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The Patriot Duo in the CW mode is intended for Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, Coagulation and hemostasis) of soft tissues including:

Urology
Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, Coagulation and hemostasis) including: Urethral Strictures, Bladder Neck Incisions (BNI), Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors, Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP), Laser Resection of the Prostrate (HoLRP), Laser Enuculeation of the Prostate (HoLEP), Laser Ablation of the Prostate (HoLAP), Condylomas and Lesions of external genitalia.

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitas, Hemorrhoids, Cholecystectomy, Benign and Malignant Neoplasm, Angiodysplasia, Colorectal cancer, Telangiectasias, Telangiectasias of the Osler-Weber-Renu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions

Thoracic and Pulmonary
Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue including: Laryngeal Lesions, Airway obstructions including carcinoma, Polyps and Granulomas, Palliation of obstructing carcinomas of the tracheobronchial tree

Gynecology
Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis), Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision, ablation and or vessel coagulation, Soft tissue excision procedures such as excisional conization of the cervix

ENT
Endoscopic endonasal surgery (incision, excision, resection, ablation,vaporization, coagulation and hemostasis of soft tissue) including: Endonasal/sinus Surgery, Partial turbinectomy, Polypectomy, Dacryocystorhinostomy, Frontal Sinusotomy, Ethmoidectomy, Maxillary antrostomy, Functional endoscopic sinus surgery, Lesions or tumors of the oral, nasal, glossal, pharyngeal and, laryngeal, Tonsillectomy, Adenoidectomy

Dermatology and Plastic Surgery
Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas, Lesions of skin and subcutaneous tissue, Skin tags, Plantar warts

General Surgery
Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy, Lysis of adhesion, Appendectomy Biopsy, Skin incision, Tissue dissection, Excision of external tumors and lesions, Complete or partial resection of internal organs, tumors and lesions, Mastectomy, Hepatectomy Pancreatectomy, Splenectomy, Thyroidectomy, Parathyroidectomy, Herniorrhaphy, Tonsillectomy, Lymphadenectomy, Partial Nephrectomy, Pilonidal Cystectomy, Resection of lipoma, Debridement of Decubitus Ulcer, Hemorrhoids, Debridement of Statis Ulcer, Biopsy

Arthroscopy
Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue), Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including: Percutaneous Laser Disc Decompression/Discectomy, Foraminoplasty, Ablation and coagulation of soft vascular and non vascular tissue, In minimally invasive spinal surgery

The Patriot Duo in the Quasi-CW (SuperPulse) mode is intended for:

Urology
Ablation of Benign Prostatic Hypertrophy (BPH), Laser Resection of the Prostrate (LRP), Laser Enucleation of the Prostate (LEP), Laser Ablation of the Prostate (LAP), Transurethral Incision of the Prostate (TUIP), Condylomas, Urethral strictures, Lesions of external genitalia, Bladder neck incisions (BNI), Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors, Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi, Treatment of distal impacted fragments remaining in the ureters following lithotripsy.

Lithotripsy and Percutaneous Urinary Lithotripsy Indications
Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones.

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and haemostasis) including: Appendectomy, Polyps, Biopsy, Gall Bladder calculi, Biliary/Bile duct calculi, Ulcers, Gastric ulcers, Duodenal ulcers, Non Bleeding Ulcers, Pancreatitis, Haemorrhoids, Cholecystectomy, Benign and Malignant Neoplasm, Angiodysplasia, Colorectal cancer, Telangiectasias, Telangiectasias of the Osler-Weber-Renu disease, Vascular Malformation, Gastritis, Esophagitis, Esophageal ulcers, Varices, Colitis, Mallory-Weiss tear, Gastric Erosions

Gynecology
Open and laparoscopic gynecological surgery (incision, resection, ablation, vaporization, coagulation and hemostasis) of the soft tissue.

Note: The Patriot Duo for CW mode is only cleared for BPH when using over 150 W

Patriot Laser is seeking to introduce the Patriot Duo Laser, fibers and related accessories into commerce using fibers provided by InnovaQuartz, LLC, previously cleared by the FDA via the Premarket 510(k) notification process K180140, the InnovaQuartz LLC side fire fiber was previously cleared by the Premarket 510(k) notification process K233157.

