoral canal for either primary or revision total hip arthroplasty and is labeled as MR Conditional. The Restoration Modular 115mm Conical Distal Stem utilizes a male locking taper for mating with one of the compatible Restoration Modular Proximal Femoral Bodies and Locking Bolt.

The provided text is a 510(k) summary for the Insignia Hip Stem and Restoration Modular 115mm Conical Distal Stem. It focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing related to Magnetic Resonance (MR) conditional safety. It does not describe a study involving device performance for its primary function (hip replacement) or human reader performance.

Therefore, many of the requested categories (e.g., effect size of human readers with AI, training set size, ground truth for training set) are not applicable to this document.

Here's a breakdown of the information that is available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MR safety testing are implicitly the standards themselves (e.g., ASTM F2052-15). The document states that the components were "evaluated per the following standards" and that "The labeling has been modified to include the MR conditional symbol, and to provide the parameters under which a patient who has the device can be safely scanned in the MR environment." This implies that the devices met the requirements of these standards to be considered MR Conditional. Specific numerical performance results are not provided in this summary.

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

The study involved testing of the Insignia Hip Stem components and the Restoration Modular 115mm Conical Distal Stem. The sample size refers to the number of device components tested for MR compatibility. This information is not explicitly stated in the summary. The tests are non-clinical (laboratory-based), so data provenance like country of origin or retrospective/prospective is not applicable in the human data sense.

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

This category is not applicable. The ground truth for MR safety testing is established by the specifications of the ASTM standards, not by human experts adjudicating medical images or conditions.

4. Adjudication method for the test set

This category is not applicable. The evaluation is based on meeting parameters defined by engineered standards, not on human 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

This category is not applicable. The device is a hip implant, not an AI-assisted diagnostic tool.

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

This category is not applicable. The device is a hip implant, not an algorithm. The MR safety testing is inherently "standalone" in the sense that it evaluates the physical properties of the device itself.

7. The type of ground truth used

The ground truth for the MR safety testing is defined by the ASTM standards referenced (ASTM F2052-15, ASTM F2213-17, ASTM F2119-07 (Reapproved 2013), ASTM F2182-19). These standards establish protocols and acceptance criteria for classifying medical devices as MR Conditional.

8. The sample size for the training set

This category is not applicable. This is a physical medical device undergoing non-clinical safety testing, not a machine learning algorithm that requires a training set.

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

This category is not applicable. As mentioned above, there is no training set.

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The Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the C2-T1) for the following indications: degenerative disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), turnors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The Insignia Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The Insignia Anterior Cervical Plate System consists of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The instruments in this system are intended for use in surgical procedures. This submission seeks clearance for redesigned Insignia plates and screws.

This is a 510(k) premarket notification for a medical device (Insignia™ Anterior Cervical Plate System), not an AI/ML medical device. Therefore, the information typically requested regarding acceptance criteria and performance studies for an AI/ML device (e.g., sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance) is not applicable or present in this document.

The provided document describes a spinal implant and its mechanical testing to demonstrate substantial equivalence to a predicate device. It explicitly states under "Clinical Information": "Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document focuses on:

• Device Description: Spinal plates and screws made from titanium alloy.
• Intended Use: Anterior screw fixation to the cervical spine (C2-T1) for various spinal conditions.
• Technological Comparison: Demonstrating substantial equivalence to predicate devices in intended use, indications, design, function, and technology.
• Performance Data (Nonclinical): Mechanical testing (static compression, static torsion, dynamic compression, screw push-out) according to ASTM F1717 and FDA guidance for spinal plating systems.

No information about AI/ML algorithms, image analysis, diagnostic performance, or human-in-the-loop studies is present.

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Hip Arthroplasty Indications:
· Painful, disabling joint disease of the hip resulting from: noninflammatory degenerative joint disease (including osteoarthritis or avascular necrosis), rheumatoid arthritis or post-traumatic arthritis.

• · Revision of previous unsuccessful femoral head replacement, hip arthroplasty or other procedure.
  · Correction of functional deformity
  · Treatment of nonunion, femoral neck and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques.

