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The Extremity All Suture System is intended to be used for suture or tissue fixation in the foot/ankle, knee, 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 Reconstruction
Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

The Extremity All Suture System (EASS) includes the Griplasty™ System – Base of Thumb and Griplasty™ System – Micro, Mini and Small Suture Anchor. The system incorporates soft tissue fixation devices; 'all suture' anchors with an expandable push-in design, provided preloaded in an inserter handle with associated single-use instruments, and supplied sterile (ethylene oxide) for single use. The EASS anchors are constructed from a hollow braid with a suture component assembled through the hollow braid.

All sutures, inclusive of suture line and anchor, are made with non-absorbable Ultra High Polyethylene (UHMWPE) per ASTM F2848. All needles are made with Stainless Steel per ASTM F899. The instrumentation is made stainless steel and medical grade Acrylonitrile Butadiene Styrene (ABS). The anchor and impacted into a pilot hole. The sutures are manually tensioned to set the anchor by bunching the suture sleeve.

Griplasty" System – Base of Thumb: Comprises a suture anchor implant (with or without needles) and associated instrumentation for use in carpometacarpal (CMC) joint arthroplasty.

Griplasty" System – Micro, Mini and Suture Anchor: Comprises a range of all suture anchor implants (with or without needles) and associated instrumentation for use in securing soft tissue to bone.

The provided text describes the "Extremity All Suture System" (EASS) and its mechanical testing for FDA 510(k) clearance. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of anchors tested, but it mentions testing the "worst-case size anchors."
• Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It is implied to be a prospective, lab-based mechanical test.

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

Not applicable. This was a mechanical testing study, not a study requiring expert clinical judgment for ground truth. The "ground truth" was established by engineering analysis and direct measurement of pull-out force.

4. Adjudication Method for the Test Set

Not applicable. This was a mechanical testing study, not a study requiring adjudication of expert opinions.

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 surgical fixation system, not an AI-powered diagnostic or assistive technology for human readers.

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

Not applicable. This device is a surgical fixation system, not an algorithm.

7. The Type of Ground Truth Used

The ground truth used for the mechanical testing was the measured pull-out load of the anchors, determined through standardized mechanical tests (as per FDA Guidance Document for Suture Anchors, ASTM F543-17, and ASTM F1839-08). The acceptance criteria for this ground truth were based on direct comparison to the performance of "similar sized predicate suture anchor devices."

8. The Sample Size for the Training Set

Not applicable. This device is a medical implant, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

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

Study Details from the provided text:

• Study Type: Non-clinical mechanical testing.
• Objective: To demonstrate that the Extremity All Suture System (EASS) has a non-inferior pull-out load compared to predicate devices.
• Methodology:
  • Mechanical testing was performed on "worst-case size anchors" of the EASS.
  • Tests were conducted following the FDA Guidance Document for Suture Anchors, ASTM F543-17, and ASTM F1839-08.
  • Engineering analysis identified the smallest anchor as the ""worst-case" (least resistance to pull-out force).
  • Statistical analysis and comparison of subject and predicate device pull-out loads were performed.
• Results: The study "showed the subject device to have non-inferior (i.e. similar / 'substantially equivalent') pull-out load and performance as the predicate devices."

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The Field Orthopaedics BTES Screw Range is intended for use in the fixation of fractures, osteotomies, and arthrodesis. appropriate for the size of the device, in adults and in both, children (2-12 years) and adolescents (12- 21 years), in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The FO Fenestrated Screws are not for the delivery of bone graft, bone cement, or bone void filler.

The Field Orthopaedics BTES Plate Range and Plate Screws are in the fixation of fractures, osteotomies, and arthrodesis of the hand and other small bones. The system may be used in both adults and pediatric patients.

The Field Orthopaedics Bony Trauma Extremity System (BTES) is an extremity trauma system consisting of a range of screws and a range of plates cleared in K200043.