The Patriot Duo Laser, fibers and related accessories are substantially equivalent to the predicate devices, The U.S. Laser Worx Patriot 1 Family of Lasers, fibers and associated accessories (K162334) and the Olympus Surgical Technologies America Soltive Preimum SuperPulse Laser, Laser fibers and accessories (K183647). The Patriot Duo is essentially the exact same device in the CW mode of operation as the as the Patriot 1 Family of Lasers. The Patriot Duo also employs a Quasi CW (SuperPulse) module allowing the Patriot Duo to operate in both the CW and Quasi CW (SuperPulse) modes to expand the Indications for Use (IFU's) to include Laser Lithotripsy and a variety of other clinical indications in the Quasi CW (SuperPulse) mode.

In the Patriot Duo each mode of operation is completely independent and may not be used at the same time or simultaneously, hence Patriot Laser LLC is simply requesting FDA Premarket Approval of two previously cleared modalities to be available in one system.

The U.S. Laser Worx Patriot 1 Family of lasers and accessories received FDA Premarket clearance April 27, 2017 (K162334) and the Olympus Surgical Technologies America Soltive Preimum SuperPulse Laser, Laser fibers and accessories received FDA Premarket clearance August 10, 2019 (K183647) for its Quasi CW (SuperPulse) Thulium Fiber Laser. Patriot Laser is simply combining two previously cleared technologies into the same console making it more beneficial for the medical community to treat more patients and a wider array of medical conditions using the same device.

The Patriot 1 Family of Lasers, 200, 400, 600 and 1000 micron sterile, disposable, single-use fibers (K162334) are indicated for incision, excision, resection, ablation, vaporization and coagulation of soft tissue encountered urology, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

The Olympus Surgical Technologies America Soltive Preimum SuperPulse Laser (K183647) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery, and gynecological surgery.

The Patriot Duo Laser, fibers, and related accessories are indicated for incision, excision, resection, ablation, vaporization, and coagulation of soft tissue encountered in urology, lithotripsy, gastroenterology, thoracic and pulmonary, gynecology, ENT, dermatology and plastic surgery general surgery and arthroscopy.

The Patriot Duo, the Patriot 1 Family of Lasers and the Soltive Premium are medical grade, infrared devices, which provide continuous and or Quasi CW (SuperPulse) laser energy at a wavelength 1945.5 nm +/- 8 % and 1920 nm – 1960 nm respectfully. The very slight difference in wavelength is clinically negligible. The Patriot Duo has the same intended uses as the previously cleared devices by the FDA via the 510K Notification process.

A comparison matrix listing the Characteristics and Technical Data of the Patriot Laser Patriot Duo and representative predicate devices is listed below.

The intended use and indications for use of the Patriot Duo Laser, fibers and related accessories are equivalent to the intended use and indications for use of the predicate devices the Patriot 1 Family of Lasers, fibers and related accessories and The Soltive Premium Laser, Laser fibers and accessories.

In addition, similar technological characteristics and principles of operation apply for all three laser systems. The Patriot Duo Laser, fibers and related accessories, components share the same fundamental technology as the previously cleared or predicate devices.

Performance testing was conducted and demonstrated that technological differences in optical and energy outputs of the laser do not alter the safety and effectiveness when compared to the optical and energy outputs of the predicate laser systems.

In regard to safety or effectiveness whereas the Patriot Duo, the Patriot 1 Family of Lasers and the Soltive Premium are very similar products. Patriot Laser believes that the performance characteristics of the Patriot Duo raises no safety concerns.

N/A

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The Patriot SI Implant System is intended for sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.

The Patriot SI Implant System is a minimally invasive sacroiliac joint fusion implant that pierces the cortical bone of the ilium and sacrum and is intended for the purpose of stabilizing and fusing the sacroiliac joint with intrinsic fixation features. It is available in one size and may be implanted using the designated surgical instruments into the SI joint space. Bone graft materials may be used with the Patriot SI Implant System. The Patriot SI Implant System device is made from additively manufactured titanium alloy, Ti-6Al-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot SI Implant System device is provided sterile and individually packed.