Additional indication specific to use of Insignia Hip Stems with compatible Howmedica Osteonics Constrained Liners:
· When the stem is to be used with compatible Howmedica Osteonics Constrained Liners, the device is intended for use in primary or revision patients at high risk of hip dislocation due to a history of prior dislocation, bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability.

Additional indication specific to use of Insignia Hip Stems with compatible ADM and MDM Acetabular Components:
· When the stem is to be used with compatible Howmedica Osteonics ADM and MDM Acetabular Components, the device is indicated for Dislocation risks

Insignia Femoral Stems are intended for cementless use only and are intended for total and hemiarthroplasty procedures.

The Insignia Hip Stem is a sterile, single-use device that is intended for cementless fixation into a prepared femoral canal for either primary or revision total or hemi hip arthroplasty. The basic design of the Insignia Hip Stem is similar to other commercially distributed hip stems, such as the Accolade II and Omnifit HFx hip stems. The Insignia Hip Stem is manufactured from Ti-6Al-4V ELI alloy, features a collar, commercially pure titanium plasma sprayed proximal surface, and plasma sprayed hydroxyapatite coating.

The Insignia Hip Stem includes 12 sizes ranging from Size 0 through 11. Each stem size is offered in a Standard Offset and a High Offset option at a single 132 degree neck angle. The stem is designed only for use with compatible V40 Howmedica Osteonics femoral heads, sleeves, and cemented or uncemented acetabular components.

This is a medical device submission for the Insignia Hip Stem, which is a physical implant, not a software device or AI algorithm. Therefore, the questions regarding acceptance criteria and studies related to AI or algorithm performance are not applicable to the provided text.

The document discusses the mechanical and material performance of the hip stem rather than the diagnostic or predictive performance of an AI system. No information about AI acceptance criteria, training sets, test sets, expert adjudication, or MRMC studies for AI devices is present in the provided text.

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The Insignia™ Anterior Cervical Plate System is intended for anterior screw fixation to the cervical spine (C2-T1) for the following indications: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), trauma (including fractures), tumors, deformity (kyphosis, lordosis or scoliosis), pseudarthrosis, failed previous fusions, spondylolisthesis, and spinal stenosis.

The Insignia Anterior Cervical Plate System is intended for anterior fixation to the cervical spine. The Insignia Anterior Cervical Plate System consists of a variety of sizes of plates and screws that are manufactured from titanium alloy conforming to ASTM F136 and are offered non-sterile. The instruments in this system are intended for use in surgical procedures.

The provided document, a 510(k) summary, describes a medical device called the "Insignia™ Anterior Cervical Plate System" and its substantial equivalence to predicate devices. However, this document does not contain the kind of information typically found in a study proving a device meets acceptance criteria for an AI/ML-based diagnostic or assistive technology.

The document is for a physical medical implant, a spinal fixation system, and the "performance data" section refers to nonclinical mechanical testing (e.g., static and dynamic compression, torsion testing) to demonstrate its physical performance and substantial equivalence to existing devices. It explicitly states: "Clinical Information: Not applicable; determination of substantial equivalence is not based on an assessment of clinical performance data."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria in the context of AI/ML performance (e.g., accuracy, sensitivity, specificity, reader improvement, ground truth methodology) because the document describes a purely mechanical device, not a diagnostic or AI-driven one.

The prompt's requirements (e.g., "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the loop performance)," "type of ground truth used") are specific to AI/ML device evaluations, which are not relevant to this 510(k) submission for a spinal plate system.

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Insignia Digicast is a computer aided system intended for use as an aid in orthodontic diagnostics for use by dental professionals trained in orthodontic treatment including radiographic analyses and diagnostics.

Insignia Digicast is a software product and service that creates digital models of patients' teeth, which are used primarily to record the status of a patients' dentition prior to treatment. Clinicians may also use the digital model to support their diagnosis. The Insignia Digicast system scans a traditional impression, processes the scan, and electronically delivers a digital study model to the dental professional. The dental professional may view, measure, and analyze the Insignin Digicast three dimensional viewer software. The main analysis tools include TJ Moyers, Bolton analyses, ABO scoring, and Arch and Overbite/Overjet measurements. There are no accessories or patient contacting components of Insignia Digicast.

