Posterior pedicle screw fixation: The Rogozinka Spinal Rod System Direct ("U"-shaped head) and Offset ("T"-shaped head) screws when placed in the vertebral levels L3 to S1 are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (L5-S1) vertebral joint; (b) who are receiving fusions using autogenous bone graft only; and (c) who are having the device fixed or attached to the lumbar and sacral spine. Other and Offset Screws are intended only for sacral/iliac attachment as specified below.

Posterior hook and/or sacral/iliac screw fixation: The Rogozinski Rod System is intended for the treatment of degenerative disc disease (defined as spinal instability and one of the following: decreased disc height, ridging of vertebral end plates, scaring or thickening of ligamentous tissues and/or change in the facet process), scoliosis; spondylolisthesis; fracture; unsuccessful previous attempts at spinal fusion; or tumor resection. The Rogozinski Thoracolumbar Spinal Rod system is limited to non-cervical use.

Device Description

The Rogozinski Thoracolumbar Spinal Rod System consists of two stainless steel rods attached to the spinal column through the use of hooks and/or screws. Universal cross-bars may be used to connect rods to provide a more rigid construct, as well as screws to rods and hooks to rods. Screws are provided in a variety of lengths and in up-angle, neutral, down-angle and pedicle hooks are provided in several sizes to accommodate varying patient morphology. Screws used with this system feature a "T" shaped head for offset attachment to the rod using a coupler, crossbar, and set screw or a "T"-shaped head for direct attachment to the rod use screw. Up-angle, down-angle, neutral and pedicle hooks may be attached either directly to the rod or offset from the rod attached with to the rod with a crossbar mechanism.

AI/ML Overview

The provided text describes a spinal rod system and references several studies to support its safety and effectiveness. However, it does not include specific acceptance criteria for the device's performance, nor does it present a study proving the device meets such criteria directly.

Instead, the documents focus on demonstrating substantial equivalence to predicate devices and supporting the overall clinical utility and safety of pedicle screw fixation through meta-analyses, historical cohort studies, and randomized trials of similar systems or approaches, rather than directly evaluating the "Rogozinski Thoracolumbar Spinal Rod System Smith & Nephew Spine" against predefined performance metrics.

Therefore, I cannot provide a table of acceptance criteria and reported device performance as that information is not present. I can, however, extract details about the referenced studies that informed the device's acceptance.

Here's an analysis of the provided text based on your requested information, highlighting what is missing and what can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria: Not explicitly stated. The document does not define specific numerical thresholds (e.g., fusion rate > X%, complication rate < Y%) that the Rogozinski system needs to meet. Instead, acceptance appears to be based on demonstrating substantial equivalence to predicate devices and showing that the class of devices (pedicle screw fixation) is safe and effective through literature review and clinical studies.
Reported Device Performance: Not directly reported for the Rogozinski system itself. The performance data presented refers to the general category of pedicle screw fixation or specific predicate devices in comparative studies.

Analysis of Supporting Studies Mentioned:

The three primary studies referenced are:

Madjetko et al. (1994): A meta-analysis of literature on degenerative spondylolisthesis.
Yuan et al. (1994): An open, non-randomized, historical cohort study comparing pedicle screw devices to non-instrumented and non-pedicle screw instrumentation.
Zdeblick (1993): A prospective, randomized study of lumbar fusion comparing different instrumentation types.

Let's break down the information for these studies:

Study 1: Madjetko et al. (1994) - Degenerative Lumbar Spondylolisthesis: A Meta-Analysis of Literature 1970-1973