The BTES screw range consists of a range of screws intended for standalone use, and a range of screws intended to be used with the BTES plate range. The standalone screw range consists of 1.2 mm solid, partially threaded screws of various lengths; 1.5 – 5.0 mm cannulated, partially threaded screws in both headless and headed designs of various lengths; and 2.0 - 3.0 mm Cannulated, fenestrated, partially threaded screws in both headless and headed designs of various lengths. The range of screws intended to be used with the BTES plate range consists of 1.2, 1.5, and 2.0 mm solid, fully-threaded screws of various lengths.

The purpose of this Special 510(k) device modification is to notify FDA of the sterile NX Nail System, which is a line extension to the BTES Screw Range described above and cleared in K200043. NX Nail implants are made from the same titanium alloy using the same manufacturing processes as BTES implants, are non-compressive in design, and are available in lengths ranging from 12 to 90 mm and diameters ranging from 2.0 to 5.0 mm. NX Nail implants are offered nonsterile and sterile (gamma radiation). This Special 510(k) also includes added instruments for implanting NX Nail devices.

Materials: All BTES screws in the Screw Range are made with Titanium alloy ELI (as per ASTM F136). All plates are available as identical configurations in both Titanium alloy ELI (as per ASTM F136) and CP Titanium (ISO 5832-2). Instruments are made from medical grades stainless steel, anodized aluminum, and marked with epoxy resin.

The provided document is a 510(k) summary for a medical device (Bony Trauma Extremity System (BTES) Screw Range, NX Nail System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials or extensive AI performance evaluations.

Therefore, many of the requested elements are not applicable or cannot be extracted directly from this document. The information provided primarily pertains to the physical characteristics of the device and its equivalence to a prior cleared device.

However, I can extract the following information about the performance data related to the device. The "acceptance criteria" here refers to the internal criteria Field Orthopaedics Pty Ltd (or BioVera, Inc., the submitter) established for their verification and validation activities, and the "reported device performance" indicates that these criteria were met.

1. Table of acceptance criteria and the reported device performance

The following information cannot be found in the provided document:

2. Sample sizes used for the test set and the data provenance: The document does not specify sample sizes for any of the engineering analyses or user evaluations. The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided. For a physical device like this, "ground truth" would typically refer to physical and mechanical testing standards, and "experts" might be engineers or surgeons, but details are absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to the type of data presented.
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 an AI device, so an MRMC study is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the engineering tests would be established by industry standards (e.g., ASTM standards for material properties, bending strength tests). For the surgeon user evaluation, the "ground truth" would be the subjective assessment of functionality by the surgeons. However, explicit details on these standards or how the "ground truth" was formally established are not in this summary.
8. The sample size for the training set: Not applicable, as this is not a machine learning or AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not a machine learning or AI device.

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The Field Orthopaedics BTES Screw Range is intended for use in the fixation of fractures, and arthrodesis, appropriate for the size of the device, in adults and in both, children (2-12 years) and adolescents (12- 21 years), in which growth plates have fused or in which growth plates will not be crossed by screw fixation. The FO Fenestrated Screws are not for the delivery of bone graft, bone cement or bone void filler.

The Field Orthopaedics BTES Plate Range and Plate Screws are intended for use in the fixation of fractures, osteotomies and arthrodesis of the hand and other small bones. The system may be used in both adults and paediatric patients.

The Field Orthopaedics Bony Trauma Extremity System (BTES) is an extremity trauma system consisting of a range of screws and a range of plates.

The BTES screw range consists of a range of screws intended for standalone use, and a range of screws intended to be used with the BTES plate range. The standalone screw range consists of 1.2 mm solid, partially threaded screws of various lengths; 1.5 – 5.0 mm Cannulated, partially threaded screws in both headless and headed designs of various lengths; and 2.0 - 3.0 mm Cannulated, fenestrated, partially threaded screws in both headless and headed designs of various lengths. The range of screws intended to be used with the BTES plate range consists of 1.2, 1.5 and, 2.0 mm solid, fully-threaded screws of various lengths.

The BTES plate range consists of a variety of configurations including straight, L, T, and H frames. Key features of the plate range include anatomical contouring, locking screw, rotational correction, and compression holes. The plate thickness ranges from 0.6 – 1.2 mm with a number of holes ranging from 1 – 16 holes.

Materials: All screws in the screw range are made with Titanium ELI(as per ASTM F136).