The provided document describes the Insignia Digicast, a software product and service that creates digital models of patients' teeth for orthodontic diagnostics.

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

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state numerical acceptance criteria (e.g., specific accuracy thresholds for measurements). Instead, it relies on demonstrating substantial equivalence to predicate devices (OrthoCAD iQ and Lava Digital Models) through qualitative comparisons of features and mode of use, and quantitative comparisons of measurement accuracy.

   Feature/Measurement	Acceptance Criteria (Implied by Substantial Equivalence)	Insignia Digicast Performance (Reported)
   Teeth Width	Functionally equivalent to predicates	Bench tested, successfully validated
   Space	Functionally equivalent to predicates	Bench tested, successfully validated
   T-J Moyers Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
   Bolton Analysis	Functionally equivalent to predicates	Bench tested, successfully validated
   Arch Measurements	Functionally equivalent to predicates	Bench tested, successfully validated
   Overbite/Overjet	Functionally equivalent to predicates	Bench tested, successfully validated
   Overall Performance	Substantially equivalent to predicate devices	Deemed substantially equivalent

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

   • Sample Size: Not specified in the provided document. The document states "data from bench testing" was used, but does not quantify the number of cases or models tested.
   • Data Provenance: Not explicitly stated. Given it's bench testing, it's likely synthetic data, cadaver models, or a collection of patient impressions, but the origin (e.g., country) is not mentioned. It is a retrospective evaluation against existing (presumably traditional) measurements.

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

   • Not specified. The document indicates that bench testing was used to "evaluate the performance characteristics... compared to the predicate device." It doesn't mention expert involvement in establishing a separate ground truth for the test set beyond the comparisons made with the predicate device's established performance.

4. Adjudication Method for the Test Set:

   • Not specified. This information is typically relevant for human-reader evaluations, which did not occur for this device.

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. The document explicitly states: "Clinical testing has not been conducted on this product."

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

   • Yes, a standalone evaluation was performed. The "Non-Clinical Performance Data" section describes "bench testing" to evaluate the "performance characteristics of Insignia Digicast," which is an algorithm-only assessment. The software was "successfully validated to confirm the performance of the device."

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

   • The "ground truth" for the non-clinical performance evaluation was based on comparisons to the predicate device, OrthoCAD iQ, for characteristics such as teeth width, space, and various analyses (T-J Moyers, Bolton, Arch, Overbite/Overjet). This implies the predicate device's measurements served as the reference or accepted standard.

8. The sample size for the training set:

   • Not specified. The document does not provide any details regarding the training data or its size.

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

   • Not specified. Since no information on the training set is provided, the method for establishing its ground truth is also unknown.

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Insignia with iTero is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient. The Insignia Orthodontic System is compatible with the iTero scanner.

The Insignia software creates a computer model of the patient's dentition based on a stone model, iTero scan file or impression of the patient's dentition. The iTero scanner produces a digital scan of a patient's tooth data as an alternative to the physical dental impressions. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive. Insignia with iTero consists of the following components and accessories: 1) Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist. 2) Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets. 3) Patient-specific foam bracket placement jigs to affix the brackets in position. 4) Either commercially-available or patient-specific shaped traditional archwires. The device does not include the adhesive that affixes the brackets to the teeth.

The provided text describes the "Insignia with iTero" device, an orthodontic treatment planning software and appliance system. It claims substantial equivalence to two predicate devices: "Insignia (K121524)" and "Biomet 3i Using Cadent iTero Scanner (K102209)".

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a typical pass/fail format with specific thresholds. Instead, it relies on the concept of "substantial equivalence" to predicate devices. The primary performance aspect highlighted is the accuracy of the digital impression file generated from the iTero scanner.

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

• Sample Size: Not specified. The document only mentions "Accuracy testing of the digital impression file..." without providing the number of scans or measurements included in this testing.
• Data Provenance: Not specified. It's unclear if the testing was retrospective or prospective, or the country of origin of the data.