2. Sample size used for the test set and the data provenance:
- Sample Size: This is a meta-analysis, not a single test set. It included 25 papers published between 1970 and 1973. The total number of patients across these papers is broken down by group:
  - Nonoperative/natural history: 3 papers total
  - Posterior decompression without fusion: 11 papers with 216 patients total
  - Posterior decompression without instrumentation: 6 papers with 84 patients total
  - Posterior decompression with "control" device (legally marketed Class II devices): 4 papers with 138 patients total
  - Posterior decompression with fusion with pedicular instrumentation: 5 papers (patient count not specified beyond 5 papers)
  - Anterior spinal fusion: 3 papers with 72 patients total.
- Data Provenance: Retrospective (literature review, studies published between 1970-1973). Country of origin is not specified, but peer-reviewed medical literature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This is a meta-analysis. The "ground truth" would be established by the primary studies reviewed, which is not detailed here. The authors of the meta-analysis (Madjetko SM, Comolly P., Shott S) are the "experts" performing the analysis, but their qualifications are not provided beyond their names.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As a meta-analysis, it synthesizes existing literature; it does not involve a "test set" with adjudication in the typical sense of a device evaluation study.
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. This is a meta-analysis of surgical outcomes, not a diagnostic imaging study involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. Not applicable to this type of study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Outcomes data and clinical results from the original studies (e.g., fusion rates, patient satisfaction, maintenance of physiological spinal alignment).
8. The sample size for the training set:
- Not applicable. This is a meta-analysis, not an algorithm development study.
9. How the ground truth for the training set was established:
- Not applicable.

Study 2: Yuan et al. (1994) - Historical Cohort Study of Pedicle Screw Fixation in Thoracic, Lumbar, and Sacral Spinal Fusions

This study is an "open, non-randomized, historical cohort study."
2. Sample size used for the test set and the data provenance:
- Sample Size: 2,634 patients with degenerative spondylolisthesis.
  - Pedicle screw group: 2,177 (81.1%)
  - Non-instrumented group: 456 (17.0%)
  - Non-pedicle screw instrumentation group: 51 (1.9%)
- Data Provenance: Retrospective ("historical cohort study"). Country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The study collected data on patients' outcomes, likely based on surgical records and follow-up examinations by various clinicians.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. Given the retrospective nature, it's unlikely a formal adjudication process was used in the context of ground truth establishment for a single test set. Data was "collected."
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. This is a clinical outcomes study, not a diagnostic imaging study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Outcomes data: Fusion rates, complication rates (intraoperative and postoperative events), implant breakage, screw fracture/loosening, re-operations, time to fusion, maintenance of spinal alignment.
8. The sample size for the training set:
- Not applicable. This is a clinical study, not an algorithm development study.
9. How the ground truth for the training set was established:
- Not applicable.

Study 3: Zdeblick (1993) - A Prospective, Randomized Study of Lumbar Fusion

This is a "prospective, randomized study."
2. Sample size used for the test set and the data provenance:
- Sample Size: 124 patients undergoing lumbar or lumbosacral fusion.
  - Group I (posterolateral fusion using autogenous bone graft): Number not explicitly stated but implied from totals.
  - Group II (autogenous posterolateral with Luque II screw-inter fixation system): Not explicitly stated.
  - Group III (autogenous posterolateral fusions supplemented with TSRH screw-rod fixation system): Not explicitly stated.
  - Specifically for degenerative or isthmic spondylolisthesis: 56 patients. 21 of these were in Group II.
- Data Provenance: Prospective, randomized clinical trial. Country of origin not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. "Each patient clinically assessed and assigned a rating." This implies clinical experts (physicians) made these assessments, but their number or specific qualifications are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified. For clinical assessment, it's common for a single clinician to assess or for multiple to be involved in the overall care and outcome determination, but a formal adjudication method for ground truth labeling is not 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. This is a clinical trial comparing surgical techniques/devices, not a diagnostic imaging study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Outcomes data primarily: Fusion rates (radiographic assessment), clinical results (ratings of "excellent," "good," etc.).
8. The sample size for the training set:
- Not applicable. This is a clinical trial.
9. How the ground truth for the training set was established:
- Not applicable.

Summary of Device-Specific Information from the Text:

The document primarily focuses on establishing substantial equivalence for the Rogozinski Thoracolumbar Spinal Rod System to numerous predicate devices. It then supports the utility of pedicle screw fixation (the general class of devices) through literature, rather than presenting a direct study validating the Rogozinski system's performance against specific acceptance criteria.

The "Information Bearing on Safety and Effectiveness" section aims to demonstrate that:

Pedicular instrumentation, in general, improves fusion rates.
Pedicle screw devices are at least as safe and effective as currently marketed Class II devices.
While complication rates might be higher with instrumented fusion, pedicle screw devices do not have higher or more significant complications than other available Class II instrumentation.

This approach is typical for 510(k) submissions, where the focus is on showing the new device is "substantially equivalent" to legally marketed predicate devices, and the available scientific literature supports the safety and effectiveness of the device type.

