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The Iconix® HA+™ anchors are intended to be used for soft-tissue to bone fixation in the foot, ankle, knee, hip, hand, wrist, elbow and shoulder. Specific indications are listed below.

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Repair

Hand Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Repar

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair. Iliotibial Band Tenodesis. Medial Patellofemoral Ligament (MPFL) Repair/ Reconstruction, Quadriceps Tendon Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

The Iconix® HA*TM Anchor is comprised of a suture sleeve structure and working suture. Nonabsorbable braided ultra-high molecular weight polyethylene (UHMWPE) sutures are spliced through a suture anchor sleeve comprised of non-absorbable braided polyester and bioceramics. Up to two non- absorbable round or flat braided UHMWPE working sutures can be added inside the suture anchor sleeve. The UHMWPE sutures are available undyed (white) and black.

Sutures supplied meet United States Pharmacopeia (USP) requirements for non-absorbable suture except for diameter. Suture dyes are FDA approved. The inserter is comprised of a metallic shaft with over molded handle. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Iconix® HA*M Anchors are available in common sizes and lengths and will be sold sterile for single use with no components or accessories. The device is intended for use in a hospital/clinic/surgical setting.

This document describes the validation study for the Iconix® HA+TM Anchor, a medical device used for soft-tissue to bone fixation. This is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the "acceptance criteria" and "device performance" are primarily demonstrated through comparison to the predicate and established performance benchmarks for such devices, rather than a clinical accuracy study for AI/software.

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

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device, not an AI/software device, the "acceptance criteria" and "reported device performance" are primarily based on meeting established standards and demonstrating comparable mechanical properties to a predicate device.

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

The provided document describes non-clinical performance testing and an animal study. It does not describe a clinical study with a human-derived test set in the way an AI/software device would.

• Non-clinical Mechanical Testing: The sample sizes for insertion, cyclic, and pullout testing are not specified. The studies were performed to compare against the predicate device.
• Animal Study: The sample size for the animal study is not specified. The purpose was to evaluate biological safety and in vivo performance.
• Data Provenance: The document implies these were prospective laboratory and animal studies conducted by the manufacturer, Riverpoint Medical, LLC. There's no mention of country of origin for the data or whether it was retrospective.

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

This question is not applicable in the context of this device and study type.

• For non-clinical mechanical testing, the "ground truth" is typically defined by engineering specifications and objective measurements (e.g., force, displacement), not expert interpretation.
• For the animal study, "ground truth" would be established through histological analysis, observation of biological responses, and potentially pathological evaluation, conducted by veterinary pathologists or researchers, but this is not explicitly detailed as "experts establishing ground truth" in the sense of a diagnostic interpretation task.

4. Adjudication Method for the Test Set

This is not applicable. There was no human "test set" requiring adjudication in the context of an AI/software performance study. Mechanical and biological test results are typically objectively measured against defined criteria.

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

This is not applicable. This device is a physical bone anchor, not an AI/software diagnostic tool. There were no human "readers" involved in interpreting findings from the device itself.

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

This is not applicable. This device is a physical bone anchor, not an algorithm or software. The mechanical and biological tests assess the device's inherent function, which is a "standalone" evaluation of its physical properties.

7. The Type of Ground Truth Used

• Mechanical Testing: Ground truth was based on objective engineering measurements (e.g., load-to-failure, displacement) and comparison to the predicate device's established performance and industry standards for bone anchors.
• Biocompatibility/Animal Study: Ground truth was based on biological responses and safety profiles observed in the animal model, likely through histological analysis, gross observations, and clinical pathology, evaluated against established safety benchmarks for implantable materials.
• Suture Testing: Ground truth was based on United States Pharmacopeia (USP) requirements for tensile strength.

8. The Sample Size for the Training Set

This is not applicable. This is a physical device, not an AI/software model that requires a training set.

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

This is not applicable, as there was no training set.

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Align anterior cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Align anterior cages are intended for use at ether one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radios. Align 2-screw anterior cages may be used as a stand alone device only when two (2) vertebral body bone screws are used. Align 4-screw anterior cages may be used as a stand alone device only when at least two (2) vertebral body bone screws are inserted in the two medial fixation holes with one superior screw trajectory. If the physician chooses to use Align anterior cages with fewer than two (2) screws in the two medial fixation holes with one inferior and one superior screw trajectory, then an additional spinal fixation system cleared for use in the lumbosacral spine must be used.