The provided FDA 510(k) clearance letter for the Patriot SI Implant System does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria for the purposes of an AI/software device.

The document is for a physical medical implant device (sacroiliac joint fusion implant). The information it provides is:

• Device Type: Patriot SI Implant System (a physical implantable device)
• Intended Use: Sacroiliac joint fusion for conditions including sacroiliac joint disruptions and degenerative sacroiliitis.
• Materials: Additively manufactured titanium alloy, Ti-6Al-4V-ELI, with or without hydroxyapatite (HA) coating.
• Testing Information: "Non-clinical cadaveric biomechanical testing was performed to support substantial equivalence of the Patriot SI Implant system." This type of testing is relevant for mechanical implants, not AI/software.
• Predicate Device: Patriot-SI Posterior Implant System (K232259).

Therefore, I cannot provide details on acceptance criteria and study design for an AI/software device based on this document. The questions posed in your request (sample size, expert qualifications, MRMC studies, standalone performance, ground truth types) are universally applicable to AI/software performance studies, but the source document is entirely about a physical hardware device.

If you have a document describing an AI/software medical device, I would be happy to analyze it according to your criteria.

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The Patriot-SI Posterior Implant System is intended for sacroiliac joint fusion including sacroiliac joint disruptions and degenerative sacroiliitis. When the Patriot Implant System (i.e., an "in-line" or "in-line" or "intraarticular" device) is implanted, it must be used with a Spinal Simplicity Liberty-SI Lateral System device (i.e., a "transfixing" device) implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct.

The Patriot-Sl Posterior Implant System is a minimally invasive sacrolliac joint fusion implant that is intended for implantation on a trajectory in line with the joint space (i.e., the device is an in-line or intra-articular implant). The Patriot Implant System device is required to be implanted with the Spinal Simplicity Liberty-Sl Lateral System device implanted across the same sacroiliac joint to create a hybrid SI joint fusion construct for the purpose of stabilizing and fusing the sacroiliac joint. It is available in one size and may be implanted using the designated surgical instruments through a posterior approach into the Sl joint space, fixating on both the sacrum and ilium via external threads. Bone graft materials may be used with the Patriot-Sl Posterior Implant System. The Patriot-SI Posterior Implant System device is manufactured titanium alloy, Ti-6AI-4V-ELI per ASTM F3001 and is offered with or without a hydroxyapatite (HA) coating per ASTM F1185. The Patriot-SI Posterior Implant System device is provided sterile and individually packed.

This document describes a spinal implant device, not an AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and AI-specific metrics (like MRMC studies or standalone AI performance) is not applicable.

The document is a 510(k) premarket notification for the "Patriot-SI Posterior Implant System," which is a physical medical device for sacroiliac joint fusion. The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device (NADIA® SI Fusion System, K190580) based on non-clinical mechanical tests and cadaver testing.

Here's a breakdown of the provided information, emphasizing why the AI/ML-specific questions are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a physical implant, "acceptance criteria" and "reported device performance" are based on mechanical properties and safety/effectiveness relative to its predicate, rather than AI model metrics like sensitivity, specificity, or AUC. The document lists the types of non-clinical mechanical tests performed to support substantial equivalence:

The conclusion states that "performance testing provided in this 510(k) application demonstrates that the Patriot SJ Posterior Implant System is capable of performing as intended and is as safe and effective as the legally marketed predicate device." Specific numerical acceptance criteria or performance values are not included in this summary document.

2. Sample Size for Test Set and Data Provenance:

Not applicable, as this is a physical device. Mechanical tests involve test specimens, and cadaver testing involves human cadavers, but these are not "datasets" in the AI/ML sense. Data provenance regarding country of origin or retrospective/prospective is not relevant here.

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

Not applicable. Ground truth for mechanical testing is derived from engineering principles and standards, and for cadaver testing, it pertains to the anatomical and biomechanical performance, typically evaluated by biomechanical engineers and potentially surgeons. There isn't a "ground truth" established by a panel of medical experts in the way it would be for an AI diagnostic algorithm.

4. Adjudication Method:

Not applicable. This concept pertains to resolving discrepancies in expert labeling or diagnoses for AI training/testing, which is not relevant for a physical implant's mechanical and cadaver testing.