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

• Not specified. The document simply mentions "Accuracy testing" without detailing how the ground truth for this testing was established or if experts were involved in its determination.

4. Adjudication Method for the Test Set:

• Not specified. There's no mention of any adjudication method (e.g., 2+1, 3+1, none) for the accuracy testing.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or performed. The device is not presented as an AI-assisted diagnostic tool for human readers but rather as a treatment planning software and appliance system. The evaluation focused on the accuracy of the digital impression and substantial equivalence to existing devices, not on human reader improvement with AI.

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

• Yes, implicitly. The "Accuracy testing of the digital impression file generated from the iTero scanner" appears to be a standalone performance evaluation of the scanner component, which produces a digital output (algorithm only) as an alternative to physical impressions. The software then uses this digital model for treatment planning. The "Insignia software" itself also operates in a standalone manner to calculate bracket positions.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• Not explicitly defined. For the "accuracy testing of the digital impression file," the ground truth likely involved a comparison against a highly accurate reference measurement of the dentition. This could be a physical impression measured with high-precision instruments or a different, highly accurate 3D scanning method considered the gold standard. However, the document does not specify the exact nature of this ground truth.

8. The Sample Size for the Training Set:

• Not applicable/not specified. The document describes a "proprietary software that calculates the position of dental brackets" and the "iTero scanner" which produces digital scans. While these systems likely have internal algorithms that were developed and potentially "trained," the document does not discuss a training set in the context of machine learning or AI models in the modern sense. The focus is on the output accuracy of the system's components.

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

• Not applicable/not specified. As with the training set itself, the document does not provide details on how ground truth would have been established for any internal training or development of the software or scanner's algorithms.

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The Insignia Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients, using appliances individualized for the orthodontic patient.

The Insignia software creates a computer model of the patient's dentition based on either a stone model or impression of the patient's dentition. Insignia operators and the orthodontist use this computer model to determine the placement and/or modification of dental brackets to achieve the intended repositioning of the teeth. Ormco then manufactures foam bracket placement jigs to position the brackets on the patient's teeth in specific positions prescribed by the orthodontist. The orthodontist uses the foam jigs to place and secure the brackets with a commercially-available dental adhesive.

Insignia consists of the following components and accessories:

1. Proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist.
2. Commercially-available metal, plastic, or ceramic brackets and/or individually modified metal brackets.
3. Patient-specific foam bracket placement jigs to affix the brackets in position.
4. Either commercially-available or patient-specific shaped traditional archwires.
   The device does not include the adhesive that affixes the brackets to the teeth.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Insignia device:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria (e.g., minimum accuracy percentages, error tolerances) for the Insignia software. Instead, it relies on a comparison to a predicate device and a statement of "successful validation."

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

The document does not specify a sample size for any test set used to validate the software. It merely states "the Insignia software has been successfully validated." There is no information provided regarding data provenance (e.g., country of origin, retrospective or prospective nature).

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

The document does not mention the use of experts to establish a ground truth for a test set. The validation information is extremely high-level and lacks details about specific methodologies.

4. Adjudication Method for the Test Set

Since no test set with expert-established ground truth is described, there is no information provided regarding an adjudication method.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. The document explicitly states: "Clinical testing has not been conducted on this product." The focus is on software validation and biocompatibility, not on human-in-the-loop performance or comparison to human readers.

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

A standalone study of the algorithm's performance, separate from human interaction, was done, but with very limited detail. The statement "the Insignia software has been successfully validated to confirm the performance of the device" indicates a standalone evaluation of the software. However, the specifics of this validation (e.g., metrics, methodology, dataset) are not provided in the summary.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for the software validation. Given the nature of the device (treatment planning and bracket positioning), the ground truth for an ideal outcome would likely be established through engineering design specifications, simulated clinical scenarios, or potentially comparisons to historical treatment outcomes, but this is not detailed.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size. As a software for treatment planning, it's possible that the "training" refers more to the development and refinement of algorithms based on orthodontic principles and mechanical models rather than traditional machine learning training data.

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

The document does not describe how ground truth for a training set was established. This lack of detail is consistent with the generally high-level overview of software validation provided in the summary.

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