Align anterolateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Align anterolateral cages are intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Align anterolateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

Align lateral cages are indicated for intervertebral body fusion of the spine in skeletally mature patients who have had at least six months of non-operative treatment. The device systems are designed for use with allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and/or autograft to facilitate fusion. One device is used per intervertebral body space. Align lateral cages are intended for use at either one level in the lumbar spine, from L2 to S1, for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. Align lateral cages are intended to be used with supplemental spinal fixation system cleared for use in the lumbosacral spine.

Align implants are intervertebral body fusion devices intended for lumbar interbody fusion using an anterior lumbar interbody fusion surgical approach (ALIF), anterolateral (i.e., oblique) lumbar interbody fusion surgical approach (OLIF), or a lateral lumbar interbody fusion surgical approach (LLIF). The devices are intended to improve stability of the spine while supporting fusion. The Align constructs are intended for use at one or two contiguous levels in the lumbar spine (L2-S1). Components are offered in different shapes and sizes to meet the requirements of the individual patient's anatomy and are provided sterile. Align devices are available in six configurations: modular constructs, standard constructs, fully round ALIF (FRA) constructs, and open constructs for ALIF approach, anterolateral (i.e., oblique) constructs for OLIF approach, and lateral constructs for LLIF approach. Align cages are secured on the vertebral bodies using bone screws. A cover plate assembly prevents the screws from backing out after insertion. The cages and cover plates are made of titanium alloy (Ti-6Al-4V ELI) per ASTM F3001 Standard Specification for Additive Manufacturing Titanium-6 Alulminum-4 Vanadium ELI (Extra Low Interstitial) with Powder Bed Fusion. The bone screws and cover plate screws are made from titanium alloy (Ti-6Al-4V ELI) per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications. All constructs are zero profile, reducing potential for vessel interference with the anterior column. With the exception of the modular constructs, all cages and bone screws are also available with a hydroxyapatite coating.

The provided text is related to a 510(k) premarket notification for a medical device called "Align" by Acuity Surgical Devices, LLC. It describes the device, its indications for use, and a comparison to a predicate device. However, it explicitly states that no clinical data was provided to demonstrate substantial equivalence. This means there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as such a study is not part of this 510(k submission. The submission relies on non-clinical testing and substantial equivalence to a predicate device and reference devices to demonstrate safety and effectiveness.

Here’s what I can extract based on the document:

1. A table of acceptance criteria and the reported device performance:
Not applicable as no clinical acceptance criteria or performance study results are provided. The submission focuses on demonstrating substantial equivalence through non-clinical testing.

2. Sample size used for the test set and the data provenance:
Not applicable as no clinical study with a test set is described. Non-clinical testing was performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical study requiring expert ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no clinical study with adjudication is described.

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. The device is an intervertebral body fusion device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. The device is a surgical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable as no clinical study requiring a ground truth is described.

8. The sample size for the training set:
Not applicable as no clinical study or AI model with a training set is described.

9. How the ground truth for the training set was established:
Not applicable as no clinical study or AI model with a training set and ground truth establishment is described.

Summary of Non-Clinical Testing (as provided in the document):

The device's substantial equivalence is supported by non-clinical testing, which includes:

• Performance testing per ASTM F2077 for Static Axial Compression, Dynamic Axial Compression, Static Compression Shear, and Dynamic Compression Shear.
• Performance testing per ASTM F2267 for Subsidence and Expulsion testing.
  • Note: These tests performed on the predicate device (K201671) are deemed applicable to the modified devices because there is no difference in size, dimension, raw material, or manufacturing method/equipment, except for a nanometer-thin layer of hydroxyapatite applied to the surface.
• Performance testing of HA®® Surface integrity was conducted per the Promimic protocol, which was accepted by FDA for the clearance of reference devices K201614, K170392, and K101225.
• Performance testing of the break-off cover plate screw per the protocol accepted by FDA for the clearance of the reference device K130958.

The document concludes that these non-clinical tests indicate that "Align" is substantially equivalent to the predicate and reference devices.