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

Not applicable. This type of study assesses the impact of AI on human reader performance for diagnostic tasks. The Patriot-SI system is a surgical implant, not a diagnostic AI.

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

Not applicable. There is no algorithm to evaluate in a standalone manner.

7. Type of Ground Truth Used:

For the mechanical tests, the "ground truth" is defined by the requirements of the ASTM standards (F3574 and F2077) and the performance characteristics of the predicate device. For cadaver testing, it relates to the successful implantation and biomechanical stability observed. This is distinct from pathology, expert consensus, or outcomes data used for AI models.

8. Sample Size for the Training Set:

Not applicable. There is no AI model, and therefore no training set.

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

Not applicable. As there's no training set, there's no ground truth to establish for one.

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PATRIOT® Spacers (including CONSTITUTION®, SIGNATURE®, CONTINENTAL®, TransContinental®, and TransContinental® M) are interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondylolisthesis, deformity (degenerative scoliosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and had at least six (6) months of non-operative treatment. PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

When used as thoracolumbar intervertebral body fusion devices, SUSTAIN® Spacers (including SUSTAIN® R. SUSTAIN®-IR, and SUSTAIN®-RT) are indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12-L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc hemiation (with myelopathy), soondylolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). 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. SUSTAIN® Spacers are to be used with autograft and/or allogenic bone graft comprised of cancellous, and/or corticocancellous bone graft. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated PEEK versions.

PATRIOT® (including CONSTITUTION®. SIGNATURE®. Spacers TransContinental®, CONTINENTAL®, TransContinental® and M) are thoracolumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the spine. CONSTITUTION® PLIF Spacers are inserted using a posterior or transforaminal approach. SIGNATURE® TLIF Spacers are inserted using a transforaminal or lateral approach. CONTINENTAL® ALIF Spacers are inserted using an anterior, anterolateral, or lateral approach. TransContinental® and TransContinental® M Spacers are inserted using an anterior, anterolateral, or lateral approach. All approaches may be used in the lumbar spine; only anterior, anterolateral, or lateral approaches may be used in the thoracic spine. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

SUSTAIN® Spacers (including SUSTAIN® R, SUSTAIN®-IR, and SUSTAIN®-RT) are devices that can be used as intervertebral fusion devices or as vertebral body replacement devices. When used as interbody fusion devices, each of the spacers provides a different shape to accommodate various surgical approaches to the spine. SUSTAIN Small, SUSTAIN-R, and SUSTAIN-RT Spacers are inserted using a posterior or transforaminal approach. SUSTAIN Arch Spacers are inserted using a transforaminal or lateral approach. SUSTAIN Large Spacers are inserted using an anterior, anterolateral, or lateral approach. SUSTAIN Oblique and SUSTAIN G Spacers are inserted using a posterior, transforaminal, or lateral approach. These spacers are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. Each spacer has an axial hole to allow grafting material to be packed inside the spacer.

These spacers are used to provide structural stability in skeletally mature individuals following discectomy, corpectomy, or vertebrectomy (including partial). All approaches may be used in the lumbar spine; only the anterior, anterolateral, or lateral approach may be used in the thoracic spine.

This document describes the premarket notification (510(k)) for two medical devices: PATRIOT® Lumbar Spacers and SUSTAIN® Spacers. It seeks clearance for additional implants and indications for these devices.

Based on the provided text, the acceptance criteria and the study that proves the device meets the acceptance criteria primarily revolve around demonstrating substantial equivalence to already legally marketed predicate devices, rather than a de novo clinical trial with specific performance metrics for the AI component. This is typical for 510(k) submissions for Class II medical devices like intervertebral body fusion devices, where the focus is on a comparison to existing cleared products.

Therefore, the table for "acceptance criteria and reported device performance" will be framed differently than for a typical AI/ML medical device, as the "performance" here is primarily about mechanical and physical characteristics matching predicates, and clinical support comes from literature rather than a new study with specific metrics.

Here's a breakdown of the information requested, as extractable from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

This document describes a 510(k) submission based on substantial equivalence and mechanical testing, not a clinical study with a "test set" of patients in the typical sense for AI/ML device validation.