Summary

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K954696

Rogozinski Thoracolumbar Spinal Rod System Smith & Nephew Spine a division of Smith & Nephew Richards Inc. 1450 Brooks Road Memphis, TN 38116

MAR 1 1996

1. Description

The Rogainski Thoracolumbar Spinal Rod System onsists of two stainless steel rods attached to the spiral column through the use andor screws. Universal cross-hars may be used to rods to provide a more rigid construct, as well as screws to rods and hooks to rods. Scews at provided in a variety of lengths and in-angle, neutsal, dover-angle and pedicle hooks are provided in several sizes to accomodate varing patient morphology. Screws used with this system feature a "T" shaped head for offect attachment to the rod using a coupler, crossbar, and set screw or a "T". shaped head for direct attachment to the rod use screw. Up-angle, down-angle, neutral and pedice hooks may be attached editer directly to the rod or offset from the rod attached with to the rod with crossbar mechanism.

Identification of the Predicate Device(s) 2.

The Rogozinski Thoracolumbar Solnal Rod System are substantially equivalent to the Harington "Lag" Screw manufactured by Zimer, Inc. the ISOLA® Spinal System by Acromed, Inc., the CD Spiral System by SolamorDanel, the GDLH™ Posterior Spiral System by SofamorDanel, the TSRFM Spiral System by Sofamor Danet of Posterior Spinal System by Sofanor Danel, the Unit Rod System by Sofamor Danel, the MOSS™ Modular Segmental System by DepuyMotest™, the Modulock™ Posterior Spinal Fixation System by Zimmer, Inc., and the Wilse System of Internal Fixation by Advanced Spine Fixation Systems, Inc.

3. Intended Use(s)

Posterior pedicle screw fixation: The Rogozinka Spinal Rod System Direct ("U"-shaped head) and Offset ("T"-shaped head) screws when placed in the pertebral levels 1.3 to SL are intended only for patients: (a) having severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar - first sacral (LS-S 1) vetebral joint; (b) who are receiving fissions using autogenous bone graft only; and (c) who are having the device fixed or attached to the lumbar and sacral spine. Other and Officet Screws are intended only for sacral/linac attachment as specified below.

Posterior hook and/or sacrabiliae screw fization: The Rogozinski Rod System is intended for the treatment of degeneralive disc disease (defined as spinal instability and one of the following: decreased disc height, ridging of vertebral end plates, scaring or thickening of ligamentous tissues and or change in the process, solicis; spendyblishes; fracture; unsucessful previous attempts at spinal fusion; or tumor resection. The Rogozinski Thoracolumbar Spinal Rod system is limited to non-cervical use.