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The DJO EMPOWR POROUS FEMUR WITH HAnano Surface™ is indicated for use in total knee arthroplasty patients, receiving total joint replacement because of disability or suffering due to:

· degenerative, post-traumatic or rheumatoid arthritis;

· avascular necrosis of the femoral condyle:

post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;

· moderate valgus, varus or flexion deformities;

· treatment of fractures that are unmanageable using other techniques.

This device may also be indicated in the salvage of previously failed surgical attempts. The device is intended for uncemented applications.

While knee replacements are not intended to withstand activity levels and loads of normal healthy bone, they are a means of restoring mobility and reducing pain for many patients.

The EMPOWR Porous Femur with HA"™ Surface is a line extension to the EMPOWR Knee Platform and EMPOWR Porous Knee Platform (cleared via K143242 and K171991), to include a hydroxyapatite-coated porous femoral component in the system.

The EMPOWR Porous Femur with HA"" Surface™ has an adjunct hydroxyapatite (HA) coating on the 3D Matrix® porous coating inside the cement pocket. Since the device is porous coated, it is indicated for cementless use.

This document, K210308, is a 510(k) Premarket Notification for a medical device. It describes a new iteration of a total knee implant, the EMPOWR POROUS FEMUR with HAnano Surface™. The document focuses on demonstrating substantial equivalence to a predicate device, as clinical testing was not required for this submission. Therefore, the information provided primarily concerns non-clinical testing and comparisons, rather than a detailed study proving the device meets an extensive set of acceptance criteria through clinical trials.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence through non-clinical testing, rather than explicit performance metrics derived from a clinical trial with pre-defined success/failure thresholds. The reported performance is framed in terms of meeting these comparison points.

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

• Sample Size for Test Set: Not applicable in the context of human clinical data for this 510(k) submission. The "test set" here refers to non-clinical laboratory tests on device components or full devices. The document does not specify the number of samples used for each non-clinical test (e.g., how many devices were subjected to abrasion testing).
• Data Provenance: The data comes from non-clinical laboratory testing performed by the manufacturer, DJO Surgical (Legal Name: Encore Medical, L.P.). The document does not specify the country of origin for these lab tests, but it is implied to be internal testing or contracted testing performed under the manufacturer's oversight. The testing is not retrospective or prospective clinical data, but rather bench and material testing.

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

• This question is not applicable as there was no "ground truth" derived from human experts for a clinical test set. The ground truth in this context would be the results of the non-clinical tests (e.g., passing or failing a fatigue test, measured wear rates). These results are obtained through standardized testing protocols, not expert consensus on medical images or patient outcomes.

4. Adjudication Method for the Test Set

• This question is not applicable. There was no human "test set" in need of adjudication. The non-clinical tests have objective outcomes based on established methods and criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Improvement with AI vs. Without AI Assistance

• Not applicable. This device is a medical implant (total knee prosthesis), not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant. No AI component is described in the provided text.

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

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

7. The Type of Ground Truth Used

• As discussed, "ground truth" here refers to the outcomes of the non-clinical tests. The types of "ground truth" used are:
  • Engineering Test Results: Measurements from abrasion testing, pin-on-disk wear testing, fatigue testing, contact area testing.
  • Biocompatibility/Safety Testing: Bacterial endotoxin assessment results compared against pre-defined specifications (20 EU/device).
  • Material and Geometric Specifications: Confirmation that the new device's substrate material, geometry, and porous coating are identical to the predicate.
  • Predicate Device Performance: Reliance on the previously cleared predicate's mechanical testing results for identical geometries.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of this 510(k) submission as it does not involve machine learning or AI.

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

• Not applicable. See point 8.

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The Innovasis® TxTiHA™ IBF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These implants are used to facilitate fusion in the lumbar spine and are placed via a transforaminal approach.

This device is intended to be used with internal spinal fixation systems such as the Imovasis Excella® Spinal System. The interior of the implant is intended to be packed with autograft.