• Sample Size for Test Set: Not applicable in the context of a prospective clinical trial. The "testing" referred to is mechanical testing of the devices themselves, on samples of the physical product. The number of samples for these mechanical tests is not specified in the document but would follow the requirements of the ASTM standards.
• Data Provenance: The mechanical testing is performed in a lab setting. The clinical support data is "published clinical data" for interbody fusion devices, implying retrospective analysis of existing medical literature. The specific country of origin for this literature is not stated but would typically encompass international studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable. For this type of 510(k) submission, ground truth isn't established by expert consensus on a test set of patient cases in the way it is for diagnostic AI. The "ground truth" for mechanical testing is derived from adherence to engineering standards. The rationale for clinical safety and effectiveness for new indications relies on a review of existing clinical literature by the manufacturer and the FDA.
• Qualifications of Experts: Not applicable in this context. The FDA's review committee would consist of qualified experts in orthopedic devices.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. This wasn't a clinical test set requiring adjudication of patient cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This submission does not involve an AI component that assists human readers.

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

• Standalone Study: Not applicable. This device is an intervertebral body fusion device, not a software algorithm.

7. The Type of Ground Truth Used

• Ground Truth:
  • For Mechanical Performance: Engineering standards (e.g., ASTM F2077, ASTM F2267) define the "ground truth" for mechanical properties and performance.
  • For Clinical Efficacy/Safety: Published clinical literature and established medical understanding of interbody fusion devices (for the new indications) serve as the "ground truth" for safety and effectiveness.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set. The "training" in the context of device development would involve engineering design, prototyping, and iterative mechanical testing, not data-driven machine learning.

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

• Ground Truth for Training Set: Not applicable. As there is no AI/ML component, there's no "training set" or establishment of ground truth for such a set in the machine learning sense.

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PATRIOT® COLONIAL® ACDF Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radioulopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment. All PATRIOT® TPS coated spacers are indicated for the same use as non-coated versions.

PATRIOT® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate Systems.

When used as cervical intervertebral body fusion devices, SUSTAIN® SUSTAIN® R are intended for one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radior myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (0) weeks of non-operative treatment. All SUSTAIN® TPS coated spacers are indicated for the same use as non-coated versions.

SUSTAIN® Spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation, such as the ASSURE®, PROVIDENCE®, or XTEND® Anterior Cervical Plate Systems.

PATRIOT® COLONIAL® ACDF Spacers are cervical interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. PATRIOT® Spacers are inserted through an anterior cervical approach, and are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

SUSTAIN® Spacers, including SUSTAIN® R, are devices that may be used as cervical intervertebral fusion devices. These spacers are available in different shapes and heights to accommodate various surgical approaches and anatomical needs. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

The provided text is a 510(k) premarket notification for an intervertebral body fusion device. While it describes the device, its indications for use, and a basis for substantial equivalence, it does not include the detailed information required to answer your specific questions about acceptance criteria and a study proving device performance against those criteria.

Specifically, the document mentions:

• Mechanical testing (static compression-shear and torsion) in accordance with ASTM F2077 to demonstrate substantial equivalence to predicate spacers.
• Bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST72:2011.
• Clinical literature being provided in the submission to support additional indications.

However, it does not provide:

1. A table of acceptance criteria and reported device performance. It only states that testing was conducted "to demonstrate substantial equivalence."
2. Sample size used for the test set or data provenance for any clinical study.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication method.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes.
6. Details of a standalone (algorithm-only) performance study. The device is a physical implant, not an AI algorithm.
7. The type of ground truth used (e.g., pathology, outcomes data), as no specific clinical study is described in detail.
8. Sample size for the training set. There's no mention of a "training set" as this is not an AI/machine learning device.
9. How ground truth for the training set was established. (Not applicable for this type of device).

The document is a regulatory submission for a physical medical device (intervertebral body fusion spacers), not an AI/software device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or reader studies with ground truth established by experts.

Therefore, I cannot provide the requested information based on the given input.