All plates are available as identical configurations in both Titanium ELI (as per ASTM F136) and CP Titanium (ISO 5832-2).

The instrumentation is made from medical grades stainless steel, anodized aluminium, and marked with epoxy resin.

The provided document is a 510(k) clearance letter from the FDA for a Bony Trauma Extremity System (BTES) manufactured by Field Orthopaedics Pty Ltd. This document primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and mechanical performance. It does not describe the development or validation of an AI/ML-based medical device.

Therefore, I cannot provide the information requested in your prompt regarding acceptance criteria and study details for an AI/ML device, as the document does not contain any such information.

The document discusses:

• Device Name: Field Orthopaedics Bony Trauma Extremity System (BTES) Plate Range and Plate Screws; Field Orthopaedics Bony Trauma Extremity System (BTES) Screw Range.
• Regulation Number/Name: 21 CFR 888.3030 (Single/multiple component metallic bone fixation appliances and accessories)
• Classification: Class II
• Predicate Devices: K051567 (Aptus Titanium Fixation System, Medartis) and K180348 (FO Micro Screw System, Field Orthopaedics Pty Ltd)
• Performance Data: "ASTM F382 static four-point bend testing was performed against predicates. ASTM F543 torsion testing, pullout strength testing and insertion torque testing was performed against predicates. The results of mechanical and user testing, and theoretical analysis demonstrate the Field Orthopaedics Bony Trauma Extremity System to be substantially equivalent to the identified predicate devices. The acceptance criteria for the mechanical testing were all met, supporting the overall conclusion of substantial equivalence for the Bony Trauma Extremity System."

This indicates mechanical performance testing was conducted, not a clinical study involving AI/ML. The "acceptance criteria" mentioned refer to the parameters for these mechanical tests, not statistical performance metrics for an AI algorithm.

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The Field Orthopaedics Micro Screw System consists of the following kits with the following indications:

The FO Micro Screw Kit is intended for fixation of fractures, osteotomies, and arthrodeses of small bones in the foot, hand, and forearm.

The FO Pin and Wire Kit is intended for fixation of bone fractures or as guidance at insertion of implants into the skeletal system.

The Field Orthopaedics Micro Screw System is an extremity trauma system consisting of the FO Micro Screw Kit and the FO Pin and K-Wire Kit.

The FO Micro Screw Kit includes 1.5 mm and 2.0 mm diameter cannulated compression screws with lengths ranging from 6 mm to 16 mm increments and 0.6 mm single trocar K-wires of length 70 mm. Accompanying the screws is a specifically designed instrument kit, tailored to the insertion of the 1.5 and 2.0 FO Micro Screw.

The FO Pin and K-Wire Kit includes 0.6, 0.8, 1.0 and 1.2 mm double trocar K-wires of length options 70 mm and 150 mm; and 1.6 and 2.0 mm double trocar Pins of length 150 mm. Accompanying the FO Pins and K-Wires are appropriately sized guide sleeves to aid insertion.

Materials: All Field Orthopaedics Micro Screws are made from Titanium Alloy (ASTM F136).

All Field Orthopaedics Pins and K-Wires are made from Stainless Steel Alloy (ASTM F138).

The instrumentation is made from medical grades stainless steel, anodized aluminium, and marked with epoxy resin.

The provided text describes the 510(k) summary for the Field Orthopaedics Micro Screw System and does not contain information about the acceptance criteria or a study proving the device meets specific performance metrics in the context of an AI/ML device.

The document discusses the mechanical performance of a physical medical device (screws, pins, and K-wires for bone fixation) and compares it to predicate devices based on:

• Mechanical testing: Torsional strength, maximum torque to drive-in and remove screws, and pull-out force, as per ASTM F543.
• Theoretical engineering analyses.
• Simulated surgeon-user testing.

It concludes that the device possesses greater strength than predicate devices and meets the strength requirements for solid screws (ASTM F543).

Therefore, I cannot extract the requested information (such as acceptance criteria table with reported device performance, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth types for AI/ML models) because this document is about the regulatory submission for a physical orthopedic implant system, not a software/AI/ML medical device.

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