The Innovasis® AxTiHA™ Stand-Alone ALIF System is an intervertebral body fusion device for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbar spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to a Grade 1 spondylolisthesis or retrolisthesis at the involved levels(s). These implants are used to facilitate fusion in the lumbar spine and are placed via an anterior (ALIF) approach. Hyperlordotic implants (those with a lordotic angle greater than or equal to 20°) are indicated for use with a supplemental spinal fixation system such as the Innovasis® Excella® Spinal System. The AxTiHA Stand-Alone interbody implants with a lordotic angle less than 20°, when used with all three internal fixation screws, do not require use of supplemental fixation. The interior of the AxTiHA implant is intended to be packed with autograft or allogenic bone graft composed of cancellous and/or corticocancellous bone graff.

TxTiHA™ IBF System
The TxTiHA system is an intervertebral body fusion device with associated instrumentation for use in Transforaminal Lumbar Interbody Fusion (TLIF) surgeries. The implant is an additive manufactured device made from the titanium alloy Titanium-6 Aluminum-4 Vanadium Extra Low Interstitial (Ti-6AI-4V ELI) conforming to the ASTM F3001 specifications and features a Promimic HAM® Surface® ! Implants are available in various lengths, widths, heights, and degrees of lordosis to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth. Implants are supplied sterile. Reusable instruments to support the TLIF surgery are provided with the implants in sterilization trays.

AxTiHA™ Stand-Alone ALIF System
The AxTiHA system is for Anterior Lumbar Interbody Fusion (ALIF). The implants are an additive manufactured device comprised of Ti-6Al-4V ELI per ASTM F3001 and feature a Promimic HA®®® Surface. Implants are available in multiple size options to facilitate a more precise anatomical fit. The implants have a tapered leading edge which aids in implant insertion due to limited anatomical space, feature a bi-convex profile to match the anatomy, and include anti-migration features to ensure implant stability during the fusion process. The large graft cavity and open geometric Tetracell™ Technology structure provide increased volume for autograft loading and bone through-growth.

The provided text is a 510(k) summary from the FDA for two intervertebral body fusion devices, the TxTiHA™ IBF System and the AxTiHA™ Stand-Alone ALIF System. This document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance data, rather than presenting a clinical study or acceptance criteria in the typical sense for a new AI/medical device.

Therefore, the information required to answer your specific questions about acceptance criteria and a study proving device performance (especially those related to clinical trials, AI, ground truth, and human reader performance) is not present in this document.

However, I can extract the information that is available:

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

The document does not provide a table of acceptance criteria with numerical performance data. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing:

The core "acceptance" for this type of device (a 510(k) submission) is demonstrating "substantial equivalence" to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety and effectiveness.

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

• Sample Size: Not applicable. The document describes non-clinical performance testing of the devices themselves (e.g., mechanical strength), not a clinical test set involving patient data or imaging. Therefore, concepts like sample size of patients, data provenance, retrospective/prospective studies, or country of origin are not mentioned.
• Data Provenance: The non-clinical tests likely occurred in a lab setting. The company is Innovasis, Inc. in Salt Lake City, Utah, USA.

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 document does not describe a clinical study requiring human experts for ground truth establishment.

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

Not applicable. There is no test set in the clinical sense described here.

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-assisted device, nor does the document describe an MRMC study.

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

Not applicable. This is not an AI device.

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

Not applicable. The "ground truth" for these physical devices is their compliance with specified ASTM standards and material properties, verified through non-clinical mechanical testing, rather than clinical outcomes or expert labels.

8. The sample size for the training set:

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable. There is no training set described.

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The EVOL® -SI Joint Fusion System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The EVOL® -SI Joint Fusion System is designed to treat dysfunctions of the sacroiliac joint. It includes titanium alloy (Ti-6Al-4V ELI per ASTM F136-13) screws and optional washers as well as instruments to place them in the body. It is designed to cross the sacroiliac joint anchoring the sacrum to the pelvis. Each screw is treated with a hydroxyapatite (HA) surface treatment that is approximately 20 nanometers thick.

Here's an analysis of the provided FDA 510(k) summary, specifically focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for the mechanical and endotoxin tests. It refers to "the worst-case subject EVOL® -SI Joint Fusion System implants" for endotoxin testing, implying a limited number. The data provenance is not specified, but these are typically laboratory-based tests performed by the manufacturer or a contract research organization.