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The Patriot Spinal Fixation System, when used in the non-cervical posterior spine (TI to S1), is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudoarthrosis, and failed previous fusion.
In addition, when used placed between L5 and S1, the Patriot Spinal Fixation System is indicated for the treatment of severe spondylolisthesis (Grade 3 and 4) in skeletally mature patients receiving fusion with autologous bone graft.

The Patriot Spinal Fixation System is a posterior, non-cervical, spinal fixation system consisting of a variety of shapes and sizes of rods, screws, and crosslinks, to provide temporary internal fixation and stabilization during bone graft healing as an adjunct to fusion of the thoracic, lumbar and sacral spine.

I am sorry but this document does not contain the information you are looking for. This document is a 510(k) premarket notification for a medical device called the "Patriot Spinal Fixation System." It primarily focuses on demonstrating the device's substantial equivalence to previously marketed predicate devices based on its design, materials, manufacturing, indications for use, and mechanical testing results.

The document does not contain information about:

• Acceptance criteria and reported device performance in the context of an AI/algorithm-based medical device.
• Sample sizes used for test sets or data provenance for such studies.
• Number of experts or their qualifications for establishing ground truth for AI model testing.
• Adjudication methods for test sets.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes of human reader improvement with AI assistance.
• Standalone (algorithm only) performance studies.
• Types of ground truth used in AI model development (e.g., expert consensus, pathology, outcomes data).
• Sample sizes for training sets for AI models.
• How ground truth for training sets was established for AI models.

The "testing performed" mentioned in the document refers to mechanical integrity testing of the spinal fixation system components (static and dynamic compression, static torsion per ASTM F1717), not performance validation of an AI algorithm.

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PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, TransContinental® and TransContinental® M Spacers) are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral 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).

PATRIOT® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

PATRIOT® Spacers (Constitution® PLIF, Signature® TLIF, Continental® ALIF, and TransContinental® and TransContinental® M Spacers) are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. Each of the PATRIOT® spacers provides a different shape to accommodate various surgical approaches to the lumbar spine. The Constitution® PLIF Spacer is inserted using a posterior approach. The Signature® TLIF Spacer is inserted using a transforaminal approach. The Continental® ALIF Spacer is inserted using an anterior approach. The Transcontinental® and Transcontinental® M Spacers are inserted using an anterior or lateral approach. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

PATRIOT® Spacers are made from PEEK radiolucent polymer (ASTM F2026) with titanium alloy or tantalum markers (ASTM F560). The Signature® R Spacer also includes an internal titanium alloy or commercially pure titanium (ASTM F67) component, and the TransContinental® M Spacer also includes an integrated titanium alloy nut. The Signature® Ti Spacer is made from titanium alloy or commercially pure titanium. The titanium alloy is TAV (ASTM F136) or TAN (ASTM F1295).

The provided text describes a 510(k) submission for PATRIOT® Spacers, which are intervertebral body fusion devices. The submission aims to gain clearance for additional spacers and sterile lumbar PATRIOT® spacers. The study presented is a confirmatory static compression testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document states, "Confirmatory static compression testing was conducted in accordance with ASTM F2077-03 with the subject device meeting all acceptable criteria." This indicates that the acceptance criteria were defined by the ASTM F2077-03 standard, and the device successfully met those criteria.

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

This information is not provided in the document. The text only mentions "confirmatory static compression testing" without specifying the number of samples or whether the data was retrospective or prospective, or its country of origin.

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

This information is not applicable to this type of study. The study involves mechanical testing (static compression testing), not clinical or diagnostic evaluation requiring expert review of medical data. The "ground truth" here is the performance metrics defined by the ASTM standard.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human interpretation or adjudication involved in static compression testing.

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

No, an MRMC comparative effectiveness study was not done. This study is a mechanical test for substantial equivalence, not a clinical study involving human readers and AI assistance.

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

No, this is not an algorithm-based device. PATRIOT® Spacers are physical medical devices (intervertebral body fusion devices), and the testing described is mechanical performance testing, not software or AI algorithm testing.

7. The Type of Ground Truth Used

The ground truth used for this study is the performance specifications and criteria outlined in the ASTM F2077-03 standard for static compression testing of intervertebral body fusion devices.