4. Information Bearing on Safety and Effectiveness

Martjetto et.a.l. presented the results of the literature relating to degeneralive spondylolisthess. Accepted for inclusion in this meta-analysis were 25 papers published between 1970 and 1973 representing with degeneralive spondylolistesis with radicular leg pain or neurogenc claudication involving the lumbar spine from 11-51. Degenerative spondylolisthess is characterized by degenerative articles is association with disc degeneration. Remodeling of the face is the cephalad on the caude lumbar vertebra. This meta-analysis stratified pages into the following groups: (i) Nonoperativelnatural history - 3 papers todal, (ii) Posterior decompression procedures without fusion - 1 I papers with 216 palients total, (ii) Posterior decompression without instrumentation - 6 pages with 84 patients total, (iv) Posterior decompression with "control" device, i.e. legally marketed Jass II devices - 4 papers with 138 patients total, (v) Posterior decompression with fision with pedicalar instrumentation - 5 papers with (v) Anterior spinal fusion - 3 pages with 72 patients total. Mardietto stated that the recognized advantages of pelicular instrumentation over control devices as an adjunct to posterolateral spinal first-schieve threcolums spinal control from a posterior and maintenance of physiologic spinal alignners in all planes, (ii) no space-scupying metallic devices within the degencrative lund (iv) the ability to achieve fixation across segments with deficient or abserty spinal elements, potentially minimizing the spiral sequiring instrumentation and fusion. Mardietto concluded that the results of the support the clinical in the surgical management of degeneralive lumbar spondylolishesis, spinal fusion significantly improves patient salisfaction, and adjunctive spinal instrumentation entral FDA Class II devices and pedicular instrumentation are comparable with regards to rates of fision, patient satisfactions. The results of an open, northinded, historical cohort study presented by Yuan et al." support Madjetto findings. This historical cohort study collected data on patients who has pedicle screw devices as well as those who had received legally marked spinal fusion devices or no instrumentation at all. A total of 2,634 patients with degenerative spondylolisthesis were included in this cohot study with 2,177 (81.1%) in the pedicle screw group, 456 (1.9%) in the non-instrumented group, and 51 (1.9%) in the non-pedicle screw instrumentation group. The safety of pedicle screw devices for the treatment of degenerative spondytoing the nature and frequency of intraoperative and postoperative events. Intractive events related to pedices occurred infrequently. The rate of implant breakage was externely low (0.2%) The remaining intracter were were felt to be related to surgical technique rather than the implant. Pedice serents were comprised mainly of screw fracture and screw looseniant control group for degeneralive spondylolisthesis was non-instrumented fixations, no such rate compansons for these events could be made. However, many of these events were without consequence. For postoperative events that could have occurred in both trainent groups, the nature of these events were comparable. Additionally, the time adjusted rates of events were not statistically different between the two teather was higher in the pedicle scever group than in the non-instrumented group (17.6% versus 15.0%) primarily due to device removals. The rates of referations, which can ocur in both teatment groups were simlar. In terms of effectiveness, the pedicient group had a statistically higher rate of fusion the non-instrumented control group (simple: 89.1% versus 70.4%). Additionally, the ime to fision tended to be faster for the pedice sorew goup patients. Maintenance of spiral alignment and ober levels, although not statistically different, fixation gov. Yuan concluded that the benefits of pedicle sorew fixation for the treatment of degenerative spondylolisthesis were demonstrates compared to conventional non-instrumented control surgical treatments with pedicle screw palients achieving better over. Garfin" in a summation of the works of Martjetko et al. and Yuan et al. states that data derved from a scientifically valid study show that perient of to a significant number of people. The literature review as well as the color story show the finion rate markedly improves when is added and that pedicle screw systems are at least as the currently macked, commercially available Class II users of increasing the fusion rate. Gafin further states that albough the complication rates are higher in those has have instrumented fusion, pedice screw devices have no higher complication rates and no nore significati complivations than the currently available Class I instrumentation. Therefore, in properly chosen patches, matched to the appropriate device and procedure, the results in obtaining a fuccessful outcome may be better using pedices, than with other system that are

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currently available and approved for use in the United States of a randomized study of 124 patients undergoing lumbar or lumbosaral fusion for degenerative conditions of the spine. Patients were randomly assigned to one of the following three treatment groups: (1) posteroiseral fision using autogenous bone graft, (I) autogenous posterolated with the Luque II screwinter fixation system (Sofamor) and (III) autogenous posterolateral fusions supplemented with the TSRH screwrod fixation system (Solamor)Danek). Of the 124 patients entered into the study, 56 presented with degeneralive or istimic spondylolishes: 21 in Group II. The fision rate for degeneralive spondylolisthers for Groups I, II, and III were 65%, 50%, and 86%, respectively. The fusion rate for istumic spondylolistis for Groups I, II, and III were 80%, 89%, and 100%, respectively. Overall fision rates for Groups I, II and III were 65%, 77%, and 95%, respectively. Zdeblick also assessed each patient chically and assigned asch a rating of either "excellent", "good". The overall good or excellent clinical results were 71% in Group II, and 95% in Group III. Zdeblick concluded that pedically higher rate of fusion in degeneralive lumbar disease than did fusion without instrumentation and that the clinical results mimic the radiographic results in all three Groups,

ี Madjetko SM, Comolly P., Shott S: Degenerative Lumbar Spondylolisthesis: A Meta-Analysis of Literature 1970-1993. Spine 19(208):2265-22655, 1994. " Yuar HA, Garfin SR, Dickman CA, Martical Cohor Study of Pedice Scew Fixation in Thoracic, Lumbar, and Saral Spinel Fisions, Spine 19(20S):2279S-2296S, 1994.

Garfin SR: Summation. Spine 19(20S):2300S-2305S, 1994.

17 Zdeblick TA: A Prospective, Randomized Study of Lumbar Fusion. Spine 18(8):983-991, 1993.

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.