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

This information is not applicable. The device's performance is objectively measured against engineering standards (ASTM) and biological contamination limits (ANSI/AAMI, USP), not against expert interpretations of data.

4. Adjudication Method for the Test Set

This information is not applicable, as there is no human interpretation or adjudication involved in the mechanical or endotoxin testing.

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

No. This document describes a medical device (surgical implant) and not an AI/imaging diagnostic tool. Therefore, an MRMC study is not relevant.

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

No. This document describes a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth is established through:

• Established engineering standards: ASTM F543 and ASTM F1264 for mechanical properties.
• Established biological safety standards: ANSI/AAMI ST72 and USP for endotoxin limits.
• Comparison to predicate devices: The "substantial equivalence" is based on the new device's performance meeting or exceeding that of legally marketed predicate devices, which serve as a benchmark for safety and effectiveness.

8. The Sample Size for the Training Set

This information is not applicable. This is a 510(k) submission for a physical medical device, not an AI/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 information is not applicable (see point 8).

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S.I.N. Dental Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit or multi-unit restorations. When a one-stage surgical approach is applied, the S.I.N. Dental Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Implants with lengths less than 7 mm are intended for delayed loading only.

The subject device consists of four Morse taper connection product lines: Unitite, Unitite Compact, and Strong SW CM. All implants are threaded cylindrical root-form designs. The Unitite provided with an acid-etched and HA surface, the Strong SW CM is provided with an acid-etched surface, Each product line has abutments available in multiple designs (temporary, cementable, angled, UCLA, ball, multi-unit). Subject device abutments are straight only.

Unitite implants are available in six implant body diameters (2.9. 3.5. 4.0. 4.3. 5.0 and 6.0 mm) and eight lengths (5, 6, 7, 8.5, 10, 11.5, 13, and 15 mm). Strong SW CM implants are available in four implant diameters (3.5, 3.8, 4.5.5.0 mm) and five lengths (8.5. 10. 11.5. 13. and 15 mm). Unitite abutments are available in five prosthetic platform diameters (3.3, 3.5, 4.0, 4.5, and 4.8 mm). Strong SW CM abutments are available in four prosthetic platform diameters (3.3, 3.5, 4.5 and 4.8 mm). Subject Device components are made of commercially pure titanium, titanium alloy, cobalt-chromium, or polycarbonate.

The provided text is a 510(k) Summary for the S.I.N. Dental Implant System (K170392). It details the device, its intended use, and a comparison to predicate devices, but does not contain any information about clinical studies with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case studies related to device performance.

The document states: "No clinical data were included in this submission."

Therefore, based on the provided text, I cannot complete the requested information. However, I can extract the information provided about performance data (non-clinical) and the device's characteristics.

Here's what I can provide based on the given text:

1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the traditional sense of performance metrics for a clinical study with a device output. Instead, it describes non-clinical testing performed to demonstrate substantial equivalence to predicate devices.

2. Sample sized used for the test set and the data provenance
Not applicable. No clinical test set. Non-clinical tests were conducted; however, specific sample sizes for these tests are not provided in the summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No clinical test set or ground truth established by experts is mentioned.

4. Adjudication method for the test set
Not applicable. No clinical test set or adjudication process is mentioned.

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. The device is a dental implant system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. The device is a physical dental implant system, not an algorithm or AI.

7. The type of ground truth used
Not applicable. No clinical ground truth is mentioned.

8. The sample size for the training set
Not applicable. No training set is mentioned as this device is not an AI/ML algorithm.

9. How the ground truth for the training set was established
Not applicable. No training set or ground truth for it is mentioned.

Summary of what the document implies about meeting acceptance criteria:

The document demonstrates that the "S.I.N. Dental Implant System" meets the requirements for substantial equivalence to its predicate devices through a series of non-clinical tests. These tests cover aspects like sterilization, shelf-life, biocompatibility, and physical performance (e.g., insertion). The "acceptance criteria" here implicitly refer to the successful completion of these standard tests demonstrating that the device is as safe and effective as the legally marketed predicate devices, and that any differences do not raise new questions of safety or effectiveness. The absence of clinical data in the submission indicates that the FDA deemed the non-clinical evidence sufficient for a finding of substantial equivalence.

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