8. The Sample Size for the Training Set

This information is not applicable as this is a mechanical performance study, not a machine learning study that would have a training set.

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

This information is not applicable as there is no training set for this type of mechanical testing.

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The PATRIOT® TransContinental™ M Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral 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). The PATRIOT® TransContinental™ M Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation.

The PATRIOT® TransContinental® M Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectorny. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The PATRIOT® TransContinental® M implants are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion. PATRIOT® TransContinental™ M Spacers are made from PEEK radiolucent polymer, with an integrated titanium alloy nut and titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.

Here's an analysis of the provided 510(k) summary regarding the PATRIOT® TransContinental™ M Spacer, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary for a medical device (an intervertebral body fusion device) seeking substantial equivalence. The "acceptance criteria" discussed in this context are not typically for an AI/ML diagnostic device's performance metrics (like sensitivity/specificity), but rather for the physical, mechanical, and biological properties of the implant itself, demonstrating that it is as safe and effective as a predicate device.

Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The PATRIOT® TransContinental™ M Spacer is an interbody fusion device. Its acceptance criteria and the study proving it meets them are focused on demonstrating that the new device is "substantially equivalent" to previously cleared predicate devices in terms of its design, materials, and mechanical performance.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the summary. For mechanical testing of medical implants, the "sample size" refers to the number of physical devices or material specimens tested. These are generally small, statistically determined samples to ensure robust testing for design verification and validation.
• Data Provenance: The data is generated from in vitro mechanical testing studies performed under controlled laboratory conditions, not from human patient data. Therefore, notions of "country of origin" or "retrospective/prospective" do not apply.

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

• This question is not applicable in the context of this 510(k) summary. "Ground truth" for mechanical testing is established by engineering standards (e.g., ASTM F2077, F2267) and the results obtained from the tests themselves, measured by calibrated equipment. There is no human interpretation or expert consensus involved in establishing the "ground truth" for the mechanical performance of the device in this context. The experts involved would be the engineers and technicians conducting the testing and interpreting the results against established standards.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like "2+1" or "3+1" are used for interpreting ambiguous human-read data (e.g., medical images). Here, the "test set" consists of mechanical performance data, which is objectively measured and compared against predefined criteria (ASTM standards, FDA guidance).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where human readers evaluate cases with and without AI assistance. The PATRIOT® TransContinental™ M Spacer is a physical implant, not a diagnostic AI tool, so this type of study is not applicable.

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

• No, a standalone performance study was not done. This concept also applies to AI/ML diagnostic algorithms. This device is a passive implant; its "performance" is mechanical stability and biological integration, not diagnostic accuracy.

7. The Type of Ground Truth Used

• The "ground truth" for this device's performance is based on established engineering standards (ASTM F2077, F2267) and FDA guidance documents for the mechanical properties and material specifications of intervertebral body fusion devices. The device is expected to meet or exceed the performance benchmarks defined by these standards, demonstrating equivalence to already-cleared devices.

8. The Sample Size for the Training Set

• Not applicable. There is no AI/ML "training set" associated with the development or testing of this type of passive medical implant. The design of the device is based on engineering principles, material science, and anatomical considerations, not machine learning from a dataset.

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

• Not applicable, as there is no training set in this context.

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PATRIOT® TransContinental™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with deqeneration 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).

The PATRIOT® TransContinental® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.

The PATRIOT® TransContinental® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

PATRIOT® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.

This document is a 510(k) premarket notification for the PATRIOT® TransContinental® Spacer, an intervertebral body fusion device. It describes the device and its intended use, but it does NOT contain a study or data proving the device meets acceptance criteria.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It does not typically require new clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this document does not contain that information. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

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PATRIOT™ Spacers (Colonial™ ACDF) are interbody fusion devices intended for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-T1) at one level. DDD is defined as discogenic 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) weeks of non-operative treatment. PATRIOT™ Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the ASSURE® or PROVIDENCE® Anterior Cervical Plate System.

PATRIOT™ Spacers (Colonial™ ACDF) are interbody fusion devices.

This document is a 510(k) clearance letter from the FDA for a medical device called "PATRIOT Spacers". It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the given input.

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